Genasense ®: Survival data from Phase 3 melanoma trial due April 2011
- Genasense ® Phase 3 trial results: In April 2011, Genta expects to report final data on overall survival (OS) from AGENDA, the Company's randomized, double-blind, Phase 3 trial of dacarbazine with or without Genasense ® (oblimersen sodium) Injection in patients with advanced melanoma. Formal followup on all patients concludes in March 2011, two years from randomization of the last patient. While differences in early endpoints of overall response and progression-free survival favored the group treated with Genasense, those differences did not achieve statistical significance. The Company believes that a statistically significant increase in OS would enable submission of applications for regulatory approval of Genasense in advanced melanoma during 2011.
- Genasense ® Phase 2 data in melanoma: A Phase 2 trial of Genasense plus Abraxane ® and Temodar ® as 1 st-line treatment of patients with advanced melanoma has yielded promising results. Final response and survival data from this trial have been submitted for presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2011.
- Tesetaxel Phase 3 program: The Company is currently recruiting investigator sites for a proposed multinational, Phase 3, randomized study of tesetaxel in patients with advanced gastric (stomach) cancer. Tesetaxel has received both Fast Track and Orphan Drug designations for this indication by the U.S. Food and Drug Administration (FDA). The Company has completed the "Scientific Advice" process for this trial with the European Medicines Agency. Discussions regarding this protocol have also been held with regulatory authorities in the U.S. and Japan. The IND process has also been initiated in Korea and China.
- Tesetaxel Phase 2 Program and Special Studies: In the past 12 months, Genta has initiated a broad Phase 2 program in other priority diseases including breast, prostate, and bladder cancer, as well as melanoma. Initial data from several of these trials have been submitted for presentation at ASCO. The Company expects to present results from its weekly dose-ranging and pharmacokinetic study of tesetaxel at the ASCO meeting, and to advance this new schedule into an ongoing trial in women with advanced breast cancer. Based on promising clinical results, the company will convene an expert advisory panel to identify a potential regulatory strategy for tesetaxel in breast cancer.
- Ganite ® Clinical Trials: During 2010, the Company reported initial data from a clinical and pharmacokinetic study of Ganite ® (gallium nitrate injection) to treat chronic lung infections with Pseudomonas aeruginosa. Several preclinical studies have shown that gallium nitrate has potent anti-infective activity against certain drug-resistant bacteria. The Company is supplying Ganite ® at no charge for an ongoing clinical study in patients with cystic fibrosis who are susceptible to resistant bacterial infections, which is being jointly conducted by the University of Washington and University of Iowa. The study is funded in part by FDA, the National Institutes of Health, and the Cystic Fibrosis Foundation. The Company continues to supply Ganite ® for a clinical trial in patients with advanced non-Hodgkin's lymphoma who have relapsed from bone marrow transplantation.
- Oral Gallium Compounds: In 2010, Genta extended its internal research and development program on oral gallium-containing compounds. The program goal is to isolate novel, patentable, orally bioavailable compounds that can achieve specific target plasma concentrations that are known to be active. A number of compounds have completed initial animal testing. The Company hopes to identify a lead compound from this group and to file an Investigational New Drug (IND) exemption with FDA during 2011. Clinical work with such compounds will focus primarily on diseases associated with accelerated bone loss, with potential secondary anticancer indications.
- Intellectual Property: In the past 8 months, the Company has filed 5 patent applications on processes and intermediate compounds used in the manufacturing of tesetaxel. In 2010, two U.S. patents were issued, and the Company has filed 2 new patent applications on compositions and therapeutic uses of novel oral gallium-containing compounds.