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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,