Protalex, Inc. Completes Analysis of Data from Phase 1b Dose Escalation Study of PRTX-100 in Patients with Active Rheumatoid Arthritis

New drug formulated from highly-purified form of staphylococcal protein A

SUMMIT, N.J.--(BUSINESS WIRE)--Aug 29, 2012 - Protalex, Inc. (OTCBB: PRTX), a clinical stage biopharmaceutical company focused on the development of a class of drugs designed to treat autoimmune and inflammatory diseases including rheumatoid arthritis (RA), today announced results from its recently completed Phase 1b randomized, multiple-dose, dose-escalation study. The study conducted in South Africa of PRTX-100 in adult patients with active RA demonstrated that the drug was generally safe and well-tolerated at all dose levels 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.

A total of 37 patients who had active RA on methotrexate were enrolled in four dose-escalating cohorts ranging from 0.15 μg/kg to 1.50 μg/kg PRTX-100 or placebo, administered weekly for four weeks. Safety and disease activity were evaluated over sixteen weeks following the first dose. The primary disease activity response endpoint was the number of patients with a DAS28-CRP < 3.2 at week six.

The results showed that the PRTX-100 patients as a group had more responders than placebo at all times, that responders increased over time during the sixteen week study evaluation period, and that the maximum tolerated dose was not reached at the highest dose level.

Additionally, in this study PRTX-100 did not decrease CRP (C-Reactive Protein) levels, even in those patients whose swollen and tender joint count and global VAS (Visual Analogue Scale) scores had decreased to low levels after treatment. Because CRP is a statistically important component of the DAS28-CRP score, we performed a post-hoc analysis using CDAI scores, which do not include CRP. In the placebo, 0.15 µg/kg, and 0.45 µg/kg dose groups, one of eight patients in each group attained low disease activity (CDAI ‰¤10) on two or more consecutive visits. In the 0.90 µg/kg and 1.50 µg/kg dose groups, two of eight and two of five patients, respectively, attained this same endpoint, and maintained a CDAI < 10 through the week sixteen final visit. Of the four apparent responders in the 1.50 µg/kg group, two attained a CDAI ‰¤6 (remission), one attained a CDAI ‰¤10 (low activity), and one achieved a CDAI of 10.1 at one or more visits. The mean time to peak response in this group occurred six weeks after their last dose.

“As previously noted, the initial disease activity results demonstrated an acceptable safety profile and at the higher dose levels, more patients showed improvement as scored by the CDAI. These results warrant further study of PRTX-100 at doses of 1.50 µg/kg and higher, and the next trial which will have study centers in both the U.S. and South Africa, should provide a better understanding of safety and treatment effect on RA disease activity measurements. The new trial should also help us define the optimal dose”, stated William E. Gannon, Jr., M.D., Chief Medical Officer of Protalex.

Patient enrollment in the first cohort of the new study is expected to commence later in the 4th quarter of 2012.

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, which are available at the SEC's website at www.sec.gov.

About PRTX-100

PRTX-100 has the ability, at very low concentrations, to bind to and to regulate activation of human B-lymphocytes and macrophages which are the key cells mediating inflammation in certain autoimmune diseases. Laboratory studies indicate that the mechanism involves interaction with specific intracellular signaling pathways. Pre-clinical studies also demonstrate that very low doses of PRTX-100 have potent therapeutic effects in certain models of immune-mediated inflammatory diseases. The South Africa clinical trial results demonstrated that PRTX-100 was well-tolerated in patients with active RA at all dose levels, and that more patients in the higher dose cohorts, than the lower dose cohorts, showed improvement in their CDAI score

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, which is formulated with a highly-purified form of staphylococcal protein A, has completed a Phase 1b clinical trial on adult patients with active rheumatoid arthritis in South Africa which was designed to evaluate and assess, among other things, its safety and tolerability. Protalex is planning to further study the safety and treatment effect of PRTX-100 at higher dose levels with a new clinical trial expected to commence later in the 4th quarter 2012.

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.

Contact: LHA Media
Adam Handelsman, 212-838-3777
Managing Director
ahandelsman@lhai.com

 

 

Posted: August 2012

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