sexta-feira, outubro 28, 2005
Schering pára ensaio clínico do vicriviroc em naives
Desta vez, não é por causa de toxicidade (GSK) mas por falta de eficácia.
Sobra ainda o CCR5 da Pfizer...
Dear HIV Community,
Schering-Plough Corporation is issuing the below press release this evening, announcing the termination of its phase II trial in treatment-naive patients living with HIV. The trial was stopped based on the recommendation of the DSMB after a return of detectable virus was observed in some patients late in therapy who were in the vicriviroc-containing arm of the study, vs. the control arm of Combivir + Sustiva.
This decision was not based on hepatotoxicity or other significant safety issues in patients receiving vicriviroc in the study or in a second phase II study in treatment-experienced HIV patients, which is continuing.
While we are disappointed with this development, we will continue to evaluate the potential use of vicriviroc in combination with other treatment regimens, including those used in the treatment-naïve patient population.
Director, Global Product Communications and Advocacy Relations
SCHERING-PLOUGH DISCONTINUES PHASE II STUDY OF VICRIVIROC IN TREATMENT-NAÏVE HIV PATIENTS,CONTINUES PHASE II STUDY IN TREATMENT-EXPERIENCED HIV PATIENTS
Press announcement from Schering-Plough
KENILWORTH, Oct. 27, 2005
Schering-Plough Corporation (NYSE: SGP) today reported that it has discontinued a Phase II study with its investigational CCR5 receptor antagonist, vicriviroc, used in combination with Combivir in treatment-naïve HIV patients. This decision was due to a return of detectable virus in some patients late in therapy compared to the control regimen of Combivir and Sustiva, a current standard of care for treatment-naïve patients living with HIV.
The company noted that this decision was not based on hepatotoxicity or other significant safety issues in patients receiving vicriviroc in the study or in a second Phase II study in treatment-experienced HIV patients, which is continuing. The Phase II study in U.S. treatment-experienced patients is being conducted by the NIH-sponsored AIDS Clinical Trials Group (ACTG) and is fully enrolled.
Schering-Plough said that it discontinued its Phase II treatment-naïve study following a recommendation from the independent Data Safety Monitoring Board (DSMB), which has been meeting regularly to conduct reviews of the safety and efficacy data. The increased incidence of detectable virus was only seen in some patients after several weeks of treatment. The study had been under way since spring 2004 in 23 centers in Europe and Canada, with 92 patients enrolled. Patients already enrolled in the treatment-naïve study will continue to receive vicriviroc until they can be switched to an alternative regimen in consultation with their physician. Clinical trial investigators for the study, their Ethics Committees and Health Authorities are being notified.
“We believe this decision is the appropriate action to take to ensure that patients receive the most effective treatment available,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. “We will continue to evaluate the potential use of vicriviroc in combination with other treatment regimens, including those used in the treatment-naïve patient population.”
Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company's Web site is www.schering-plough.com.