$PRTX Announces FDA Acceptance of Investigational New Drug


Protalex Announces FDA Acceptance of Investigational New Drug Application for PRTX-100 to Treat Immune Thrombocytopenia


Protalex, Inc. (PRTX), a clinical-stage biopharmaceutical company, announced today that it has received notice from the Office of Hematology and Oncology Products of the U.S. Food and Drug Administration (FDA) that it has reviewed the Investigational New Drug Application (IND) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act for PRTX-100 and concluded that clinical studies with PRTX-100 in patients with Immune Thrombocytopenia (ITP) may be initiated. PRTX-100, Protalex’s lead drug, is a highly purified form of Staphylococcal Protein A and is the subject of ongoing clinical development in rheumatoid arthritis (RA) under a separate IND previously submitted to the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products.

ITP is an autoimmune-mediated condition characterized by bruising and increased bleeding as a result of immune-mediated accelerated destruction of platelets and impaired production of platelets. The diagnosis of ITP is based upon a low platelet count, usually less than 100,000 per microliter of blood, in the absence of other possible causes of reduced platelet numbers such as an underlying illness or medication. ITP is recognized by the FDA as an orphan disease which is defined as a condition that affects fewer than 200,000 people nationwide.

The Company expects to commence enrollment in a Phase I/II open-label, dose-escalating study of PRTX-100 in adults with persistent/chronic ITP in the second quarter of 2015.

The two most recently approved drugs used to treat ITP, Nplate® (romiplostin) and Promacta®(eltrombopag) both increase the production of platelets but do not appear to affect the underlying platelet destruction process. In contrast, pre-clinical data indicate that PRTX-100 may have the potential to treat ITP by reducing the immune-mediated destruction of the platelets. Furthermore, PRTX-100 has established an acceptable safety profile based on data from patients treated in five clinical studies including patients with RA, another autoimmune disease.

About Immune Thrombocytopenia (ITP)

According to the ITP Foundation, Immune Thrombocytopenia (ITP) is a bleeding disorder characterized by a low amount of platelets (thrombocytes) in the blood; platelet counts are below 100’000 x 106/L. Other blood components such as red and white blood cells remain normal. ITP is also known as immune thrombocytopenia’s former names, idiopathic thrombocytopenic purpura and immune thrombocytopenic purpura. In ITP, the platelets are attacked and prematurely removed by the body’s immune system. Normally, the immune system helps to fight off infections and diseases. If the immune system mistakenly attacks part of a person’s own body, this is called an autoimmune disease. In ITP mostly abrupt bleeding occurs and is associated with a platelet count of below 20’000 x 106/L. The most feared complication is bleeding in the brain, which is very rare, but can be life threatening.

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 (RA) and Immune Thrombocytopenia (ITP). Protalex’s lead product, PRTX-100, is a formulation of a proprietary, highly purified form of Staphylococcal Protein A, which is an immunomodulatory protein produced by bacteria. PRTX-100 has the ability, at very low concentrations, to bind to human B-lymphocytes and macrophages and to modulate immune processes. The safety, tolerability and pharmacokinetics of PRTX-100 have been characterized in five clinical studies. In two Phase 1b clinical trials in adult patients with active RA, PRTX-100 was generally safe and well tolerated at all dose levels, and at certain higher doses, more patients showed improvement in measures of RA disease activity than did patients at the lower dose or placebo cohorts.

Nplate® is a registered trademark of Amgen, Inc. and Promacta® is a registered trademark of GlaxoSmithKline plc.

Forward-Looking Statements

Statements in this press release 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 or clinical 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.

Anne Marie Fields, 212-838-3777
[email protected]


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