Under terms of the agreement, Clinical Data's PGxHealth division will provide IGSP with non-exclusive, confidential access to its STRENGTH studies conducted to discover genetic variants associated with baseline lipid parameters and the response of these parameters to statins (used to treat elevated levels of cholesterol).
In return, Clinical Data receives the right to evaluate the commercial potential of any findings derived from studies where either the STRENGTH clinical and/or genetic databases are utilized in IGSP studies.
Should Clinical Data be interested in any such findings, the Company also receives first right to negotiate a commercial license relating to any and all of the findings.
Researchers at Duke IGSP are planning a series of studies to find and validate associations between genetic variants and responses to drugs used for dyslipidemia (or "hypercholesterolemia") in a family practice setting and are also carrying out similar studies in the areas of hypertension and asthma.
Duke researchers, their staff and named collaborators will use PGxHealth's STRENGTH data to help plan, validate and analyze findings from these studies.
Carol Reed, M.D., Senior Vice President and Chief Medical Officer of Clinical Data, said, "We are very pleased to enter into this agreement with Duke IGSP, a true leader in medical innovations and genomic medicine."
"We expect that these new studies will deepen our understanding of how genetics plays a role in the efficacy of pharmaceutical products for hypercholesterolemia, potentially leading to improved efficacy and safety of treatments for these common chronic diseases."
David Goldstein, Ph.D., of Duke IGSP, said, "This collaboration provides Duke with powerful leads generated by Clinical Data to identify and evaluate gene variants that make a real difference to how to better treat patients with hypercholesterolemia."
"In addition, with Clinical Data's commercial footprint in this area, they make an ideal partner for us to advance genomics into medical practice."
"We are pleased to have reached this agreement in which patients and physicians, as well as both parties, have the potential for significant benefit."
Drew Fromkin, Executive Vice President of Clinical Data, said, "IGSP research will open up new commercialization opportunities derived both from our investment in STRENGTH and from the research expertise and strong scientific capabilities of the Duke University investigators."
"We are very excited about this opportunity, PGxHealth's role in advancing this research, and the relationship that has been established with Duke University and its leadership."
As previously announced, the Clinical Data STRENGTH studies involved evaluating the response of 679 patients to atorvastatin, pravastatin, simvastatin, lovastatin and cerivastatin; and genotyped approximately 175 genes.
Approximately 700 additional patients were evaluated at baseline. Clinical Data researchers have completed SNP- and haplotype-based association analyses of response to statins as measured by changes in lipid parameters and for baseline variables.