Progen prepares for accelerated clinical development of PI-88 following FDA meeting

By E. Janene Geiss

Philadelphia, May 16 - Progen Industries announced Tuesday that it has received notification from the Food and Drug Administration guiding the accelerated development of its anticancer drug PI-88.

The FDA has recommended that Progen submit a Special Protocol Assessment detailing the phase 3 clinical development plan, according to a company news release.

The assessment is an agreement that the phase 3 trial protocol design, clinical endpoints and statistical analyses are acceptable to the FDA to support regulatory approval. As a result, Progen said it will advance its liver cancer program to phase 3, thereby reducing the development timeframe of PI-88 by up to three years.

The FDA told Progen that it supports a registration approach based on a single pivotal trial. It said it supports an accelerated approval based on meeting the secondary endpoint of disease-free survival, rather than the primary endpoint of overall survival. The FDA said it also supports Progen advancing stage 1 of its current phase 2 trial directly to a phase 3 trial rather than executing stage 2 of the phase 2 trial. These three critical drivers will accelerate PI-88's development, officials said.

"[The company] 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," Justus Homburg, chief executive officer, said in the release.

So far, 172 patients with post-operative liver cancer have been involved in the phase 2 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, officials said.

Progen is a Brisbane, Australia, biotechnology company focused on small-molecule cancer therapeutics.

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