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CCR5 Maraviroc EAP, Monogram Provides Update on Trofile(TM) Co-Receptor Tropism Assay
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Pfizer announces maraviroc NDA filed with priority review by FDA
Overview of the Maraviroc EAP
http://www.maravirocEAP.com
Maraviroc is an investigational drug being developed for use in combination with other antiretroviral medications for the treatment of human immunodeficiency virus, type-1 (HIV-1) infected treatment-experienced patients.
Maraviroc uses a new mechanism of action that blocks viral entry into human cells by binding to the chemokine (C-C motif) receptor 5 (CCR5) co-receptor located on the surface of the CD4 cell. It belongs to a new class of drugs known as CCR5 antagonists. The mechanism prevents HIV from entering target cells thereby preventing the initiation of HIV's replication cycle. This is different from currently available oral HIV/AIDS antiretroviral drugs (such as protease inhibitors, nucleoside reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors) which work by inhibiting HIV/AIDS replication intracellularly. Maraviroc has also been shown in vitro to be effective against HIV/AIDS strains that are resistant to the current classes of HIV/AIDS antiretroviral agents.
Maraviroc, in combination with other antiretrovirals, is currently under development for the treatment of HIV. The trials, MOTIVATE-1 and 2 (Maraviroc Plus Optimized Therapy In Viremic Antiretroviral Treatment-Experienced Patients), represent 24-week data of Optimized Background Therapy (OBT), with or without maraviroc, in over 1,000 highly treatment-experienced patients with CCR5-tropic HIV-1.
The purpose of the maraviroc EAP is to provide access to maraviroc for patients who have limited or no other treatment options. This study will also permit collection of safety data in a larger and diverse population. It will also evaluate the effectiveness of maraviroc in treatment-experienced patients who are followed according to local medical practice.
The program has the capacity to enroll up to 6000 men and women worldwide.
SOUTH SAN FRANCISCO, Calif., Feb. 13 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (NASDAQ: MGRM) announced today that its collaborator Pfizer, Inc. (NYSE: PFE) has separately announced today that the U.S. Food and Drug Administration (FDA) has granted priority review status and the European Medicines Agency (EMEA) has agreed to the accelerated review procedure for the marketing authorization applications for maraviroc, potentially the first in a new class of HIV treatments. Pfizer submitted the U.S. and EU applications in December 2006 for maraviroc as treatment for antiretroviral-experienced patients with a specific strain of HIV (CCR5-tropic HIV-1).
Priority Review is granted by FDA to products that, if approved, would be a significant improvement compared to existing approved therapies. The goal for reviewing a product with Priority Review status is six months from the filing date, rather than the typical review period of up to one year.
Monogram's co-receptor tropism assay, Trofile(TM), was used for patient selection for maraviroc's clinical development program, and the two companies are engaged in a collaboration agreement to make Monogram's assay available for patient use on a global basis. "Throughout the clinical development of maraviroc, physicians and patients relied on Trofile to predict a patient's likelihood for response," said Monogram CEO William Young. "We believe this new model of drug and diagnostic collaborations will create a more personalized and effective treatment for patients with HIV."
Maraviroc is designed to work differently from other available HIV medications. CCR5 antagonists block the virus from gaining access into healthy cells via the CCR5 co-receptor, a common pathway for viral entry. Monogram's Trofile co-receptor tropism assay identifies whether individual strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co- receptors to infect healthy cells. This helps clinicians determine whether a CCR5 antagonist like maraviroc may be a good therapeutic option for treating individual patients. Pfizer expects to present the results of a phase III study of maraviroc at an upcoming scientific meeting.
Maraviroc and other entry inhibitors currently in development come at a time when increasing drug resistance makes treating HIV more difficult than ever. Highly sensitive and precise diagnostic tools are playing an ever more important role in the development of new therapeutic approaches that give new hope to physicians and patients running low on options.
About Monogram Biosciences, Inc.
Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at http://www.monogrambio.com/.
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