The results of clinical studies with MDV3100 were described at the 2009 ASCO Genitourinary Cancer Symposium in February by the trials' principal investigator, Dr. Howard Scher of Memorial Sloan-Kettering Cancer Center. In general, the drug, at 240 mg once a day, was very effective at lowering PSA levels and also in reducing the number of circulating tumor cells, without any significant toxicity.
"I think it is quite likely that the exciting results seen in the smaller population will also be evident in the larger Phase 3 trial and that the drug could be approved for use in the next few years," said Jung, who is also a member of the California NanoSystems Institute (CNSI) at UCLA.
Of 30 men with anti-androgenresistant prostate cancer who received low doses of MDV3100 in the multisite Phase 1/2 trial designed to evaluate safety, 22 showed a sustained decline in PSA levels, an indication that their cancer was responding favorably to the drug. This trial is still underway, and results from a total of 140 patients receiving higher doses of the drug will be reported within the next year, Sawyer said.
The Phase 3 clinical trial will evaluate the drug's effect on survival in a large group of patients with metastatic prostate cancer.
MDV3100 and RD162 are second-generation anti-androgen therapies that prevent male hormones from stimulating the growth of prostate cancer cells. These new compounds appear to work well even in prostate cells that have a heightened sensitivity to hormones; that heightened sensitivity makes prostate cancer cells resistant to existing anti-androgen therapies.
Approximately 186,000 new cases of prostate cancer are diagnosed each year in the United States. The male hormones testosterone and dihydrotestosterone, which are also known as androgens, spur the growth of pr
|Contact: Stuart Wolpert|
University of California - Los Angeles