Australian Biotechnology Firm To Test New Drug

Progen Industries has announced the commencement of two new studies of its drug compound PI-88 in treating two major diseases, cancer and cardiovascular disease. The healthy volunteer studies have begun in England, and will be completed by early 2001.

The objective of the first study is to compare the safety, tolerability and pharmacokinetic profile (concentration in the body over time) of PI-88 when administered subcutaneously (injection under the skin), rather than intravenously, with the aim that PI-88 can be administered in a subcutaneous form to oncology patients.

The second study will examine the safety and tolerability of rapid intravenous infusions of PI-88 in order to obtain an optimal anti-thrombotic effect when the drug is delivered intravenously as proposed for cardiovascular indications.

The study will run parallel to Progen's current phase 1b clinical trial of PI-88 in human cancer patients. The phase 1b trial has commenced at the Royal Melbourne Hospital and the Peter MacCallum Cancer Institute, Melbourne, with completion expected later this year. The information obtained from the phase 1b trial and the healthy volunteer studies will be used in the design of Progen's planned phase II trials.

The advantage of subcutaneous administration of PI-88 is that it can be administered either by the patient or the care-giver, similar to insulin injections. These healthy volunteer studies will provide us with information regarding the appropriate dose level and schedule of a subcutaneous mode of delivery that can be adopted in future trials with oncology patients. Researchers are exploring alternative methods of administration as the PI-88's clinical trial program is expanded in cancer patients.

The healthy volunteer study will also allow the examination of the anti-thrombotic effects and determine appropriate dose levels of intravenously delivered PI-88. This information is critical for planned clinical trials in cardiovascular disease, as PI-88 will be delivered at higher doses than in cancer patients for anti-thrombotic effect, and will be administered over a shorter time. The data obtained from the healthy volunteer studies will assist in the planning and design of the next phase of clinical trials with PI-88.

Progen is planning three phase II cancer trials and one phase I/II cardiovascular trial for PI-88. Each trial will be undertaken in a different cancer type and the specific cancers to be investigated are currently under review.