World News: 12:00 GMT Wednesday 15th May 2019. [Pluristem Therapeutics, Inc. via Globe Newswire via SPi World News]
HAIFA, Israel, May 15, 2019 (GLOBE NEWSWIRE) -- . (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, announced the publication of a in the titled “PLX-PAD Cell Treatment of Critical Limb Ischemia: Rationale and Design of the PACE Trial.” The article, written by key physicians conducting the pivotal study, presents the Company’s ongoing Phase III study evaluating PLX-PAD cell therapy for the treatment of critical limb ischemia (CLI). The pivotal study is also designed to measure long-term outcomes and collect parameters to assess the potential economic benefit of this kind of treatment. Additionally, an that also appears in lends strong support for the study’s design and potential impact.
The paper cites the significant need that exists for new and effective CLI treatment options when revascularization is not an alternative, and the shortcomings and differentiation from other therapies that have failed to demonstrate meaningful benefits in controlled clinical studies to date. Pluristem’s PLX-PAD cell therapy has been successfully evaluated in two Phase I CLI studies, with additional supportive data from a Phase II intermittent claudication (IC) study. In these studies, PLX-PAD cells have demonstrated a favorable safety profile as well as significant pain reduction, an increase in tissue perfusion, a reduction in surgical events and significant improvement in HbA1c (blood glucose control) and CRP levels (blood test marker for inflammation in the body).
“Several therapies have been tested to meet the medical need of these patients and have not succeeded in demonstrating meaningful benefits to date,” commented Prof. Lars Norgren, Department of Surgery, Faculty of Medicine and Health, Örebro University, Sweden and lead author of the paper. “From an immunological point of view, it has been shown that treatments using the patient’s own cells, and in particular those with cardiovascular risk factors or CLI, are reduced in functionality. One reason Pluristem’s PLX-PAD cell therapy is so desirable is that the young healthy placenta cells being used in the therapy are of a better quality and have the potential for higher efficacy than previously seen.”
“CLI is a widely recognized disease leading to losses of limbs. With the aging of the world’s population, the incidence of this problem continues to increase,” commented Dr. John Lantis, MD, Vice Chairman of the Department of Surgery and Chief of Vascular and Endovascular Surgery at Mount Sinai West and a co-author of the paper. “For these patients who do not have an option for revascularization, and those for whom the risks of intervention outweigh the benefits, we need another option. An intervention focused on office-based injections that could grow new blood vessels could definitely be a game changer for many patients. It is exciting to be a part of a study that may truly give us a new medical option.”
“We are grateful for the opportunity to bring CLI patients closer to a medical solution and we thank those who are participating in the study, as well as the investigators who are working to efficiently advance this important late-stage study,” said Zami Aberman, Chairman and Co-Chief Executive Officer of Pluristem. “Our goal is to make this potentially ground-breaking treatment available to CLI patients, an underserved patient population, as quickly as possible.”
Pluristem recently enrollment of half of the study’s population (n=123). An interim analysis may be allowed following a 12-month follow-up period and could support an application for conditional marketing approval in Europe, under the European Adaptive Pathways Program. The Company’s PLX-PAD CLI program has also been granted Fast Track Designation, and selected for an Expanded Access Program (EAP), by the U.S. Food and Drug Administration (FDA) as well as awarded a €7.6 million grant from the European Union’s Horizon 2020 Research and Innovation Program.
Globe Newswire: 12:00 GMT Wednesday 15th May 2019
SPi News is published by Sector Publishing Intelligence Ltd.
© Sector Publishing Intelligence Ltd 2019. [Admin Only]
Sector Publishing Intelligence Ltd.
Agriculture House, Acland Road, DORCHESTER, Dorset DT1 1EF United Kingdom
Registered in England and Wales number 07519380.