SYDNEY, Australia ¿ The volatile stock price of Brisbane-based Progen Industries Ltd. jumped sharply last week on the news of a successful preliminary trial of the company¿s antitumor drug PI-88.
Progen¿s disclosure amounted to a confirmation of the preliminary statement made in December and gave additional details about a planned trial in the U.S. The news was enough to push the company¿s share price up almost 10 percent in one day.
After starting last week at around A$4.20 (US$2.64), Progen¿s share price jumped to A$4.60 on the day of the disclosure, and continued climbing to finish Friday at A$5.25.
However, Progen¿s share price is known to swing wildly. In November, it was A$6, and it touched A$9.30 last May, after PI-88 received extensive coverage in the Australian media.
Progen managing director Alan Scott said that part of the variation in share price was due to shareholders¿ exercising options issued as part of the initial public offering. The additional shares of the market had diluted the stock and pushed the share price down, but because the strike price (that is, the price of the shares issued through the options) was just A$3.50, shareholders were still happy.
As previously announced by Progen, the U.K. trials involved administering large doses of PI-88 to a small but unspecified number of healthy volunteers, with no unexpected reactions observed.
Scott said the initial trial counted as a Phase I trial, with the company now planning a Phase I/IIa trial on 34 patients in the U.S., to start in May or June. The patients will have a range of solid-tumor cancers, including cancers of the breast and colon.
Scott said Progen representatives recently met with FDA officials in Washington, and the company is ¿clear to finalize¿ its investigational new drug application for Phase I trials.
That application should be finalized by May, and the company is preparing submissions to the ethics committees of various hospitals chosen to conduct the trial.
¿With preparations for the cancer trials already well advanced, we are currently on track to commence the trial as soon as approvals have been received,¿ Scott said.
PI-88 was developed by researchers at the John Curtin School of Medical Research, at the Australian National University, in Canberra. The molecule is a re-tailored polysaccharide with a sulphate chain attached, and inhibits the growth of new blood vessels around tumors, thus starving the tumors of blood. The molecule also helps prevent the spread of cancer cells to other parts of the body.