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DUBLIN, Calif., Nov. 9 — SuperGen Inc. (Nasdaq: SUPG)
announced today that data from an ongoing phase I study of its anticancer
compound decitabine shows "encouraging and objective responses in more than
half (24/42) the patients, yet at very low dosages of merely one-third to
one-tenth of the maximally tolerated dosing schedules established in various
European clinical studies," said Hagop M. Kantarjian, M.D., chairman of the
leukemia department at M. D. Anderson Cancer Center (University of Texas).
Dr. Kantarjian presented his clinical data to colleagues attending this
week's "19th Annual Symposium on Innovative Cancer Therapy for Tomorrow" in
New York City, which is being co-sponsored by Mount Sinai School of Medicine
and the Chemotherapy Foundation.
According to Dr. Kantarjian, previous investigations of decitabine at
maximally tolerated doses in hematologic and solid tumors — despite the
drug's obvious antileukemic effects in CML (chronic myelogenous leukemia),
MDS (myelodysplastic syndromes) and AML (acute myelogenous leukemia) —had been
hampered by the drug's association with delayed and prolonged
myelosuppression (a reduction of bone marrow activities such as production of red and white
blood cells). However, Dr. Kantarjian hypothesized that myelosuppression
might be minimized at lower doses of decitabine, given over a longer period of
time, without compromising decitabine's proven ability to suppress cancer via its
hypomethylating mechanism of action.
"We are impressed, certainly, that so many of our patients showed very
good results with a lower-dose/longer duration regimen of decitabine," added
Dr. Kantarjian. "This regimen appears to be minimally toxic, yet quite
effective at inducing hypomethylation."
"Since our 1999 acquisition of decitabine, which is one of three
franchise compounds in SuperGen's rich pipeline, this drug has demonstrated
significant activity in a wide range of solid tumors and hematological malignancies,"
added Dr. Joseph Rubinfeld, chairman and chief executive officer of
SuperGen. "We now have a Phase III clinical study of decitabine under way in MDS, and
we are devoting appropriate resources to bringing this compound to market as
soon as possible."
According to the Leukemia & Lymphoma Society, about 10,000 new cases of AML, 4,700 new cases of CML and at least 10,000 new cases of MDS are diagnosed annually in the United
States. Worldwide, it is estimated that there are more than 50,000 new cases of MDS
each year.
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. SuperGen's lead
product, rubitecan, has completed enrollment in all three studies in its pivotal
Phase III clinical trial for pancreatic cancer. The company's other lead compound,
decitabine, is enrolling patients in a Phase III clinical trial for
myelodysplastic syndrome (MDS)
Source: SuperGen
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