C2N Diagnostics Receives Breakthrough Device Designation from U.S. FDA for Blood Test to Screen for Alzheimer’s Disease Risk

  • FDA has granted Breakthrough Device Designation to C2N’s proprietary blood test for the initial screening of amyloid pathology in the brain associated withAlzheimer’s Disease

  • C2N is conducting the PARIS Study, a two-phase pivotal clinical trial evaluating the clinical diagnostic performance of its test in individuals at high risk for Alzheimer’s Disease

Read More

AbbVie Initiates Phase 2 Clinical Trial Programs for ABBV-8E12, an Investigational Anti-Tau Antibody, in Early Alzheimer's Disease and Progressive Supranuclear Palsy

 

- Initiation of Phase 2 clinical trial programs in early Alzheimer's disease and progressive supranuclear palsy (PSP) is part of ongoing commitment to investigate ABBV-8E12 and tau-focused approaches to delay disease progression - ABBV-8E12 granted Fast Track Designation from the U.S. Food and Drug Administration for PSP - Orphan Drug Designations received from the U.S. Food and Drug Administration and European Medicines Agency for ABBV-8E12 in PSP

NORTH CHICAGO, Ill., Jan. 25, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced the start of two Phase 2 clinical trial programs to evaluate ABBV-8E12, an investigational anti-tau antibody, in patients with early Alzheimer's disease and progressive supranuclear palsy (PSP). In recognition of the lack of treatment options available to patients with PSP, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to ABBV-8E12. The FDA and European Medicines Agency (EMA) also granted Orphan Drug Designations to ABBV-8E12 for PSP.1,2

"We see potential in ABBV-8E12 and tau-focused approaches to progressive neurodegenerative diseases, such as early Alzheimer's disease and PSP," said Eric Karran, vice president, Foundational Neuroscience Center, AbbVie. "The initiation of the Phase 2 clinical trial programs and the FDA's Fast Track Designation for PSP signify important steps forward in AbbVie's ongoing commitment to investigating innovative scientific approaches with the hope of bringing new treatment options to patients."

After consultation with the FDA and EMA, AbbVie is beginning the Phase 2 clinical trial programs following completion of pre-clinical studies and a Phase 1 study in patients with PSP, which supported the further development of ABBV-8E12 in PSP and early Alzheimer's disease. Positive results from the Phase 1 study in PSP were recently released at the Clinical Trials on Alzheimer's Disease (CTAD) annual meeting in December 2016.3

The Phase 2 study in early Alzheimer's disease will enroll 400 patients to assess the efficacy and safety of ABBV-8E12 to delay disease progression (NCT02880956).4 The Phase 2 study in PSP will evaluate 180 adults and assess the efficacy and safety of ABBV-8E12 to slow disease progression (NCT02985879).5

According to the FDA, Fast Track Designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.6 In the U.S., the FDA Orphan Drug Designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.7 In the EU, Orphan Designation is granted to therapies aimed at the treatment, prevention or diagnosis of life-threatening diseases that affect no more than five in 10,000 persons in the EU and for which no satisfactory therapy is available. The medicine must also provide significant benefit to those affected by the condition.8

ABBV-8E12, licensed from C2N Diagnostics in 2015, is a humanized antibody being studied to target the tau protein, which is thought to stabilize intracellular structures required for maintenance and transport in neurons. Abnormal accumulation of altered tau protein is a hallmark in a variety of neurodegenerative conditions, where the development of tau pathology strongly correlates with clinical disease progression.9

About Alzheimer's Disease

Alzheimer's disease is a progressive, neurodegenerative disorder affecting approximately 34 million people worldwide with the patient population expected to nearly triple by 2050.10 It is the sixth leading cause of death in the U.S. and there are currently no treatments to prevent or delay disease progression.11

About Progressive Supranuclear Palsy

Progressive supranuclear palsy (also known as Steele-Richardson-Olszewski syndrome) is a progressive neurodegenerative disorder, with an estimated worldwide annual incidence of three to six per 100,000 people; and within the U.S., the disease affects approximately 20,000 individuals.12 The average onset of PSP symptoms typically begins after age 60. The most common features of PSP are loss of balance leading to unexplained falls, blurred vision, problems controlling eye movement and slurred speech. Other nonspecific symptoms of PSP, such as slowed movements or behavioral or cognitive changes, are similar to other brain disorders, particularly Parkinson's disease. For this reason, correct diagnosis of PSP is often delayed. The course of PSP is progressive and may predispose individuals to serious complications, such as choking, pneumonia, head injury and fractures caused by falls. Currently, there are no approved treatments for PSP.12 It is one of more than 20 different neurodegenerative disorders characterized by neurofibrillary degeneration and tau inclusions as a predominant central nervous system lesion.9

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

1 U.S. Food & Drug Administration. Orphan Drug Designations and Approvals: recombinant humanized anti-tau antibody. http://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=460914. Accessed January 2017. 2 European Medicines Agency. Humanised recombinant IgG4 anti-human tau antibody for the treatment of progressive supranuclear palsy. http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2016/05/WC500207488.pdf. Accessed January 2017. 3 West T, et al. Safety, tolerability and pharmacokinetics of ABBV-8E12, a humanized anti-tau monoclonal antibody, in a phase 1, single ascending dose, placebo-controlled study in subjects with Progressive Supranuclear Palsy [CTAD abstract OC33]. J Prev Alz Dis.2016;3(1):285. 4 ClinicalTrials.gov (2017). NCT02880956. https://clinicaltrials.gov/ct2/show/NCT02880956?term=8e12&rank=2. Accessed January 2017. 5 ClinicalTrials.gov (2017). NCT02985879. https://clinicaltrials.gov/ct2/show/NCT02985879?term=8e12&rank=3. Accessed January 2017. 6 U.S. Food & Drug Administration. Fast Track. http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399. Accessed January 2017. 7 U.S. Food & Drug Administration. Developing Products for Rare Diseases & Conditions. http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/ucm2005525. Accessed January 2017. 8 European Medicines Agency. Orphan Designation. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp. Accessed January 2017. 9 Schraen-Maschke S. Tau as a biomarker of neurodegenerative diseases. Biomark Med. 2008 Aug; 2(4): 363–384. 10 Barnes D, et al. The projected effect of risk factor reduction on Alzheimer's disease prevalence. Lancet Neurol. 2011 Sep; 10(9): 819–828. 11 Alzheimer's Association. 2016 Alzheimer's Disease Facts and Figures. http://www.alz.org/documents_custom/2016-facts-and-figures.pdf. Accessed January 2017. 12 National Institute of Neurological Disorders and Strokes. Progressive Supranuclear Palsy Fact Sheet. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Progressive-Supranuclear-Palsy-Fact-Sheet. Accessed January 2017.

 

Full release

C2N Diagnostics Reports Phase 1 Study Results of C2N-8E12 (ABBV-8E12) – Anti-Tau Antibody – in Subjects with Progressive Supranuclear Palsy

  • Clinical Investigator, Dr. Diana Kerwin, Presents Safety, Tolerability and PK Data at CTAD 2016 in Late-Breaking Oral Session
  • Results Demonstrate that ABBV-8E12 is Safe and Well Tolerated at Doses up to 50 mg/kg in Subjects with Progressive Supranuclear Palsy
  • Results are Guiding the Design of Phase 2 Studies in Subjects with Alzheimer’s Disease and Progressive Supranuclear Palsy

December 09, 2016

ST. LOUIS, MO – C2N Diagnostics today reported results from its Phase 1 study testing ABBV-8E12 (Formerly C2N-8E12) in patients with progressive supranuclear palsy (PSP). ABBV-8E12 is a humanized anti-tau monoclonal antibody currently under clinical investigation for the treatment of Alzheimer’s Disease and PSP, both progressive brain diseases currently lacking effective treatment options. Results from the first-in-human study were reported this morning as part of a Late-Breaking Oral Session at the Clinical Trials in Alzheimer’s Disease (CTAD) 2016 conference in San Diego, CA.

Dr. Diana Kerwin, a key investigator to the study and Chief of Geriatrics as well as Director, Texas Alzheimer’s and Memory Disorders at the Texas Health Presbyterian Hospital, presented the results. The presentation was entitled: “Safety, Tolerability and Pharmacokinetics of ABBV-8E12: A Humanized Anti-tau Monoclonal Antibody, in a Phase 1, Single Ascending Dose, Placebo-controlled Study in Subjects with Progressive Supranuclear Palsy.”

The study enrolled 30 subjects with PSP across 12 clinical sites throughout the United States. Patients were randomly assigned in a double-blinded manner to receive a one-time dose of either placebo or ABBV-8E12 at escalating doses up to 50 mg/kg. Subjects were followed out to 84 days post-dosing for safety, tolerability, and allergic reactions, as well as metabolism of the drug from the bloodstream.

Study participants were, on average, 69 years of age, with 53% being males. Demographic characteristics of the patients were well balanced across the different dose groups. ABBV-8E12 was safe and well tolerated when administered intravenously in single doses of up to 50 mg/kg. No dose-limiting toxicities occurred, and adverse event frequency and severity did not vary by dose or when compared to placebo. Further, no allergic reactions occurred in any of the study participants. Metabolism and brain penetration levels of the drug were also consistent with what has previously been observed for other monoclonal antibodies.

“We are extremely thankful to the patients and their family members who committed their time and energy to this study,” stated Dr. Joel Braunstein, CEO of C2N Diagnostics. “The burden to patients in any Phase 1 trial is high, but the information we have gathered from this study is vitally important. This was one of the first human clinical studies to test the safety of tau passive immunotherapy in individuals with PSP. We can now use these results to design longer-term studies that will assess the therapeutic potential of ABBV-8E12 in clinical indications where misfolded tau appears to play an essential role in disease progression.”

C2N established a global therapeutic partnership with AbbVie, Inc during 2015. With AbbVie’s leadership, the companies will soon launch Phase 2 clinical testing of ABBV-8E12 in both Alzheimer’s Disease and PSP.

About C2N Diagnostics

C2N Diagnostics, LLC (www.c2ndiagnostics.com) formed by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, MO and LifeTech Research, a technology research and venture development firm (www.lifetechresearch.com). In March 2015, C2N formed a global partnership with AbbVie to develop and commercialize a portfolio of anti-tau antibodies (including ABBV-8E12) for the treatment of Alzheimer’s Disease and other neurological disorders. In July 2015, C2N and AbbVie announced FDA Orphan Drug Designation of ABBV-8E12 for the treatment of PSP. Beside its therapeutic development efforts, C2N is commercializing a suite of biomarker tests to enable drug discovery, clinical drug development at lower risk and cost, and early detection of debilitating neurodegenerative disorders before symptom onset. The company's products include the SILK-Aβ®, SILK-ApoE™, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and quantitation of brain derived proteins. Beyond Alzheimer's Disease, products are in development to target Parkinson's Disease, traumatic brain injury, schizophrenia and Amyotrophic Lateral Sclerosis, among other conditions. For additional information, please contact info@c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

C2N Diagnostics Completes Phase 1 Clinical Study of C2N-8E12 (ABBV-8E12) Among Individuals with Progressive Supranuclear Palsy

  • Achievement Represents the Final Milestone Under C2N’s “Part the Cloud” 2015 Translational Research Award from Alzheimer’s Association
  • Paves Way for Future, Longer-Term Clinical Studies Involving ABBV-8E12 Through Partnership with AbbVie

October 13, 2016

ST. LOUIS, MO – C2N Diagnostics today announced that it has successfully completed the final follow-up visit of the last subject enrolled into its Phase 1, randomized controlled clinical study testing C2N-8E12 (ABBV-8E12), an anti-tau antibody, in patients with progressive supranuclear palsy (PSP). The milestone marks the last of multiple achievements under C2N’s Part the Cloud (PTC) Translational Research Award, granted to C2N by the Alzheimer’s Association in 2015. Also, this is an important program milestone under C2N’s global partnership with AbbVie, paving the way for future longer-term clinical studies involving ABBV-8E12 in neurodegenerative disorders characterized by tau pathology.

The Alzheimer’s Association’s PTC Award to C2N provided funding that supported and accelerated the launch of one of the first controlled, human clinical safety trials of an anti-tau antibody therapy in individuals with PSP (NCT02494024).

“We deeply appreciate the support we have received from Alzheimer’s Association over the last year,” stated Joel Braunstein, M.D., Chief Executive Officer, C2N. “With completion of this milestone, we are pleased to help the Alzheimer’s Association move one step closer to its goal under its Part the Cloud program; that is, to advance research on potential drug therapies that have the highest probability of slowing or stopping Alzheimer’s disease and other dementias, which currently affect more than 47 million people worldwide. From this milestone, C2N can now analyze the phase 1 data and share the study’s findings with clinicians and the patient community at a medical meeting in the future.”

The phase 1 study enrolled 30 subjects with PSP across 12 clinical sites throughout the United States. It randomly assigned individuals to receive a one-time dose of either placebo or ABBV-8E12 at escalating doses. Subjects were followed for safety, tolerability, and allergic reactions, as well as metabolism of the drug from the bloodstream.

Stated Tim West, Ph.D., C2N’s Vice President of Research & Development, “Tau is a protein involved in the pathological progression of PSP, Alzheimer’s disease, and many other serious neurodegenerative diseases. Pre-clinical studies have shown that C2N’s anti-tau antibody can slow the progression of tau pathology. We look forward to working with our partner, AbbVie, to continue testing ABBV-8E12 in future clinical studies to understand the therapeutic potential of this novel strategy to fighting disease.”

About C2N Diagnostics

C2N Diagnostics, LLC (www.c2ndiagnostics.com) formed by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, MO and LifeTech Research, a technology research and venture development firm (www.lifetechresearch.com). In March 2015, C2N formed a global partnership with AbbVie to develop and commercialize a portfolio of anti-tau antibodies (including ABBV-8E12) for the treatment of Alzheimer’s Disease and other neurological disorders. In July 2015, C2N and AbbVie announced FDA Orphan Drug Designation of ABBV-8E12 for the treatment of PSP. Beside its therapeutic development efforts, C2N is commercializing a suite of biomarker tests to enable drug discovery, clinical drug development at lower risk and cost, and early detection of debilitating neurodegenerative disorders before symptom onset. The company's products include the SILK-Aβ®, SILK-ApoE™, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and quantitation of brain derived proteins. Beyond Alzheimer's Disease, products are in development to target Parkinson's Disease, traumatic brain injury, schizophrenia and Amyotrophic Lateral Sclerosis, among other conditions. For additional information, please contact info@c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

 

C2N and AbbVie Announce FDA Orphan Drug Designation of C2N-8E12 (ABBV-8E12) for the Treatment of Progressive Supranuclear Palsy

  - Initiates Phase 1 clinical study in patients with progressive supranuclear palsy

- Investigational recombinant anti-tau antibody represents lead clinical candidate in global C2N-AbbVie collaboration to address serious brain disorders

NORTH CHICAGO, Ill., July 17, 2015 /PRNewswire/ -- C2N Diagnostics and AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted their investigational recombinant humanized anti-tau antibody, C2N-8E12 (ABBV-8E12), an orphan drug designation for the treatment of progressive supranuclear palsy (PSP). The companies also have begun a Phase 1 clinical study of C2N-8E12 in patients with PSP.

"The FDA's orphan drug designation recognizes the lack of treatment options for patients with PSP, a debilitating neurological disease, and is an important milestone in the development of potential therapies," stated Joel Braunstein, M.D., chief executive officer, C2N Diagnostics.

"We are encouraged by the preclinical data of anti-tau antibodies and are committed to exploring the potential of this class of molecules," said Jim Sullivan, Ph.D., vice president, pharmaceutical discovery, AbbVie.

C2N-8E12 is a humanized antibody targeting the tau protein found in neurofibrillary tangles in the brain of patients with tauopathies such as PSP and Alzheimer's disease (AD).  The Phase 1 study is a randomized, double-blind, placebo-controlled, single ascending dose, multicenter study that will evaluate the safety, tolerability and pharmacokinetics of C2N-8E12 in an estimated 32 subjects with PSP (https://clinicaltrials.gov/ct2/show/NCT02494024).

About Orphan Drug Designation The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.1

The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval for an investigational use. Sponsors must establish safety and efficacy of a compound in the treatment of a disease through adequate and well-controlled studies.

About Progressive Supranuclear Palsy Progressive supranuclear palsy (also known as Steele-Richardson-Olszewski syndrome) is a progressive neurodegenerative disorder, with an estimated annual incidence of one per 100,000 people over the age of 60. Within the U.S., the disease affects approximately 20,000 individuals. The most common features of PSP are the presence of loss of balance leading to unexplained falls and, in later stages, blurred vision and problems controlling eye movement may occur. Other nonspecific symptoms of PSP, such as slowed movements or behavioral or cognitive changes, are similar to other brain disorders, particularly Parkinson's disease. For this reason, correct diagnosis of PSP is often delayed. The course of PSP is progressive and may predispose individuals to serious complications, such as choking, pneumonia, head injury and fractures caused by falls. Currently, there are no approved treatments for PSP. It is one of more than 20 different neurodegenerative disorders characterized by neurofibrillary degeneration and tau inclusions as a predominant central nervous system lesion. 2,3

About AbbVie AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook orLinkedIn page.

About C2N Diagnostics C2N Diagnostics, LLC (www.c2ndiagnostics.com) was formed by scientific co-founders Drs. David Holtzman andRandall Bateman of Washington University School of Medicine in St. Louis, MO and LifeTech Research, a technology research and venture development firm (www.lifetechresearch.com). C2N is commercializing a suite of biomarker assays and tools to enable drug discovery, clinical drug development at lower risk and cost, and early detection of debilitating neurodegenerative disorders. The company's products include the SILK-Aβ®, SILK-ApoE™, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and quantitation of brain derived proteins. Beyond Alzheimer's Disease, products are in development to target Parkinson's Disease, traumatic brain injury, schizophrenia and Amyotrophic Lateral Sclerosis, among other conditions. For additional information, please contactinfo@c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

Forward-Looking Statements Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K/A, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

  1. www.FDA.gov
  2. Litvan I, Agid Y, Jankovic J, et al. Accuracy of clinical criteria for the diagnosis of progressive supranuclear palsy (Steele-Richardson-Olszewski syndrome). Neurology 1996;46:922-30.
  3. Williams DR, Lees AJ. Progressive supranuclear palsy: clinicopathological concepts and diagnostic challenges. Lancet Neurol 2009;8:270-79.

AbbVie And C2N Enter Into A Worldwide License Agreement For Alzheimer's Disease Therapy

NORTH CHICAGO, Ill., March 19, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has entered into an exclusive worldwide license agreement with C2N Diagnostics, a privately held protein diagnostic and therapeutic discovery company, to develop and commercialize a portfolio of anti-tau antibodies for the treatment of Alzheimer's Disease and other neurological disorders.  This partnership builds upon AbbVie's commitment to pursue transformational disease-modifying therapies in Alzheimer's Disease. Tau stabilizes proteins that are responsible for the structure and transport in neuronal cells. Abnormal accumulation of altered tau protein is a leading indicator in a variety of neurodegenerative conditions including Alzheimer's Disease, Progressive Supranuclear Palsy and Corticobasal Degeneration.  In these conditions, the development of tau pathology strongly correlates with clinical disease progression.

"The need for new approaches and therapies to address Alzheimer's disease is critical," said Jim Sullivan, Ph.D., vice president, pharmaceutical discovery, AbbVie.  "C2N's portfolio of anti-tau antibodies represents one of the most promising approaches to delaying progression of devastating neurodegenerative disease.  Combining the world class expertise in Alzheimer's Disease at C2N with AbbVie's proven capabilities in neuroscience will enable the rapid advancement of anti-tau antibodies into patients."

Financial terms of the collaboration were not disclosed.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs more than 26,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

About C2N Diagnostics

C2N Diagnostics, LLC (www.c2ndiagnostics.com) was formed by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, MO and LifeTech Research, a Maryland-based technology research and venture development firm (www.lifetechresearch.com). C2N is commercializing a suite of biomarker assays and tools to enable drug discovery, clinical drug development at lower risk and cost, and early detection of debilitating neurodegenerative disorders. The company's products include the SILK-Aβ®, SILK-ApoE™, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and quantitation of brain derived proteins. Beyond Alzheimer's Disease, products are in development to target Parkinson's Disease, traumatic brain injury, schizophrenia and Amyotrophic Lateral Sclerosis, among other conditions. For additional information, please contact info@c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995.  The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements.  AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements.  Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.  Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.  AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

 

SOURCE AbbVie

RELATED LINKS

http://www.abbvie.com

C2N Expands Partnership with Washington U to Commercialize Blood Test for Detection of Early AD

July 14, 2014 ST. LOUIS - C2N Diagnostics, LLC (C2N) today announced that it has expanded its partnership with Washington University School of Medicine (WUSM) in St. Louis. The objective of this collaboration is to commercialize a clinical blood test for detecting the earliest stages of Alzheimer’s disease (AD) as well as mild cognitive impairment (MCI). Under terms of the agreement, C2N has acquired the exclusive worldwide commercial license rights to a suite of technologies developed in the laboratories of Professors Randall Bateman, MD and David Holtzman, MD, in the Department of Neurology at WUSM.

The licensed technologies build upon the Stable Isotope Labeling Kinetics (SILK™) platform pioneered at WUSM and already marketed by C2N. The new technologies enable a novel approach to measure the metabolism of brain-derived proteins implicated in AD and MCI. For the first time, instead of analyzing AD proteins in cerebrospinal fluid, it is now possible to detect the same metabolic markers in patients’ blood samples.

This capability has implications for the advancement of new treatments, early prevention, and personal wellness. Alzheimer’s is now one of the major global healthcare concerns. Approximately 44 million people currently have clinical AD. Millions more have MCI that places them at high risk for progression to clinical AD. The number of cases of AD and MCI are expected to increase sharply in the years ahead due to the aging baby boomer population.

Pharmaceutical companies developing new drugs targeting AD increasingly recognize that early intervention provides the greatest chance of halting or reversing disease progression. Biomarkers are needed to detect this early pathology, which can begin at least 15 years before the onset of any clinical symptoms. At the same time, dynamic biomarkers, like those offered by the SILK™ platform, may also track treatment responses during the pre-symptomatic stages of disease.

Since 2008, C2N has applied the SILK-Aβ® test to measure the kinetics of beta-amyloid in cerebrospinal fluid. The test has served as a primary endpoint in clinical drug studies to demonstrate target engagement and guide dose selection. The SILK-Aβ® isoforms test is also highly sensitive to identifying people with brain amyloidosis (one of the earliest indicators of AD), even before amyloid deposits are seen with brain imaging. Still, the more invasive nature of cerebrospinal fluid sampling has impeded the full potential of the SILK-Aβ® method.

“With a simplified SILK-Aβ® test available through blood sampling, we now have an opportunity to validate a unique therapeutic and diagnostic marker,” stated Dr. Joel B. Braunstein, CEO of C2N. “We plan to achieve this validation by collaborating with pharmaceutical companies that are testing their compounds in phase 2 and phase 3 clinical studies, as well as by participating in natural history studies tracking the progression of AD. If successful, we expect to be able to offer a reliable and informative screening test that is also convenient for patients.”

Alzheimer’s Disease and Mild Cognitive Impairment

Data compiled by the Alzheimer’s Association (alz.org) estimate that currently 5 million Americans over the age of 65 suffer from AD. As the population ages, this number is expected to increase to 7.1 million by the year 2025. While AD is the 5th leading cause of mortality in the U.S. for those over age 65, it is the only disease in the top 10 most prevalent diseases which has no known cure or preventative agent. While deaths from AD have increased almost 70% in the past decade, those from most other major diseases, including cancers and heart disease, have decreased. Currently AD is diagnosed based on clinical assessment by skilled neurologists or based on an amyloid imaging brain scan: there are no approved blood based biomarkers for this disease. Early detection of AD is a major research focus since early detection would pave the way for early intervention. Mild cognitive impairment (MCI) is often a precursor of clinical AD. The disorder is associated with cognition changes that are serious enough to be noticed by the individuals experiencing them or to other people, but the changes are not severe enough to interfere with activities of daily living. Individuals with MCI have a significantly increased risk of eventually developing AD, with approximately 50% of such individuals converting to AD within three years.

SILK-Aβ® Technology

Dr. Randall Bateman and Dr. David Holtzman originally developed the SILK™ technology at WUSM. Scientific American recognized the SILK-Aβ® assay as one of the top 50 new innovative technologies of the year. Similar to a pulse chase assay, the SILK-Aβ® assay relies on in vivo labeling of human subjects with a stable isotope labeled amino acid. The stable isotope labeled amino acid is non-radioactive, safe to the environment and to humans, and is incorporated into newly generated proteins. Using a highly sensitive mass spectrometer, we can measure the incorporation of the stable isotope into Aβ and thereby assess the metabolism of Aβ. This ability is particularly useful for early detection of brain amyloidosis or when assessing the pharmacodynamic effect of drugs that are hypothesized to alter the metabolism of Aβ in humans. With these new developments, we have expanded the use of the assay to measuring Aβ metabolism in plasma.

About C2N Diagnostics

C2N Diagnostics, LLC (www.c2ndiagnostics.com) formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C2N is developing a suite of novel biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s products include the SILK-Aβ®, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and absolute quantitation of brain derived proteins. Beyond AD, products are in development to target Parkinson’s disease, Huntington’s disease, brain injury, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, please contact info@c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

C2N Diagnostics Makes Three New Hires to Speed Commercialization of Diagnostics and Theranostics

Dr. Timothy D. Veenstra – Former Director of the Laboratory of Proteomics and Analytical Technologies at the National Cancer Institute – to lead effort as C2N’s New Senior Vice President of Diagnostic Sciences and Innovation September 19, 2013

ST. LOUIS - C2N Diagnostics (C2N) today announced that it has added three highly accomplished individuals to its growing team of scientists and operators committed to bringing best-in-class biomarker tests to the market. These individuals will be focused on three primary objectives at C2N: (i) commercialize a clinical test for early detection of Alzheimer’s disease (AD) pathology; (ii) development and clinical validation of a pipeline of novel therapeutic and disease progression biomarkers; and (iii) laboratory quality control.

Timothy D. Veenstra, PhD, has joined the company as Senior Vice President of Diagnostic Sciences and Innovation. For the past 11 years, Dr. Veenstra served as the Director of the Laboratory of Proteomics and Analytical Technologies at the National Cancer Institute in Maryland. He brings to C2N a wealth of experience in the application of proteomic technologies, especially mass spectrometry, for the discovery and analysis of disease-related biomarkers. He has contributed to over 350 published manuscripts and authored the recently published book: “Proteomic Applications in Cancer Detection and Discovery” (John Wiley & Sons, ©2013).

“Progress made over the past decade has brought us to a point where serious efforts to apply proteomic technologies to bear on real-world clinical problems must be pursued,” remarked Dr. Veenstra. “The research being conducted at C2N Diagnostics affords me opportunity to be part of new and exciting techniques that will revolutionize how Alzheimer’s and other neurological disorders are diagnosed and treated in the future. The impact these developments will have on public health will be profound.”

Philip Verghese, PhD, joins C2N as a Principal Scientist. Dr. Verghese is a protein and lipid biochemist with extensive experience in acute and chronic neurodegenerative disease models. He conducted his post-doctoral training in the laboratory of Dr. David Holtzman, one of C2N’s scientific founders, under the BrightFocus foundation postdoctoral research fellowship. His work on apolipoprotein E (apoE) (for Alzheimer’s disease) and nicotinamide mononucleotide adenylyltransferase 1 (NMNAT1) (for acute neurodegeneration in the developing brain) has been published in high impact journals and added new perspectives in the field of neurodegeneration. Dr. Verghese’s graduate work was focused on peripheral lipid metabolism. He also holds a Graduate Diploma in Business Studies from Dublin Business School, Dublin, Ireland.

In its third hire, Mr. Phillip Herrbrich joins C2N as Laboratory Manager, where he is responsible for day-to-day quality control, inventory management and lab regulatory compliance. Mr. Herrbrich has over 10 years of industry experience working within GLP and CLIA-regulated laboratory environments, including Mid-America Transplant Services, Barnes-Jewish Hospital, and the Washington University School of Medicine.

About C2N Diagnostics

C2N Diagnostics, LLC (www.c2ndiagnostics.com) formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C2N is developing a suite of novel biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s products include the SILK-Aβ®, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and absolute quantitation of brain derived proteins. Beyond AD, products are in development to target Parkinson’s disease, Huntington’s disease, brain injury, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, please contact info@c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

C2N Diagnostics Announces Collaborative Research Agreement with Cambridge Isotopes

July 12, 2013 ST. LOUIS - C2N Diagnostics (C2N) today announced that it has signed a collaborative research and a global, exclusive supplier agreement with Cambridge Isotope Laboratories, Inc (CIL). The partnership guarantees C2N’s future access to mass quantities of highly enriched stable isotopes at predictable prices. These stable isotopes are key reagents to C2N's platform of Stable Isotope Labeling Kinetic (SILK™)-based biomarkers. Such biomarkers are showing considerable promise to detect early Alzheimer’s pathology (i.e., well before the onset of clinical symptoms) as well as to measure treatment responsiveness in preclinical and clinical drug studies.

C2N gains a research partner in CIL that is the premier manufacturer in the world of stable isotopes used in clinical research and diagnostic applications. Under terms of the agreement, C2N receives from CIL an upfront payment, commercial milestone fees, future supply guarantees of stable isotopes at predictable prices, and large quantities of GMP-grade stable isotope (13C6) labeled leucine (L-Leucine). The L-Leucine will be used in future upcoming clinical validation studies involving C2N's SILK™-based tests. CIL also commits to making significant investment in its own infrastructure and manufacturing processes. This will ensure CIL's ability to meet the future demand of stable isotopes that will incorporate into C2N's tests

"We spent considerable time evaluating the options available to C2N for obtaining access to stable isotopes used in our SILK™ tests. The logistics of having adequate supply of these reagents to enable disease screening on large numbers of at-risk individuals are far from trivial. We concluded that CIL is the best-positioned company in the world to meet our future expected demands in terms of both material quantity and material quality," stated Dr. Joel B. Braunstein, C2N's CEO. "Stable isotopes are non-radioactive, perfectly safe for people to consume and to the environment, and offer great sensitivity for tracking the in vivo metabolism of proteins implicated in diseases like Alzheimer's. This makes them highly desirable diagnostic reagents. As we expand the use of our SILK™-based biomarkers beyond research services and into clinical diagnostic applications, CIL will be an instrumental partner to help us qualify our test kits and to produce L-Leucine under GMP scaled-up conditions."

Dr. Joel Bradley, CIL's CEO, commented, "By focusing on ways to diagnose and treat early Alzheimer's disease, C2N is tackling one of the most important challenges in modern medicine. The company is making encouraging progress toward its ultimate goal of offering a convenient screening test for early Alzheimer's that can be administered in the ambulatory setting. At CIL, we acknowledge the social and commercial impact of C2N's efforts. For this reason, CIL is privileged and delighted to assist C2N with its development activities and to become C2N's exclusive supplier of stable isotopes."

About Cambridge Isotope Laboratories, Inc

Cambridge Isotope Laboratories, Inc (www.isotope.com) is the premier supplier of stable isotopes for research applications in proteomics, genomics, molecular biology, metabolic research, clinical and diagnostic research and ultra trace environmental analysis. For over 30 years, CIL has provided over 15,000 different research compounds to its base of over 35,000 medical, pharmaceutical, academic and government customers. The Company has over 400 employees operating in laboratory facilities located in four countries – the United States, Canada, Germany and France. Central headquarters is located in Tewksbury, Massachusetts.

About C2N Diagnostics

C2N Diagnostics, LLC (www.c2ndiagnostics.com) formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C2N is developing a suite of novel biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s products include the SILK-Aβ®, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and absolute quantitation of brain derived proteins. Beyond AD, products are in development to target Parkinson’s disease, Huntington’s disease, brain injury, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, please contact info@c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

SILK-Abeta Study Detects Early Changes in Brain Amyloid Pathology

June 14, 2013 ST. LOUIS - C2N Diagnostics today announced that its two co-founding scientists, Drs. Randall Bateman and David Holtzman, along with other colleagues from the Washington University School of Medicine have independently published a pivotal clinical study that appeared in the June 12th online edition of Science Translational Medicine. The publication(1), entitled “Increased in Vivo Amyloid-beta 42 Production, Exchange, and Loss in Presenilin Mutation Carriers”, presents the first study of its kind in humans.

Individuals who carry genetic mutations predisposing to early Alzheimer’s Disease (AD) as well as their siblings without the mutation (serving as controls) each underwent stable isotope labeled kinetic (SILK) testing to measure amyloid beta (Abeta ) metabolism within the brain. These SILK-derived measures were then compared with mutation status as well as the amount of amyloid deposition in the brain using PET amyloid imaging. Results were striking.

Production rates of Abeta 42 – the specific form of Abeta believed to associate closest with amyloid plaque accumulation – were about 20% higher in mutation carriers, regardless of how much amyloid they had in the brain. The rate at which Abeta 42 disappeared from the cerebrospinal fluid was also considerably faster in mutation carriers. This abnormal kinetic profile was present in most mutation carriers who had no visible plaques detectable by PET amyloid imaging, suggesting that the SILK method was more sensitive at picking up early disease changes than amyloid imaging alone. As amyloid burden in the brain increased, Abeta 42 disappearance became significantly faster and changed in a highly quantitative and predictable manner.

As a result of the SILK data collected in the study, the authors were able to develop a unique mathematical model to explain steady-state Abeta isoform kinetics. The model describes fundamental processes that affect Abeta metabolism, including normal and abnormal physiological conditions. The model also provides new insights into pre-symptomatic disease progression among individuals genetically predisposed to AD. Results from the study suggest that SILK-derived measurements hold promise for not only detecting disease early, but also guiding early AD treatment and prevention strategies.

(1) R. Potter, B.W. Patterson, D.L. Elbert, V. Ovod, T. Kasten, W. Sigurdson, K. Mawuenyega, T. Blazey, A. Goate, R. Chott, K.E. Yarasheski, D.M. Holtzman, J.C. Morris, T.L.S. Benzinger, R.J. Bateman. Increased in vivo amyloid-Abeta 42 production, exchange, and loss in presenilin mutation carriers. Sci Transl Med 5, 189ra77 (2013). Link to text: http://stm.sciencemag.org/content/5/189/189ra77

About C2N Diagnostics

C2N Diagnostics, LLC (www.c2ndiagnostics.com) formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C2N is developing a suite of novel biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s products include the SILK-Aβ®, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and absolute quantitation of brain derived proteins. Beyond AD, products are in development to target Parkinson’s disease, Huntington’s disease, brain injury, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, please contact info@c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

Pre-Competitive Consortium to Develop, Standardize, and Validate Preclinical Aged Canine Model of AD

January 02, 2013 ST. LOUIS, TORONTO & BOSTON - C2N Diagnostics, InterVivo Solutions, and inviCRO (“Companies”) today announced the formation of a pre-competitive consortium to develop, standardize, and validate an aged-canine model of Alzheimer’s disease (AD) progression. The multi-year collaboration is believed to be the first-of-its-kind. It will rely on the longitudinal measurement of disease-specific and clinically relevant biomarkers in canine aging. The study is modeled after the Alzheimer’s Disease Neuroimaging Initiative (ADNI) initiative in humans. The characterization of AD relevant biomarkers in a preclinical model of disease aims to create a robust and reliable method for the screening of candidate therapies that may prevent, slow, or reverse Alzheimer’s pathology and symptomology. Ultimately, the work from this collaboration intends to improve the translatability of Alzheimer’s preclinical drug development to human drug development.

The longitudinal study will establish temporal patterns of AD biomarkers in canine aging. Markers will derive from cerebrospinal fluid and blood, brain imaging, and cognition / behavioral measures. These markers will be used for establishing criteria for selecting clinically relevant sub-populations of aged dogs for therapeutic screening studies. The study will also establish pre-clinical biomarkers that predict clinical outcomes of disease modifying AD therapeutics.

The three contract research organizations that have formed this consortium have industry-leading expertise relevant to the project. They will work in coordinated fashion to standardize the model and create an extensive repository of benchmark data. Industry and academic collaborators will be able to rely upon these data in the future for reference:

  • C2N Diagnostics will serve as the bioanalytical core lab, performing and overseeing interpretation of all biomarker measurements from the samples collected throughout the multi-year term of the study. C2N will also contribute to the consortium its proprietary stable isotope labeling (SILK™) methods to measure the kinetics of brain-derived proteins and its absolute protein quantification techniques using mass spectrometry (SISAQ™) to measure levels of beta-amyloid isoforms and the tau protein.
  • InterVivo Solutions will be responsible for all administrative oversight of the project. They will serve as the primary liaison among members of the consortium and with parties from industry. InterVivo will also serve as the in vivo service provider including managing cognitive data collection and interpretation, collection of biological samples, and acquisition of the in vivo imaging data.
  • inviCRO will develop a 3D canine anatomical atlas and provide advanced imaging analysis . In addition, inviCRO will maintain and provide secured access to in vivo imaging data collected during the project.

Stated Joseph Araujo, CEO of InterVivo Solutions and Manager of the consortium, “We have worked hard to bring together this consortium. In our view, the research service companies represented here are best positioned to successfully carry out the multiple dimensions of this multi-year study. InterVivo has a long track record of providing translational animal models. We aid companies in the development of innovative treatment approaches for disorders of the central nervous system. This consortium represents one of our most exciting projects yet. We anticipate a key outcome from this project being the standardization and validation of a preclinical model of disease that his highly relevant to the human AD condition.”

Joel B. Braunstein, MD, CEO of C2N Diagnostics added, “We look forward with great enthusiasm to serving as the bioanalytical core lab within the consortium. In addition to providing novel insights around disease progression and natural aging in canines, we expect this study to support the characterization of highly impactful diagnostic and therapeutic biomarkers.”

The consortium is expected to grow over the ensuing months as industry and foundation partners join the effort. New partners will bring financial support and/or in-kind resources to achieve the goals of the initiative. Working with the consortium will afford new members unique access to data, a repository of samples for future biomarker discovery and testing, and participation in a network focused on developing novel therapies for AD. Key findings from the study will be disseminated to the scientific community through presentations at medical meetings and publications in peer-reviewed journals.

Interested parties should direct statements of interest or additional questions to josepha@intervivo.com.

About C2N Diagnostics

C2N Diagnostics, LLC (www.c2ndiagnostics.com) formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C2N is developing a suite of novel biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s products include the SILK-Aβ®, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and absolute quantitation of brain derived proteins. Beyond AD, products are in development to target Parkinson’s disease, Huntington’s disease, brain injury, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, please contact info@c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

About InterVivo Solutions

InterVivo Solutions, Inc (www.intervivo.com) formed in 2010 as a spin-out company of CanCog Solutions, Inc. with the goal of commercializing in vivo pre-clinical contract services and models for the human therapeutic development market. InterVivo’s mission is to develop and provide translational animal models for establishing proof of concept efficacy of therapeutics targeting human diseases of the nervous system and for assessing early safety. InterVivo strives to provide predictive animal models in appropriate species to improve the successful transition of new therapeutics from preclinical through to clinical trials. The company provides rodent models of cognitive function and aging, pain and epilepsy, obesity and addiction, and Parkinson’s disease. InterVivo also provides naturalistic canine models of human diseases with a particular emphasis on AD progression, cancer, osteoarthritis, obesity and metabolic disorder. For additional information, please contact info@intervivo.com.

About inviCRO

inviCRO, LLC (www.invicro.com) is a Boston-based CRO that offers a range of imaging services and software solutions designed to further the functionality of imaging in research in medicine. inviCRO manages more than 12 studies per month and processes more than 25,000 tomograms per quarter. inviCRO software products are used by more than 100 imaging laboratories worldwide including more than half of the top 25 pharmaceutical companies. inviCRO has grown organically to employ 22 researchers from a broad range of disciplines including advanced degrees in: physics, optics, software engineering, electrical engineering, chemical engineering, mathematics, neuroscience, biomedical engineering and statistics. For additional information, please contact info@invicro.com.

Newly Study in PNAS Links LDL Receptor to Abeta Brain Clearance

August 30, 2012 ST. LOUIS, MO – C2N Diagnostics today announced its participation in a newly published study, which appeared in the online, August 27 edition of the Proceedings of the National Academy of Sciences[1]. Conducted in the lab of Dr. David Holtzman at the Washington University School of Medicine in St. Louis, Dr. Holtzman and colleagues investigated the role of the low-density lipoprotein receptor (LDLR) in clearance of amyloid beta (Aβ) from the brain. The methods, in part, included use of C2N's proprietary "Stable Isotope Spike Absolute Quantitation" (SISAQ™) method to measure Ab levels in the blood.

Investigators examined whether overexpressed LDLR enhances the rate of Aβ clearance from the brains of mice. Brain Ab clearance rate was higher in mice genetically programmed to overexpress LDLR. The results suggest that LDLR plays an important role in Aβ brain metabolism and may represent a therapeutic avenue for clearing Aβ from the brain.

Dr. Joel Braunstein, CEO of C2N Diagnostics, noted "We are delighted to have been part of this study demonstrating the importance of LDLR in Aβ brain metabolism. Our proprietary SISAQ™ assay is uniquely well suited for quantifying Aβ levels from a host of biological samples, in a robust and reproducible manner. We look forward to expanding the use of our SISAQ™ platform in future theranostic and diagnostic applications, and to further elucidate mechanisms of neurodegeneration."

[1] Castellano, J.M., Deane, R., Gottesdiener, A.J., Verghese, P.B., Stewart, F.R., West, T., Paoletti, A.C., Kasper, T.R., DeMattos, R.B., Zlokovic, B.V., Holtzman, D.M. Low-density lipoprotein receptor overexpression enhances the rate of brain-to-blood Aβ clearance in a mouse model of β-amyloidosis. Proc Natl Acad Sci U S A 2012 Aug 27. [Epub ahead of print]. Link to text: www.pnas.org/content/early/2012/08/24/1206446109.

About C2N’s SISAQ™ Platform

C2N's SISAQ™ platform is a patent-pending, mass spectrometry-based protein quantitation method that measures the concentration of Aβ isoforms in biological samples. From a single sample, the SISAQ-Aβ™ assay allows users to measure the absolute concentration of Aβ and its various isoforms. The SISAQ™ method can be used as a stand-alone assay or in combination with C2N's stable isotope labeling methods to measure the kinetics (SILK™), or metabolism, of brain-derived proteins.

About C2N Diagnostics

C2N Diagnostics, LLC (www.C2Ndiagnostics.com) formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C2N is developing a suite of novel biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s products include the SILK-Aβ®, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and absolute quantitation of brain derived proteins. Beyond AD, products are in development to target Parkinson’s disease, Huntington’s disease, brain injury, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, please contact info@C2Ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

C2N Diagnostics Receives SBIR Award to Study Novel Tau Biomarkers in Alzheimer's Disease

August 7, 2012 ST. LOUIS, MO – C2N Diagnostics today announced that it has received a Small Business Innovation Research (SBIR) Award from the National Institute on Aging (NIA), part of the National Institutes of Health (NIH). The award will fund the development of assays for investigating Tau biology. Tau is a protein strongly implicated in the progression of Alzheimer's disease. Dr. Tim West, C2N's VP of Research and Development, will serve as the study's principal investigator.

Stated Dr. West, "We are excited that the NIA has decided to continue to support our research and development of novel mass spectrometer based analyses of proteins involved in Alzheimer's disease. We are currently completing another NIA sponsored project investigating the biology of amyloid-beta (Aβ) isoforms in individuals with and without Alzheimer's pathology. This new grant will expand the reach of our proprietary technology platform into new areas of protein biology in Alzheimer's disease. We look forward to offering the developed technology to our industry collaborators, working on novel candidate therapies to address the global health concern of Alzheimer's disease and other forms of neurodegeneration."

About C2N Diagnostics

C2N Diagnostics, LLC formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C2N is developing a suite of novel biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company's products include the SILK-Ab® and SISAQ-Ab™ Assays, which rely upon stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and absolute quantitation of brain derived proteins. Beyond Alzheimer's disease, products are in development to target Parkinson's disease, Huntington’s disease, brain injury, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, see www.C2Ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

Acknowledgement and Disclaimer

The project described above is being supported by Award Number R43 AG043206-01 from the National Institute on Aging. The content is solely the responsibility of C2N Diagnostics and its authors, and does not necessarily represent the official views of the National Institute on Aging or the National Institutes of Health.

About C2N Diagnostics

C2N Diagnostics, LLC (www.C2Ndiagnostics.com) formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C2N is developing a suite of novel biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s products include the SILK-Aβ®, SISAQ-Aβ™, and SISAQ-Tau™ Assays, which rely upon stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or in vivo metabolism, and absolute quantitation of brain derived proteins. Beyond AD, products are in development to target Parkinson’s disease, Huntington’s disease, brain injury, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, please contact info@C2Ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

C2N Diagnostics Announces Key New Hire and $1M+ Grant from Anonymous Donor to Support Alzheimer’s Biomarkers and Diagnostics Programs

March 18, 2010 ST. LOUIS, MO – C2N Diagnostics announced today that it has received a multi-year grant from an anonymous donor. The award has the potential to exceed $1M in milestone-driven funding. It significantly accelerates C2N’s efforts to develop highly informative biomarkers implicated in Alzheimer’s disease and other central nervous system (CNS) disorders.

“We are so delighted to have such amazing support from the philanthropy community to achieve our corporate objectives and vision,” stated Dr. Joel Braunstein, managing member of C2N. “This award will allow us to enhance a number of our existing biomarker assays and to possibly create several key new ones. We see C2N’s assays as becoming an invaluable part of the drug development process in the field of neurodegeneration. Support from our generous new donor brings us one step closer to the realization of this goal.”

C2N’s existing SILK-Aß™ assay relies on stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or in vivo metabolism, of amyloid-beta – a small peptide implicated as a key mediator of Alzheimer’s disease. The assay has potential to provide unparalleled sensitivity in clinical trials for evaluating the impact of disease-modifying drugs on neurally-derived Aß. Expansion of C2N’s SILK platform will enable the technology to be applied toward a variety of other important settings, and to provide vital new insights in disease progression.

In addition to the anonymous grant, C2N announced today a key new hire to its team. Dr. Yan “Helen” Hu joins C2N as Principal Research Scientist. In this capacity, Dr. Hu will manage internal R&D initiatives at C2N. Dr. Braunstein added, “We are very pleased to have Helen join us from San Francisco, where she worked at Genentech, Inc within its pre-clinical group. She has considerable expertise in molecular genetics and biology, and adds to the existing talent of our lab team at C2N.”

At Genentech, Dr. Hu successfully led the anti-interleukin 17 program (for autoimmune and inflammatory diseases) from late stage research to preclinical development, and played a key role in preparation of an IND (Investigational New Drug) filing. While at Genentech, Dr. Hu also made important new discoveries into interleukin 17 receptor C. Previously, she obtained her PhD from Washington University and worked with Dr. David Holtzman, one C2N’s scientific founders, under the Ruth L. Kirschstein postdoctoral fellowship. In that position, she assumed a comparative proteomics approach and discovered novel biomarkers for early-stage Alzheimer’s.

About C2N Diagnostics

C2N Diagnostics, LLC formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C2N resides at the Center for Emerging Technologies in St. Louis. The company is developing a suite of biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s first commercial tool, the SILK-Aß™ assay, relies on stable isotope labeling and tandem mass spectrometry for the precise measurement of the kinetics, or in vivo metabolism, of amyloid-beta – a small peptide implicated as a key mediator of Alzheimer’s disease. Other products are in development to target Parkinson’s disease, Huntington’s disease, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, see www.c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

Download Press Release as PDF

C2N Diagnostics Awarded "Fast Track" SBIR by NIA/NIH

December 17, 2009 ST. LOUIS, MO – C2N Diagnostics has received a Fast Track Small Business Innovation Reasearch (SBIR) Award from the National Institute On Aging (NIA), part of the National Institutes of Health (NIH). The award of nearly $1 million will fund milestone-driven research to improve the diagnosis and treatment of Alzheimer’s disease. Dr. Tim West, C2N’s Director of Laboratory Operations, will serve as the study’s principal investigator.

Stated Dr. West, “NIA/NIH’s award provides C2N with funding for an exciting metabolic biomarker initiative that we have underway. This initiative will build upon the existing products we currently offer to our industry collaborators, who are focused on developing promising new therapies to address the global health concern of Alzheimer’s disease and other forms of neurodegeneration.”

About C2N Diagnostics

C2N Diagnostics, LLC formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C2N resides at the Center for Emerging Technologies in St. Louis. The company is developing a suite of biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s first commercial tool, the SILK-Aß™ assay, relies on stable isotope labeling and tandem mass spectrometry for the precise measurement of the kinetics, or in vivo metabolism, of amyloid-beta – a small peptide implicated as a key mediator of Alzheimer’s disease. Other products are in development to target Parkinson’s disease, Huntington’s disease, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, see www.c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

Acknowledgement and Disclaimer

The project described above was supported by Award Number R44AG034725 from the National Institute On Aging. The content is solely the responsibility of C2N Diagnostics and its authors, and does not necessarily represent the official views of the National Institute On Aging or the National Institutes of Health.

C2N Diagnostics Announces Successful Completion of Milestones Under $300,000 Alzheimer’s Drug Discovery Foundation Award

November 12, 2009 ST. LOUIS, MO – C2N Diagnostics reported today that it has successfully accomplished each of the milestones defined under its partnership with the Alzheimer’s Drug Discovery Foundation (ADDF) and ADDF’s affiliate, the Institute for the Study of Aging. Under the terms of the collaborative financing, ADDF awarded $300,000 to C2N for the purpose of readying the company to perform an industry-grade SILK-Aß™ assay.

“We are very grateful and appreciative for ADDF’s support,” reported Dr. Joel Braunstein, managing member of C2N. “Beginning in 2008, ADDF provided funding to us at a vital time in the company’s history. They made it possible for us to validate and optimize certain steps of the assay. Leaders within the pharmaceutical industry are now incorporating our SILK-Aß™ assay into their clinical development programs. In part through our work with ADDF, we can be confident that we have a robust assay to provide to industry partners.”

C2N’s SILK-Aß™ assay relies on stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or in vivo metabolism, of amyloid-beta – a small peptide implicated as a key mediator of Alzheimer’s disease. The assay has potential to provide unparalleled sensitivity in clinical trials for evaluating the impact of disease-modifying drugs on neurally-derived Aß. Further, it can answer previously unanswerable scientific questions about the role of Aß and other proteins in the disease process.

Dr. Randall Bateman, one of C2N’s scientific co-founders and co-inventors of the platform technology, and an Assistant Professor in the Department of Neurology at the Washington University School of Medicine in St. Louis, Missouri added, “The ADDF is a pioneer in supporting the translational activities of investigators and emerging companies focused on new ways to fight Alzheimer’s disease. I expect C2N to return to the field techniques that will enable more accurate and rapid development of therapies to counter Alzheimer’s disease.”

Dr. Howard Fillit, executive director of ADDF, stated “C2N’s technology will have an important impact on Alzheimer's disease drug development. For the first time, it is possible to measure, in vivo in the human brain, the pharmacodynamic and pharmacokinetic effect of drugs on the metabolism of proteins relevant to Alzheimer's disease, such as beta-amyloid. C2N’s technology will have wide applications on other target proteins and in other neurodegenerative diseases of the central nervous system. We are pleased that C2N clearly delivered on their funded milestones, reflecting the excellence of their scientific and business management."

About Alzheimer’s Disease

Alzheimer’s disease is a progressive neurological disorder characterized by loss of memory and decline in basic mental ability. Though several drugs are available to treat the symptoms of Alzheimer’s, none halt or modify disease progression. The risk of developing Alzheimer’s disease increases significantly with age. By the age of 85, approximately 1 out of 2 people likely have the disease. Alzheimer’s disease affects more than 20 million elderly people worldwide, and the incidence is likely to grow rapidly over the following decades. According to the Alzheimer’s Research Trust, an estimated 4.6 million new cases of Alzheimer’s are diagnosed each year worldwide, and roughly 500,000 of these occur in the United States alone.

About C2N Diagnostics

C2N Diagnostics, LLC formed in late 2007 by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, the Washington University Office of Technology Management, and LifeTech Research, a Maryland-based technology research and commercialization firm (www.lifetechresearch.com). C2N resides at the Center for Emerging Technology in St. Louis. The company is developing a suite of biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The company’s first commercial tool targets Alzheimer’s disease. Other products are in development to target Parkinson’s disease, Huntington’s disease, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For more information, see www.c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

About the Alzheimer’s Drug Discovery Foundation (ADDF)

ADDF (www.alzdiscovery.org) is the only public charity whose sole mission is to accelerate the discovery and development of drugs to prevent, treat and cure Alzheimer’s disease, related dementias and cognitive aging. We award grants to leading scientists conducting breakthrough drug discovery research. ADDF uses a venture philanthropy model to bridge the worldwide funding gap between basic research and later-stage development, using any return on investment to support new research. Since 1998, we have received over 2,000 requests to fund new ideas for Alzheimer’s drugs. For all, we provided expert reviews and recommendations to advance their programs. We granted more than $36 million to fund more than 270 Alzheimer’s drug discovery programs in academic centers and biotechnology companies in 15 countries. ADDF has invested over $8 million in 35 biotechnology companies, which have received follow-on commitments of over $1 billion.

Download Press Release as PDF

C2N Diagnostics Launches Alzheimer’s Research Tool

June 02, 2008, Business Wire Research and Biomarker Platform Creates Potential to Accelerate Drug Development and Enable Earlier Detection of Alzheimer’s Disease and Other Debilitating Neurodegenerative Disorders.

C2N Diagnostics today announced the availability of its first commercial assay and research service for the measurement of neurally-derived biomolecules in vivo. The SILK-Aß assay refers to the use of stable isotope labeling and tandem mass spectrometry for the measurement of the kinetics, or metabolism, of amyloid-beta. Amyloid-beta is a small peptide implicated as a key mediator of Alzheimers disease.

Developed in the halls of the Washington University School of Medicine by Drs. Randall Bateman and David Holtzman, the proprietary technology behind C2Ns SILK-Aß assay received recognition by Scientific American as one of the top 50 scientific advancements of 2006. Dr. Bateman is an Assistant Professor within the Department of Neurology and recipient of several distinguished awards for his innovative research that served the basis for C2Ns platform technology. Dr. David Holtzman is the Andrew B. and Gretchen P. Jones Professor and Chair of Neurology and Developmental Biology, and past recipient of the Potamkin prize and MetLife award for Alzheimers research.

With the industry availability of this assay, for the first time, it is now possible for pharmaceutical and biotechnology companies to readily evaluate the impact of their development-stage compounds on the production and clearance rates of amyloid-beta. The sensitivity of the assay intends to enable clinical researchers the ability to discriminate active from inactive drugs with a remarkably small number of patients, says Dr. Joel Braunstein, a C2N Managing Member and co-founder of LifeTech Research, a technology research and development firm that formed C2N with Drs. Holtzman and Bateman.

The long-term vision at C2N is to create a convenient-to-use test that can detect Alzheimers at its earliest stages, and to guide effective treatment development and use in patients before they manifest any clinical symptoms. With the introduction of its SILK-Aß assay, the company believes it is one step closer to this ultimate goal.

About Alzheimers Disease

Alzheimers disease is a progressive neurological disorder characterized by loss of memory and decline in basic mental ability. Though several drugs are available to treat the symptoms of Alzheimers, none halt or modify disease progression. The risk of developing Alzheimers disease increases significantly with age. By the age of 85, approximately 1 out of 2 people likely have the disease. Alzheimers disease affects more than 20 million elderly people worldwide, and the incidence is likely to grow rapidly over the following decades. According to the Alzheimers Research Trust, an estimated 4.6 million new cases of Alzheimers are diagnosed each year worldwide, and roughly 500,000 of these occur in the United States alone.

About C2N Diagnostics

C2N Diagnostics, LLC formed in late 2007 by scientific co-founders Drs. Holtzman and Bateman, the Washington University Office of Technology Management, and LifeTech Research. C2N resides at the Center for Emerging Technology in St. Louis, MO. The company is developing a suite of biomarker assays and tools to assist in pre-clinical drug discovery, clinical drug development, and the early detection and assessment of progression of debilitating neurodegenerative disorders. The companys first commercial tool targets Alzheimers disease; but other products are in development to target Parkinsons disease, Huntingtons disease, schizophrenia, and amyotrophic lateral sclerosis (ALS), among others. For additional information, see www.c2ndiagnostics.com or call 1-877-C2N-DIAG (1-877-226-3424).

About LifeTech Research

Founded in 2003, LifeTech Research, Inc is a Baltimore-Washington based technology development firm and provider of investment due-diligence research across the entire life sciences sector. The company fosters unique innovation by assisting entrepreneurs that possess important ideas and technologies that can change their fields. The collective LifeTech team brings to its portfolio companies diverse experience in regulatory affairs, manufacturing, preclinical and clinical development, technology adoption and reimbursement, business development, and finance. For additional information, see www.lifetechresearch.com.