9-30-13 8:00 AM EDT | Email Article

Protalex, Inc. (OTCBB:PRTX), a clinical-stage biopharmaceutical company, today announced that two posters relating to PRTX-100, the Company’s investigational drug, were accepted for presentation at the 2013 American College of Rheumatology ARHP Annual Meeting, to be held at the San Diego Convention Center from October 25 – 30, 2013. PRTX-100 is a highly purified form of Staphylococcal Protein A, an immunodulatory bacterial protein. The complete abstracts for the posters can be accessed in the Science section of the Company’s website at www.protalex.com.

The posters will be presented by Edward Bernton, M.D., Protalex’s Chief Scientific Officer and a co-author of both posters, and will be available for viewing as follows:


Poster Title:

    "Treatment With Staphylococcal Protein A, Which Is Immuno-Modulatory In The Murine Collagen Arthritis Model, Does Not Increase Infection Severity In Murine Listeria Or Candida Challenge Models, In Contrast To Anti-TNF Treatment”
Session Name: Cytokines, Mediators, Cell-cell Adhesion, Cell Trafficking and Angiogenesis II
Date and Session Time: Tuesday, October 29, 2013, 8:30 AM - 4:00 PM
Location: Exhibit Hall B2-C-D
Presentation Number: 1843

Poster Title:

“Complement Activation and Anaphylatoxin Generation Response to Staphylococcal Protein A Exposure: Ex Vivo and In Vivo Human Studies”
Session Name: Cytokines, Mediators, Cell-cell Adhesion, Cell Trafficking and Angiogenesis II
Date and Session Time: Tuesday, October 29, 2013, 8:30 AM - 4:00 PM
Location: Exhibit Hall B2-C-D
Presentation Number: 1865

Dr. Bernton commented, “We are pleased to be able to present data for the second consecutive year at this major U.S. meeting of rheumatology specialists. Poster 1843 compares treatment of mice with PRTX-100 and two drugs, which like many anti-TNF therapies neutralize tumor necrosis factor. PRTX-100 and the anti-TNF treatments all have been shown to decrease joint inflammation in a mouse model of autoimmune inflammatory arthritis. However, when mice are infected with either a bacterial pathogen called listeria or a fungal pathogen, the anti-TNF therapies increase the severity and lethality of the infection, whereas PRTX-100 treatment does not.

“In addition, Poster 1865 addresses a more fundamental scientific question. PRTX-100, which binds antibody molecules, has the ability to link them together into what are called immune complexes. Some larger immune complexes can activate pro-inflammatory defense proteins called the complement system. We investigated the activation of complement by adding PRTX-100 to human serum or blood, as well as in blood samples from patients dosed with PRTX-100 in our Phase 1b clinical trial. These studies showed no evidence that PRTX-100 caused significant complement activation, increasing our understanding of the safety profile of this novel drug candidate.”

The ACR/ARHP Annual Meeting

The ACR/ARHP Annual Meeting is the premier event for anyone involved in the research or delivery of rheumatologic care or services. At ACR/ARHP rheumatology leaders from around the world gather to discuss the latest science, research and treatment in rheumatology. Innovative sessions, ground-breaking scientific abstracts, educational programs and popular session formats, as well as hands-on skill training sessions are just some of the highlights of the meeting.

About Protalex, Inc.

Protalex, Inc. is a clinical-stage biopharmaceutical company focused on the development of a class of drugs for treating autoimmune and inflammatory diseases, including rheumatoid arthritis. Protalex’s lead product, PRTX-100, is a formulation of a proprietary, highly purified form of Staphylococcal Protein A, which is an immune modulating protein produced by bacteria. Protalex has completed a Phase 1b clinical trial in adult patients with active rheumatoid arthritis in South Africa which demonstrated that PRTX-100 was generally safe and well tolerated at all dose levels, and at the higher doses, more patients showed improvement in their CDAI (Clinical Disease Activity Index) for RA than did patients at the lower dose or placebo cohorts. PRTX-100 has the ability, at very low concentrations, to bind to human B-lymphocytes and macrophages and to activate processes that mediate inflammation in certain autoimmune diseases. Laboratory studies indicate that the mechanism involves interaction with specific immunologic signaling pathways.

Forward-Looking Statements

Statements in this press release, including with respect to the outcome of the Phase 1b study described, that are not statements of historical or current fact constitute "forward-looking statements." Such forward-looking statements involve known and unknown risks, uncertainties and other unknown factors that could cause the Company's actual operating results to be materially different from any historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements that explicitly describe these risks and uncertainties, readers are urged to consider statements that contain terms such as "believes," "belief," "expects," "expect," "intends," "intend," "anticipate," "anticipates," "plans," "plan," to be uncertain and forward-looking. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's filings with Securities and Exchange Commission.

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Morningstar - 2013/9/30 - Protalex Announces Two Posters Accepted for Presentation at 2013 American College of Rheumatology Annual Meeting
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