GalaGen's flagship product Sporidin-G (oral bovine immunoglobulin concentrate), for the treatment of diarrhea caused by Cryptosporidium parvum in AIDS patients, has demonstrated promising clinical results and has a good safety profile, says the company. Full results are published in the December issue of The Journal of Acquired Immune Deficiency Syndrome and Human Retrovirology.
Results from the Phase I/II study showed a 49% significant reduction in stool weight in the 12 patients treated with the oral formulation of the drug. No serious side effects were observed, and the drug was well tolerated. Patients also gained or stabilized their body weight.
As a result of this positive data, GalaGen is now conducting a Phase II/III double-blind, placebo-controlled trial with a more potent form of the drug; it has four times more antibodies specific for C parvum than the original formulation, said Robert Hoerr, president and chief executive officer of the company.
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