ABN 82 010 975 612
FDA PROVIDES MANUFACTURING CLEARANCE FOR PHASE III TRIAL OF ANTI-CANCER
- Receives green light from the Food and Drug Administration (FDA) to manufacture PI-88 for upcoming Phase
- Manufacturing in-house saves Progen approximately AUD$7.8 m in outsourcing fees
- Successful FDA meeting forms basis for New Drug Application (NDA) Chemistry Manufacturing and Control
(CMC) section submission
BRISBANE, AUSTRALIA 29 NOVEMBER 2006. Progen Industries (ASX: PGL; NASDAQ:
PGLA) today announced it has received notification from the U.S. FDA that the appropriate CMC procedures
have been put in place to progress its anti-cancer drug PI-88 to Phase III clinical trials.
This notification follows Progen's End-of-Phase II CMC meeting with the FDA, held on 24 October, and gives
Progen the "green-light" to manufacture PI-88 for its upcoming Phase III clinical trial. Manufacturing the first step
of PI-88 in-house saves Progen approximately AUD$7.8 million in outsourcing fees to a contract manufacturing
Progen's facility in Darra will manufacture the first step in the process, while a large U.S.-based contract
manufacturing company has been contracted to produce the final active ingredient (API), PI-88. Up to 150,000
doses of PI-88 will be manufactured in advance of the Phase III trial starting in mid-2007.
The End-of-Phase II CMC meeting plays a critical part in the rapid development of drugs with the FDA. At the
meeting, the details on the specifications, stability and release procedures for the active ingredient and the final
product were reviewed and discussed. No issues were identified that would delay the manufacture of the Phase
III product. Holding this meeting now avoids manufacturing related delays for the Phase III trial and forms the
basis for proceeding efficiently to submitting PI-88's CMC section of the NDA with the FDA.
The first step of manufacturing PI-88 will continue to be carried out at the P