Protalex Doses First Patient in Fourth Cohort of European Phase 1b Study of PRTX-100 in ITP

FLORHAM PARK, N.J.--()--Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company, today announced that following a planned interim analysis of data from the third dose cohort of its European Phase 1b study of PRTX-100, the Company’s highly purified form of Staphylococcal protein A (SpA,) in adults with persistent/chronic Immune Thrombocytopenia (ITP) (PRTX-100-203 Study), the Company has initiated enrollment in the fourth cohort of this dose-escalating study. The first patient in this penultimate cohort was recently dosed in the United Kingdom at 18.0 µg/kg, the highest dose of PRTX-100 used in any clinical trial to date. PRTX-100 has been granted Orphan Drug Designation in the U.S. and in Europe for the treatment of ITP.

The 203 Study is a European open-label, dose escalating study that can enroll up to 30 patients in as many as five cohorts. Patients with chronic, persistent ITP are eligible for the 203 study if they have received one prior ITP treatment and their platelet counts remain low. Each patient will receive four weekly intravenous doses of PRTX-100 and will be monitored for up to 48 weeks thereafter. The primary study endpoint of the 203 Study is to evaluate the safety of PRTX-100. Secondary endpoints include efficacy, immunogenicity, and pharmacokinetics.

Richard J. Francovitch, Ph.D., Vice President, ITP Programs at Protalex, added, “Initiating the fourth dose cohort of the PRTX-100-203 Study is an important milestone since it is the highest dose of PRTX-100 studied in clinical trials. Protalex is also very happy with the increased rate of enrollment into the 203 study since Dr. Nicola Cooper of Hammersmith Hospital, London, the National Coordinating Investigator for the trial in the UK, and other U.K. investigators joined the study. We look forward to the outcome of patients treated with the higher doses of PRTX-100 in the current cohort.”

About Immune Thrombocytopenia (ITP)

ITP is an autoimmune-mediated condition characterized by bruising and increased bleeding due to 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.

About PRTX-100

PRTX-100, a new generation immunomodulatory therapy, is a highly purified form of SpA, an immunomodulatory protein known to modify aspects of the human immune system. PRTX-100 has the ability, at very low concentrations, to bind to human B-lymphocytes and macrophages and to modulate immune processes. Pre-clinical data indicate that PRTX-100 may have the potential to treat ITP by reducing the immune-mediated destruction of the platelets. The two most recently approved drugs used to treat ITP, Nplate® (romiplostin) and Promacta®/Revolade™ (eltrombopag) both increase the production of platelets but do not appear to affect the underlying platelet destruction process. The safety, tolerability, and pharmacokinetics of PRTX-100 have been characterized in six clinical studies, and PRTX-100 has been granted Orphan Drug Designation in the U.S. and Europe for the treatment of ITP. In two Phase 1b clinical trials in adult patients with active Rheumatoid Arthritis (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. PRTX-100 is given as a short intravenous infusion.

Nplate® is a registered trademark of Amgen, Inc. and Promacta®/Revolade™ are registered trademarks of Novartis AG.

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 RA and Immune Thrombocytopenia (ITP). In the U.S., Protalex has open INDs for the treatment of RA and ITP and in Europe, an open IMPD for ITP. Please visit the Protalex website at www.protalex.com to learn more about Protalex and its lead drug candidate, PRTX-100.

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.

Contacts

LHA
Anne Marie Fields, 212-838-3777
afields@lhai.com

Contacts

LHA
Anne Marie Fields, 212-838-3777
afields@lhai.com