PGLAF Progen Industries

Results of PI-88 Phase II Clinical Trial in Melanoma Presented at ASCO BRISBANE, Australia, May 16 /PRNewswire-FirstCall/ -- Progen Industries Limited (NASDAQ:PGLAF)(ASX:PGL) today announced results from a Phase II melanoma pilot clinical trial. Key outcomes of the trial are as follows: -- Treatment with the Company's PI-88 cancer therapy delivered as a single agent was associated with an acceptable safety profile and signs of benefit in some patients with advanced melanoma. -- 44 patients were enrolled in the Phase II trial, with 37 being evaluable for efficacy. -- One patient had a partial response and another 10 patients had stable disease (3 with long term clinical benefit) as determined by industry recognized RECIST criteria. -- The median survival rate of the patients on this trial was 9.0 months. Survival seen in this study is comparable to that seen in clinical trials of other melanoma therapies. It is difficult to compare data from different trials because of varied patient populations, however a pivotal Phase III randomized trial resulting in the registration of the drug temozolomide in Australia, in which 305 patients were treated with dacarbazine (DTIC) or temozolomide, showed a median survival of 6.4 and 7.7 months respectively.(1) The data seen in this Phase II study, in which a substantial number of patients had clinical benefit for prolonged periods, has resulted in the PI-88 melanoma program progressing to a larger randomised Phase II melanoma trial, which will investigate PI-88 as first line treatment in combination with chemotherapy agent DTIC, compared with DTIC alone. This trial forms part of the Company's Phase II program in which PI-88 is being investigated in lung cancer (non small cell) in combination with Taxotere(R) (docetaxel), multiple myeloma, liver cancer (hepatocellular carcinoma) adjuvant therapy -- post-surgery and melanoma. Progen Managing Director Lewis Lee commented. "The data from this PI-88 Phase II trial are encouraging. These have provided the Company and the investigators sufficient evidence and justification to enter a combination trial of PI-88 and DTIC and continue our partnering initiatives for PI-88." PI-88 Clinical investigator Dr Damien Thomson said " These new data provide further support for the investigation of PI-88 and provides us additional confidence to examine the potential benefit of PI-88 as 'first line' treatment of metastatic melanoma in combination with chemotherapy agent dacarbazine (DTIC), where we hope the drug will provide additional benefit to patients." Dr Brian Creese, Ph.D., Progen's Head of Clinical Development, added "All of these early but encouraging data that have emerged from this trial are consistent with what we might expect from PI-88's mechanism. The aim of the PI-88 clinical development program is to provide a new treatment option for physicians and patients in several severe cancer types." The company yesterday announced the Underwriting of the exercise of the current May 2005 listed Options, effectively increasing cash reserves by approximately A$8.93 million. A detailed Clinical Trial Data Summary is posted on our website: http://www.progen.com.au/ (1) Middleton MR et al. Randomized Phase III Study of Temozolomide Versus Dacarbazine in the Treatment of Patients with Advanced Metastatic Melanoma. Journal of Clinical Oncology. Vol 18(1). Jan 2000. pp.158- 166 Contact: Sarah Meibusch (Progen) T: +61 7 3273-9100 E: DATASOURCE: Progen Industries Limited CONTACT: Sarah Meibusch of Progen Industries Limited, +61-7-3273-9100, Web site: http://www.progen.com.au/

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