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Progen Provides Update On Phase 3 Clinical Program For PI 88 In Liver Cancer
Progen
Pharmaceuticals Limited (ASX: PGL; Nasdaq: PGLA) provided an update
on clinical trial enrollment associated with its phase 3 hepatocellular
carcinoma (HCC, primary liver cancer) study. The study has begun initiating
sites and is now open for patient recruitment, though a thorough
examination of available surgical cases has not yet found any eligible
patients who are able to be enrolled by 31 December 2007. Consequently, the
Company now anticipates that first patient in will be achieved early in the
new year. Given the delay is solely due to the first site being initiated
so close to year-end, the Company does not expect that this will have any
impact on overall study timelines or registration strategy.
At this point in time, Progen has received regulatory approval to
conduct the phase 3 trial in several countries. The Company has also
obtained ethics approval at five trial centres, one of which has been
initiated and is open to recruitment. Further regulatory and ethics
approvals will follow early in 2008, and sites will be initiated as soon as
they are able to begin enrollment.
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 randomized phase II 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 about 60 hospitals in 14 countries.
Disease-free survival will be the 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 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
http://www.progen.com.au
Oferã Progen Update Pe Faza 3 clinice Programul de PI 88 În Ficat de Cancer - Progen Provides Update On Phase 3 Clinical Program For PI 88 In Liver Cancer - articole medicale engleza - startsanatate