Biomune Systems Inc.'s Immuno-C has been granted orphandrug status for the treatment of cryptosporidiosis in peoplewith AIDS and other immune impairments.

The designation gives the company seven-year exclusivity forthis indication.

The immunologic drug is derived from colostrum, the earlymilk that cows produce after giving birth, which is rich inimmunoglobulins that carry antibodies to different diseases,including cryptosporidiosis. Biomune's ultrafiltrationtechnology enables the company to obtain high concentrates ofthe immunoglobulin from the milk. It is then purified into apowder.

David Derrick, Biomune's president, said Immuno-C has thepotential to treat a variety of diseases, but the company choseto initially focus on cryptosporidiosis because it was sure thedrug was effective for this indication and FDA would give it anaccelerated review.

Biomune of Salt Lake City had a pre-IND (investigational newdrug) meeting with the agency in July. Now that Immuno-C hasbeen granted orphan status, the company plans to apply for aresearch grant from FDA's Office of Orphan ProductsDevelopment.

Biomune was founded in 1981 as NEW AGE (NatureEnhancement Worldwide Through Agricultural GeneticEngineering) and went public in 1983. Under its original name,the company developed a methodology to produce artificialcolostrum, which it currently markets worldwide.

Biomune is now focused solely on developing Immuno-C.Derrick said the drug has resulted in a 100 percent cure rate incows and pigs with cryptosporidiosis and has repeatedlyproduced high levels of antibodies.

ImmuCell Corp. is also developing a polyclonal antibody for thedisease in AIDS patients. Under a license-and-supplyagreement, Univax Biologics Inc. conducted a Phase I/II trial ofthe drug, CryptoGAM, in 40 AIDS patients with chroniccryptosporidiosis, which is characterized by extreme diarrhea.The company reported in March that diarrhea levels remainedunacceptably high in some patients following treatment.

Derrick said ImmuCell develops its product throughhyperimmunization. Cows are exposed to the disease, and whenthey give birth, colostrum that contains antibodies specific tothat disease is obtained. He said Biomune poolsimmunoglobulin from thousands of cows that containantibodies to a variety of diseases.

Financed by private investors, Biomune currently has about $3million in cash and a burn rate of $80,000 per month.

-- Brenda Sandburg News Editor

(c) 1997 American Health Consultants. All rights reserved.