PGLAF Progen Industries

PI-88 Phase II Clinical Trial Targeting Liver Cancer Launched BRISBANE, Australia, July 13 /PRNewswire-FirstCall/ -- Progen Industries Limited (NASDAQ:PGLAF)(ASX:PGL), an oncology-focused drug discovery and development company, announced the commencement of the fourth and largest in the series of PI-88 Phase II clinical trials. This trial will evaluate PI-88, the company's lead anti-cancer compound, in patients with primary liver cancer (hepatocellular carcinoma or "HCC") following surgical removal (resection) of the primary tumor. The launch of the Phase II HCC trial is very significant to PI-88's clinical development as it represents the first time that PI-88 is being evaluated for its ability to prevent/reduce recurrence of disease. Following resection of the primary liver tumor, patients present with a low tumor burden providing the opportunity to demonstrate PI-88's anti-angiogenic and anti-metastatic mechanism of action. Although early diagnosis and treatment may improve patient well-being and survival, HCC recurs frequently in the first 12 months after hepatic resection. This trial will examine the effect of PI-88 given as an adjuvant therapy following curative hepatic resection. Asian clinical trial collaborator Medigen Biotechnology Corporation is conducting the trial in Taiwan under Progen regulatory (FDA) sponsorship. The large randomized study will involve approximately 340 patients with two treatment arms (each arm representing one different dose level of PI-88) and a control arm (no treatment). The objective of the trial will be to determine the number of patients with recurrence over 48 weeks post surgery with or without PI-88 as adjuvant therapy. This announcement coincides with the treatment of the first patient in the trial. The participating hospitals namely, National Taiwan University Hospital (Taipei), Chang Gung Memorial Hospital (Linkou), Veterans General Hospital (Taichung) and China Medical University Hospital represent a broad cross section of the most prestigious hospitals in Taiwan. "We are looking forward to seeing the results of this trial," commented Progen's Managing Director Lewis Lee. "To determine a drug's ability to prevent recurrence via inhibiting angiogenesis generally requires a huge investment with a trial program that can last many years. This is impractical and undesirable in terms of research dollars needed, as well as having impact on the therapy's patent life. However, the current trial design and target disease represents a very sensible and practical opportunity to assess PI-88's potential to improve cancer patient survival after tumor bulk has been removed. By attacking the growth of blood vessels to the tumor (angiogenesis) and the spread of the tumor (metastasis) we hope PI-88 will reduce the number of patients that have disease recurrence in the 12 months following surgery." This trial represents the fourth in a series of PI-88 Phase II trials launched. In previous trials, PI-88 has demonstrated benefit and disease impact in some patients. From the PI-88 Phase I single agent trial completed in January this year, over 40% of the melanoma patients showed retarded tumor growth for periods lasting up to 35 months. The Phase II multiple myeloma trial completed in August 2003 showed 41% of patients with cancer stabilization for periods up to 2 years. These data has provided the company with the additional confidence to expand the current PI-88 Phase II clinical program which now includes clinical investigation into Melanoma, Multiple Myeloma, Non-Small-Cell Lung Cancer and now HCC. DATASOURCE: Progen Industries Limited CONTACT: Sarah Meibusch of Progen Industries Limited, +61-7-3273-9100,

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