Endometriosis results, which seem middling, but at least narrows the dose range somewhat:
>>WALTHAM, Mass.--(BW HealthWire)--June 19, 2002--PRAECIS PHARMACEUTICALS INCORPORATED (NASDAQ:PRCS - News) today announced preliminary results of its Phase II/III study of Plenaxis(TM) (abarelix for injectable suspension) for the treatment of endometriosis. The study compared the safety and efficacy of various doses of Plenaxis to the standard dose of Lupron Depot® for treating endometriosis-associated pain. The data will be presented on Friday, June 21st at the 84th Annual Meeting of The Endocrine Society in San Francisco, CA, by William Schlaff, M.D., of the University of Colorado Health Sciences Center, an investigator for the study.
This randomized, double-blind, active-control study included 363 premenopausal women with surgically confirmed, moderate to severe endometriosis. Three different doses of Plenaxis (30 mg, 60 mg and 120 mg), administered subcutaneously, were compared to the standard dose of Lupron Depot® (3.75 mg), administered intramuscularly. Patients were treated once every 4 weeks over a 24-week period, receiving a total of 6 doses of drug. Patients were then followed for 48 weeks post-treatment. The primary endpoint was defined as the achievement of all of the following: (i) improvement of pelvic pain, (ii) improvement in pelvic tenderness and (iii) elimination of dysmenorrhea (difficult and painful menstruation) at 4 and 24 weeks.
The percentage of patients treated with Plenaxis (at any dose) who experienced improvement in endometriosis-associated pain was no different than Lupron Depot® at 4 weeks. At 24 weeks, only patients treated with a 60 mg dose of Plenaxis experienced statistically equivalent relief of endometriosis-associated pain compared to patients treated with Lupron Depot®. More patients experienced an elimination of dysmenorrhea at 4 weeks at all doses of Plenaxis (30 mg: 95.7%; 60 mg: 95.7%; 120 mg: 96.7%) compared to patients treated with Lupron Depot® (71.6%).
In addition to the pre-specified endpoints, estrogen levels were also measured at various time points during the study. This data demonstrated that patients treated with Plenaxis experienced a more rapid reduction in estrogen levels compared to patients treated with Lupron Depot®.
The most common adverse event for all groups was headache. No treatment-related serious adverse events or systemic allergic reactions were reported in any group. The use of hormonal therapies that lower estrogen levels, including Plenaxis, results in bone mineral density loss. Initial analysis of the results of this study suggests that patients treated with Plenaxis experienced more bone mineral density loss than those treated with Lupron Depot®, and that this loss was dose-related. The Company is conducting additional analyses of this data to clarify the extent and magnitude of the bone loss. In addition, the Company has submitted a protocol to the United States Food and Drug Administration (FDA) for a pharmacokinetic study which would evaluate the use of a less frequent dosing regimen for Plenaxis to reduce drug exposure and attendant bone mineral density loss. Assuming timely FDA concurrence with the proposed protocol, the Company anticipates completing this study by year-end, at which time the results would be submitted to the FDA for review, together with a proposal for additional trials to support the filing of a New Drug Application.
Commenting on the study, Dr. Schlaff stated, "This data suggests that Plenaxis (abarelix for injectable suspension) may provide patients suffering from endometriosis with an important future treatment alternative to existing hormonal therapies."
Endometriosis is a condition where endometrial tissue grows beyond the uterine lining. Endometrial tissues, regardless of location in the body, respond to the normal menstrual cycling of women. When the location of the endometrial tissue prevents the appropriate sloughing of tissue that normally occurs during menstruation, inflammation, gastrointestinal symptoms and internal scarring occurs. This causes, among other things, pain, fatigue, heavy menstrual bleeding, painful sexual intercourse and infertility. Existing treatments for endometriosis include the use of pain management medications, birth control pills and hormonal therapies. The use of currently available hormonal therapies to suppress estrogen production causes an initial estrogen surge in women, which can result in a worsening of the signs and symptoms of endometriosis such as pain, cramping and excessive bleeding, the risk of tumor flare in breast cancer and the development of ovarian cysts.
The Company is planning to report second quarter 2002 results on July 26, 2002. For information regarding live webcasts and investment community conference calls related to second quarter 2002 results, please refer to praecis.com approximately one week prior to the financial reporting release date.<<
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Cheers, Tuck |
