Progen Pharmaceuticals Limited has announced that its investigational anti-cancer drug PI-88 has been awarded Fast Track status by the U.S. 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.
Mr. 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 2 clinical data and the high unmet need for treatments for patients with resectable primary liver cancer. The key Phase 2 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 3 trial, we look forward to collaborating closely with the FDA to expedite the development and approval of PI-88."
Conservatively, over half a million new cases of HCC are diagnosed worldwide each year, making it the fifth most common cancer and the third major cause of deaths due to cancer worldwide. The most common causes of HCC are related to chronic infection with hepatitis B and C (HBV, HCV). Due to late disease diagnosis, currently only about 25% of patients are eligible for surgery and half of those patients will have their disease recur within 12-15 months. No products have been approved by the FDA to prolong the time a patient remains disease free following surgery.