Data from Protalex' Phase I Clinical Trial of PRTX-100 Presented at the American College of Clinical Pharmacology.NEW HOPE, Pa. -- Protalex, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :PRTX) today announced that data from its Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of PRTX-100 was presented at the American College of Clinical Pharmacology meeting in Boston, MA on September 17, 2006. The abstract was entitled: Phase I study of the safety and pharmacokinetics of staphylococcal protein A in healthy adults. PRTX-100 is in development for autoimmune disorders including rheumatoid arthritis and idiopathic thrombocytopenic purpura Idiopathic Thrombocytopenic Purpura Definition Idiopathic thrombocytopenic purpura, or ITP, is a bleeding disorder caused by an abnormally low level of platelets in the patient's blood. (ITP ITP - Intent to Package ), a disorder in which the blood does not clot. As previously announced, the data demonstrated that in a single dose Phase I clinical trial, 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 United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. 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 Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II in the ITP indication in early 2007. About PRTX-100 PRTX-100 is a highly-purified form of Staphylococcal Protein A. PRTX-100 binds directly to monocytes monocytes, n.pl the largest of the white blood cells. They have one nucleus and a large amount of grayish-blue cytoplasm. Develop into macrophages and both consume foreign material and alert T cells to its presence. 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. About Protalex, Inc. Protalex, Inc. is a biotechnology company engaged in the development of a new class of drugs for the treatment of Rheumatoid Arthritis (RA), Idiopathic Thrombocytopenic Purpura (ITP) and a host of other autoimmune disorders. Additional information about Protalex, Inc. can be found at www.protalex.com. Cautionary Statement Regarding Forward Looking Information This release contains forward-looking information about Protalex, Inc. that are intended to be covered by the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Forward-looking statements are statements that are not historical facts. These statements can be identified by the use of forward-looking terminology such as "believe," "expect," "may," "will," "should," "project," "plan," "seek," "intend," or "anticipate" or the negative thereof or comparable terminology, and include discussions of strategy, and statements about industry trends and Protalex's future performance, operations and products. This forward-looking information should be considered only in connection with "Risk Factors" in Protalex's Annual Report on Form 10-KSB filed with the Securities and Exchange Commission ("SEC") on July 28, 2006 and its other periodic reports filed with the SEC. Protalex assumes no obligation to update any forward-looking statements or information set forth in this press release. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion