Perlegen Sciences announced today that it has completed the
collection of more than 3,000 DNA samples from diabetic patients
treated with Actos(R) and Avandia(R) in order to analyze the genetic
variability associated with adverse events due to treatment with this
class of medications.
An estimated 200 million people worldwide have type 2 diabetes,
including close to 20 million in the United States. In the late 1990s,
insulin sensitizing thiazolidinediones (TZDs, the class of drugs to
which Actos(R) and Avandia(R) belong) were approved in the United
States for the treatment of type 2 diabetes. The main side effect from
TZDs is fluid retention, leading to edema, weight gain, and
potentially aggravating heart failure. Last week, the US Food and Drug
Administration requested "black box" labels be added to the packaging
of both drugs, warning about the risk of cardiovascular events. This
new labeling may significantly impact the use of these agents.
Perlegen, a leader in identifying genetic variation related to
drug response and predisposition to disease, has collected DNA from
more than 3,000 subjects in more than 160 centers worldwide who have
been treated with Actos(R) or Avandia(R). Perlegen will use these
samples to identify genetic variations that may contribute to a
patient's risk of experiencing adverse events. Results of these
analyses may help to direct patients to the drug that is most
appropriate for their use, and may provide researchers with important
new targets or pathways for drug discovery and development. The
company has licensed its own phase III ready TZD from Mitsubishi
Pharma.
"Our early results have demonstrated a significant genetic
component to the adverse effect profile of these TZDs," commented
David R. Cox, MD, PhD, Perlegen's Chief Scientific Officer, "Through
our analysis of this valuable sample set, using both genotyping and
sequencing technologies, we hope to provide patients and physicians
with critical decision making information, while revealing biological
insights that will enable the discovery of safer medicines."
About Perlegen Sciences
Perlegen's mission is to discover and commercialize genetic
variations that can make a difference to patients and physicians. The
company's expertise is in understanding human genetic variation within
and across diverse patient populations and in conducting studies aimed
at identifying those variations that are predictive of drug response.
Perlegen also applies its expertise to discovering genetic variations
associated with disease, to enable the discovery of novel targets
leading to new therapeutics as well as clinically useful diagnostics
or biomarkers.
