Independent Review of Orathecin(TM) Phase III Trial Supports Drug's Activity in Pancreatic Cancer Patients who Failed Prior Trea
November 17 2003 - 9:20AM
PR Newswire (US)
Independent Review of Orathecin(TM) Phase III Trial Supports Drug's
Activity in Pancreatic Cancer Patients who Failed Prior Treatments
Data presented at "Innovative Cancer Therapy for Tomorrow"
symposium to be used as basis for registrational filing with FDA
DUBLIN, Calif., Nov. 17 /PRNewswire-FirstCall/ -- SuperGen Inc.
announced today that the long-term follow-up and independent review
of results from the previously announced Phase III clinical program
of its investigational oral anticancer compound Orathecin(TM)
(rubitecan) capsules supports the drug's activity in patients with
refractory pancreatic cancer who have failed prior treatments. The
data, previously presented at a symposium during the 2003 Annual
Meeting of the American Society of Clinical Oncology (ASCO), has
been reviewed by an independent third-party expert radiology review
panel and was recently presented by Howard A. Burris, III, M.D. at
the "Chemotherapy Foundation Symposium XXI - Innovative Cancer
Therapy for Tomorrow" in New York City. The Chemotherapy
Foundation(R), The Page and William Black Post-Graduate School for
Continuing Medical Education and the Mount Sinai School of Medicine
jointly sponsored the event. The study randomized 409 patients,
most of whom had previously failed two or more chemotherapies, to
Orathecin or 'best choice'. Approximately 90 percent of patients in
the 'best choice' group received a chemotherapeutic agent such as
gemcitabine, 5-FU, mitomycin C, capecitabine, or docetaxel. The
primary study end-point was overall survival with secondary
end-points of tumor response and time to disease progression. As
previously reported, statistical significance of survival was
confounded by the high percentage of patients failing 'best care'
and then receiving Orathecin. However, both secondary end-points
were statistically achieved. Response rate (6 percent vs. 1
percent), time to progression (58 days vs. 48 days) and median
survival (109 days vs. 94 days) were all improved with Orathecin
compared to 'best choice', despite the fact that patients who
failed best alternative therapy were allowed to crossover to
Orathecin at disease progression. In patients who demonstrated an
objective response to Orathecin, the median time to progression and
survival was 269 and 338 days respectively. Additionally, 22
percent (44/198) of patients randomized to Orathecin achieved
stable disease (less than 50 percent shrinkage without new
disease), versus 13 percent (27/211) for patients receiving 'best
choice'. This finding is also statistically significant and
independently verified. The total number of patients achieving
'disease control', defined as complete response plus partial
response plus stable disease, was 28 percent (56/198) versus 13
percent (28/211), for 'best choice'. Dr. Burris also presented an
overview of the observed toxicities, which were generally
manageable for patients with advanced stage pancreatic cancer. Less
that 5 percent of patients in either arm discontinued therapy for
drug related toxicity. Severe or life-threatening adverse events
with an incidence greater than 5 percent in patients who received
Orathecin versus the 'best choice' included: asthenia (19 percent
vs. 16 percent), abdominal pain (15 percent vs. 11 percent), pain
(4 percent vs. 6 percent), sepsis (5 percent vs. 7 percent), nausea
(12 percent vs. 8 percent), anorexia (7 percent vs. 9 percent),
diarrhea (9 percent vs. 4 percent), vomiting (11 percent vs. 5
percent), leucopenia (19 percent vs. 10 percent), anemia (15
percent vs. 7 percent), thrombocytopenia (9 percent vs. 8 percent),
dehydration (11 percent vs. 9 percent) and bilirubinemia (6 percent
vs. 2 percent) respectively. "This data suggests that Orathecin may
offer clinical benefits to pancreatic cancer patients with no
current therapeutic options," said Dr. Burris, Director of Drug
Development at the Sarah Cannon Cancer Center in Nashville, Tenn.
Based in Dublin, California, SuperGen is a pharmaceutical company
dedicated to the acquisition, rapid development and
commercialization of therapeutic anticancer products. The Company's
website can be reached at http://www.supergen.com/. This press
release contains 'forward-looking' statements within the meaning of
Section 21A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended, and are
subject to the safe harbors created thereby. Such forward-looking
statements include statements regarding expectations about
Orathecin(TM) and the clinical benefits it may offer The success of
Orathecin could differ materially from those projected in the
forward-looking statements as a result of known and unknown risk
factors and uncertainties associated with drug development. Such
factors include, but are not limited to: risks and uncertainties
related to interpretation of clinical trial data for Orathecin,
whether results from the other large scale Orathecin studies
currently being analyzed will be consistent with the results
presented here, how quickly study data can be analyzed, whether an
NDA will be submitted to, as anticipated or at all, and filed by
the FDA, how long the FDA review process will take, and if
Orathecin will ever be approved by the FDA and reach the market.
References made to the discussion of the risk factors are detailed
in the company's filing with the Securities and Exchange Commission
including the report on Form 10-Q for the quarter ended September
30, 2003. These forward-looking statements are made only as of the
date hereof, and we disclaim any obligation to update or revise the
information contained in any such forward-looking statements,
whether as a result of new information, future events or otherwise.
Contact: Tim Enns, Vice President, Investor Relations &
Business Development, SuperGen, Inc., 800-353-1075, ext. 111
DATASOURCE: SuperGen Inc. CONTACT: Tim Enns, Vice President,
Investor Relations & Business Development, SuperGen, Inc.,
+1-800-353-1075, ext. 111 Web site: http://www.supergen.com/
Copyright