The FDA has granted orphan drug designation to Sporidin-G,a drug developed by GalaGen Inc. to treat Cryptosporidiumparvum (C. parvum), an infection of the gastrointestinal tractthat is often fatal in patients with weakened immune systems,the Arden Hills, Minn., company said.GalaGen filed an investigational new drug (IND) applicationfor Sporidin-G last year and has begun Phase I/II clinical trialswith it in pediatric AIDS patients with C. parvum-associateddiarrhea.Meanwhile, Biomune Systems Inc. has announced successfulresults in animal tests of its rival cryptosporidiosis product,Immuno-C. The company hopes to file an IND application byJune 15.Biomune also plans to file an application for NASDAQ listingwithin the next few weeks, according to LeGrand Holbrook,head of research and development.GalaGen's Sporidin-G is an oral prescription medicationderived from the colostrum of dairy cows that have beenimmunized against C. parvum, the parasite that contaminatedthe Milwaukee water supply in March 1993. "Theimmunization procedure results in a high level of specificantibodies against the parasite. The resulting product is animmunoglobulin concentrate derived from the rawcolostrum," said Robert Hoerr, GalaGen's president and chiefoperating officer.In contrast, Biomune's Immuno-C is derived directly fromimmunoglobulins in the whey of milk from cow's that are notimmunized in advance. Tests of this drug in mice infectedwith C. parvum conducted by Kansas State Universityresearchers produced a better-than-expected recovery rate,according to Holbrook.Cryptosporidiosis is spread through contaminated water, andthe severe outbreak in Milwaukee may have been linked toflooding, which may have carried the disease in farm manure.Although cows have a natural immunity to cryptosporidiosis,the disease can be fatal in humans with weakened immunesystems. No successful treatment for cryptosporidiosis has yetbeen found.GalaGen is a privately held biopharmaceutical companyformed in 1992 as a spinoff from Land O'Lakes Inc., the largeMidwestern dairy cooperative. Biomune of Salt Lake City isfocused on technologies to strengthen existing immunedefenses.Philippa Maister, Jim Shrine
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