Progen Prepares for Accelerated Clinical Development of PI-88 Following FDA Meeting Tuesday May 16, 5:53 am ET
BRISBANE, Australia, May 16 /PRNewswire-FirstCall/ -- Progen Industries (Nasdaq: PGLAF - News; ASX: PGL - News) today announced it has received notification from the US Food and Drug Administration (FDA) guiding the accelerated development of its anti-cancer drug PI-88. The FDA has recommended that Progen submit a Special Protocol Assessment (SPA) detailing the Phase III clinical development plan. An SPA is an agreement that the Phase III trial protocol design, clinical end-points and statistical analyses are acceptable to the FDA to support regulatory approval. As a result, Progen will advance its liver cancer (Hepatocellular Carcinoma) program to Phase III, thereby reducing the development timeframe of PI-88 by up to three years.
There are three critical drivers that will accelerate PI-88's development: * the FDA supports a registration approach based on a single pivotal trial; * the FDA supports an accelerated approval based on meeting the secondary end-point of disease-free survival (that is the time for the disease to recur), rather than the primary end-point of overall survival; * Progen will advance Stage 1 of its current Phase II trial directly to Phase III, rather than executing Stage 2 of the Phase II trial before proceeding to Phase III.
"Progen is strongly committed to pursuing this accelerated path to successfully commercialise PI-88," said Mr. Justus Homburg. "This is an important milestone for the Company. It has expedited the entire clinical program, and will result in PI-88 being launched to market much earlier than anticipated. The financial benefit to Progen is very significant."
So far, 172 patients with post-operative liver cancer have been involved in the Phase II clinical trial program executed by Progen and its Taiwan-based strategic partner Medigen Biotechnology. Liver cancer is the leading cause of cancer death in most Asian countries and is a rapidly growing cause of cancer deaths in North America. Because it limits metastasis and tumor growth, Progen's PI-88 is especially well-suited to a post-operative setting where there is a low tumor burden. Additionally, there are currently no registered drugs for the post-operative treatment of liver cancer and few new compounds are in development.
Progen CEO Justus Homburg will host an investor call in on Wednesday 17 May at 9.30am Australian EST (4:30pm PDT Tuesday 16 May, 7:30pm EDT). Please follow the dial-in instructions below: