FLORHAM PARK, N.J.--(BUSINESS WIRE)--Protalex, Inc. (OTCQB: PRTX), a clinical-stage biopharmaceutical company, today announced that preliminary results from its European Phase 1b open-label, dose-escalation study of PRTX-100 in adult patients with persistent/chronic immune thrombocytopenia (ITP) (PRTX-100-203 Study) will be presented at the upcoming European Hematology Association (EHA) 23rd Annual Meeting being held in Stockholm from June 14-17, 2018. The 203 Study has recently completed enrollment; safety and platelet count data will be presented from all patients enrolled. The abstract is available on the EHA website at www.ehaweb.org and on the Company’s website at www.protalex.com.
The poster will be available for viewing as follows:
| Poster Title: |
"A Phase 1B Open-Label Dose-Escalation Study of PRTX-100, a Highly Purified Form of Staphylococcal Protein A (SpA), in Adult Patients with Persistent/Chronic Immune Thrombocytopenia” |
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| Session Title: | Platelets Disorders | ||||
| Date and Time: | Friday, June 15, 2018 at 17:30 - 19:00 CEST | ||||
| Location: | Poster Area | ||||
| Presentation Number: | PF 658 | ||||
| Presenter: | Nichola Cooper, FRCP, FRCPath, MD | ||||
“We are very pleased to complete enrollment of the 203 Study in Europe and we look forward to presenting the data at the EHA meeting. We are thankful to the investigators and particularly the patients who participated in this trial,” stated Richard J. Francovitch, Ph.D., Protalex’s Vice President, ITP Programs. “We are satisfied with the safety data obtained from the 203 Study, that along with additional data from the ongoing PRTX-100-202 Study, will inform the future clinical development of PRTX-100 in ITP.”
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 eight human clinical studies (seven completed, one ongoing), 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 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.