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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

ImmuCell Announces Continued Clinical Program to Develop


Business Wire (06/02/93)

Portland, Maine--ImmuCell Corp. on Wednesday announced the continuation of the Phase I/II human clinical trials for CryptoGAM, an orally administered polyclonal antibody product for the treatment of cryptosporidiosis in AIDS patients and others with weakened immune systems. The trials are being conducted by Univax Biologics Inc. of Rockville, Md., the licensee of the marketing rights to CryptoGAM. Univax has completed a Phase I/II trial involving 40 AIDS patients with chronic cryptosporidiosis. About 10 percent to 15 percent of all AIDS patients in the United States experience cryptosporidium infection, which often leads to death. Cryptosporidium parasites attack the small intestine and cause extreme and often debilitating diarrhea. There is no effective treatment currently available for the condition. The antibodies used in CryptoGAM are grown in cows immunized with a vaccine developed by ImmuCell. Univax President and CEO Thomas P. Stagnaro said in a quarterly letter to Univax shareholders on June 2, "Our first controlled study under a Univax IND (Investigational New Drug Application) accomplished its goal of demonstrating safety and showing activity. A truly effective product for this indication would not only reduce parasite counts but also reduce diarrheal volume. In our study, the parasite level was reduced; however, diarrhea volume remained unacceptably high in some patients." Univax expects to continue enrolling patients to analyze higher doses and possible alternative delivery modes of CryptoGAM.


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Information in this article was accurate in June 4, 1993. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.