Bladder Cancer
Marina Biotech is conducting preclinical studies in bladder cancer utilizing our tauRNAi platform. Bladder cancer ranks as the 4th most common cancer in men, and the 9th leading cause of death in men in the US. Approximately 75% of all bladder cancer cases in the US are in men. In the US, it is currently estimated that on a yearly basis, more than 70,000 new patients will be diagnosed with bladder cancer and approximately 15,000 deaths will occur from bladder cancer. The majority of new cases are classified as non-muscle invasive, meaning the cancer is confined to the interior lining of the bladder. While surgical removal is first-line therapy for non-muscle invasive disease, surgery is not curative and most patients will experience recurring tumors. Patients may also progress to a more serious and deadly muscle invasive form of the cancer. RNAi-based therapies can target specific disease-causing proteins, and thus could provide for greater control of this disease and improved quality of life for bladder cancer patients.
Direct instillation (intravesical) of therapeutics via a catheter is a well accepted route for treatment of bladder cancer, and this provides for a localized application for a target-specific UsiRNA encapsulated in a DiLA2 liposome. Numerous studies conducted by Marina Biotech and collaborators with a mouse model of bladder cancer have demonstrated a significant reduction in tumor growth following intravesical treatment and analysis of tumor tissue has confirmed this occurs by an RNAi-mediated mechanism of action. Toxicology evaluation and other studies required prior to the initiation of clinical studies are underway; these are expected to be completed for submission of a Investigational New Drug Application (IND) with the US FDA in the second half of 2011.
Hepatocellular Carcinoma
Marina Biotech is utilizing the tauRNAi platform in preclinical studies of hepatocellular carcinoma, more commonly known as liver cancer. Leading causes of liver cancer include viral infection (hepatitis), toxins, and damage to the liver that result in cirrhosis. Worldwide there are more than 500,000 new cases of liver cancer each year. It is currently estimated that in the US, more than 20,000 new cases of liver cancer will be diagnosed and 19,000 deaths are expected to occur due to liver cancer. The incidence of liver cancer appears to be increasing in the US and current therapies have only modest benefit for extension of life and thus deaths from liver cancer are increasing at a nearly equal rate.
Systemic administration via intravenous infusion is the expected route of administration for an RNAi-based therapeutic. Marina Biotech has demonstrated significant reduction in tumor growth in mouse models of liver cancer and an RNAi-mediated mechanism has been confirmed. Studies required for submission of a Investigational New Drug (IND) Application with the US FDA are underway and are expected to be completed in the second half of 2011.