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Home » PROTALEX ANNOUNCES RESULTS OF PRTX-100 SAFETY STUDY
PROTALEX ANNOUNCES RESULTS OF PRTX-100 SAFETY STUDY
Protalex has announced data from its Phase I clinical trial of PRTX-100, which is in development for autoimmune disorders including rheumatoid arthritis and idiopathic thrombocytopenic purpura (ITP), a disorder in which the blood does not clot.
The data demonstrated that in a single dose of PRTX 100 was safe and well-tolerated. There were no serious adverse events deaths and no major safety lab or vital sign abnormalities. All 36 volunteers who enrolled in the study completed the trial.
The company plans to meet with the FDA during the fourth quarter and expects to file an investigational new drug application for PRTX-100 in ITP. Protalex anticipates proceeding to a Phase II clinical trial in the ITP indication in early 2007.
PRTX-100 is a highly-purified form of Staphylococcal Protein A. PRTX-100 binds directly to monocytes and a subset of B-cells that are involved in the development and progression of various autoimmune diseases, enabling the compound to modulate the function of these cells and restore the balance of the immune system.
KEYWORDS Drug Pipeline Alert
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