DUBLIN, Calif., April 26 /PRNewswire-FirstCall/ -- SuperGen, Inc.
(Nasdaq: SUPG) today announced that it has completed the pre-specified interim
analysis of the Orathecin(TM) (rubitecan) capsules phase II clinical trial
studying Orathecin plus gemcitabine as first-line combination therapy for
advanced pancreatic cancer patients who have not undergone chemotherapy. The
multi-center trial enrolled 39 patients with primary advanced pancreatic
cancer. Patients received 1000 mg/m2 gemcitabine every week for three out of
four weeks with concurrent 1.5 mg/m2 Orathecin given daily for five of the
seven days each week. The cycle was repeated every four weeks until
progression or patient withdrawal.
This protocol included a prospectively defined interim analysis (to be
conducted after half of the patients had died) to estimate median survival.
The analysis result is an estimated median survival of 6.0 months, with a
Kaplan-Meier one year survival to be 27%. Although the estimated one year
survival is encouraging compared to similar studies in this indication, the
study did not meet the pre-specified threshold for median survival in order to
proceed to a phase III randomized study. The safety profile for this patient
group was very similar to prior studies of Orathecin as a single agent or in
combination with gemcitabine. The study will remain closed to enrollment, but
open for patient follow-up.
"We are working with our clinical advisors, investigators and potential
partners to evaluate the best options for Orathecin that will maximize this
product's potential to help patients in need and realize its commercial value
for our stockholders," said James S. Manuso, President and Chief Executive
Officer.
About Orathecin
Orathecin(TM) (rubitecan) Capsules, an orally active camptothecin, is a
topoisomerase I inhibitor that is being developed for the treatment of
pancreatic cancer.
Orathecin has Orphan Drug status in both the U.S. and EU. The Orathecin
phase III clinical program is believed to be the largest program in pancreatic
cancer ever initiated worldwide, with more than 1,800 patients. Orathecin has
also been evaluated in numerous other cancers and blood disorders.
About SuperGen
Based in Dublin, California, SuperGen is a pharmaceutical company
dedicated to the acquisition, rapid development and commercialization of
therapies for solid tumors, hematological malignancies and blood disorders.
SuperGen's marketed products include Nipent(R) (pentostatin for injection);
Mitomycin (generic brand of Mutamycin(R)); and SurfaceSafe(R) cleaner.
SuperGen is currently developing additional anticancer therapies based on
inhibition of a variety of cell signaling pathways. These include but are not
limited to aurora kinase, tyrosine kinase, Axl, Pim-1 kinases and DNMT. For
more information about SuperGen, please visit http://www.supergen.com.
This news release contains certain "forward-looking" statements within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements are typically preceded by words such as "believes," "expects,"
"anticipates," "intends," "will," "may," "should," or similar expressions, and
include statements regarding the expected timeline for review of the interim
results of the Orathecin clinical trial. These forward-looking statements are
not guarantees of SuperGen's future performance and involve a number of risks
and uncertainties that may cause actual results to differ materially from the
results discussed in these statements Factors that might cause results to
differ materially from those expressed or implied by such forward-looking
statements include, but are not limited to, whether the drug will be
partnered, whether any addition clinical trials will be conducted, if future
trials will produce significant results and whether product will ever reach
the commercial market; and other risks and uncertainties detailed from time to
time in the Company's filings with the Securities and Exchange Commission,
including their most recently filed Forms 10-Q or 10-K. SuperGen undertakes no
duty to update any of these forward-looking statements to conform them to
actual results.
Contacts:
Timothy L. Enns Sharon Weinstein
SuperGen, Inc. Noonan Russo
SVP Corporate Communications Director Investor Relations
& Business Development
Tel: (925) 560-0100 x111 Tel: (212) 845-4271
E-mail: tenns@supergen.com E-mail: sharon.weinstein@eurorscg.com
SOURCE SuperGen, Inc.
Web site: http://www.supergen.com
(SUPG)