Title: Abarelix Depot-M Showing Positive Results In
May 23, 2000
NEW ORLEANS, LA -- May 23, 2000 -- Praecis
Pharmaceuticals Incorporated announced the results of two Phase III studies for
its lead compound, abarelix depot-M, for the treatment of prostate cancer.
Praecis is developing this product globally with its corporate collaborators.
These two studies, which included
520 prostate cancer patients, showed the intended benefits of abarelix depot-M
when compared head to head with leuprolide acetate depot or leuprolide acetate
depot and bicalutamide, two drugs commonly used for treating prostate
The data were presented at
the 36th annual meeting of the American Society of Clinical Oncology (ASCO) in
New Orleans by David McLeod, M.D., Director of Urologic Oncology at Walter Reed
Army Medical Center.
is one of the most commonly diagnosed cancers in men. According to the American
Cancer Society, approximately 180,000 new diagnoses of, and 32,000 deaths from,
prostate cancer will occur in the United States this year. Current prostate
cancer therapies include surgery, radiation therapy, hormonal therapy or a
combination of these. Hormonal therapies reduce the male hormone, testosterone,
to low levels and are used because approximately 85 percent of newly-diagnosed
prostate cancers are hormone-dependent tumors that require testosterone for
their continued growth. Shutting off the body's normal production of
testosterone, therefore, is the primary goal of hormonal treatment.
Available hormonal therapies may
cause an initial surge or increase in the level of testosterone before the
desired effect of lowering testosterone occurs. In the studies reported today,
zero percent of the patients treated with abarelix depot-M experienced a
testosterone surge compared to more than 80 percent of patients treated with
leuprolide acetate depot, or a combination of leuprolide acetate depot plus
bicalutamide. Further, abarelix depot-M suppressed testosterone levels more
rapidly, achieving suppression by day eight in 70 percent of patients compared
to zero percent of patients treated with either leuprolide, or leuprolide plus
bicalutamide. Each treatment therapy studied achieved and maintained
testosterone suppression from day 29 through day 85 in more than 90 percent of
patients. Reported side effects, such as hot flashes, were similar for all three
hormonal treatment regimens.
studies show that abarelix depot-M represents a potentially new prostate cancer
treatment which acts rapidly without causing a testosterone surge when therapy
is initiated," said Marc B. Garnick, M.D., Praecis' Chief Medical Officer.
"Based on the results of these trials, Praecis plans to continue clinical
evaluation of abarelix depot-M and plans to file a New Drug Application with the
United States Food and Drug Administration by fourth quarter, 2000."
"These positive clinical results
validate Praecis' core technology for drug discovery and our ability as a
company to bring pharmaceuticals through the drug development process. We look
forward to advancing our other clinical programs which are aimed at treating
patients suffering from other serious human diseases," said Malcolm L. Gefter,
Praecis' President and Chief Executive Officer.