Halozyme Therapeutics公司宣布暂停旗下在研胰腺癌治疗药物的II期临床试验，以评估该药物的安全性。
这家总部设于美国加州的生物制药公司声称，公司只是暂时停止代号为PEGPH20胰腺癌治疗药物202临床试验的受试者招募和给药工作，在此期间公司将研究PEGPH20所引起的凝血风险。Halozyme公司是基于一个独立数据监测委员会的建议而做出上述决定的，已有的临床数据显示，PEGPH20给药组患者的血栓栓塞事件发生率高于非PEGPH20给药组，该委员会目前计划评估相关的临床试验数据。对于暂停受试者招募及给药工作，Halozyme表示这是在数据监测委员会在进行数据评估过程中的预防措施。
凝血风险也是其他抗肿瘤药也存在的一个问题，比如最近在一些患者发生血栓栓塞事件后，Ariad公司的抗白血病药物Iclusig就停止了相关试验，并在美国和欧洲接受安全性调查。FDA最初暂停了Iclusig在美国的销售，随后在修改适应证以及说明书黑框警告后，FDA才恢复了Iclusig的销售。在附加安全建议提示相关风险后，EMA也允许Iclusig在欧洲继续销售。
对于PEGPH20未来的命运，Halozyme公司CEO，Helen Torley表示，“患者的安全是我们优先考虑的问题。我们会尽快向数据监测委员会提供其他信息，以便委员会完成评估工作，我们也可以决定接下去的步骤。”
FDA orders halt to Halozyme testing
The Food and Drug Administration has placed a clinical hold on a pancreatic-cancer drug being tested by Halozyme Therapeutics, the company said Wednesday.
The agency took such action because of the medication's potential to cause blood clots in patients undergoing testing with the drug.
Halozyme, a biotech firm based in San Diego, already said last weekthat it had voluntarily halted enrollment and dosing of the drug, PEGPH20, in patients with pancreatic cancer.
Halozyme said on April 4 that an independent data monitoring committee had reported the blood clot issue, and that it decided to halt the study pending further analysis of the problem.
Shares of Halozyme traded at $8.12 apiece at closing time Wednesday -- down 17 cents, or ab0ut 2 percent. On Thursday, the day before Halozyme's announcement, shares had closed at $11.59 each.
PEGPH20 is meant to help cancer drugs better reach their target by removing abnormally high levels of a substance called hyaluronan from the area surrounding a tumor. Hyaluronan can reduce the tumor's permeability to medication by restricting blood flow and increasing fluid pressure in that tumor.
PEGPH20 is a modified form of Halozyme's Hylenex drug, which is injected subcutaneously to make that layer beneath the skin more permeable to fluids. Hylenex only acts at the injection site and is destroyed in the blood. PEGPH20 is designed to last longer and to survive in the blood, so that it can be given intravenously.
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