PI-88 Phase II Clinical Trial Targeting Liver Cancer Launched
13 Julio 2004 - 10:36PM
PR Newswire (US)
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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