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Drug Development Platform Utilizes Ex-Vivo Analysis of Human Tumor Spheroids

Posted on: Monday, 3 April 2006, 12:00 CDT

Results of a study presented today at the 97th Annual Meeting of the American Association of Cancer Research (AACR) affirms the utility of ex-vivo analysis of programmed cell death in human tumor microspheroids as a means to guide clinical trial development.

The study titled "Bortezomib combinations in ovarian cancer: Ex vivo analysis of activity and synergy in human tumor primary culture spheroids" (AACR # 2158) examines the activity of the novel proteasome inhibitor Bortezomib (Velcade(TM) by Millennium Pharmaceutical, Cambridge, MA) in combination with other drugs in ovarian cancer specimens.

The Ex-Vivo Assay (EVA(TM)) method developed by investigators at Rational Therapeutics (Long Beach, CA) uses human tumor microspheroids isolated directly from patients to explore drug actions and interactions. EVA results have been shown in published studies to correlate with patient response, time to progression and survival.

The research team was led by Robert Nagourney, M.D., medical and laboratory director of Rational Therapeutics and medical director of the Malcolm Todd Cancer Institute at Long Beach Memorial Medical Center.

"Our success in applying the EVA assay to identify effective chemotherapy combinations in ovarian cancer has enabled us to now focus use of the assay on the newest classes of targeted agents," said Dr. Nagourney.

The study presented today identifies novel potential uses for Bortezomib in treating ovarian cancer. These uses include a Bortezomib & Platin combination that was the subject of a positive trial published by investigators in New York (Aghajanian C, J Clin Oncol, Sept. 2005). Bortezomib has been approved for treating multiple myeloma, and is under investigation as a treatment for other types of tumors. Dr. Nagourney notes that several other chemotherapeutic combinations look promising as well.

"The complex effects associated with proteasome inhibition make Bortezomib an ideal candidate for the EVA analysis-based approach," he added. "The redundancy and crosstalk of cancer response pathways may be best addressed using whole cell experimental models that concurrently examine all of the effects of these new drugs."

As the average cost of developing a new drug soars to nearly $1 billion with up to a decade required to gain approval, clinically validated drug testing assays have become a priority for government agencies and the pharmaceutical industry. The EVA assay holds promise as a means to guide drugs through the Phase I - Phase II transition, which is an especially costly part of that process.

Dr. Nagourney went on to observe, "Since drugs don't know what diseases they were invented for, it is incumbent upon us to use all available tools to match drugs to the patients in need."

About Rational Therapeutics

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

Source: Business Wire

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