Too hyped for my taste, but should help the stock (unless last week's climb was based on this news):
News Alert from PR Newswire via Quote.com
Topic: (NASDAQ:SUPG) Supergen Inc,
Quote.com News Item #8701152
Headline: SuperGen expands Phase III studies of RFS 2000(R) For Pancreatic
Cancer to More Than 50 Sites Across U.S.
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Company's Strategy is to Establish RFS 2000 as a Broad Spectrum Anticancer
Drug for Treating Solid Tumors and Hematological Malignancies
"This is the most hopeful development I have seen
in 30 years of fighting cancer."
John S. Stehlin, M.D., Surgical Oncologist
Director, Stehlin Foundation for Cancer Research
SAN RAMON, Calif., Jan. 6 /PRNewswire/ -- SuperGen Inc.
(NASDAQ:SUPG, SUPGW) announced today that it has significantly expanded its
Phase III studies of RFS 2000(R), the Company's proprietary drug, to treat
pancreatic cancer.
The Phase III program is comprised of two studies. The first compares RFS
2000 to Gemzar(R) in patients who have not had prior chemotherapy.
Gemcitabine (Gemzar(R), Eli Lilly & Company), was recently approved by the FDA
to treat pancreatic cancer. Analysts expect Gemzar to realize $325 million in
sales this year, and $550 million in 1999 -- even though Gemzar extends the
median time of survival of pancreatic-cancer patients by only four to six
weeks and has little impact on shrinking the cancer. The second study
compares RFS 2000 in patients who have previously been treated with
gemcitabine, to 5-FU, a drug that has been the traditional treatment against
pancreatic cancer.
"Until now, there has not been a single drug that was really effective in
treating pancreatic cancer," said John S. Stehlin, M.D., the surgical
oncologist who founded the Houston-based Stehlin Foundation for Cancer
Research in 1969. "RFS 2000 is the most hopeful development I have seen in 30
years of fighting cancer."
The median survival for patients diagnosed with pancreatic cancer is four
to five months. Patients responding to RFS 2000 have a median survival of
16-18 months, according to Dr. Stehlin, "which is absolutely remarkable," he
said. In addition, two pancreatic cancer patients achieved complete remission
while using RFS 2000.
An additional advantage of RFS 2000, Dr. Stehlin pointed out, is that the
drug can be given orally on an outpatient basis, in contrast to other cancer
drugs that have to be given intravenously either in a hospital or physician's
office.
"RFS 2000 is the most important drug in our broad pipeline, and our most
advanced and top-priority clinical project," said Dr. Joseph Rubinfeld,
chairman and chief executive officer of SuperGen. "Our expanded Phase III
studies have been designed to provide us with the pivotal data we will need to
support a New Drug Application to the FDA in the most timely manner possible."
RFS 2000 is a second-generation, topoisomerase-I inhibitor that causes
breaks in the DNA of rapidly dividing cancer cells, thus destroying them.
Pancreatic cancer -- which caused the deaths of celebrities and
dignitaries such as Cardinal Bernadin, Michael Landon, Marcello Mastroianni,
Juliet Prowse and Donna Reed -- is one of the most deadly cancers: It kills
28,000 people every year, most within four to five months after diagnosis.
In addition to pancreatic cancer, RFS 2000 has shown activity in many
tumor types, including: ovarian, breast, lung and colorectal cancers. A
clinical study underway at the M.D. Anderson Cancer Center in Houston using
RFS 2000 has shown efficacy in fifty percent of patients suffering from
myelodysplastic syndrome (MDS)/chronic myelomonocytic leukemia (CMML), thus
indicating a very broad spectrum of activity encompassing both solid tumors
and hematologic malignancies.
Several advantages distinguish RFS 2000 as a potential therapy for
treating cancer. One advantage is its side-effects profile relative to other
anticancer drugs. In studies to date, none of the cardiac, pulmonary,
hepatic, neurological or renal toxicities that limit the acute and/or chronic
dosages of most chemotherapies have been observed and, in fact, studies
suggest that RFS 2000 could be used to treat cancer on a chronic, rather than
acute, basis. The primary side effects are manageable hematological
toxicities, low-grade cystitis (bladder irritation), and some gastrointestinal
disorder -- "In all, a relatively benign profile," said Dr. Stehlin.
Equally important, RFS 2000 is an oral drug, where patients can be dosed
at home, thus providing convenience for patients and potentially considerable
cost-savings to the healthcare system.
Based in San Ramon, California, SuperGen is a pharmaceutical company
dedicated to the development and commercialization of products intended to
treat life-threatening diseases, particularly cancer. SuperGen has an
evolving portfolio of anti-cancer drugs. The company is currently marketing
Nipent(TM) for the first-line and refractory treatment of hairy cell leukemia,
a type of B-lymphocytic leukemia.
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 statements involve certain risks and
uncertainties associated with an emerging pharmaceutical company. Actual
results could differ materially from those projected in the forward-looking
statements as a result of risk factors discussed in SuperGen's reports on file
with the U.S. Securities and Exchange Commission (including but not limited to
the report on Form 10-Q for the quarter ended September 30, 1998).
SOURCE SuperGen Inc.
-0- 01/06/99
/CONTACT: L. Robert Cohen of SuperGen, Inc., 925-327-0200, or Jon Siegal
or Steve Danehy of Ronald Trahan Associates, Inc., 617-332-0101/
/Web site: supergen.com
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