Protalex Adds Three Industry Leaders to Clinical Development Team
Gains Significant Clinical, Regulatory and Commercial Expertise to Advance Development of PRTX-100
FLORHAM PARK, N.J.-- Protalex, Inc. (OTCQB:PRTX), a clinical-stage biopharmaceutical company, announces the engagement of three senior industry leaders to advance the clinical development of the Company’s lead product candidate PRTX-100, a formulation of a proprietary, highly purified form of Staphylococcal Protein A. Joining Protalex’s leadership team are John B.L. McClain, M.D. as Medical Director, Richard J. Francovitch, Ph.D. as Vice President of ITP Programs, and Michelle Catalina, Ph.D. as Director of Preclinical Studies. Each will also join the Company’s Scientific Advisory Board (SAB).
“I am pleased to welcome Drs. McClain, Francovitch and Catalina to the Protalex team. Their collective clinical, regulatory and commercial expertise gained at multinational pharmaceutical companies and academic and military institutions will be invaluable as we expand development of PRTX-100 in rheumatoid arthritis and other indications such immune thrombocytopenia (ITP), where there remains medical need for safe and effective therapies,” noted Arnold Kling, President of Protalex. “As we prepare to report the initial data set from our U.S. based Phase 1b clinical trial in rheumatoid arthritis, we are particularly pleased to enhance our leadership team with individuals who can guide the continued development of this promising drug to take full advantage of its immunomodulatory properties.”
Dr. McClain joins Protalex with 18 years of broad international industry experience in clinical development, product safety and as a chief medical officer. Prior to entering industry, Dr. McClain spent over 20 years in clinical and academic positions and has extensive in-depth experience in research, product development, product safety, manufacturing, commercial relations and international regulatory affairs. Most recently, Dr. McClain was an independent pharmaceutical consultant focused primarily in infectious disease research programs. Prior to entering consulting, Dr. McClain was Chief Medical Officer at Aeras Global TB Vaccine Foundation for eight years, and for nine years prior to that, he was an executive with MedImmune, first as Director, Clinical Development Transplantation and later as Medical Director, Pharmacovigilance. Dr. McClain holds a B.S. in Biology from Spring Hill College and an M.D. from the University of Alabama. He completed a fellowship in infectious diseases at Walter Reed Army Medical Center.
Dr. Francovitch joins Protalex with 27 years of experience developing and commercializing pharmaceutical products, and having a significant focus in oncology and hematology. For the past 15 years he was an executive with GlaxoSmithKline Pharmaceuticals (GSK) where he rose to Vice President and Head of the Hematology Franchise and Global Commercial Leader for Promacta®/Revolade™ in the Global Oncology Commercial Center of Excellence. Among his accomplishments at GSK, Rich managed the successful global launches of new products and indications across different therapeutic areas and led cross-functional matrix teams from Phase 1 through Phase 4 product development. At GSK he also was a major force in establishing the hematology franchise in oncology, launching four separate products and accelerating the franchise's growth through business development and discovery activities. In leading the global commercialization for Promacta®/Revolade™, he was responsible for launching indications in ITP and hepatitis C associated thrombocytopenia. Prior to the formation of GSK, Rich spent 12 years at SmithKline Beecham/French in management positions in a variety of therapeutic areas including oncology, hematology, cardiology and infectious diseases. Dr. Francovitch holds a B.S. in Biology from the University of Maryland and a Ph.D. in Pharmacology from Tulane University and also completed a post-doctoral fellowship in pharmacology at Duke University.
Dr. Catalina has been an Immunology Consultant to Protalex for the past year. In this role she designed and implemented in vitro and in vivo preclinical studies for the Company’s proprietary drugs and developed key preclinical and clinical immunologic assays. Dr. Catalina also managed technical transfer and provided oversight for assays being developed externally or outsourced. She will continue to provide direction with design, data analyses and interpretation for ongoing and future clinical trials. Prior to joining Protalex, Dr. Catalina was an instructor at the University of Massachusetts Medical Center in Worcester (UMass), where she directed projects related to the production of tetrameric molecules for detection of antigen-specific T-cells and the generation and maintenance of antigen-specific T-cells. Dr. Catalina holds a B.S. in Biochemistry from the University of Illinois and a Ph.D. in Immunology from the University of Texas, Southwestern Medical Center in Dallas. She conducted post-doctoral research on the role of antigen-specific T-cells and chronic viral infections under the direction of Dr. Katherine Luzuriaga at UMass.
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 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.
Anne Marie Fields, 212-838-3777
Source: Protalex, Inc.
Released May 5, 2014