Protalex Announces Presentation Highlighting PRTX-100 Phase 1b Clinical Data in Patients with Immune Thrombocytopenia at the European Hematology Association 23rd Annual Meeting

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”

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.

Contacts

LHA Investor Relations
Miriam Weber Miller, 212-838-3777
mmiller@lhai.com