BioNumerik Pharmaceuticals and ASKA Pharmaceutical Co. Announce Results from Phase III Clinical Trial of Ta...( - Data provides evidence of surviva...),Health

- Data provides evidence of survival increase in advanced non-small cell lung cancer patients receiving Tavocept in conjunction with paclitaxel and

cisplatin

- Multiple statistically significant findings include reductions in

chemotherapy-induced kidney damage and vomiting

SAN ANTONIO and TOKYO, March 18 /PRNewswire/ -- BioNumerik Pharmaceuticals, Inc. ("BioNumerik") and ASKA Pharmaceutical Co., Ltd. ("ASKA") today announced the results of a Phase III clinical trial of Tavocept(TM) in patients with advanced non-small cell lung cancer. Tavocept is an investigational new drug with potential for oncology and non-oncology indications that was originated and developed by BioNumerik.

The multicenter, double-blind, randomized, placebo controlled Phase III clinical trial was conducted by ASKA in Japan through the joint venture, KI Pharmaceuticals, Inc., with BioNumerik. The trial included 182 patients with advanced non-small cell lung cancer who received the chemotherapy drugs paclitaxel and cisplatin as first-line therapy every three weeks. Half of all patients in the trial received Tavocept along with their chemotherapy, while the other half received a placebo and chemotherapy. The primary trial endpoint was to evaluate Tavocept's potential for preventing and reducing the severity of sporadic and cumulative nerve damage, or neuropathy, experienced by patients receiving paclitaxel and cisplatin chemotherapy.

The trial results indicate that the number of patients reporting either severe sporadic or cumulative neuropathy was approximately 50% lower in the Tavocept arm of the trial compared to the placebo arm. While this outcome represents a strong trend in favor of Tavocept (p = 0.1565), the results are not statistically significant (p < 0.05). BioNumerik and ASKA believe the lack of statistical significance is likely due to the relatively small size of the trial.

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