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| |  European Phase II/III Pivotal 3TC/AZT Data Published in Jama MONTREAL, July 9, 1996 -- BIOCHEM PHARMA INC. (TSE, ME: BCH NASDAQ: BCHXF) BioChem Pharma Inc. announced today that the two pivotal European Phase II/III studies conducted in AZT-experienced and AZT-therapy naive patients evaluating the effect of 3TCr in combination with AZT on surrogate markers of HIV were published in this week's July 10, 1996 edition of The Journal of the American Medical Association (JAMA). These studies, conducted by Professor Katlama et al. and by Professor Staszewski et al., were two of the four pivotal Phase II/III 3TCr/AZT combination studies which formed the basis of the registration dossiers submitted to regulatory authorities throughout the world last year seeking approvals of 3TCr for use in combination with AZT. 3TCr (Epivir(TM)) has been commercially available in the U.S. and Canada since end-1995. Additional approvals have since been granted in Australia, Switzerland, Brazil, New Zealand and Uruguay, with final approvals pending in several other markets worldwide including in Europe. Publication of European Phase II/III results in AZT-therapy naive patients - Katlama et al. In this 48-week (24 weeks double-blind, 24 weeks open-label) randomized, multicenter, comparative trial of 129 AZT-therapy naive patients whose CD4 counts on study entry were between 100-400 cells/mm3, the authors concluded that "the combination of 3TC and AZT results in a potent and sustained antiviral effect in antiretroviral-naive patients that is superior to that observed with AZT monotherapy." The authors reported that the combination of 3TC/AZT was well-tolerated with no differences between treatment groups. Nausea was the most commonly reported adverse event. Publication of European Phase II/III results in AZT-experienced patients - Staszewski et al. In this 48-week (24 weeks double-blind, 24 weeks open-label) randomized, multicenter, comparative trial of 223 AZT-experienced patients with CD4 counts on study entry of between 100-400 cells/mm3, the authors concluded that, "in AZT-experienced HIV-1 patients, combination treatment with 3TC and AZT is well-tolerated and provides greater and more sustained increase in CD4 cell counts and decreases in viral load than continued AZT monotherapy." The authors added that "the combination of 3TC/AZT was well-tolerated in this study, with the majority of adverse events reported related to underlying disease, associated infections, or recognized AZT side effects." The most frequently reported drug-related adverse event was nausea. Additional data from both of these studies continue to be collected. Katlama et al. have subsequently presented data out to 104 weeks to show that the effect of the combination of 3TC and AZT on viral load and CD4 cell count is sustained in patients for whom data was available. Further data being presented this week at the XI International Conference on AIDS in Vancouver, B.C. supports the authors' conclusions. Phase II/III 3TC/AZT Meta-analysis In a symposium hosted by Glaxo Wellcome and BioChem Pharma held in Vancouver earlier this week, Professor Staszewski from the Goethe Universitat in Frankfurt, Germany presented results from a meta-analysis of the four pivotal Phase II/III 3TC studies. The meta-analysis, a retrospective study of all four registration studies, was conducted in order to evaluate whether the surrogate marker changes observed in the 3TC/AZT combination studies would translate into clinical benefit. The analysis showed that the combination of 3TC and AZT is associated with a significant decrease in clinical progression compared to the control arms. While prospective clinical endpoint studies are underway with 1900 patients, the results from the meta-analysis provide a first indication of the likely clinical effectiveness of the combination. Staszewski concluded that the 3TC/AZT combination treatment corresponded to a 66 percent reduction in progression to a new CDC (Centre for Diseases Control) Class C alone event and to a 49 percent reduction in progression to a new CDC Class B/C event. Expanded Access Program Safety Data In addition, Dr. Marcus Conant from San Francisco presented data from the North American expanded access program which was established to provide 3TC to patients who had failed or were intolerant to other approved therapies with a CD4 count of 300 cells/mm3 or less on entry into the program. At the time 3TC was approved for use in the U.S. by the FDA in November 1995, this program had enrolled 32,000 patients from more than 1400 sites in North America. Patients in the program were seen monthly for clinical assessments and collection of laboratory safety data. Conant, who noted that this was the largest expanded access program ever undertaken, concluded that the safety profile reported in the patients receiving 3TC as monotherapy or in combination with AZT was similar to that reported from the four pivotal clinical trials. In addition, sessions at this and other satellite symposia have previewed triple combination therapy data to be presented at the Conference later this week. 3TC plus AZT, the most widely used combination treatment for HIV infection and AIDS in the U.S., is also the most widely used two-drug combination in triple drug regimens. A series of studies to be presented later this week will show that the addition of a protease inhibitor, such as indinavir, ritonavir, saquinavir or nelfinavir, to the combination of 3TC/AZT works to keep viral load to undetectable levels in a majority of patients, with some triple combination data extending out to 48 weeks. "We are pleased that the combination of 3TC and AZT has rapidly gained acceptance as the cornerstone of HIV combination treatment," stated Dr. Gervais Dionne, Executive Vice President, Research & Development of BioChem Pharma. "We believe that further studies to be presented later this week will serve to confirm the pivotal role played by 3TC/AZT in the treatment of HIV infection and AIDS." 3TC is approved under the trade name Epivir(TM) in the U.S., Australia, and Brazil and, as 3TCr in Canada, New Zealand, Uruguay and Switzerland. The European Union's Committee for Proprietary Medicinal Products (CPMP) voted in early 1996 in favor of recommending the approval of Epivir(TM) for marketing in Europe and the final decision on marketing approval by the European Commission is awaited. Under the terms of a license agreement between BioChem Pharma and Glaxo Wellcome, BioChem Pharma receives royalties based on sales of 3TCr (Epivir(TM)) worldwide, subject to special arrangements in Canada, where a Glaxo Wellcome BioChem Pharma partnership is commercializing 3TCr. BioChem Pharma is an international biopharmaceutical company dedicated to the research, development and commercialization of innovative products for the prevention, detection and treatment of human diseases. The Company's shares are traded on the Montreal and Toronto Stock exchanges (BCH) and on NASDAQ (BCHXF).
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