Genomas awarded $1.2 million to develop DNA-guided system for management of statin therapy

Genomas, a biomedical company advancing DNA-guided medicine and personalized healthcare, has announced the award of a Fast-Track Phase I-II Small Business Innovation Research (SBIR) Grant totaling $1.2 million.

The grant, entitled "DNA Diagnostic System for Statin Safety and Efficacy," was awarded by the National Institute of General Medical Sciences (NIGMS).

Statins are the most prescribed drugs in the world. Drugs in this class include atorvastatin (Lipitor(R)), rosuvastatin (Crestor(R)), and simvastatin (Zocor(R) and generic formulations). Statin-induced neuro-myopathy (SINM) is the main clinically relevant safety risk of these drugs. In medical practice, SINM presents as a constellation of nerve and muscle side effects. Clinical symptoms of SINM include muscle aches (myalgia), cramps, weakness, and muscle injury (myositis, monitored in serum by elevation of certain enzymes). Statin usage is ultimately limited by these side effects which are disabling to 10% of patients, require alteration of therapy, burden healthcare with management costs, and reduce compliance.

Under the SBIR program, Genomas will integrate the clinical expertise of its strategic partner, Hartford Hospital, with the company's proprietary physiogenomics technology to develop DNA-guided clinical management systems that predict and compare an individual's risk of SINM from statin medications. PhyzioType(TM) Clinical Management Systems are composed of an ensemble of inherited DNA markers genotyped by arrays and interpreted by a biomathematical algorithm in order to convey to physicians predicted comparisons of side effect risk among drugs for the individual patient.

In announcing the award, Gualberto Ruano, M.D., Ph.D., President and CEO of Genomas commented: "By interfacing complex patient reactions to statin drugs with physiogenomics, we can translate the variability observed in medical practice into clinical decision support for DNA-guided medicine. Our revolutionary SINM PhyzioType(TM) System enables the diagnosis and drug-specific prediction of statin neuromuscular side effects addressing a high impact medical need in cardiovascular medicine and will be significantly advanced with this major SBIR award."

The research leading to this award has been published in the renowned journal Muscle & Nerve in September 2007. Researchers at the Division of Cardiology of Hartford Hospital and at the Department of Laboratory Medicine, University of California San Francisco, were co-authors of the publication and are co-investigators in the grant, which also includes the Rogosin Institute.

To date, Genomas has secured $3.1 million of NIH SBIR funding for PhyzioType(TM) product development. These programs have been anchored by the novel partnership with Hartford Hospital for translating DNA-guided medicine into clinical practice.