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Biovista and FDA to Collaborate on a Medication Safety Initiative


1/12/2010 10:08:56 AM

CHARLOTTESVILLE, Virginia, January 12 /PRNewswire/ -- Biovista Inc. today announced that the U.S. Food and Drug Administration (FDA) has licensed its technology platform to help analyze, identify, and better understand the way certain drugs can cause harmful side effects.

The FDA's Office of Clinical Pharmacology, within the Center for Drug Evaluation and Research (CDER), will test the use of Biovista's Adverse Event Analysis (AEA) technology and work closely with Biovista scientists to carefully study the serious side effects of several drugs or classes of drugs, identified by FDA, to help promote safer use of these medications. The goal of the collaboration is to explore the possibility of being able to predict which patients may be most likely to experience adverse reactions to these medications so that healthcare providers can better protect their safety.

"We look forward to working with Biovista and using its technology platform which may help reduce risks associated with using certain medications and help improve how healthcare providers go about selecting the drugs they prescribe for their patients," said Lawrence J. Lesko, Ph.D., Director of the Office of Clinical Pharmacology at CDER. "This license is an example of how FDA hopes to work with leading-edge technologies and collaborators to meet the goals of the agency's Safe Use Initiative."

"We are very pleased to collaborate with FDA in the analysis of drug side effects, using our AEA technology. CDER's Office of Clinical Pharmacology has a track record of innovation. We believe FDA's new Safe Use Initiative is a natural fit for our unique AEA technology, and we look forward to working closely with FDA and potentially helping to improve the safe use of drug products," said Aris Persidis, Ph.D., President of Biovista Inc.

About Biovista's Adverse Event Analysis technology

Biovista's AEA technology forms part of the company's Clinical Outcomes Search Space (COSS(tm)) platform that focuses on mechanism of action-based correlations between drugs, disease efficacy and adverse events. The AEA technology cross-correlates over 8,000 diseases and 12,000 adverse events known to medicine against any target, drug or combination. This enables researchers to link pre-clinical experimental data directly with potential clinical outcomes, and to explore the possible risks of adverse events from a mechanistic perspective. It also helps researchers explain adverse events after these occur, in cases where these events were unexpected or not monitored for during trials, and to differentiate the causes of adverse events among a drug or the underlying disease.

About the Safe Use Initiative

The goal of FDA's Safe Use Initiative is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use.

CONTACT: For more information, please contact: Dr. Aris Persidis,
Biovista, Inc., arisp@biovista.com, +1-434-242-6514



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