Navigation Links
Protalex, Inc. Announces Screening Of First Patients In U.S. For New Trial Of PRTX-100 In Patients With Active Rheumatoid Arthritis
Date:11/8/2012

SUMMIT, N.J., Nov. 8, 2012 /PRNewswire/ -- Protalex, Inc. (OTCBB: PRTX), a clinical stage biopharmaceutical company, today announced that it has begun screening patients at sites in the U.S. for its new multicenter Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in adults with active rheumatoid arthritis (RA). Protalex is focused on the development of a class of drugs designed to treat autoimmune and inflammatory diseases including RA.

The primary objective of this Phase 1b study of PRTX-100 will be to further assess the safety and tolerability of intravenous PRTX-100 administered weekly over 5 weeks in patients with active rheumatoid arthritis on methotrexate therapy. The secondary objectives include determining the effects of PRTX-100 on measures of disease activity, assessing the immunogenicity and evaluating the pharmacokinetic (PK) parameters after repeated doses, and determining possible relationships between the immunogenicity of PRTX-100 and safety, PK and efficacy parameters.

The sequential dose escalation phase of this Phase1b study will randomize up to 40 patients into the dose escalation cohorts starting at 1.50 ug/kg PRTX-100 or placebo, followed by up to 12 additional randomized patients for cohort expansion. Enrollment is expected to take place at study sites in both the U.S. and South Africa.

A more complete description of Protalex, its business and this study can be found in the reports it periodically files with the Securities and Exchange Commission (SEC) pursuant to the Securities Exchange Act of 1934, as amended, including its Annual Report on Form 10-K filed on August 29, 2012, and its Quarterly Report on Form 10-Q filed on October 12, 2012 which are available at the SEC's website at www.sec.gov

About Protalex, Inc.

Protalex, Inc. is a clinical stage biopharmaceutical company focused on the development of a class of biopharmaceutical drugs for treating autoimmune and inflammatory diseases, including but not limited to, rheumatoid arthritis. Protalex's lead product, PRTX-100, is formulated with a proprietary highly purified form of Staphylococcal Protein A, and has completed a Phase 1b clinical trial on adult patients with active rheumatoid arthritis in South Africa which demonstrated that PRTX-100 was generally safe and well tolerated at all dose level 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 and to regulate activation of human B-lymphocytes and macrophages, which mediate inflammation in certain autoimmune diseases.  Laboratory studies indicate that the mechanism involves interaction with specific intracellular 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.

Media Contact:
Mackenzie Mills
SpecOps Communications
Mackenzie@specopscomm.com
212.518.7721


'/>"/>
SOURCE Protalex, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Harwood Feffer LLP Announces Investigation of DUSA Pharmaceuticals, Inc.
2. ActiveCare Announces Record Revenue For Quarter Ending June 30, 2012
3. Echo Therapeutics Announces Third Quarter 2012 Financial Results
4. Concord Medical Announces Change to Third Quarter Financial Results Date to November 20, 2012
5. Winner Medical Announces Mailing of Definitive Proxy Materials for Special Meeting of Shareholders
6. Genoa Pharmaceuticals announces $1.2M Financing
7. Genomic Health Announces Third Quarter 2012 Financial Results and Business Progress
8. Nektar Announces that FDA Grants Fast Track Designation to Etirinotecan Pegol (NKTR-102) for the Treatment of Metastatic Breast Cancer
9. Life Technologies Announces Next-Gen Digital PCR Instrument Designed for Widespread Adoption
10. Blue Belt Technologies Announces First United Kingdom-Based NavioPFS Unicondylar Knee Replacement Surgery
11. IRIDEX Announces Tender Offer to Purchase up to 487,500 Shares of its Common Stock
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... -- Research and Markets has announced ... Applications, Technologies, Forecasts" report to their offering. ... Smart Skin, Structural Health Monitoring, Composite Smart Structures, ... involves electronic and/or electrical components and circuits that ... such as vehicle bodies or conformally placed upon ...
(Date:6/24/2016)... Research and Markets has announced the ... Tests" report to their offering. ... The World Market for Companion Diagnostics covers the ... analysis in the report includes the following: ... Kits) by Region (N. America, EU, ROW), 2015-2020 , ...
(Date:6/24/2016)... Tenn. , June 24, 2016  Arkis ... providing less invasive and more durable cerebrospinal fluid ... in funding.  The Series-A funding is led by ... Lighthouse Fund, and other private investors.  Arkis, new ... neurosurgical instrumentation and the market release of its ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Pixel Film ... Pro X. , "Film editors can give their videos a whole new perspective by ... Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery ... of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , ... for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin ... injury. Recently, he has implemented orthobiologic procedures as a method for treating his ... of the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic ...
(Date:6/24/2016)... ... 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. In ... benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued ... Sickle Cell Disease (SCD) is a disorder of the red blood cells, which can ...
(Date:6/24/2016)... ... 2016 , ... Comfort Keepers® of San Diego, CA is excited to announce ... program to drive cancer patients to and from their cancer treatments. Comfort Keepers ... of life and ongoing independence. Getting to and from medical treatments is one ...
Breaking Medicine News(10 mins):