LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of Genta Incorporated (OTCBB: GNTA.OB), a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer.
“Genta is currently advancing tesetaxel, the leading oral taxane in clinical development, in multiple cancer indications. A Phase III trial design for tesetaxel has been submitted to FDA for a Special Protocol Assessment (SPA) in advanced gastric cancer, where tesetaxel has already demonstrated strong anti-cancer activity and there is a significant unmet medical need,” commented Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. “In addition to tesetaxel, many investors associate Genta with Genasense®, whose prospects in the ongoing AGENDA Phase III melanoma trial have been largely discounted following disappointing interim results, but Genasense® still represents a significant opportunity. A detailed analysis of data and statistics for Genasense® in the report support our cautious optimism that the drug might still hit the important overall survival (OS) endpoint despite missing on Progression Free Survival (PFS). The current situation with Genasense® is analogous to the recent Provenge® story with Dendreon in prostate cancer, and Bristol-Myers Squibb’s ipilimumab in melanoma, both of which also recently hit on OS after missing on PFS.”
LifeSci Advisors’ 63-page Initiation Report discusses in depth Genta’s lead drug candidates in development. These include: tesetaxel, a novel, orally absorbed taxane in the same drug class as paclitaxel and docetaxel; Genasense® (oblimersen sodium injection), which is a modified DNA-based antisense Bcl-2 inhibitor drug that may enhance the effectiveness of anticancer therapy; and oral gallium, which is being evaluated as potential treatment for diseases associated with accelerated bone loss. Tesetaxel has shown activity against multiple tumor types during the 5 Phase II studies that have been completed, with additional Phase II studies ongoing or planned. The company has announced their intention to pursue advanced gastric cancer as the lead indication for tesetaxel, and is working to finalize a Phase III study design for tesetaxel in that indication based on guidance from regulatory agencies in the US and Europe. Final overall survival data is expected from Genta’s Phase III AGENDA trial for Genasense® in 1H2011. In addition, Genta is developing an oral formulation of their marketed product Ganite® (gallium nitrate injection), which is marketed in the U.S. and is indicated for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The oral gallium products, with their improved convenience and pharmacokinetics, have potential to treat several bone loss indications with large unmet needs, including bone metastases, Paget’s disease and osteoporosis. Further included in the report is a complete background of Genta’s clinical programs, their clinical performances to date, competitive landscapes, upcoming expected milestones, market dynamics upon approval, and associated risks.