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Biotech / Medical : Genta, Inc. (GNTA) -- Ignore unavailable to you. Want to Upgrade?

To: bob zagorin who wrote (1716)	6/3/2003 9:52:17 AM
From: bob zagorin	Respond to of 1870

Genasense(TM) Plus Taxotere(R) Reported Active in Patients with Hormone-Refractory Prostate Cancer at ASCO Meeting New Randomized Trial Will Formally Assess Activity of the Combination CHICAGO, Jun 3, 2003 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated (Nasdaq: GNTA) and Aventis today announced the presentation of clinical data from a Phase 2 clinical trial of Genasense(TM) (oblimersen sodium), Genta's lead anticancer drug, in combination with Taxotere(R) (docetaxel) Injection Concentrate for patients with advanced, hormone-refractory prostate cancer (HRPC). The results of this trial, which was jointly conducted by Dr. Anthony Tolcher from the Cancer Treatment and Research Center, San Antonio TX, and Dr. Kim Chi, from the British Columbia Cancer Center in Vancouver, were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. The companies also announced that the European Organization for the Research and Treatment of Cancer (EORTC) will initiate a new, randomized, multi-center trial of the Genasense/Taxotere combination in patients with prostate cancer. Genasense inhibits production of Bcl-2, a protein that is highly expressed in HRPC and is believed to be a fundamental cause of resistance to anticancer therapy. Preclinical data from Dr. Tolcher's laboratory -- some of which was published as part of the annual meeting of the American Association for Cancer Research -- had established that Genasense amplified the activity of Taxotere in prostate cancer, and that this synergy was maximized when Genasense was administered in advance of the chemotherapy, which was the schedule employed in this clinical trial. Dr. Chi presented a comprehensive summary of clinical, pharmacokinetic, and safety data from a trial using the Genasense/Taxotere combination in 29 evaluable patients with HRPC who had received extensive prior treatment. All patients were refractory to standard hormonal therapy; 6 had failed prior chemotherapy, and 25 had been previously treated with radiation therapy. A total of 164 cycles of combined Genasense/Taxotere therapy was administered. Overall, 14 of 29 patients (48%) achieved greater than 50% reduction in blood levels of PSA (prostate specific antigen), a standard surrogate marker that measures the extent of prostate cancer. Of the group of patients who had measurable disease on physical examination or by X-ray, 4 of 13 (31%) showed an objective partial response. The new EORTC trial will randomly assign men with HRPC who have not previously received chemotherapy to either Taxotere alone or Taxotere plus Genasense. The objectives of the study are to assess activity and safety of the combination. The study will be chaired by Dr. Cora Sternberg, Chief of the Department of Medical Oncology at the San Camillo and Forlanini Hospitals in Rome, and will be conducted at leading cancer centers throughout the European Community. "Despite the older age of this patient population and their extensive prior treatment, we are encouraged by the results of the current trial," noted Dr. Chi. "This combined treatment regimen was generally well tolerated, and the side-effect profile appears to be similar to reactions that would be encountered with the use of chemotherapy alone. A randomized comparison of Taxotere with Genasense or Taxotere alone is the next step in the evaluation of this innovative combination." About the EORTC As the leading cancer cooperative group in Europe, the aims of the European Organization for Research and Treatment of Cancer (EORTC) are to conduct, develop, coordinate, and stimulate laboratory and clinical research in Europe to improve the management of cancer and related problems by increasing patient survival and quality of life. The EORTC seeks to facilitate the passage of experimental discoveries into state-of-the-art treatment, and to minimize the delay between the discovery of new anti-cancer drugs and their therapeutic benefit for patients with cancer. More information about the EORTC can be obtained at the organization's website: eortc.be. About Prostate Cancer Prostate cancer is the second most common cause of cancer deaths among men in the U.S. Approximately 180,000 new cases of prostate cancer are diagnosed in the U.S. each year, and an estimated 31,900 deaths were reported in 2000. Initial therapy for localized prostate cancer includes either surgical removal or localized intense radiation therapy. Patients who have extensive disease at the time of diagnosis, or who relapse from local therapy, are then commonly treated with drugs that block production of androgen hormones (like testosterone), which otherwise would stimulate the growth of prostate cancer cells. After treatment for a median time of 18 months, men usually become refractory to such anti-androgen therapy, and they are then candidates for chemotherapy, such as Taxotere. This progression of prostate cancer -- from localized disease, to metastatic but still hormone sensitive disease, and finally to hormone-refractory disease -- has been shown to be accompanied by a progressive increase in Bcl-2 content of prostate cancer cells, which may in part account for the general resistance of this disease to standard chemotherapy.