The study, which will enroll approximately 25 patients, is designed to assess the safety and preliminary efficacy of Pivanex in patients with either metastatic or primary hepatic tumors. The endpoints of the study are safety, tumor response and survival. Pivanex, an analog of butyric acid, is a small molecule drug that attacks cancer cells through the mechanism of cellular differentiation. Traditional chemotherapeutic drugs often kill both cancer cells and normal cells, thereby causing systemic side effects such as anemia, nausea, vomiting and risk of infection. Unlike these traditional cancer therapies, Pivanex induces changes in gene expression in cancer cells, causing them to undergo apoptosis, or programmed cell death, while sparing normal healthy cells.
Hepatic tumors represent an increasing clinical problem.
Each year there are approximately 500,000 newly diagnosed cases of metastatic hepatic cancer worldwide, and the incidence of primary hepatic cancer is increasing due to the increasing incidence of hepatitis C infection. While administration of chemotherapy via hepatic arterial infusion has been shown to have some benefit in treatment of these tumors, such treatment is limited by the resultant toxicity. Administration of Pivanex via hepatic arterial infusion may provide an improvement over existing treatment options by allowing a maximum dosage of the drug to be delivered to the tumor site with the potential for reduced systemic toxicity. Titan has assembled a deep pipeline of products utilizing novel technologies that have the potential to significantly improve the treatment of these diseases. Titan also establishes important partnerships with multinational pharmaceutical companies and government institutions for the development of its products.