US FDA Fast Tracks PI-88 for the Treatment of Post Resection Liver Cancer
Under the FDA Modernization Act of 1997, the fast track program isdesigned to facilitate the development and expedite the regulatory review ofnew drugs that demonstrate the potential to treat serious or life-threateningdiseases where there is an unmet medical need. The Fast Track designation willenable Progen to file a New Drug Application (NDA) on a rolling basis as databecomes available. This permits the FDA to review the different components ofthe Drug Master File as they are completed in advance of receiving the finalsubmission.
Mr. Justus Homburg, Progen's CEO commented, "This designation will speedthe process of bringing this potentially clinically very important drug topatients 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 fortreatments for patients with resectable primary liver cancer. The key Phase 2study showed that PI-88 has the potential to improve the time a patientremains disease free following surgery. As we enter the final stages ofclinical development and commence a multinational Phase 3 trial, we lookforward to collaborating closely with the FDA to expedite the development andapproval of PI-88."
Conservatively, over half a million new cases of HCC are diagnosedworldwide each year, making it the fifth most common cancer and the thirdmajor cause of deaths due to cancer worldwide. The most common causes of HCCare related to chronic infection with hepatitis B and C (HBV, HCV). Due tolate disease diagnosis, currently only about 25% of patients are eligible forsurgery and half of those patients will have their disease recur within 12-15months. No products have been approved by the FDA to prolong the time apatient remains disease free following surgery.
The fast track designation is fully aligned with Progen's Phase 3 trialdesign. The double blinded, placebo-controlled Phase 3 trial will be poweredfor the primary endpoint of disease-free survival determining if PI-88 canprevent early recurrence following curative hepatic surgery. The trial willbegin later this year and targets 600 patients with liver cancer postresection, in more than a dozen countries.
Progen Pharmaceuticals Limited is an Australian-based globally focusedbiotechnology company committed to the discovery, development andcommercialization of small molecule therapeutics primarily for the treatmentof cancer.
PI-88 is one of a new class of multi-targeted cytostatic cancertherapeutics. It is a novel anti-cancer compound with a first-in-classmechanism as a heparan sulfate mimetic. Its anti-tumor activity is based oninhibition of two biological processes - angiogenesis (the growth of new bloodvessels) and metastasis (the spread of cancer to other sites) - critical tothe growth and progression of cancer. In a Phase 2 trial in post-resectionliver cancer, PI-88 demonstrated a 25% improvement in the primary endpoint ofdisease-free rate at 48 weeks and 78% improvement in secondary endpoint ofdisease-free survival. These results, combined with positive feedback from theFDA, provide Progen with confidence in the potential of PI-88 for thisindication and we are therefore aggressively pursuing its development towardsregistration and commercialization.Progen Information: Justus Homburg Progen Pharmaceuticals Limited T: +61 7 3842 3333 E: firstname.lastname@example.org Noreen Dillane Progen Pharm
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