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Maraviroc Shows Significant Benefits in HIV Positive Patients
Jul 31, 2005, 21:23, Reviewed by: Dr.
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"We are pleased that FDA recognizes the value of maraviroc's innovative mechanism and the possibilities that a novel therapy brings to this high-medical need for a growing population."
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By Pfizer,
Results from early-stage clinical trials, presented today at the 3rd International AIDS Society Conference on Pathogenesis and Treatment, indicate that maraviroc, an investigational drug for treatment of HIV/AIDS, was well-tolerated and decreased patient levels of HIV significantly in 10-day monotherapy studies in asymptomatic HIV-positive patients.
Maraviroc works through a different mechanism of action from currently marketed drugs. In a category of compounds known as "CCR5-antagonists," maraviroc blocks HIV from entering white blood cells, where the virus replicates, takes over the cell's DNA for its own reproduction, and ultimately destroys a patient's immune system.
Safety data from six multi-dose phase 1/2a studies involving 259 healthy and HIV-positive volunteers showed that maraviroc's safety and toleration profile was similar to placebo in doses up to 300 mg twice-daily in short term studies, with headache, dizziness, nausea, asthenia, and flatulence as the most common adverse events reported. In two 10-day monotherapy studies in 63 patients, maraviroc reduced HIV viral load by 1.6-1.84 log (logarithmic measures of virus per milliliter of blood) at all total daily doses tested from 200 to 600 mg. The data also showed that maraviroc's efficacy did not change following dosing with or without food. All doses tested for efficacy from 200 mg total daily dose to 600 mg total daily dose caused a similar reduction in patient's viral load.
Pfizer researchers at the company's Sandwich, UK laboratories identified the lead compound that they ultimately refined to become maraviroc in 1997. Maraviroc is now in advanced development, currently enrolling worldwide phase 2b/3 trials. An independent Data Safety Monitoring Board (DSMB) comprised of international experts oversees these studies.
Independent of the data presented at the IAS conference, Pfizer also announced that the U.S. Food and Drug Administration has granted fast track designation for maraviroc's clinical development program. FDA based the fast-track designation on the potential for maraviroc's mechanism of action to meet an unmet medical need in HIV patients who have exhausted currently available options, the company said.
"We are pleased that FDA recognizes the value of maraviroc's innovative mechanism and the possibilities that a novel therapy brings to this high-medical need for a growing population," said John LaMattina, Ph.D., president of Pfizer Global Research and Development. "The data presented today support our continuing worldwide study of maraviroc." 
- The results were presented today at the 3rd International AIDS Society Conference on Pathogenesis and Treatment
www.pfizer.com
Pfizer is committed to bringing meaningful improvement to the lives of people living with HIV/AIDS and those at risk around the world. Our commitment is embodied in our products, partnerships, pipeline and philanthropy.
Through partnerships and focused philanthropic efforts, we strive to support HIV prevention efforts, build improved healthcare infrastructure and further access to HIV/AIDS medicines. Current initiatives include the US Southern States HIV/AIDS Prevention Initiative; the building of the Infectious Disease Institute in Kampala, Uganda; the Pfizer Global Health Fellows Program; and the Diflucan� Partnership Program.
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of July 26, 2005. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about a product candidate that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for the product candidate as well as their decisions regarding labeling and other matters that could affect its commercial potential; and competitive developments.
A further list and description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2004 and in its reports on Form 10-Q and Form 8-K.
http://www.pfizer.com
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