Management of statin therapy: $1.2 million to develop DNA-guided system

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Genomas awarded $1.2 million to develop DNA-guided system for

management of statin therapy

http://www.news-medical.net/?id=36498

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®), rosuvastatin (Crestor®),

and simvastatin (Zocor® 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 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 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 product development. These programs have been anchored

by the novel partnership with Hartford Hospital for translating DNA-

guided medicine into clinical practice.

http://www.genomas.net/