Progen Pharmaceuticals Limited announced that its investigational anticancer drug PI-88 has been awarded fast track status by the US Food and Drug Administration (FDA). The fast track designation has been granted to PI- 88 for the prevention of tumor recurrence following curative liver resection in patients with hepatocellular carcinoma (HCC, primary liver cancer).
Under the FDA Modernization Act of 1997, the fast track program is designed to facilitate the development and expedite the regulatory review of new drugs that demonstrate the potential to treat serious or life-threatening diseases where there is an unmet medical need. The fast track designation will enable Progen to file a new drug application (NDA) on a rolling basis as data becomes available. This permits the FDA to review the different components of the Drug Master File as they are completed in advance of receiving the final submission.
Justus Homburg, Progen's CEO commented, "This designation will speed the process of bringing this potentially clinically very important drug to patients with liver cancer. The FDA decision to award fast track status to PI-88 was based on recent phase II clinical data and the high unmet need for treatments for patients with resectable primary liver cancer. The key phase II study showed that PI-88 has the potential to improve the time a patient remains disease-free following surgery. As we enter the final stages of clinical development and commence a multinational phase III trial, we look forward to collaborating closely with the FDA to expedite the development and approval of PI-88."