This excerpt taken from the MOGN 10-K filed Mar 11, 2005.
Saforis Oral Suspension Overview
Saforis oral suspension is a late-stage, novel, proprietary oral formulation of L-glutamine, an amino acid which is critical to the repair of cellular damage. In multiple clinical trials, Saforis oral suspension decreased the duration and/or severity of chemotherapy-induced inflammation of the tissues lining the mouth, or oral mucositis. Additionally, Saforis oral suspension reduced the healing time of oral mucositis, reduced patients requirements for analgesics to treat pain due to oral mucositis, improved patients ability to swallow, thereby improving nutrition and improved patients overall quality of life. In 2004, a phase 3 trial of Saforis oral suspension was completed in 326 randomized patients and it met its primary clinical objective of clinically significant reduction of oral mucositis in patients receiving Saforis oral suspension compared to those patients receiving the placebo. A second phase 3 trial is planned to begin in 2005. Our goal is for Saforis oral suspension to be the first product marketed in the United States for the prevention and treatment of chemotherapy-induced oral mucositis. Saforis received Fast Track Designation from the Food and Drug Administration in 2002, which is designed to facilitate the development and expedite the review of applications of drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address an unmet medical need for such a condition.
Oral mucositis is one of the most common dose-limiting toxicities of cancer chemotherapy and radiotherapy. The incidence of oral mucositis in patients receiving chemotherapy ranges from 15 percent in those patients receiving standard chemotherapy doses to 76 percent in patients receiving high chemotherapy doses related to bone marrow transplantation, or BMT. In addition, virtually all patients experience oral mucositis following radiotherapy of the head and neck region.
Oral mucositis usually occurs within 5 to 7 days after the administration of chemotherapy or radiotherapy, and can last for 2 to 3 weeks, or longer in patients with below-normal numbers of white blood cells. As mucositis becomes more severe, breaks in the tissue
surface, or ulcers, develop. These ulcers may be extremely painful; may temporarily interfere with oral intake and nutrition; may reduce the patients quality of life; and may result in serious clinical complications, including systemic infection. Severe oral mucositis with extensive ulceration may require hospitalization and direct into the bloodstream, or intravenous, administration of narcotics for pain management and supplements for nutrition. Further, oral mucositis frequently leads to dose reductions in subsequent chemotherapy cycles, and the pain of mucositis may discourage patients from continuing cancer treatment.
L-glutamine has multiple functions in the human body, including enabling the transfer of nitrogen between tissues and regulation of protein synthesis. L-glutamine is a conditionally essential amino acid, because it is critical in times of serious illness when tissue repair is necessary or during times of high levels of cell replication. When such increased demands occur, the requirements for L-glutamine can exceed the bodys ability to produce sufficient amounts and intake of L-glutamine is needed to maintain normal plasma concentrations.
The rapidly dividing cells of tissues lining the mouth cavity, or oral mucosa, use L-glutamine not only as the primary fuel for cell replication, but also as the nitrogen source for cellular repair. Thus, the availability of L-glutamine becomes critical when these tissues have been injured as a result of chemotherapy or radiotherapy.
When L-glutamine is taken orally, it does not readily dissolve and it is quickly converted into an ineffective molecule. Both topical delivery to the oral mucosa or swallowing of L-glutamine has previously been limited by these factors and by widespread metabolism throughout the body. Even when administered intravenously, this widespread metabolism may limit the L-glutamine available within the oral mucosa.
Saforis oral suspension, with its proprietary delivery system, delivers 100 times more L-glutamine into mucosal epithelial cells compared to L-glutamine without this proprietary delivery system. The availability of adequate L-glutamine should allow damaged cells to regain normal function after injury, regulate and support protein synthesis, and provide critical metabolic energy and nitrogen that can optimize growth rates of replicating cells in rebuilding tissues.