Investigator Reports on Results of Genta's Antisense Product G3139 In Malignant Melanoma Trial
Presentation at the Cold Spring Harbor Conference on Programmed Cell Death Reports Encouraging Survival Data of Patients Treated With G3139 and DTIC.
LEXINGTON, Mass., Sept. 30 /PRNewswire/ -- Genta Incorporated (Nasdaq: GNTA) announced that Dr. Burkhard Jansen from the University of Vienna presented an update yesterday at Cold Spring Harbor, N.Y., on the nearly completed Phase 1/2a clinical trial of Genta's lead cancer compound, G3139, in patients with stage 4 malignant melanoma. Dr. Jansen had previously presented promising initial results from this study at the American Society of Clinical Oncology (ASCO) meeting held May 15-18, 1999 in Atlanta, GA. Dr. Jansen and his colleagues are testing G3139 in combination with DTIC (dacarbazine), which is currently a standard chemotherapeutic agent used worldwide to treat metastatic melanoma.
At the Cold Spring Harbor Conference, Dr. Jansen reported that patients are experiencing a strong trend toward prolonged survival while on this new therapeutic regimen of G3139 and DTIC. In the first nine patients who have been followed the longest, Dr. Jansen reported that the median survival has not yet been reached as a number of patients on the study continue to survive and will exceed the median survival times observed in other recent studies using DTIC alone.
Two patients, whose disease had progressed on other therapies and who entered the study in mid-1998, experienced stable disease; major regression of indicator metastases; and survival beyond one year. Dr. Jansen presented photographic documentation of patients with dramatic improvement of their metastatic melanoma, including one patient with near complete remission of extensive metastases after treatment using G3139 given by twice-daily subcutaneous injections for seven days, with DTIC given on the fifth day.
He also reported that these twice-daily subcutaneous injections achieved similar plasma levels to intravenous infusions. This new approach to G3139 administration is predicted to be more convenient for both patients and physicians.
Studies also demonstrated that G3139 treatment led to rapid reduction of the Bcl-2 protein levels in biopsies of the melanoma lesions. Increases in Bcl-2 protein have been widely reported to be associated with many different cancers and with the resistance to a wide variety of chemotherapeutic agents, hypoxia, and radiation. It has been shown that this protein inhibits apoptosis, or programmed cell death, by which these agents induce cell death. In view of these results, Dr. Jansen and his colleagues recommended that this regimen should proceed rapidly to a more definitive, Phase 3 trial comparing this combination regimen to DTIC alone.
Howard Fingert, M.D., Vice President for Clinical and Regulatory Affairs of Genta, stated, "Since this was a Phase 1-2a dose-escalation study and patients often entered with poor prognosis after failure of other treatments including DTIC and various biologic agents, the initial response and survival data reported by Dr. Jansen's group are certainly encouraging. The potential to improve survival in malignant melanoma would be a major step forward in the treatment of this disease. These clinical results will provide a basis to expand clinical development of G3139 for malignant melanoma, in addition to ongoing programs in other cancer types including prostate, renal cell, breast, small cell lung, colon, leukemia, and lymphoma."
G3139 was designed to reduce the Bcl-2 protein level in cancer through an "antisense" mechanism that specifically targets the messenger-RNA produced by the bcl-2 gene. In many human cancers, the Bcl-2 protein is believed to be a major factor in inhibiting apoptosis, or programmed cell death, and in contributing to resistance by those cancers to treatment with anticancer drugs. In Dr. Jansen's study, all 13 patients who were enrolled into the protocol had higher Bcl-2 levels observed in melanoma biopsies at baseline, a result consistent with other reports showing high frequency of Bcl-2 in malignant melanoma.
Genta Incorporated (Nasdaq: GNTA) is a biopharmaceutical company whose strategy consists of building a product and technology portfolio concentrating on cancer therapy including its Anticode(TM) (antisense) products intended to treat cancer at its genetic source. For more detailed information about Genta, please visit our website at www.Genta.com .
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SOURCE Genta Incorporated
CO: Genta Incorporated
ST: Massachusetts
IN: MTC
SU:
09/30/1999 11:47 EDT prnewswire.com |
