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Pluristem Attracts in $8 Millon in Funding for Phase III Critical Limb Ischemia (CLI) Study
Pluristem Therapeutics announces that its critical limb ischemia (CLI) program in the European Union has been awarded an $8 million grant from the EUs Horizon 2020 program. Pluristem Therapeutics is a clinical-stage biotechnology company that uses placental cells and a proprietary, three-dimensional technology platform to develop cell therapies for a broad range of diseases. To learn more, view our interview with Dr. Racheli Ofir, VP Research & Intellectual Property for Pluristem Therapeutics, or read the full press release from Pluristem below.
Pluristem’s Phase III Critical Limb Ischemia Study Wins $8 Million Grant from Europe’s Horizon 2020 Program
- The study will enroll about 250 patients in Europe and the U.S.
- The grant will cover a significant portion of the study expenses
- PLX-PAD was previously selected by the EMA to be developed via the Adaptive Pathways project
HAIFA, Israel, Aug. 09, 2016 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI), a leading developer of placenta-based cell therapy products, today announced that its critical limb ischemia (CLI) program in the European Union has been awarded an $8 million grant. The grant is part of the European Union’s Horizon 2020 program, which is its largest Research and Innovation program.
The Phase III study of PLX-PAD in CLI will be a collaborative project carried out by an international consortium led by the Berlin-Brandenburg Center for Regenerative Therapies (BCRT) under the leadership of Prof. Hans-Dieter Volk and Prof. Petra Reinke together with Pluristem.
The consortium, which will include leading European research institutes and clinical sites, will undertake an extensive scientific program in parallel to the trial, using in-depth immunological, endocrine, and molecular analyses to better understand the mechanism of action of PLX-PAD in CLI.
As previously announced, Pluristem’s PLX-PAD development program has been selected for the EU’s Adaptive Pathways project, whose goal is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options.
“We are honored to have been awarded this Horizon 2020 grant designed to support the manufacturing and development of our cell products for potential commercialization. This grant is a vote of confidence and an expression of hope by the European Union that we may be able to provide a regenerative therapy for millions of CLI patients around the world. Pluristem is committed to developing PLX-PAD for patients with peripheral artery disease, and this grant will help us move towards our goal of rapid entry into the European and U.S. markets, given positive results,” stated Pluristem Chairman and CEO Zami Aberman.
The pivotal study for Pluristem’s PLacental eXpanded (PLX) PAD cells in the treatment of CLI is a double blind, randomized, placebo controlled trial in an estimated 250 patients with CLI Rutherford Category 5 who are unsuitable candidates for revascularization. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM), with the second dose administered two months after the first. The primary endpoint will be time to amputation and death.
Patients will be enrolled in clinical sites located throughout Europe and the U.S. Pluristem’s intention is to utilize this study as a single pivotal trial for regulatory approval in both regions. PLX-PAD cells are designed to address the $12 billion global CLI market.
About the Berlin-Brandenburg Center for Regenerative Therapies
The Berlin-Brandenburg Center for Regenerative Therapies (BCRT) was founded as a cooperative research institution of the Charité University Hospital in Berlin, which is one of the largest university hospitals in Europe, and Germany’s largest research association, the Helmholtz Association. The goal of the BCRT is to enhance endogenous regeneration by cells, biomaterials, and factors which can be used to develop and implement innovative therapies and products. The primary focus of the BCRT is on diseases of the immune system, the musculoskeletal system and the cardiovascular system for which currently only unsatisfactory treatment options are available.
About the Adaptive Pathways
The purpose of Europe’s Adaptive Pathways is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only. After a therapy is selected for the program, the Adaptive Pathways group conducts high level discussions and provides guidance to the applicant regarding the formal regulatory processes that precede a trial targeting early approval and further expansion of the indications.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss obtaining the $8 million grant as a part of the EU’s Horizon 2020 program, the estimated use of the grant, the potential for obtaining conditional marketing approval in Europe in the event of positive results of our pivotal CLI trial and Pluristem’s intention to utilize the results of the CLI trial in applying for regulatory approval in both the Europe and the U.S. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Prepares for Phase III Trial of PLX-PAD in Critical Limb Ischemia
- CLI is an unmet medical need whose treatment addresses a $12 billion global market
- Multinational study to be conducted in U.S. and Europe
- Estimated trial enrollment of approximately 250 patients
- Primary endpoint for BLA will be time to amputation and death
HAIFA, Israel, Aug. 02, 2016 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading developer of placenta-based cell therapy products, today announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on the proposed Phase III trial of its PLX-PAD cells in the treatment of critical limb ischemia (CLI). This Phase III trial is intended to support a biologics license application (BLA).
The Phase III study is a double blind, randomized, placebo controlled trial in an estimated 250 patients with CLI Rutherford Category 5 who are unsuitable candidates for revascularization. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM), with the second dose administered two months after the first. The primary endpoint will be time to amputation and death (amputation free survival). Clinical sites will enroll patients in the U.S. and Europe. In parallel, the study protocol has been submitted as a single pivotal trial to European national competent authorities, following scientific advice from the European Medicines Agency (EMA), and approval is expected in the upcoming months. Pluristem’s intention is to utilize this 250 patient trial as a single pivotal trial to apply for regulatory approval in both the U.S. and Europe.
In Critical Limb Ischemia (CLI) fatty deposits block arteries in the leg, leading to greatly reduced blood flow, pain at rest, non-healing ulcers, and gangrene. Patients with CLI are at an immediate risk for limb amputation and death. With poor treatment options, CLI patients who cannot undergo revascularization procedures have a high unmet medical need.
“This is a significant leap forward for Pluristem, as we prepare to enter into a U.S. Phase III trial with our cell therapy for the treatment of CLI. There are few treatment options for this serious cardiovascular condition, which too often leads to amputation and death. We look forward to starting this trial by early 2017,” stated Pluristem Chairman and CEO Zami Aberman. “Concurrent with this U.S. FDA process, we are also moving the CLI indication forward in Europe and Japan. Our PLX-PAD cells address a $12 billion global market in the treatment of CLI.”
As part of its global strategy, Pluristem intends to conduct a pivotal trial in Japan in addition to the pivotal trial planned in the U.S. and Europe. Pluristem reached an agreement with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the protocol of a pivotal trial in 75 patients for PLX-PAD in CLI via Japan’s accelerated regulatory pathway for regenerative medicine. Pluristem’s strategic decision is to partner with a Japanese partner to conduct this study. In May 2015, the EMA’s Adaptive Pathways Pilot Project selected the PLX-PAD program for the accelerated pathway, which may lead to conditional marketing approval following a single successful pivotal study.
Previous studies of PLX-PAD in peripheral artery disease
The design of the Phase III study protocol is based on two successful Phase I trials in CLI. Patients in the Phase I studies were Rutherford categories 4 and 5, and not suitable candidates for leg revascularization. Data from the two Phase I studies showed a favorable safety profile and promising data on amputation free survival one-year post-treatment, improved tissue perfusion, and a reduction of ischemic pain at rest. An ongoing Phase II trial in intermittent claudication is expected to complete enrollment of its target of 170 patients by the end of 2016. Intermittent claudication is an earlier stage of peripheral artery disease that can precede CLI.
About Critical Limb Ischemia
In Critical Limb Ischemia (CLI), fatty deposits block arteries in the leg, leading to greatly reduced blood flow. This causes leg pain at rest, non-healing ulcers and gangrene. Patients with CLI are at high risk for limb amputation and death within a year of diagnosis. While some conservative treatments exist to relieve pain and provide local ulcer care, most patients will ultimately need a revascularization procedure. Many, however, are not suitable candidates for revascularization, and have high rates of major amputations (up to 40% at 6 months from diagnosis in patients with Rutherford category 4 or 5).