Oral mucositis is a serious side-effect that frequently limits the ability to administer chemotherapy and radiation therapy. Cytotoxic drugs most commonly associated with mucositis are: Cytarabine, Doxorubicin, Etoposide, 5-FU and Methotrexate. Oral mucositis results in inflammation and ulceration of the lining of the mouth and throat resulting in bleeding, pain, and difficulty in eating and drinking. In severe cases oral mucositis increases the risk of infection of oral soft tissues and impaired nutrition and can cause patients to require total parenteral (IV) nutrition, IV narcotic analgesics to control pain, and hospitalization.

A major consequence of oral mucositis is the interruption of radiation or chemotherapeutic treatment and this inevitably results in decreased efficacy of a treatment regime. Based on approximately 400,000 patients receiving radiation or chemotherapy for solid tumors the estimated size of the US market exceeds $1 billion.

Oral mucositis is a complex disease with multiple mechanisms of action. VT-211 is an oral combination of two well-known, approved drugs that impact multiple targets to inhibit many of the pathways involved in the disease. Each component drug of VT-211 has demonstrated significant pre-clinical efficacy and excellent clinical safety and tolerability. Pre-clinical trials are currently underway and are scheduled to be concluded in Q4 2007. Vicus anticipates that trials will be initiated by Q1 2008.