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Statins are the most prescribed drugs in the world. Drugs in this classinclude atorvastatin (Lipitor(R)), rosuvastatin (Crestor(R)), and simvastatin(Zocor(R) and generic formulations). Statin-induced neuro-myopathy (SINM) isthe main clinically relevant safety risk of these drugs. In medical practice,SINM presents as a constellation of nerve and muscle side effects. Clinicalsymptoms of SINM include muscle aches (myalgia), cramps, weakness, and muscleinjury (myositis, monitored in serum by elevation of certain enzymes). Statinusage is ultimately limited by these side effects which are disabling to 10%of patients, require alteration of therapy, burden healthcare with managementcosts, and reduce compliance.
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Under the SBIR program, Genomas will integrate the clinical expertise ofits strategic partner, Hartford Hospital, with the company's proprietaryphysiogenomics technology to develop DNA-guided clinical management systemsthat predict and compare an individual's risk of SINM from statin medications.PhyzioType(TM) Clinical Management Systems are composed of an ensemble ofinherited DNA markers genotyped by arrays and interpreted by a biomathematicalalgorithm in order to convey to physicians predicted comparisons of sideeffect risk among drugs for the individual patient.
In announcing the award, Gualberto Ruano, M.D., Ph.D., President and CEOof Genomas commented: "By interfacing complex patient reactions to statindrugs with physiogenomics, we can translate the variability observed inmedical practice into clinical decision support for DNA-guided medicine. Ourrevolutionary SINM PhyzioType(TM) System enables the diagnosis anddrug-specific prediction of statin neuromuscular side effects addressing ahigh impact medical need in cardiovascular medicine and will be significantlyadvanced with this major SBIR award."
The research leading to this award has been published in the renownedjournal Muscle & Nerve in September 2007. Researchers at the Division ofCardiology of Hartford Hospital and at the Department of Laboratory Medicine,University of California San Francisco, were co-authors of the publication andare co-investigators in the grant, which also includes the Rogosin Institute.
To date, Genomas has secured $3.1 million of NIH SBIR funding forPhyzioType(TM) product development. These programs have been anchored by thenovel partnership with Hartford Hospital for translating DNA-guided medicineinto clinical practice.
ABOUT GENOMAS
Genomas(R) Inc. is a biomedical company advancing DNA-guided medicine andpersonalized healthcare. The company develops revolutionary PhyzioType(TM)Systems for DNA-guided diagnosis and prevention of metabolic disorders inducedby drugs in cardiovascular and psychiatric medicine. PhyzioType(TM) Systemsprovide physicians with the unprecedented capability to select for eachpatient the safest drug treatment. Genomas is located in Hartford, CT on thecampus of Hartford Hospital. For more information please accesshttp://www.genomas.net
SOURCE Genomas, Inc.
