SAN ANTONIO and TOKYO, March 18 BioNumerikPharmaceuticals, Inc. ("BioNumerik") and ASKA Pharmaceutical Co., Ltd.("ASKA") today announced the results of a Phase III clinical trial ofTavocept(TM) in patients with advanced non-small cell lung cancer. Tavoceptis an investigational new drug with potential for oncology and non-oncologyindications that was originated and developed by BioNumerik.
The multicenter, double-blind, randomized, placebo controlled Phase IIIclinical trial was conducted by ASKA in Japan through the joint venture, KIPharmaceuticals, Inc., with BioNumerik. The trial included 182 patients withadvanced non-small cell lung cancer who received the chemotherapy drugspaclitaxel and cisplatin as first-line therapy every three weeks. Half of allpatients in the trial received Tavocept along with their chemotherapy, whilethe other half received a placebo and chemotherapy. The primary trial endpointwas to evaluate Tavocept's potential for preventing and reducing the severityof sporadic and cumulative nerve damage, or neuropathy, experienced bypatients receiving paclitaxel and cisplatin chemotherapy.
The trial results indicate that the number of patients reporting eithersevere sporadic or cumulative neuropathy was approximately 50% lower in theTavocept arm of the trial compared to the placebo arm. While this outcomerepresents a strong trend in favor of Tavocept (p = 0.1565), the results arenot statistically significant (p < 0.05). BioNumerik and ASKA believe thelack of statistical significance is likely due to the relatively small size ofthe trial.
A surprising and medically important observation from the trial was anobserved increase in the median survival time for patients receiving Tavoceptas compared to those receiving placebo. The median survival time observed forpatients receiving Tavocept was approximately 40 days longer than for patientsreceiving placebo. For patients with adenocarcinoma, the most frequentlyoccurring type of lung cancer, the median survival time was increased byapproximately 138 days for patients receiving Tavocept as compared to thosereceiving placebo.
Frederick H. Hausheer, M.D., Chairman & Chief Executive Officer ofBioNumerik, and Chairman of KI Pharmaceuticals, Inc. stated: "We areencouraged by the observed evidence of Tavocept's potential to protect againstsporadic (i.e. intermittent) and cumulative chemotherapy-induced neuropathy.The observed survival benefit in this patient population along withsignificant reductions in renal toxicity, vomiting and anemia further supportour belief in this drug's therapeutic potential. We observed that asubstantial proportion of the patients from the trial are still alive and wewill continue to monitor the survival of these patients. We believe that thisPhase III trial outcome is an important step towards the validation of ourapproach to cancer drug discovery and development."
Hashime Kanazawa, Ph.D., Executive Director of ASKA, and President of KIPharmaceuticals, Inc. stated: "We are pleased with this result, particularlythe multiple statistically significant findings that were observed. This datawill be the basis for further studies, which we intend to pursueexpeditiously. We are currently in the process of reviewing a number ofadditional Tavocept clinical trial designs."
Additional observations from the trial included a statisticallysignificant reduction in cisplatin-induced kidney damage (nephropathy) and astatistically significant reduction in chemotherapy-induced vomiting forpatients receiving Tavocept in comparison to those receiving placebo. Therewere also substantially fewer instances of physician chemotherapy dosereductions, treatment delays or discontinuance of chemotherapy treatment dueto neuropathy in the Tavocept arm of the study, compared to the placebo arm.Patient quality of life questionnaire scores were more favorable in theTav