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Comments from Nelson Vergel:
Gang
As you know, GSK stopped their naive and treatment experienced studies of their entry inhibitor Aplaviroc due to liver toxicities. Now Schering has come up with a decision to stop their study of Vicriviroc in naive patients since it seems that their drug cannot really do the job of Sustiva (they were comparing Vicriviroc+Combivir versus Sustiva+Combivir for naive patients). Pfizer seems to be continuing with their naive and treatment experienced studies of their Maraviroc, but who the heck knows if they will surprise us also. TANOX seems to be moving ahead with their IV TNX 355 but theirs has been viewed as a "add-on:" on top of HAART also. Incyte's new nucleoside (old Reverset, now it is called dexelvucitabine (DFC)) has shown results that do not excite the community either.
This is teaching me several lessons:
1- Never assume that because a drug comes from a new class, it can replace anchor drugs that we have already and which are doing a pretty decent job in suppressing viral replication.
2- Be more cautious from now on about what the community accepts in naive trails. Naive patients may be exposed to unnecessary risks in an era when we have several drugs that work well for that population.
3- Start accepting the fact that many of the new drugs may be good "add-ons" to what we have , but not real replacements.
4- The "new wave" of drugs may not be as exciting, but this fact may change when we start seeing combination studies of these new agents, which is something the AIDS Treatment Activists Coalition is trying to advocate for. We are calling this : Multi-Experimental Agent Trials (MEAT). Without community activism, this may never happen since the FDA does not enforce collaboration and companies are not willing to chare pre-approval information with each other. In my opinion, this is one of the most important activist efforts that we will need to commit to in the next few months. If you want to get involved , join ATAC by going to their web site www.atac-usa.org and let them know you want to join the Drug Development Committee (DDC).
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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.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain “forward-looking” statements, including statements relating to the timing of clinical trials and the potential for vicriviroc. Forward-looking statements relate to expectations or forecasts of future events. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements. The forward-looking statements may be affected by general market and economic factors, uncertainties in the regulatory approval process, federal and state regulations and legislation, and other uncertainties described in the company's Securities and Exchange Commission filings under the heading “Disclosure Notice” including the company's second quarter 2005 10-Q. The company does not assume the obligation to update any forward-looking statement.
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.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain “forward-looking” statements, including statements relating to the timing of clinical trials and the potential for vicriviroc. Forward-looking statements relate to expectations or forecasts of future events. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements. The forward-looking statements may be affected by general market and economic factors, uncertainties in the regulatory approval process, federal and state regulations and legislation, and other uncertainties described in the company's Securities and Exchange Commission filings under the heading “Disclosure Notice” including the company's second quarter 2005 10-Q. The company does not assume the obligation to update any forward-looking statement.
Regards,
Nelson Vergel
Program for Wellness Restoration
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