Progen
Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) announced the
commencement of its global phase 3 study investigating PI-88 as an adjuvant
treatment for primary liver cancer (hepatocellular carcinoma, HCC)
following curative resection with the first patient having been randomized
onto the study. The study is known globally as PATHWAY (PI-88 in the
adjuvant treatment of HCC). The first patient to enter the trial is from
Singapore.
Dr. Ronnie Poon, Ph.D., M.D., global lead investigator for PATHWAY,
commented, "My colleagues and I are encouraged by the phase 2 data that
Progen has generated for PI-88 in this challenging disease, for which there
are no approved treatment options. If PATHWAY is successful, PI-88 could
change the standard of care for resected liver cancer patients."
PATHWAY, a double-blinded, placebo-controlled study, has been designed
to establish the efficacy and safety of PI-88 in the post resection liver
cancer setting. The trial will recruit approximately 600 patients at about
65-70 hospitals in more than a dozen countries. Disease-free survival, a
measure of the average length of time that patients remain free of tumor
recurrence, is the primary endpoint. Upon completion of this trial, the
results are expected to form the basis of global registration filings for
PI-88.
Justus Homburg, Progen's CEO, said, "Commencement of this trial
represents a significant milestone for Progen. We have designed this trial
in collaboration with world experts in this field of medicine, and with USA
FDA Fast Track and EU EMEA Orphan Drug Status, its initiation underscores
our commitment to making this important drug rapidly available to patients
who currently have few treatment options available."
Liver cancer is one of the top five causes of cancer deaths in the
world, with over half a million new cases per year. Although surgical
resection is one of the few treatment options with curative potential,
recurrence is common within the first 12 to 15 months following surgery and
five-year survival following resection is less than 50%.
Dr. James Garner, Progen's Vice President of Clinical and Medical
Affairs, added, "Since the release of our promising phase 2 data last year,
our team has worked tirelessly to design a world-class phase 3 trial for
PI-88 in liver cancer. We are very thankful for the support of key opinion
leaders and clinicians all over the world, many of whom will now be serving
as investigators in PATHWAY. While the study is starting later than we had
hoped as a result of some delays opening sites due to a
greater-than-expected impact from holidays over the past couple of months,
Progen continues to aggressively drive country regulatory and hospital
ethics approvals to conduct this phase 3 trial."
The study now has regulatory approval in almost half of the
participating countries and more than a dozen sites have been granted
approval by ethics committees. Sites are being initiated so as to be able
to commence patient recruitment as soon as these necessary approvals have
been granted.
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 April
2007, data from a randomised phase 2 trial in the post resection liver
cancer setting was presented at the European Association for the Study of
the Liver (EASL) meeting in Barcelona, Spain. PI-88, in this disease
setting, has been granted Orphan Drug designation by the European Medicines
Evaluation Agency (EMEA) and Fast Track designation by the United States
Food and Drug Administration (FDA). These results 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 the phase 3 study: The phase 3 study investigating PI-88 as a
post- resection treatment for hepatocellular carcinoma (HCC, primary liver
cancer) following curative resection is a double-blinded,
placebo-controlled study that has been designed to establish the efficacy
and safety of PI-88 in the post-resection HCC setting. The trial will
recruit approximately 600 patients at 65-70 hospitals in more than a dozen
countries. Disease-free survival is the study's primary endpoint. Upon
completion of this trial, the results are expected to form the basis of
global regulatory filings for PI-88.
About Progen: Progen Pharmaceuticals is a globally focused
biotechnology company committed to the discovery, development and
commercialization of small molecule pharmaceuticals primarily for the
treatment of cancer. Progen has operations in Australia and the US.
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 capital needs, general economic conditions, and other
risks and uncertainties detailed from time to time in the Company's filings
with the Australian Securities 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
progen.au