Progen Industries Ltd has completed the PI-88 Phase II trial in Multiple Myeloma and achievement of the study's primary efficacy endpoints. The primary endpoint of the study was to investigate clinical efficacy in patients who had exhausted other treatment options. For the purposes of this study, a clinical response was prespecified as patients remaining stable or experiencing a decrease in blood levels of paraprotein (a marker of multiple myeloma disease severity). This endpoint was achieved in 39% of patients in the study.
The Phase II trial was conducted in three centres in Australia: The Alfred Hospital in Melbourne, the Newcastle Mater Misericordiae Hospital and the Wesley Hospital in Brisbane under the guidance of principal investigators Drs. Andrew Spencer, Arno Enno and John Bashford. Nineteen patients were enrolled in the study. All patients had relapsed or refractory multiple myeloma, which means their tumours had either responded to chemotherapy and then progressed, or had never responded to chemotherapy. Patients were treated with PI-88 subcutaneously, on four consecutive days each week and were monitored for levels of paraprotein.
Dr. Robert Don, Vice President for Research and Development at Progen said. "PI-88 activity has been seen in this disease and these results indicate that stabilization of multiple myeloma with PI-88 with acceptable side effects is possible. The PI-88 clinical trial program has been deliberately designed to investigate PI-88's safety and efficacy across a range of cancers to ensure a comprehensive data package is available."
Progen Managing Director Lewis Lee commented, "The completion of this Phase II trial is an important milestone for demonstrating the company's ability to discover, develop and trial new drugs. There is no doubt this core competency will be a critical component of our business strategy for progressing other drug candidates through the clinic. In conjunction with the increasing revenue and profitability in our Life Sciences and Contract Manufacturing Divisions, commercialising R&D investments will help cement Progen's image as an innovative and competitive biotechnology company."
Progen has recently formed a new business development team to embark on licensing Progen's lead candidates to pharmaceutical and biotechnology companies. The team is led by Dr. Darren Schliebs, Vice President for Business Development. Dr. Schliebs brings business development and licensing expertise, gained in the US market, coupled with a strong background in scientific research and biotechnology. He believes the timing is right for Progen to bring in a valuable licensing deal. "With the recent advances in the area of angiogenesis [blood vessel growth] -- for example, US biotech Genentech's favourable Phase III Avastin results combined with chemotherapy in advanced colorectal cancer, people are refocusing on this field for new cancer therapies. With the current and anticipated data from our clinical program Progen is building an attractive licensing package for PI-88. I am excited to be involved in such an innovative drug discovery and development program," said Dr. Schliebs.