KENILWORTH, N.J., March 3 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today provided an update on vicriviroc, its investigational CCR5 receptor antagonist, currently being evaluated by the NIH-sponsored Adult AIDS Clinical Trials Group (ACTG) in an ongoing Phase II clinical study of 118 U.S. treatment-experienced HIV patients. Patients who entered this trial were heavily treatment experienced with advanced HIV disease and low CD4 counts. The ACTG Study Monitoring Committee (SMC) for this trial has informed the ACTG and Schering-Plough that five cases of malignancy have been observed in patients treated with vicriviroc. The five cases included four patients with lymphoma and one patient with gastric adenocarcinoma (stomach cancer). The ACTG has concluded that a causal association between vicriviroc and the lymphoma cases could not be established at this time. ACTG further concluded that since vicriviroc, at the two highest doses tested, together with an optimized background antiretroviral regimen showed evidence of virologic activity and CD4 count increases, the trial will continue.
Patients and investigators in the trial are immediately being informed of these results. ACTG is taking additional measures to assure the safety of patients in the trial. These include introducing long term follow-up (3-5 years) and unblinding the patients in order that they and their physicians may make a more informed decision about their treatment options. Schering-Plough intends to continue to work closely with the ACTG as well as the U.S. Food and Drug Administration and other Health Authorities to fully determine the potential role of vicriviroc in HIV therapy.
Schering-Plough 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 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com/.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements relating to the timing of clinical trials and the potential market for vicriviroc. Forward- looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering- Plough's Securities and Exchange Commission filings, including Item 1A. Risk Factors in the Company's 2005 10-K.
