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Rational Therapeutics Release: Laboratory Assay Identifies Topotecan As Promising Therapy For Recurrent Breast Cancer

10/19/2005 5:10:12 PM

British Journal of Cancer Reports Novel Finding for Drug Typically Used to Treat Lung and Ovarian Cancers

LONG BEACH, Calif.--(BUSINESS WIRE)--Nov. 3, 2003-- A study published in the November issue of the British Journal of Cancer reports that an ex-vivo laboratory assay based on drug-induced apoptosis (i.e., programmed cell death) has identified a novel Topotecan-based combination as a promising treatment for patients with recurrent breast cancer. The findings represent an unexpected application for Topotecan (brand name Hycamtin by GlaxoSmithKline), a drug that is currently used to treat ovarian and small cell lung cancers. The results also support the use of ex-vivo assays to identify previously unrecognized drug combinations for the treatment of advanced malignancies.

The study (entitled "Ex Vivo Analysis of Topotecan: Advancing the Application of Laboratory-Based Clinical Therapeutics" -- British Journal of Cancer 2003; 89, 1789-1795) was conducted by a team of investigators led by Robert Nagourney, M.D., medical and laboratory director of Rational Therapeutics (Long Beach, Calif.) and medical director of the Malcolm C. Todd Cancer Institute at Memorial Medical Center of Long Beach.

In the study, 697 individual human tumor biopsy specimens were tested against Topotecan in combination with a wide variety of other chemotherapy drugs. The tumors represented nearly every known type of cancer.

"Our research team was particularly intrigued by the highly favorable interaction between Topotecan and 5-Fluorouracil in breast cancer specimens," says Dr. Nagourney. "Based on the results, it appears that this previously untested combination may hold promise for the treatment of one of the most common human cancers."

To test this combination's clinical efficacy investigators at Long Beach Memorial Center's Malcolm C. Todd Cancer Institute have launched a formal Phase II Trial of Topotecan & Capecitabine (brand name Xeloda, an oral formulation of 5-Fluorouracil) in recurrent breast cancer. To qualify, patients cannot have previously received Capecitabine.

"The Ex-Vivo Apoptotic (EVA) Assay developed at Rational Therapeutics enables physicians to optimize drug therapies by individualizing treatment regimens," adds Dr. Nagourney. "Another important use of this approach is the identification of new drugs and drug combinations, as illustrated by this latest discovery."

The principle underlying the EVA assay's success is its capacity to measure drug-induced cancer cell death or apoptosis. This approach is in stark contrast to earlier laboratory tests that measured the ability of drugs to inhibit cell growth. While earlier assays consistently failed to provide clinically relevant information, the new cell death measures have been shown to correlate with patient response and survival. These clinically validated assays can identify treatment combinations that might otherwise not be considered.

Breast cancer is the leading cause of cancer death in women between the ages of 15 and 54, and the second leading cause in women 55 to 74. According to the American Cancer Society, breast cancer will afflict 211,000 women in 2003, with 39,000 deaths attributed to the disease. Despite notable progress in the management of newly diagnosed breast cancer, patients with recurrent disease remain a clinical challenge for which new therapeutic approaches are critically needed.

About Rational Therapeutics

Rational Therapeutics is a Long Beach, California-based research and clinical center specializing in cancer therapeutics. Founded in 1993 by Robert Nagourney, M.D., Rational Therapeutics specializes in assay-directed therapy that enables doctors to provide treatment protocols that are specifically tailored for each individual patient.


Tellem Worldwide Erik Deutsch, 310-479-6111

Source: Rational Therapeutics

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