Genta Inc. released the results from a pilot study on advanced melanoma incorporating the Company’s cancer drug Genasense(R) (oblimersen sodium). This study was featured earlier this week in a presentation at the World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers in Berlin, Germany, an international conference organized every year by a co-leader of the AGENDA trial, the European Association of Dermatologic Oncology (EADO).
Genasense, delivered for the first time in a high-dose, 1-hour intravenous (IV) format, was used along with the most common melanoma drug temozolomide (Temodar(R); Schering Plough, Inc.), and a paclitaxel suspension (Abraxane(R); Abraxis Bioscience, Inc.). Using a standard dose and schedule of Genasense, 500 mg over 24 hours for 7 days, showed good tolerability for 18 patients and was associated with clinical activity in prior results using this investigational combination of drugs.
Genasense, administered in this more aggressive schedule (1-hour IV twice a week for 4 weeks at 900 mg each) is showing good response with patients. Of the 10 patients with Stage IV metastatic melanoma taking part in the trial, three showed partial response after the first two treatment periods, which ran from 24 to 40 weeks. One of the patients has maintained stable disease parameters for a 16 week period, two have seen their cancer progress, four are within the first treatment cycle and are thus too early to evaluate properly, and there was one case of Grade 3 (neutropenia) adverse event observed.
GETA President of Pharmaceutical Development Dr. Loretta M. Itri commented on the chemical profile of the Genasense drug, and noted the complete and partial responses resulting in patient conditions stabilizing for a 3-month interval (disease control rate), by saying “with a preliminary disease control rate of 67%, we view these data as very promising”.
GETA’s enrollment in AGENDA, a Phase 3, placebo-controlled, randomized, double-blind trial utilizing the Genasense drug, was also addressed by Dr. Itri, where she confirmed GETA’s intent to continue to follow the trial “in order to determine overall survival”. Dr. Itri also mentioned GETA’s plans to start a Phase 2 study of a “proprietary oral taxane, tesetaxel, in advanced melanoma”.
GETA is a biopharmaceutical company with a two-pronged approach to research DNA/RNA-based Medicines and Small Molecules. Genasense is GETA’s lead DNA/RNA product and is designed to inhibit a specific protein made by cancer cells which, if absent, might greatly improve all types of chemotherapy treatment.