BioChem Pharma Inc. - Epivir 3TC clinical endpoint study stopped early results show significant reduction in HIV disease progression or death.LAVAL, Quebec--(BUSINESS WIRE)--July 23, 1996-- BioChem Pharma Inc. today announced that a study to determine the effect of the anti-HIV therapy 3TC(R) (Epivir(TM)) on survival or delay in disease progression has been stopped after an interim analysis of data showed a 54 percent reduction in the rate of progression to AIDS or death for HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. patients who had 3TC in their treatment regimen, compared to placebo. The trial, begun in March 1995, was originally scheduled to end in March 1997. The study was designed to investigate the clinical efficacy of adding 3TC to patients' existing anti-HIV therapy, or adding 3TC to AZT AZT or zidovudine (zīdō`vy  dēn'), drug used to treat patients infected with the human immunodeficiency virus (HIV), which causes AIDS; also called for patients who were not receiving therapy at study entry. The most common existing therapy among patients recruited into the study was AZT alone. Discontinuation of the study nearly eight months early was recommended by an independent Data Safety and Monitoring Board (DSMB DSMB Data & Safety Monitoring Board Clinical research A committee of independent clinical research experts who review data in ongoing clinical trials, ensuring that participants are not exposed to undue risk, and look for any differences in effectiveness ) following a scheduled interim analysis of data from the trial. The recommendation was made on the basis of data which exceeded the pre-specified requirements for possible discontinuation due to the superior efficacy of one treatment arm. The trial's coordinating committee endorsed the DSMB recommendation. "Members of the DSMB have reviewed the results of this study and unanimously recommend the discontinuation of the trial to allow all participants access to the 3TC/AZT combination," said Professor Ragnar Norrby, Chairman of the DSMB and a clinician at the University of Lund, Sweden. The clinical endpoint study, known as CAESAR, an acronym of the countries involved in the study, (Canada, Australia, Europe, South Africa), was initiated in March 1995. Patients recruited into the study had CD4 counts of between 25 to 250 cells/mm3 and were currently receiving one of three "background" treatments - AZT alone, AZT + ddI or AZT + ddC. Patients were then randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to one of three regimens: their current HIV therapy plus 3TC; current HIV therapy plus 3TC and loviride (investigational non-nucleoside reverse transcriptase inhibitor Noun 1. non-nucleoside reverse transcriptase inhibitor - an antiviral drug used against HIV; binds directly to reverse transcriptase and prevents RNA conversion to DNA; often used in combination with other drugs NNRTI ; Janssen Pharmaceutica); or, current therapy plus placebo. Results from the scheduled interim analysis of the data were reviewed by the DSMB on July 15, 1996. These results showed that amongst the 1,892 HIV positive patients recruited, progression to the combined endpoint of AIDS or death was reduced by 54 percent for those treated with 3TC compared to placebo. The addition of 3TC also resulted in a significant survival benefit when assessed alone. The addition of loviride was not shown to provide additional clinical benefit to that seen with 3TC in the overall trial. Additional analyses are underway to determine the effect of loviride within specific groups of the study population. The addition of 3TC or loviride to the existing treatment regimens resulted in no additional clinical or laboratory side effects Side effects Effects of a proposed project on other parts of the firm. over the control arm. All three arms were generally well tolerated with 5 percent of patients receiving current therapy plus placebo, 3 percent of patients receiving current therapy plus 3TC and loviride and only 2 percent of patients receiving current therapy plus 3TC withdrawing from the study due to adverse events. Today's news comes on the heels of several major presentations of data two weeks ago in Vancouver, BC, at the XI International Conference on AIDS in which the addition of a third drug to the cornerstone combination of 3TC/AZT resulted in unmeasurable plasma HIV RNA HIV RNA AIDS RNA of HIV origin, a serum marker of a Pt's 'HIV-ness,' now the standard by which Pt response to antiretovirals is evaluated; HIV RNA levels correlate with CD4+ count, response to antiviral therapy, clinical stage and disease progression. levels in many patients. The results reported today also support the findings of a meta-analysis presented in Vancouver which suggested that the combination of 3TC/AZT may have been associated with a delay in disease progression in the four pivotal clinical trials on which the drug's accelerated approval was based. Epivir is now approved in the US and Brazil and, under the trade name 3TC, in Canada, New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. , Uruguay, Australia, South Africa and Switzerland. The European Union's Committee for Proprietary Medicinal Products (CPMP CPMP Committee for Proprietary Medicinal Products CPMP Core-Plus Mathematics Project CPMP Crew Procedures Management Plan (NASA) CPMP Canadian Project Management Professional CPMP Corporate Planning and Management Practices ) voted in April 1996 in favor of recommending the approval of Epivir 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 receives royalties based on sales of 3TC(R) (Epivir(TM)). Under the terms of the agreement, Glaxo Wellcome has the right to develop, manufacture and sell 3TC(R) (Epivir(TM)) worldwide, subject to special arrangements in Canada, where a Glaxo Wellcome BioChem partnership is commercializing 3TC(R). 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 Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. (BCH BCH Beach BCH Banco Central de Honduras BCH Boot Console Handler BCH Boulder Community Hospital (Boulder, CO, USA) BCH Broadcast Channel BCH Belfast City Hospital BCH Banco Central-Hispano ) and on NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on (BCHXF). CONTACT: BioChem Pharma Inc. Christine Lennon, 514/978-7938 REPEATS: New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of 212-752-9600 or 800-221-2462; Boston 617-236-4266 or 80 |
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