SYDNEY — Preliminary results from a healthy-volunteer trial for the PI-88 product being developed by Australian company Progen Industries Ltd. has cleared the way for the drug to be tested in cancer patients by May and June of next year.
Progen Chairman Alan Scott said that the trial uses the different regulations of the British health system to initially test for the maximum dose that can be administered. It is not a Phase I trial.
He said the healthy-volunteer trial will not be completed until February, and the maximum dose has not yet been established, but preliminary results show large doses of PI-88 have no unwanted side effects on healthy subjects.
The next tests will explore the efficacy of the drug, which treats solid tumors, but will look at the effect in a range of major cancers, including breast and colorectal cancer. Many of the details of the tests have not been established, but the company expects to test more than 30 subjects. A statement issued by Progen to the Australian stock exchange states that the subjects in the healthy-volunteer trials show no clinically significant physical changes.
The statement said initial preparations for the cancer trials had begun, and the company signed a contract with U.S.-based cancer-trial expert, Gail Eckhart, to advise on design.
Eckhart is a member of the angiogenic task force of the National Cancer Institute, and has been a principal investigator in a number of cancer trials. Australian cancer trials could begin as early as May or June 1999, but that time frame will depend on the completion of the healthy-volunteer trial and on the FDA's approval of an investigational new drug application made by Progen, the statement 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 is believed capable of halting the action of the enzyme heparanase, common to all tumor cells. Because heparanase is a vital link in the mechanism by which a tumor cell burrows into a blood vessel wall, blocking the enzyme helps prevent the spread of secondary tumors.
The share price of Progen, which swung wildly earlier this year after the company received considerable publicity, jumped by A20 cents to A$5.00 (US$3.07) after last week's announcement and has since stayed around A$5.00. *