SYDNEY, Australia ¿ Investors have pushed up the share price of Progen Industries Ltd., in expectation of the Brisbane-based company becoming the first company to run FDA-approved trials in Australia.
Progen managing director Alan Scott said that, once approval is given, as far as he knows, Progen will be the first Australian company to run FDA-approved trials in Australia.
He said many drug trials have been held in the country, and some met FDA requirements without being approved by the U.S. body before being held. But the trial being planned by Progen will be the first FDA-approved trial held in Australia.
Pre-approval meant that the FDA was happy with the way the trial was to be conducted and so would consider the results. Progen said it hopes to receive approval this week for a trial which, the company said, might involve between 30 and 60 patients in testing Progen¿s prime compound, PI-88.
Because PI-88 affects the blood supply to solid tumors, the company said it can be used on a range of solid tumors.
Scott said the trials will involve patients with a range of solid tumor cancers, including colon, lung and breast cancer tumors, and will mainly check the toxicity of the drug. But, if the compound has noticeably beneficial effects, the trials could be extended. The company previously said it hoped to develop the drug to the end of Phase II tests, before accepting a major pharmaceutical partner for the Phase III tests.
Last week, speculation that the FDA would approve the trial pushed the share price up from A$4.60 (US$2.94) to an intra-day high of A$5.15 on Wednesday, and the stock has so far held its gains. On Friday, the share price closed at A$5.08.