BioNumerik has recently started recruitment into it’s Phase III trial with Tavocept in NSCLC.
This is a drug with the dual promise of both enhanced efficacy and attenuated toxicity when combined with conventional combination doublet chemotherapy.
The trial is described thus by BioNumerik:
The Phase III Tavocept trial is an international, randomized, multicenter, double-blind, placebo-controlled trial to be conducted at approximately 80 to 100 clinical sites in the United States, Russia, Ukraine, Eastern Europe and Latin America. The 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. BioNumerik estimates that patient enrollment for the trial could be completed in late 2010 to early 2011.
The uniquely distinctive aspect to this trial is that it is intended to confirm the suggestions from earlier randomised trials of possibly the longest benefit yet seen in advanced NSCLC (7.7 months for adenocarcinoma).
And there’s more to come…the earlier trials showed medically and statistically significant reductions in favor of Tavocept in the incidence and severity of side effects commonly observed with the chemotherapy control regimens, including reductions in kidney toxicity, anemia, nausea and vomiting, and treatment discontinuation due to chemotherapy-induced neuropathy.
Can’t think of many (any) drugs with this degree of potential for simultaneous improvements in both utility and tolerability.
Keep an eye on this one!
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