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Tuesday February 18 9:18 AM EDT - Researchers Publish Pivotal efficacy Data From Two VISTIDE Studies in the Treatment of Newly Diagnosed CMV Retinitis
Results from Phase II/III Studies, Including SOCA-sponsored Trial, Appear in Annals of Internal Medicine
FOSTER CITY, Calif.--(BW HealthWire)--Feb. 18, 1997-- Gilead Sciences Inc announced today the publication of data from two pivotal clinical studies that demonstrated the effectiveness of VISTIDE(R) (cidofovir injection) as a treatment for previously untreated, newly diagnosed cytomegalovirus (CMV) retinitis in patients with AIDS. One Phase II/III study was independently conducted by Studies of the Ocular Complications of AIDS (SOCA) research group, and the other was sponsored by Gilead.
SOCA Study Summary
Data from this randomized, controlled Phase II/III SOCA trial, published in the February 15 issue of the Annals of Internal Medicine, demonstrate that VISTIDE treatment at either a 5 mg/kg maintenance dose or a lower 3 mg/kg maintenance dose delayed the progression of CMV retinitis in newly diagnosed, previously untreated patients.
In March 1996, representatives of the SOCA treatment centers stopped enrollment in this study prior to its planned completion following a review of accumulated data demonstrating that VISTIDE had a statistically significant effect in delaying progression of CMV retinitis at either of the two dose regimens evaluated. At the time enrollment was stopped, the study had enrolled 64 of the 90 patients planned for the study.
SOCA is a collaborative, multidisciplinary research group established through the National Institutes of Health's (NIH) National Eye Institute (NEI) to perform multicenter clinical studies regarding the ocular complications of AIDS. The SOCA study of VISTIDE was performed with funding support from the NEI and Gilead and in collaboration with the AIDS Clinical Trials Group (ACTG), which is supported by the National Institute of Allergy and Infectious Diseases (NIAID).
GS 106 Study Summary
Data from a second Phase II/III study of VISTIDE were also published in the same issue of Annals of Internal Medicine. These data include results from a 48-patient controlled, randomized study sponsored by Gilead in which VISTIDE therapy led to a statistically significant delay in the time to progression of CMV retinitis in newly diagnosed, previously untreated patients.
In both studies, time to progression was measured through the use of full-field, retinal photographs of both eyes evaluated by ophthalmologists unaware of a patient's treatment assignment. In addition, clinical investigators in both studies reported that VISTIDE treatment was well tolerated. Oral probenecid and hydration were co-administered in both studies to minimize the potential for nephrotoxicity, the dose limiting side effect of VISTIDE.
VISTIDE is currently available in the United States for the treatment of newly diagnosed and relapsing CMV retinitis in patients with AIDS and was cleared for this indication by the U.S. Food and Drug Administration in June 1996. The product has been recommended by European regulatory authorities for marketing clearance in the European Union. Upon clearance, VISTIDE will be marketed outside the United States by Gilead's international partner, Pharmacia & Upjohn.
VISTIDE is administered by intravenous infusion once per week for two weeks (induction) and then once every other week thereafter (maintenance). As a result of infrequent dosing, administration of VISTIDE does not require an indwelling cathether, which may make therapy more acceptable to patients. In contrast, the other intravenous therapies for the treatment of CMV retinitis are administered daily or multiple times daily and often require a surgically implanted catheter for delivery.
CMV retinitis is a sight-threatening viral infection that may affect a patient's vision over time and ultimately lead to blindness. Retinitis is the most frequent manifestation of CMV infection in people with AIDS, occurring in approximately 15 to 40 percent of patients.
Gilead Sciences is a biopharmaceutical company dedicated to the research, development and commercialization of human therapeutics. The Company's technology platforms include nucleotide analogues that inhibit viral replication and non-nucleotide compounds discovered through structure-based drug design. Gilead's first product, VISTIDE, is currently marketed in the United States for the treatment of cytomegalovirus (CMV) retinitis, a potentially sight-threatening infection in patients with AIDS. In addition, the company has product candidates in development for the potential treatment of herpes simplex virus, human immunodeficiency virus, hepatitis B virus, human papillomavirus and influenza. Gilead common stock is traded on The Nasdaq Stock Market under the symbol GILD.
Note to Editors: VISTIDE is a registered trademark of Gilead Sciences, Inc.
Additional written materials and recent releases regarding Gilead are available through the Gilead Fax-On-Demand Information Service by
dialing 1-800-276-7318.
CONTACT: Gilead Sciences, Inc.
Lana Lauher 415/573-4858 (Investor Inquiries)
Laurie Hurley 415/573-4894 (Media Inquiries)
or
Corporate Communications, 1-800-GILEAD-5
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