DUBLIN, Calif., Sept. 20 /PRNewswire-FirstCall/ -- SuperGen Inc. (Nasdaq: SUPG - News) announced that data from a clinical study of decitabine will be presented today at the Leukemia 2002 - Towards the Cure conference in Miami. This event is sponsored by the Global Organization Against Leukemia (GOAL) and the MD Anderson Cancer Center and is a forum for the presentation of data illustrating the progress and opportunities in leukemia research. The meeting, which runs from September 19-22, will emphasize the close integration of basic science and patient-oriented research.
The study, conducted by Principal Investigator Dr. Jean-Pierre Issa at the MD Anderson Cancer Center in Houston, enrolled 50 patients with 'relapsed, refractory or poor prognosis hematological malignancies'. 45 of the 50 patients enrolled in the study completed at least one course of therapy, and 8 complete responses (18%) and 8 partial responses (18%) were observed. Responses were seen in acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) and chronic myelogenous leukemia (CML). A low incidence of 4 percent (2) treatment deaths was also reported.
"Low-dose decitabine in hematologic malignancies showed promising activity with a relatively low degree of toxicity, and will be followed up by several phase II studies in various groups of leukemias. At these low doses, biologic activity with demethylation and gene reactivation was observed, confirming the potential of decitabine in modifying epigenetic expression patterns (epigenetic therapy). Ongoing and planned studies will explore the optimal way of exploiting this gene reactivation in cancer therapy," said Dr. Issa.
"In the next several years, I believe that decitabine could become a front-line therapy for the treatment of several hematologic malignancies. Further down the line, the drug could be proven to help increase the efficacy of other treatments or maybe even as a preventative agent for certain types of cancer," noted Dr. Peter Jones, Director of the Norris Comprehensive Cancer Center at the University of Southern California, who has been studying decitabine for the last 25 years.
As a result of this and other impressive Phase I studies, SuperGen has moved forward with the work from MD Anderson and has initiated and is actively recruiting patients to three phase II multicenter studies in chronic, accelerated and blast phase 'Gleevec (STI 571) refractory' CML with the low- dose decitabine schedule.
"The most advanced study with decitabine is currently the Phase III, multicenter trial for the treatment of MDS, with 103 out of 160 patients already enrolled," said Dr. Joseph Rubinfeld, chairman and chief executive officer of SuperGen. "We expect patient enrollment to be completed by January 2003."
"Hypermethylation describes a mechanism in cancer by which critical genes required to hinder cancer progression are silenced. This unique mechanism in cancer affects the activity of several key cellular pathways by blocking the expression of tumor suppressor genes," added Dr. Rubinfeld. "Hypermethylation is emerging as a key mechanism exploited by cancer cells to bypass normal cell regulation. Decitabine's unique mechanism of action traps the enzyme responsible for gene silencing."... |
