To: Mark F. Beno who wrote (765 ) 3/24/1998 1:34:00 PM From: John R Resseger Read Replies (1) | Respond to of 1476
From the new 10k on edger Peptic Ulcers and Stomach Cancers Discovered in 1983, Helicobacter ("H.") pylori is now recognized as the predominant cause of ulcers. Scientists estimate that this spiral-shaped bacterium leads to 90 percent of duodenal ulcers and 80 percent of gastric ulcers. This organism is present in all parts of the world. The prevalence of infection increases with age, with greater than 90 percent of people by age 20 in developing countries and 50-60 percent of people over 60 in developed countries infected with this bacteria. The CDC estimates that two-thirds of the world's population is infected with H. pylori, including about 25 million Americans. More recently, this bacteria has been associated with stomach cancer. No single agent therapy has been found to wipe out this infection, and antibiotic resistance is increasing. The Company is engaged in ongoing efforts aimed at developing a vaccine for H. pylori. Using NST technology, the Company has produced H. pylori bacteria that are antigenically enhanced when compared to conventionally grown H. pylori. These cells have been inactivated (killed) and combined with a proprietary mucosal adjuvant for use as a vaccine. A clinical trial is in progress under a U.S. Food and Drug Administration ("FDA") Investigational New Drug Application ("IND") to assess the safety and immunogenicity of this H. pylori vaccine preparation. This randomized double-blinded Phase I clinical trial is being conducted in volunteers with and without subclinical gastric infection. Preclinical models indicate that the vaccine has both prophylactic and therapeutic applications. In addition, Company scientists and collaborators have identified host cell receptors and have purified adhesins from H. pylori. The Company has cloned the genes, produced the recombinant proteins and produced quantities of the adhesins for preclinical animal testing. See "Production Facility". Further, the Company is evaluating other surface proteins and acellular antigens as potential vaccine candidates. These potential vaccine products for use in humans have been licensed to SmithKline (See "Strategy for Commercial Development.") through a joint venture, MicroCarb Human Vaccines Inc. ("MCHV"), for further development and possible commercialization. The Company may enter into other collaborations regarding these and other potential products for uses other than as human vaccines. (See "Strategy for Commercial Development.")