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Protalex says phase 1 PRTX-100 trial shows drug safe, well tolerated
By Elaine Rigoli
Tampa, Fla., May 4 - Protalex, Inc. has completed its phase 1 human trial of PRTX-100, developed to combat various autoimmune disorders.
Protalex said this study was performed in healthy volunteers and was designed to assess the safety and tolerability of PRTX-100. The basic safety data demonstrate that PRTX-100 was safe and well tolerated. There were no deaths or serious adverse events.
The pharmacokinetic profile was favorable and the preclinical pharmacokinetic data were confirmed by the data in this phase 1 trial, according to a news release.
A comprehensive final report is expected to be available by the end of June.
The company said it recently finalized a new test as part of its ongoing effort to optimize the drug production process for phase 2, which will start prior to the end of 2006.
"The successful completion of the phase 1 trial and the development of the critical assay months ahead of schedule, demonstrate our ability to effectively execute our plan on all levels. The completion of the phase 2 trial in idiopathic thrombocytopenic purpura will serve as the next major milestone and will also provide the critical validation for PRTX-100's unique mechanism of action," president and chief executive officer Steven H. Kane said in the release.
"We believe that success in phase 2 will solidify our efforts to bring to market this much-needed product for sufferers of various autoimmune disorders."
Protalex, based in New Hope, Pa., is a biotechnology company engaged in the development of a new class of drugs for the treatment of rheumatoid arthritis, idiopathic thrombocytopenic purpura and other autoimmune disorders.
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