BioNumerik Pharmaceuticals announced the treatment of the first patients in their Phase 3 trial of Tavocept (BNP7787) for primary adenocarcinoma of the lung. This study is an international, randomized, multicenter, double-blind, placebo-controlled trial to be conducted at approximately 80 to 100 clinical sites in the U.S., Eastern Europe and Latin America. The study’s primary objective is to confirm whether Tavocept plus taxane and cisplatin chemotherapy significantly increases overall survival in patients with advanced primary adenocarcinoma of the lung compared to taxane and cisplatin treatment alone. Tavocept’s ability to prevent or mitigate common chemotherapy-induced toxicities will be prospectively evaluated by pre-specified secondary endpoint analyses. It is estimated that patient enrollment for the trial could be completed in late 2010 to early 2011. In previous studies, Tavocept demonstrated the potential to substantially increase overall and one year patient survival while concurrently preventing and reducing the incidence and severity of common chemotherapy side-effects as compared to other currently available treatments for advanced lung cancer.
Tavocept is a development drug that is believed to target the thioredoxin and glutaredoxin systems, both of which are overexpressed in adenocarcinoma of the lung. It is postulated that Tavocept interferes with key components of the thioredoxin and glutaredoxin systems, which are believed to be major mechanisms involved in the increased survival observed in lung cancer patients receiving Tavocept with chemotherapy.
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