Progen Prepares for Accelerated Clinical Development of PI-88 Following FDA Meeting
16 Mayo 2006 - 5:53AM
PR Newswire (US)
BRISBANE, Australia, May 16 /PRNewswire-FirstCall/ -- Progen
Industries (NASDAQ:PGLAF)(ASX:PGL) today announced it has received
notification from the US Food and Drug Administration (FDA) guiding
the accelerated development of its anti-cancer drug PI-88. The FDA
has recommended that Progen submit a Special Protocol Assessment
(SPA) detailing the Phase III clinical development plan. An SPA is
an agreement that the Phase III trial protocol design, clinical
end-points and statistical analyses are acceptable to the FDA to
support regulatory approval. As a result, Progen will advance its
liver cancer (Hepatocellular Carcinoma) program to Phase III,
thereby reducing the development timeframe of PI-88 by up to three
years. There are three critical drivers that will accelerate
PI-88's development: * the FDA supports a registration approach
based on a single pivotal trial; * the FDA supports an accelerated
approval based on meeting the secondary end-point of disease-free
survival (that is the time for the disease to recur), rather than
the primary end-point of overall survival; * Progen will advance
Stage 1 of its current Phase II trial directly to Phase III, rather
than executing Stage 2 of the Phase II trial before proceeding to
Phase III. "Progen is strongly committed to pursuing this
accelerated path to successfully commercialise PI-88," said Mr.
Justus Homburg. "This is an important milestone for the Company. It
has expedited the entire clinical program, and will result in PI-88
being launched to market much earlier than anticipated. The
financial benefit to Progen is very significant." So far, 172
patients with post-operative liver cancer have been involved in the
Phase II clinical trial program executed by Progen and its
Taiwan-based strategic partner Medigen Biotechnology. Liver cancer
is the leading cause of cancer death in most Asian countries and is
a rapidly growing cause of cancer deaths in North America. Because
it limits metastasis and tumor growth, Progen's PI-88 is especially
well-suited to a post-operative setting where there is a low tumor
burden. Additionally, there are currently no registered drugs for
the post-operative treatment of liver cancer and few new compounds
are in development. Progen CEO Justus Homburg will host an investor
call in on Wednesday 17 May at 9.30am Australian EST (4:30pm PDT
Tuesday 16 May, 7:30pm EDT). Please follow the dial-in instructions
below: Toll free - Australia: 1 800 500 485 International -- USA: 1
888 891 6274 Participant code: 763078 Media and Investor Relations:
Rebecca Wilson Buchan Consulting Ph: +61 2 9237 2800 / 0417 382 391
Progen Information: Sarah Meibusch Director, Business Development
Progen Industries Limited Ph: +61 7 3842 3333 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.
DATASOURCE: Progen Industries Limited CONTACT: Rebecca Wilson of
Buchan Consulting for Progen Industries Limited, , Ph:
+61-2-9237-2800, +61-0417-382-391; Sarah Meibusch, Director,
Business Development of Progen Industries Limited, , Ph:
+61-7-3842-3333
Copyright
Progen (NASDAQ:PGLAF)
Gráfica de Acción Histórica
De Sep 2024 a Oct 2024
Progen (NASDAQ:PGLAF)
Gráfica de Acción Histórica
De Oct 2023 a Oct 2024
Real-Time news about Progen Industries (NASDAQ): 0 recent articles
Más de Progen Industries Limited (MM) Artículos de Noticias