Clinical Trial: MDV3100 Prostate Cancer Drug Improves Survival by 5 Months

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An experimental drug for prostate cancer known as MDV3100 has been shown in a clinical study to improve survival of patients with the disease 4.8 months longer than those on a placebo. The drug, marketed by Medivation Inc which is based in San Francisco, is in the final stages of clinical development.

MDV3100 was co-developed by three doctors at the University of California Los Angeles using a $500,000 research grant by the Prostate Cancer Foundation. The team theorized that androgen-receptor signaling is a driver in prostate cancer and that blocking the signaling would stop its growth. MDV3100 works, in part, by suppressing the male hormones that fuel cancer.

For the AFFIRM study, about 1,200 men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy were enrolled. The men were randomized to either receive 160 milligrams per day of MDV3100 or a placebo. Those on the drug had an increased median survival rate of 4.8 months (18.4 months for men treated with MDV3100 versus 13.6 months for those on placebo).

The trial was so successful, and the safety profile favorable, that the Independent Data Monitoring Committee (IDMC) halted the trial early and provided those on placebo the active drug.

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“We're very excited because of the survival benefit,” said David Hung, chief executive officer of Medivation, in a telephone interview. “18 months ago, once a man with prostate cancer failed chemo, he went to hospice. Now these men will have another treatment option.”

“The clinical advancement of MDV3100 is one of the most important events in the history of prostate cancer research and the Prostate Cancer Foundation,” said Howard Soule, PhD, chief science officer and executive vice president of PCF. “For men whose disease has progressed since receiving hormone therapy and docetaxel chemotherapy, MDV3100 should provide a new therapy to extend survival.”

Full results will be presented at a future scientific conference, noted representatives from Medivation and partner Astellas Pharma Inc. The drugmakers plan to meet with the US Food and Drug Administration (FDA) in early 2012 and, if all goes as planned, they expect the drug to be available to patients in 2013.

Additional studies on MDV3100 are also ongoing. The PREVAIL trial is in the final stages and tests the medication on men who have not yet received chemotherapy. The Phase 2 trial TERRAIN is enrolling men whose cancer has worsened following surgical castration. A third trial is evaluating the drug in patients who have not received hormones for prostate cancer treatment.

About 241,000 men will be diagnosed with prostate cancer this year, and 33,700 will die, according to the National Cancer Institute. About 1 man in 6 will be diagnosed with the cancer in his lifetime, according to the American Cancer Society.

Sources Include: Prostate Cancer Foundation, Medscape Medical News

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