SAN ANTONIO, Jan. 21 /PRNewswire/ -- BioNumerik Pharmaceuticals, Inc. ("BioNumerik") today announced the treatment of the first patients in a global multi-center Phase III clinical trial of Tavocept (BNP7787) in patients with primary adenocarcinoma of the lung, the most common type of lung cancer. 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, originated and developed by BioNumerik, is an investigational new drug with potential for oncology and non-oncology indications.
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.
Meta-analysis supports survival improvements in patients with advanced non-small cell lung cancer (NSCLC):
The results of a comprehensive meta-analysis of these two previous randomized Tavocept trials were published this week by the European Journal of Clinical & Medical Oncology (EJCMO). [link to abstract] The meta-analysis examined survival outcomes for a combined total of 346 newly diagnosed randomized patients with advanced NSCLC participating in the two trials, including 211 randomized patients with primary adenocarcinoma of the lung. All patients received treatment with taxane plus cisplatin chemotherapy. Approximately half of the patients were treated with Tavocept while the other half received chemotherapy alone. The analysis demonstrated a significant overall survival benefit in favor of Tavocept treatment for the combined meta-analysis of the two trials. For the adenocarcinoma subtype, the combined analysis demonstrated a significantly (P=0.009) improved overall survival benefit in favor of Tavocept treatment, representing an approximate 7.7 month increase in overall survival, with 68% of Tavocept treated patients alive at one year after randomization vs. 48% of control patients alive at one year after randomization (p=0.003). A meta-analysis uses statistical methods to combine results from previous separate but similar studies in order to evaluate the medical outcomes both independently and in a combined manner.
Nicholas Thatcher, Professor in Medical Oncology at the University of Manchester and The Christie, England and EJCMO Editorial Board member said, "The potential to improve therapy in primary adenocarcinoma, the most common form of lung cancer, is an exciting possibility. The results of the meta-analysis provide important support for a large scale confirmatory study of Tavocept on patient survival and the prevention of common chemotherapy side effects."
Dr. Hausheer added, "If we observe results in the ongoing Tavocept Phase III trial that are consistent with results observed for the Tavocept trials discussed in the meta-analysis publication, this would be a substantial potential advance compared to other recently developed first line lung cancer drugs. For example, the cancer drug Avastin(R), also known as bevacizumab, was approved in the United States to treat lung cancer while exhibiting a survival increase of approximately two months when used with a standard chemotherapy treatment regimen. The cancer drug Alimta(R), also known as pemetrexed, when combined with cisplatin treatment in the first line setting, improved overall survival in primary adenocarcinoma patients by about 1.7 months. Recent data for the cancer drug Erbitux(R), also known as cetuximab, with chemotherapy demonstrated a survival increase of about 1.2 months compared to chemotherapy alone in patients with advanced epidermal growth-factor receptor (EGFR)-detectable non-small cell lung cancer. It is also important to consider that we have previously observed evidence of an overall survival treatment effect by Tavocept in both non-Asian and Asian populations; this is an important observation in consideration of the improved spectrum of activity of EGFR inhibitors in Asian patients and the potentially negative effect of some EGFR inhibitors on overall survival reported in Asian patients. By conducting this confirmatory Phase III Tavocept trial, we hope to improve survival in primary adenocarcinoma patients by a significantly greater margin than currently available treatments and at the same time prevent and mitigate chemotherapy induced anemia, kidney toxicity, nausea and vomiting, and peripheral nerve damage."
About Tavocept(TM):
As part of its development efforts, BioNumerik has identified important new mechanisms believed to be associated with survival increases in non-small cell lung cancer patients. BioNumerik has elucidated that Tavocept targets the thioredoxin and glutaredoxin systems, both of which are overexpressed in adenocarcinoma of the lung. It is postulated that Tavocept administration results in interference 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.
About BioNumerik:
BioNumerik Pharmaceuticals, Inc., based in San Antonio, Texas, is focused on the discovery, development and commercialization of novel drugs for the treatment of cancer and cancer supportive care. BioNumerik currently has two drug candidates, Tavocept(TM) and Karenitecin(R), in Phase III clinical development. BioNumerik has eight additional drug discovery research programs, and has generated a patent portfolio of more than 475 patents and pending patent applications worldwide.
CONTACT: BioNumerik Pharmaceuticals, Inc., Public Relations Department,
+1-210-614-1701, ext. 500, publicrelations@bnpi.com
Web site: http://www.bionumerik.com/
