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Lead Products: CANDISTAT-GTM for Thrush in AIDS, Cancer and . <br /> Transplant Patients <br /> The Disease <br /> CANDISTAT-G is specifically targeted to prevent or eliminate oral and esophageal yeast infections, also <br /> known as thrush, caused by the yeast Candida albicans. Thrush affects nearly all end-stage AIDS <br /> patients, as well as cancer and transplant patients. It causes whitish patches in the mouth and esophagus <br /> that are extremely painful, impair eating and swallowing, and can lead to malnutrition. <br /> The Market Opportunity <br /> In severely immunocompromised individuals, thrush is poorly controlled by systemic antibiotics. <br /> Therapy with front-line antifungal agents often fails and relapse after successful therapy is almost <br /> universal. There have been reports of drug resistant strains or emergence of secondary pathogenic strains <br /> associated with use of a leading antifungal agent. Another systemic antifungal agent is toxic in large <br /> doses and is generally reserved for deep systemic infections. A specific oral agent with minimal side <br /> effects and no antibiotic resistance would be extremely valuable for this patient population, and <br /> GalaGen's product CANDISTAT-G offers this profile. <br /> Sales of the leading anti-fungal agent will exceed $700 million in 1995 and patients at risk in the U.S., <br /> including cancer chemotherapy patients, bone marrow and solid organ transplant patients, and AIDS <br /> patients total more than 350,000 individuals. <br /> Development Status <br /> CANDISTAT-G is earlier in its development than SPORIDIN-G. Preclinical studies demonstrate potent <br /> inhibition of the yeast cells' ability to bind to human cheek cells. A pilot clinical trial at the Karolinska <br /> Institute in Sweden is expected to begin in the second half of 1995. A clinical trial in AIDS patients in the <br /> U.S. is anticipated to begin in early 1996. <br /> • <br />