|
|
作者：路透社 来自：路透社 发布时间：2004-3-17 |
|
|
| |
 制药大厂先灵（Schering-Plough，SGP）2月9日表示，其抗爱滋病毒（HIV）新药经初期试验证明安全而有效，且未发现损及心脏的严重副作用。此前，该公司类似药物在早期试验中曾有这项副作用。这种名为SCH-D的新药，可以阻止HIV进入人类白细胞并在其中繁殖。先灵将于2月10日在旧金山的逆转录病毒和机会性感染大会（Conference on Retroviruses and Opportunistic Infections）上公布第一阶段小规模试验的数据。不过，该公司2月9日事先公布了一份内含该试验主要数据的报告摘要。第一阶段试验由48名HIV感染者参加。这些患者分组分别接受每日两次、每次10、25、50毫克的SCH-D或安慰剂，并持续用药14天。先灵称，该药经证实安全且耐药性好，将中、高剂量组患者体内的HIV浓度减少到50分之一，其疗效接近于三种标准HIV疗法。但标准疗法是在病毒进入白血球细胞后再将其杀死。先灵高级研究主管劳克林（Mark Laughlin）博士表示，先灵计划在2004年上半年进行较大规模的第二阶段试验，通过48周或更长时间的试验观察该药的安全性和有效性。 Schering-Plough HIV drug safe, effective in trialMon February 9, 2004 05:44 PM ETNEW YORK, Feb 9 (Reuters) - Schering-Plough Corp. (SGP.N: Quote, Profile, Research) on Monday said its new type of pill for HIV was safe and effective in an early-stage trial, without a potentially serious heart side effect seen in a similar company drug tested in an earlier study.The pill, called SCH-D, is designed to prevent HIV from entering human white blood cells and reproducing inside them. Schering-Plough is racing rival drugmakers Pfizer Inc. (PFE.N: Quote, Profile, Research) and GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) to launch the first member of the new class of medicines, called CCR5 inhibitors.Schering-Plough will present data from the small Phase I trial on Wednesday at the annual meeting of the Conference on Retroviruses and Opportunistic Infections in San Francisco. An abstract containing main data from the study was made available on Monday.The trial involved 48 patients infected with HIV, divided into groups that for 14 days took either 10-, 25- or 50-milligram doses of SCH-D twice daily, or a placebo.The medicine proved safe and well tolerated and caused a 50-fold reduction in HIV among patients taking the medium and higher doses, the company said. That is similar in efficacy to three standard classes of HIV treatments, which work instead by attacking the virus after it has already entered CD4 white blood cells.Schering-Plough previously tested a similar CCR5 inhibitor, called SCH-C, which also drove down the HIV "viral load" among infected patients. But it raised the risk of causing a heart rhythm problem called QT prolongation, a delay in the time it takes the heart to electrically recharge itself."SCH-D is a better compound than SCH-C because it shows similar efficacy at a much smaller dose and doesn't pose the QT prolongation problem," said Dr. Mark Laughlin, a senior Schering-Plough research executive who will officially present the data on Wednesday.Laughlin said Schering-Plough aims to begin a larger Phase II trial of SCH-D in the first half of 2004, which could examine its safety and effectiveness over a 48-week period or longer.The HIV drug is one of the most important products in Schering-Plough's lineup of experimental medicines, along with an antifungal drug called Noxafil and the inhaled asthma treatment Asmanex.The Kenilworth, New Jersey-based drugmaker is counting on the medicines to help revive its earnings, which tumbled almost 80 percent last year when Schering-Plough's allergy pill Claritin lost U.S. patent protection and became available over the counter at a fraction of its previous price.Schering-Plough and Pfizer have said a key potential advantage of CCR5 inhibitors as a new class of medicines is that they work against types of HIV that have become resistant to existing medicines. Pfizer has already completed Phase II studies of its rival medicine, called UK-427,857, and plans to begin Phase III, or late-stage, trials within the next few months.The Pfizer drug also drove a 50-fold reduction in HIV without causing QL prolongation or troublesome interactions with other medications."We're a year ahead of Schering-Plough's drug but speed is not the important thing. The key thing is achieving quality trial data," said Chris Hitchcock, a biologist who led the Pfizer team that discovered UK-427,857 at company laboratories in Sandwich, England.Swiss drugmaker Roche (ROG.VX: Quote, Profile, Research) and partner Trimeris (TRMS.O: Quote, Profile, Research) last year launched Fuzeon, which was the first drug to stop HIV from getting into CD4 white blood cells.But Fuzeon, which works by attaching to a protein called gp41, has had poor sales because it must be injected twice daily.Pfizer and Schering-Plough, whose pills block receptors to a protein called CCR5, hope the greater convenience of their products will make them commercial successes. |
|
