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Press Release

Huntington’s Disease Therapeutic and Companion Biomarker Collaboration Forged by KineMed, Isis Pharmaceuticals, and CHDI Foundation

KineMed Inc.
Posted on: 21 Feb 13

KineMed, Inc., Isis Pharmaceuticals Inc. (NASDAQ: ISIS), and CHDI Foundation, Inc., announced today that they are collaborating to utilize KineMed’s translational biomarker platform with Isis’ antisense therapeutic program for Huntington’s disease (HD). This collaboration, which builds on an earlier alliance between CHDI and KineMed to develop companion biomarkers of therapeutic response in HD, will provide Isis access to novel biomarkers for use in the development of an antisense drug to treat HD.

“A pharmacodynamic biomarker could be an important contribution to our clinical development efforts, and we look forward to working with KineMed and CHDI to evaluate KineMed’s biomarker platform in our Huntington’s disease program,” said Frank Bennett, Ph.D., Senior Vice President of Research at Isis.

“This companion biomarker partnership represents personalized medicine in action,” said Patrizia Fanara, Ph.D., Vice President of Neuroscience KineMed. “Our neurodegeneration-specific biomarkers, which provide dynamic measures of axonal transport deficits in degenerating brain cells, predict therapeutic response in neurological and neuromuscular disorders. This is a translational biomarker that could prove crucial to the advancement of disease-modifying treatments. With the Huntington’s disease domain knowledge that CHDI brings and the therapeutic approach that Isis is pioneering, this partnership has the potential to develop biomarkers for specific therapeutics for Huntington’s disease and lead to personalized medicines for Huntington’s patients.”

“There is a critical need to identify appropriate biomarkers to determine target engagement and predict early clinical efficacy for future Huntington’s disease clinical trials,” said Jonathan Bard, Ph.D., Director of Molecular Pharmacology for CHDI Foundation. “Combining Isis’ knowledge of antisense therapies with KineMed’s expertise in developing unique pharmacodynamic biomarkers creates a collaboration with great potential for discovering such tools for Huntington’s disease.”

KineMed’s neurodegeneration biomarker of axonal transport deficit has been recently published in the Journal of Clinical Investigation1 and validated in patients with other neurological disorders.

About Huntington's disease

Huntington’s disease is an inherited neurodegenerative disorder caused by a mutation in the huntingtin gene. The defect causes a DNA sequence called a CAG repeat to occur many more times than normal. Each child of a parent with a mutation in the huntingtin gene has a 50% chance of inheriting the mutation. As a result of carrying the mutation, an individual's brain cells degenerate leading to behavioral, cognitive, and motor impairments that, over the course of the disease, significantly reduce the individual's quality of life and ultimately cause death within 15 to 25 years of overt symptom onset. There are currently no therapeutics approved that slow the progression of Huntington's disease. It is estimated that the disorder affects about 30,000 people in the United States and at least 150,000 others have a 50% risk of developing Huntington's disease at some point.

References:

1. http://www.jci.org/articles/view/64575

About CHDI Foundation

CHDI Foundation, Inc., is a privately-funded, not-for-profit, biomedical research organization exclusively dedicated to rapidly discovering and developing therapies that slow the progression of Huntington’s disease. As a collaborative enabler, CHDI seeks to bring the right partners together to identify and address critical scientific issues and move drug candidates to clinical evaluation as quickly as possible. Our scientists work closely with a network of more than 600 researchers in academic and industrial laboratories around the world in the pursuit of these novel therapies, providing strategic scientific direction to ensure that our common goals remain in focus.

For more information about CHDI, please visit www.chdifoundation.org.

About Isis Pharmaceuticals

Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis’ broad pipeline consists of 28 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, and cancer. Isis’ partner, Genzyme, is commercializing Isis’ lead product, KYNAMRO™, in the United States for the treatment of patients with HoFH. Genzyme is also pursuing marketing approval of KYNAMRO in other markets, including Europe. Isis’ patents provide strong and extensive protection for its drugs and technology. Additional information about Isis is available at www.isispharm.com.

Isis Pharmaceuticals’ Forward-Looking Statement

This press release includes forward-looking statements regarding Isis’ plans for the discovery and development of antisense drugs for Huntington’s disease, its collaboration with CHDI, the potential benefit of KineMed’s biomarker platform to Isis’ research, and development efforts in Huntington’s disease. Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs, including the commercial potential of KYNAMRO, is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing, and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Isis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis’ programs are described in additional detail in Isis’ annual report on Form 10-K for the year ended December 31, 2011 and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.

Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc. KYNAMRO™ is a trademark of Genzyme Corporation.

About KineMed, Inc.

KineMed, Inc., is a leading diagnostic biomarker discovery and drug development company focused on causal pathway discovery and the pairing of medicines with diagnostics for integrated disease management. KineMed works with collaborators and clients to develop biomarkers that provide predictive, actionable information to dramatically improve, de-risk and accelerate drug discovery, development and disease management decisions. KineMed’s technology reveals dynamic causal processes of disease rather than isolated molecular targets and provides precise measures of therapeutic effectiveness on these processes, offering “yes/no” to key treatment questions: “Is this drug right for the patient?” and “Is the drug working?”

KineMed’s biomarkers are fully translational from animal to man, seamlessly harmonizing data across pre-clinical and clinical phases of development, through to the diagnosis and management of diseases including fibrotic, neurodegenerative, metabolic, cardiovascular disease, and cancer.

KineMed’s platform addresses key industry needs:

  • Illuminating causal mechanisms of disease: Generating pivotal knowledge for developing novel therapeutics that target underlying biochemical causes rather than symptoms
  • Systems biology approach: Insight into intact living systems, rather than simplified models, ensures that drug effects are understood in their intended biological context
  • Reduce late-stage attrition: Early, decision-relevant metrics of drug activity to remove costly failures late in the development cycle and improve the overall ROI of R&D spend
  • Establish patient pre-selection criteria: Enabling more tightly focused patient selection for clinical trials to target increased response rate in a segmented population
  • Provide the link to pair medicines with diagnostics: Custom-developed assays create companion diagnostic tests for personalized medicine

In addition to assisting clients, KineMed also has an active pipeline of therapeutics and diagnostics in development and is seeking further broad collaborations with biotechnology, pharmaceutical, CRO, histopathology, diagnostics, and medical instrument partners.

For more information about KineMed, please visit: http://www.kinemed.com.

Business Wire
http://www.businesswire.com/

Last updated on: 21/02/2013

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