|[February 10, 2014]
Protalex Announces Interim Findings from U.S. Phase 1(b) Trial of PRTX-100 in Active Rheumatoid Arthritis Patients
FLORHAM PARK, N.J. --(Business Wire)--
Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company,
today announced preliminary findings from a limited interim analysis of
its U.S.-based multicenter Phase 1(b) randomized, multiple-dose,
dose-escalation study of PRTX-100 in combination with methotrexate or
leflunomide in adults with active rheumatoid arthritis (PRTX-100-104
Study). PRTX-100 is an investigational drug incorporating a highly
purified form of Staphylococcal Protein A. The interim analysis included
patients in the first four dosing cohorts of the five-cohort study
through day 85 of the study protocol.
Five U.S. clinical centers enrolled 41 patients in Cohorts 1 through 4
of the 104 Study; five patients discontinued from the study prior to
their day 85 visit. A preliminary interim analysis of Cohorts 1 through
4 indicated that PRTX-100 was generally safe and well tolerated. The
rate of adverse events (AEs) among patients receiving PRTX-100 was
comparable to that of those receiving placebo and similar to that seen
in prior clinical studies of PRTX-100; two patients discontinued the
study because of treatment-related AEs. Pharmacokinetic analyses
indicated a roughly linear increase in plasma maximum concentrations
with increasing doses of 1.5, 3.0, 6.0, and 12 mcg/kg. Effects on
measures of disease activity showed that patients who received PRTX-100
had average DAS28-CRP and CDAI scores lower than the average scores of
those who received placebo, which is consistent with a therapeutic
effect in patients with this disease. A detailed analysis of the final
104 Study results of Cohrts 1 through 4 will be prepared for scientific
presentation and publication this spring.
Additionally, Protalex has completed randomization of all 20 patients
into Cohort 5 of the 104 Study which is the final cohort. These patients
are receiving 5 weekly doses of PRTX-100 or placebo, followed by 4
monthly "maintenance" doses thereafter, with total drug exposure over
the six month study visit period not to exceed that of Cohort 4 (60 mcg).
Commenting on the findings, Edward Bernton, M.D., Protalex's Chief
Scientific Officer noted, "We are pleased that these preliminary
findings extend our knowledge of the safety and pharmacologic profile of
PRTX-100 at higher doses than used in prior studies, and have included
them in a recent submission to the U.S. Food and Drug Administration.
Moreover, we are encouraged by the promising effects on certain key
measures of disease activity, and we are excited by the potential of
PRTX-100 as a novel immunomodulatory therapy for RA and possibly other
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 rheumatoid arthritis (RA). Protalex's
lead product, PRTX-100, is a formulation of a proprietary, highly
purified form of Staphylococcal Protein A, which is an immunomodulatory
protein produced by bacteria. PRTX-100 has the ability, at very low
concentrations, to bind to human B-lymphocytes and macrophages and to
modulate immune processes. Protalex completed a Phase 1b clinical trial
in adult patients with active RA in South Africa that demonstrated that
PRTX-100 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. The safety, tolerability, and pharmacokinetics
of PRTX-100 have now been characterized in four clinical studies, with
the final cohort in a fifth clinical study nearing completion.
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 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
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"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.
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