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DUBLIN, CALIF., March 26, 2001 — SuperGen Inc. (Nasdaq: SUPG & SUPGZ) announced today that it has begun
patient enrollment in an open-label, randomized Phase III clinical study
that the company is conducting of its anticancer compound decitabine as a
treatment for advanced myelodysplastic syndrome (MDS).
The study will be conducted at 15 medical centers around the nation and will
enroll 160 total patients — 80 of whom will receive decitabine and 80 of
whom will receive the current "standard of care" therapy.
"MDS is a very serious and often fatal affliction for which there is no
cure," said Dr. Joseph Rubinfeld, chairman and chief executive officer of
SuperGen. "We are gratified to have begun patient enrollment in this
clinical study. Evidence suggests that decitabine may make an impact as a
therapy designed to combat disease progression and increase median survival.
"Evidence suggests that decitabine may make an impact as a
therapy designed to combat disease progression and increase median survival."
"It is our intention to use the results from this clinical study as the
catalyst for submitting a New Drug Application with the FDA," added Dr.
Rubinfeld.
In March 2000, results from a Phase II study of decitabine was published in
the Journal of Clinical Oncology. A total of sixty-six patients were treated
with decitabine and evaluated for efficacy. The observed overall response
rate was 49 percent, with a 64 percent response rate in "high-risk" patients
as defined by the International Prognostic Scoring System. These results
confirmed a previous observation that decitabine therapy was effective in
half of the patients studied with high-risk MDS, especially patients with
the worse prognosis.
In December 2000, at the 42nd Annual Meeting of the American Society of
Hematology (ASH), in San Francisco, Michael Lubbert of the University of
Freiberg (Germany) Medical Center presented data on a study of 124
"high-risk" patients with MDS and reported that, "Decitabine had
anti-leukemic activity . . . in 50 percent of patients with myelodysplastic
syndrome."
Also at the ASH meeting, Donald Lavelle, M.D., University of Illinois
(Chicago), reported preclinical data that demonstrated decitabine's
mechanism of action occurs through the mediation of gene expression, which
in turn potentiates the effect of alpha interferon in multiple myeloma.
These data support the potential clinical use of low-dose decitabine as a
gene therapeutic induction agent in addition to its role as a traditional
cytotoxic agent.
Based in Dublin, California, SuperGen is a pharmaceutical company dedicated
to the development and commercialization of products intended to treat
life-threatening diseases, particularly cancer.
Source: SuperGen Inc.
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