Unlike the standard treatment for prostate cancer which inhibits the activity of androgens testosterone and dihydrotestosterone, male hormones that fuel the tumor, the new drug called MDV3100 helps stop testosterone from getting into cells.
MDV3100 is made by San Francisco-based Medivation Inc. It is already through its Phase 1 and 2 clinical trials and is now seeking FDA approval for larger-scale testing on over 1,200 patients, researchers at the Howard Hughes Medical Institute (HHMI), University of California, who carried out the preliminary trails, reported.
The results of the preliminary trials featuring in the online issue of the journal Science are based on treatment of 30 men with drug-resistant advanced prostate cancer. All patients had undergone conventional anti-androgen therapy with no signs of improvement.
For the study, the patients were administered doses of MDV3100. 22 of 30 patients treated with MDV3100 showed declines in serum levels of prostate specific antigen (PSA), a biomarker of prostate cancer. More importantly, in 13 of those 22, the decline was more than 50 percent, researchers revealed.
Depleting levels of PSA indicate shrinking cancer tumors and better disease management.
"There is a lot of interest in the drug, because the preliminary results are very promising,” study’s co-author, Dr. Howard I. Scher from Memorial Sloan-Kettering Cancer Center in New York City, stated.
“It showed not only declines in PSA but also regression of the tumor on scans and also that circulating tumor cell counts, another measure of treatment, converted from unfavorable to favorable in a considerable percentage of patients,” he added.
Relatively fewer side effects make the drug more “promising”, Sawyers said. "At high doses, fatigue has been a problem in some men -- higher doses than are needed to get benefit," he said.
Prostate cancer, the cancer of the prostate gland in the male reproductive system, is the second-leading cancer killer among men. According to the American Cancer Society estimates, nearly 218,000 new cases are registered with over 28000 deaths in the United States each year.
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