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Ovarian Cancer Drug Combination Identified at Rational Therapeutics Receives FDA Approval; Researchers Utilized Human Tumor Microspheroid Platform to Identify Novel Platin Plus Gemcitabine Combination for Ovarian Cancer in 1995

Posted on: Friday, 28 July 2006, 12:00 CDT

The U.S. Food and Drug Administration (FDA) has approved the use of a two-drug combination originally developed by researchers at Rational Therapeutics Institute (Long Beach, Calif.) for the treatment of ovarian cancer.

The activity for Cisplatin and its derivative Carboplatin (Paraplatin, Bristol Meyers Squibb) plus the pancreatic cancer drug Gemcitabine (Gemzar, Eli Lilly) was first recognized as a treatment for ovarian cancer by Robert Nagourney, M.D., medical director of Rational Therapeutics and The Todd Cancer Institute at Long Beach Memorial Medical Center. His research team used a human tumor microspheroid platform (EVA(TM)) based on drug-induced programmed cell death. In November 1995, Rational Therapeutics received emergency approval from the FDA to use the Platin plus Gemcitabine combination to treat a late-stage ovarian cancer patient who had failed all conventional therapies. Dr. Nagourney used the results of the EVA analysis to identify the combination for this patient, resulting in a remission that lasted several years.

Dr. Nagourney's discovery of the two-drug combination for treating ovarian cancer led to a Phase II clinical trial (Nagourney R, Brewer C, Sommers B, et. al., Gynecologic Oncology, Jan. 2003), which was followed by a national trial conducted by the Gynecologic Oncology Group (Brewer C, Blessing J, Nagourney R., et. al., Gynecologic Oncology, April 2006).

"We are delighted that our laboratory observation based on tumor tissue profiling has given rise to a new treatment option for advanced ovarian cancer," said Dr. Nagourney. "FDA approval of the Carboplatin plus Gemcitabine combination affirms the utility of ex-vivo drug induced cell death analysis as a tool to guide drug development for other difficult to treat cancers." Results from Rational Therapeutics' EVA assay have been shown in published studies to correlate with patient response, time to progression and survival.

Dr. Nagourney added, "Clinically validated drug testing assays hold much promise as a means to guide drugs through the Phase I-Phase II transition, which is an especially costly and time consuming part of the drug development process."

According to the American Cancer Society, ovarian cancer is the leading cause of death from cancers of the female reproductive system. More than 20,000 women in the U.S. are diagnosed each year. Despite advances in therapy, only 45 percent survive five years after diagnosis.

The Todd Cancer Institute at Long Beach Memorial Medical Center is the first cancer program in the nation to apply laboratory-directed therapy as the first-line treatment for advanced solid tumors. The Center is currently hosting clinical trials for cancers of the lung, colon, stomach, pancreas and prostate.

About Rational Therapeutics

Founded in 1995, Rational Therapeutics is a pioneering oncology research and testing center specializing in individualized therapy based on ex-vivo individualized drug testing and analysis. More information about Rational Therapeutics is available at www.rationaltherapeutics.com.

Source: Business Wire

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