Wednesday July 18, 9:31 am Eastern Time
Press Release
SOURCE: SuperGen Inc.
Study Suggests SuperGen's Decitabine May Reverse
Chemotherapy Resistance in Ovarian and Colon
Cancer
Research presented at Genomic Regulation and Cancer Conference in
Scotland
DUBLIN, Calif., July 18 /PRNewswire/ -- SuperGen Inc. (Nasdaq: SUPG & SUPGZ)
announced today that in preclinical studies, chemotherapy-resistant ovarian and colon cancer
cells that were treated with decitabine became more sensitive to chemotherapy treatment.
The studies were conducted by Professor Robert Brown at the Beatson Laboratories at
Glasgow (Scotland) University and data was presented at the Genomic Regulation and
Cancer Conference in Glasgow.
``There's nothing more frustrating than a cancer that appears to be responding to
chemotherapy, only to build up resistance to it,'' said Professor Brown. ``Drugs such as
decitabine should help overcome that resistance, allowing cancers to be treated more
effectively.''
``This may only be the tip of the iceberg,'' added Professor Brown. ``Recent advances in the
way we study DNA methylation in the human genome are uncovering many important genes
which may be targets for these kind of drugs.''
``Chemotherapy is a powerful weapon against cancer, but too often it loses its effectiveness
as tumors develop resistance,'' said Dr. Mary Berrington, science information manager of the
Cancer Research Campaign, which funded the studies. ``Professor Brown's research not
only sheds light on how this resistance can occur, but may have also shown us an effective
way of reversing the process, potentially making many cancers once again sensitive to
treatment.''
``In many chemotherapy-resistant cancer cells, several key genes that allow cells to be
responsive to treatment are summarily switched off by a chemical process called DNA
methylation,'' said Dr. Joseph Rubinfeld, chairman and chief executive officer of SuperGen.
``Decitabine's unique mechanism of action, the regulation of methylation of DNA, allows the genes to be switched back on, so
that the cells are once again sensitive to the effects of the chemotherapy. In this manner, decitabine allows us to break through
the 'shield' around cancer cells.
``We have long believed that decitabine, currently in Phase III clinical studies for the treatment of advanced myelodysplastic
syndrome, could be a multi-platform drug, with uses beyond the traditional chemotherapeutic approach,'' added Dr. Rubinfeld.
``The next step is a Phase I clinical study for chemotherapy-resistant ovarian and colon cancers, and we expect to begin testing
before the end of the year.''
On March 26, 2001, SuperGen announced that it has begun patient enrollment in an open-label, randomized Phase III clinical
study of decitabine as a treatment for advanced myelodysplastic syndrome (MDS).
In March 2000, results from a Phase II study of decitabine were 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.''
Gruß Hans-Udo