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Positive results were reported in January 2010 for a GenVec-sponsored trial in which researchers injected gene encoding for tumor necrosis factor-alpha (TNF-alpha) directly into tumors. This led to pathologic complete responses in one-third of the 24 esophageal cancer patients; the median survival was four years. Patients who received the three lowest does of TNF had a five-year survival rate. The therapy resulted in nodal conversion and down-staging in the majority of patients, most of whom had surgical resection following chemoradiation and the intratumoral injections of TNF, said the researchers. Kenneth J. Chang, MD, of the University of California Irvine reported at the Gastrointestinal Cancers Symposium that the results were encouraging and warrant further evaluation. However, another investigator in the multicenter study said the regimen is complicated and time-consuming and that the trial was stopped because of treatment-related deaths that had not been fully explained. Regardless, the therapy has received FDA fast-track status for evaluation in the treatment of pancreatic cancer.

Aeolus Pharmaceuticals announced in October 2009 that recent preclinical studies have shown that its AEOL 10150 therapeutic can effectively increase regeneration of gastrointestinal stem cells, reduce the severity and duration of diarrhea and improve survival when administered at 24 hours after doses of total-body irradiation that produce lethal GI syndrome. The studies are being conducted by contract research organization Epistem, a subcontractor of the University of Maryland. The compound is being studied as part of the National Institutes of Health’s program for the screening of novel agents for bio-defense applications, such as a terrorist nuclear act. At this time, there are no therapeutic therapies FDA approved for this application.

Cellerix SA is developing cell therapy injectables for patients with automimmune disorders such as Crohn’s disease. Ontaril and Cx601 are currently in clinical trials for treating perianal fistulas in these patients.

In December 2009, Athersys entered into an agreement with Pfizer to develop and commercialize MultiStem for the treatment of inflammatory bowel disease. Under terms of the agreement, Athersys received a cash payment of $6 million from Pfizer as well as research funding and support during the initial phase of the collaboration. Milestone payment of up to $105 million may also e paid, depending on the successful achievement of certain development, regulatory, and commercial milestones. Pfizer will assume development, regulatory and commercialization and will pay Athersys tiered royalties on worldwide sales of MultiStem IBD products. Athersys is also investigating the use of MultiStem for treatment of obesity.

Selected competitors in the field of tissue engineering and cell-based therapies for gastrointestinal applications are shown in the exhibit below.

Key Competitors in Tissue Engineering and Cell Therapies for Gastrointestinal Applications

Source: MedMarket Diligence, LLC; Report #S520, "Tissue Engineering, Cell Therapy and Transplantation Worldwide."

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