We believe our new drug candidate Tavocept® has the potential to change the standard of care for women with 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 have completed an international multi-center Phase III clinical trial of Tavocept (also known as BNP7787) in patients with primary adenocarcinoma of the lung, the most common type of lung cancer worldwide (the “Tavocept Phase III Lung Trial”). Although the overall results of the Tavocept Phase III Lung Trial did not meet their stated primary endpoint, there were strong and consistent trends observed in multiple subgroups treated with the paclitaxel and cisplatin combination together with Tavocept.
In a subgroup of patients in the Tavocept Phase III Lung Trial, we observed a median overall survival of 25.0 months with a 2-year survival of 51.4% in women with adenocarcinoma of the lung receiving the chemotherapy drugs paclitaxel and cisplatin together with Tavocept. This represents an 11.8 month improvement in overall survival compared to the overall survival of 13.2 months observed for the placebo arm of this subgroup in the Tavocept Phase III Lung Trial.
These observed results were statistically significant (P-value 0.0477; HR (Hazard Ratio) = 0.58). Because they were observed in a double-blind, placebo-controlled, randomized, multi-center trial in a subgroup of 114 patients that was pre-specified through stratification factors (sex & type of chemo treatment), we believe it is much less likely that these observations are simply a chance coincidence.
For the subgroup of the Tavocept Phase III Lung Trial consisting of non-smoking females receiving paclitaxel and cisplatin together with Tavocept, we observed a median overall survival of 27.0 months for the Tavocept arm of this subgroup. This observation was statistically significant (P-value 0.0167; HR = 0.367) and represents a 13.6 month improvement in overall survival compared to the placebo arm of this subgroup. The two year survival for the Tavocept arm of this subgroup was 72.4% (more than double the two year survival of 32.3% observed in the placebo arm).
We believe the above observations from the Tavocept Phase III Lung Trial are sufficiently important to warrant further study, and represent a potential opportunity to substantially increase the survival in women with lung cancer compared with currently approved therapies.
As part of our development efforts, we have identified important new mechanisms believed to be associated with Tavocept administration. Key mechanisms have been elucidated to support Tavocept’s potential role in the observations described above in the female subgroups receiving paclitaxel and cisplatin together with either Tavocept or placebo. These data include identified molecular targets of Tavocept and various pathways involved in non-small cell lung cancer. A substantial percentage of adenocarcinoma patients have genetic mutations and undesirable protein overexpression that we believe are targeted and modulated by Tavocept.
In addition to female and non-smoker adenocarcinoma populations treated with paclitaxel/cisplatin, we have identified several other areas where we believe Tavocept has development potential. For example, we believe Tavocept has development potential for medical conditions including chemotherapy-induced neuropathy, diabetic neuropathy, protection against toxicity from radiation therapy, lymphedema and other potential medical indications.