Monogram Provides Update on Trofile(TM) Co-Receptor Tropism Assay 12/1/2006
Pfizer Launches Multi-National Expanded Access Program for Maraviroc
SOUTH SAN FRANCISCO, Calif., Dec 01, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) announced today that its collaborator Pfizer, Inc. (NYSE: PFE) has separately announced plans to establish a multi-national Expanded Access Program (EAP) that will make its investigational CCR5 antagonist maraviroc available to HIV/AIDS patients who have limited treatment options due to resistance or intolerance. Monogram's co-receptor tropism assay, Trofile, 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.
"This investigational therapy represents a potential milestone in the treatment of HIV," said Monogram CEO William Young. "We applaud Pfizer's vision to sculpt a new model for drug development that so closely integrates advanced diagnostics into the clinical program. We are proud to be a part of this ground-breaking effort."
Pfizer also confirmed plans to submit applications for marketing approval of maraviroc in both the U.S. and EU following review of the data from the two currently ongoing Phase 3 clinical trials of the drug. The company expects to submit these study results for presentation at an upcoming HIV conference.
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's EAP is intended to provide access to maraviroc for patients who, in the opinion of the program investigators, have an urgent need for novel medicines because of viral resistance or intolerance to currently available therapies. To be eligible for the program, patients must be clinically stable with documented CCR5- tropic HIV-1 infection.
In a study presented at the International AIDS Conference in Toronto in August 2006 by scientists from Pfizer, the negative predictive value of Monogram's Trofile co-receptor tropism assay was assessed for maraviroc (Study 1029). Results show that patients identified by the assay as having virus using both the CXCR4 and CCR5 receptors (dual/mixed tropic) did not respond virologically to the investigational (CCR5) therapy. These data suggest that screening patients with the Trofile assay will allow physicians to optimize treatment regimens for their HIV patients.
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.
posted
Hmmm, they're working with Pfizer huh, Pfizer had really great news of their own yesterday too. It had a nice dip there right after opening bell.
-------------------- Rule 1: Always Protect Your Capital Rule 2: Earn slow, Don't lose fast
IP: Logged |
posted
This is too boring to watch, let the market makers have fun by themselves or whatever it is they do everyday. I'm gonna watch ENPT to see how it fluctuates.
-------------------- Best Regards and Good Trading
IP: Logged |
UBBFriend: Email this page to someone!
Printer-friendly view of this topic
