Tavocept™
We believe our new drug candidate Tavocept™ has the potential to substantially increase patient survival in the most common type of lung cancer and possibly many other forms of cancer, while concurrently preventing and reducing common chemotherapy-induced side effects. We are utilizing newly identified knowledge about key cancer mechanisms in an effort to change the way that lung cancer and many other cancers are treated in ways we believe could have profound implications for patients. We are developing Tavocept as an investigational new drug with potential for oncology and non-oncology indications.
We recently treated the first patients in an international multi-center Phase III clinical trial of Tavocept (BNP7787) in patients with primary adenocarcinoma of the lung, the most common type of lung cancer worldwide (the “Tavocept Phase III Adenocarcinoma Trial”). In previous studies, Tavocept has 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. If the results of the Tavocept Phase III Adenocarcinoma Trial are consistent with prior results, Tavocept treatment could result in the largest historically observed increase in patient survival (up to 6.7 months) for a first-line agent for the treatment of primary adenocarcinoma of the lung.
Successfully treating and managing lung cancer remains one of the largest unsolved problems in medicine today. Lung cancer is the leading cause of all cancer deaths, and kills more patients annually than breast, prostate, colon, liver, melanoma and kidney cancers combined. Despite some recent improvements, the 5-year overall survival rate for lung cancer is still only 15%. Adenocarcinoma is a type of cancer that can occur in cells that are in organs such as the lung, colon, prostate and breast. Adenocarcinoma is the most common type of lung cancer, comprising about 40% to 65% of all non-Asians and 60% to 85% of all Asians diagnosed with lung cancer. The incidence of adenocarcinoma of the lung appears to be increasing.
Karenitecin®
We are developing Karenitecin® (also known as BNP1350) as an investigational new anti-tumor drug in the camptothecin class of chemotherapy drugs. We believe that Karenitecin has the potential for fewer side-effects, improved efficacy, less susceptibility to drug resistance mechanisms and an improved safety profile compared to the currently marketed camptothecin drugs. Based on prior studies, we believe Karenitecin has a lower incidence of severe diarrhea than that caused by the marketed camptothecin drug irinotecan (Camptosar®, Pfizer), and a lower incidence and severity of anemia, neutropenia and thrombocytopenia than that caused by the marketed camptothecin drug topotecan (Hycamtin®, GlaxoSmithKline).
We are conducting a multi-national Phase III clinical trial of Karenitecin in platinum- and taxane-refractory or resistant advanced epithelial ovarian cancer patients. This trial has been designed as a randomized, multi-center open label Phase III trial to prospectively evaluate the safety and efficacy of Karenitecin compared to the currently marketed drug topotecan (also known as Hycamtin®), with both drugs to be given intravenously daily for 5 consecutive days repeated every 3 weeks. The primary endpoint for the trial is Progression Free Survival, defined as the time period from the date of patient randomization to the date of first radiographic documented progressive disease or date of death due to any cause. We have received written agreement from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) regarding the clinical trial design and protocol for the trial.