Progen
Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) announced additional
data from the Phase 2 liver cancer study of PI-88 completed earlier this
year. This data was presented at the 58th Annual Meeting of the American
Association for the Study of Liver Diseases in Boston, USA(1).
As the Phase 2 trial's study period covered 48 weeks from curative
surgery, the data analysis described in this presentation was performed to
evaluate the treatment's impact when patients with a low risk of
experiencing a liver cancer recurrence within twelve months are removed
from the analysis population. Patients were removed from the patient
population if, based on published prognostic factors, they were considered
likely to complete the 12 months of the study without recurrence.
The resultant analysis of those patients who had a high risk of
recurrence in the 12-month period shows that PI-88 at least doubled the
time to disease recurrence calculated at the 60th percentile (p=0.0107)
(control (n=33): 24 weeks versus 160mg PI-88 (n=36): 48 weeks). This
compares to a 76% improvement at the 70th percentile (p=0.0867) if all
patients are included, as reported earlier this year.
Dr. James Garner, Progen's Vice President of Clinical and Medical
Affairs, commented: "We know that around 50% of untreated patients are
likely to experience disease recurrence within 12-15 months after they have
had curative liver cancer resection. Given our Phase 2 study only assessed
the recurrence of disease up to 12 months after surgery; this implies that
approximately half of the study population were unable to provide
information about the efficacy of the drug. When you remove from the
analysis patients unlikely to recur in the study time frame, the treatment
effect of PI-88 as measured in the Phase 2 study is more clearly
demonstrated."
Dr. Garner further commented: "These data further expand our confidence
that our 600-patient Phase 3 study will demonstrate PI-88's effect not only
for those patients likely to recur within a relatively short period of
time, but also for those whose chance of recurrence is delayed, as the
Phase 3 study is designed to treat and follow patients for a longer period
of time."
The double-blind placebo controlled Phase 3 study is designed to
assess, as its primary endpoint, improvement in disease free survival
(DFS), amongst approximately 600 patients in countries across North
America, Europe and Asia, following surgery to remove liver cancer tumors.
Half of the patients in this study will be administered PI-88 after
surgical removal of tumors and the remaining patients will receive a
placebo so that a direct statistical comparison between the placebo and
PI-88 can be made.
A copy of this poster presentation can be found at progen-pharma.
(1) Each year, the American Association for the Study of Liver Diseases
brings together over 6,000 hepatologists and hepatology health
professionals from around the world for its annual meeting to meet
and exchange the latest liver disease research, and discuss treatment
outcomes.
About PI-88: PI-88 is one of a new class of multi-targeted cytostatic
cancer therapeutics. It is a novel anti-cancer compound with a
first-in-class mechanism as a heparan sulfate mimetic. Its anti-tumor
activity is based on inhibition of two biological processes -- angiogenesis
(the growth of new blood vessels) and metastasis (the spread of cancer to
other sites) -- critical to the growth and progression of cancer. In a
Phase 2 trial in post- resection liver cancer, 160mg of PI-88 demonstrated
a 25% improvement in the primary endpoint of disease-free rate at 48 weeks
and 78% improvement in secondary endpoint of disease-free survival. These
results, combined with positive feedback from the FDA, provide Progen with
confidence in the potential of PI-88 for this indication and we are
therefore aggressively pursuing its development towards registration and
commercialization.
About Progen: Progen Pharmaceuticals Limited is an Australia-based
globally focused biotechnology company committed to the discovery,
development and commercialization of small molecule therapeutics primarily
for the treatment of cancer.
This press release contains forward-looking statements that are based
on current management expectations. These statements may differ materially
from actual future events or results due to certain risks and
uncertainties, including without limitation, risks associated with drug
development and manufacture, risks inherent in the extensive regulatory
approval process mandated by the United States Food and Drug Administration
and the Australian Therapeutic Goods Administration, delays in obtaining
the necessary approvals for clinical testing, patient recruitment, delays
in the conduct of clinical trials, market acceptance of PI-88, PI-166 and
other drugs, future capitals needs, general economic conditions, and other
risks and uncertainties detailed from time to time in the Company's filings
with the Australian Stock Exchange and the United States Securities and
Exchange Commission. Moreover, there can be no assurance that others will
not independently develop similar products or processes or design around
patents owned or licensed by the Company, or that patents owned or licensed
by the Company will provide meaningful protection or competitive
advantages.
Progen Pharmaceuticals Limited
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