- The company will present the upcoming Phase III trial in CLI patients to Europe’s medical and scientific community
- Pluristem is meeting with clinical investigators who will take part in the upcoming trial
HAIFA, Israel, Sept. 08, 2016 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc . (Nasdaq: PSTI ) (TASE: PSTI ), a leading developer of placenta-based cell therapy products, today announced that the Company is conducting a Symposium on the potential for its placental expanded (PLX)PAD cells in the treatment of peripheral artery disease. Pluristem’s upcoming Phase III trial in Critical Limb Ischemia patients will be presented as well. Pluristem’s Symposium is scheduled to take place on Thursday, September 8, 2016 at the Third National Conference of the German, Austrian and Swiss Societies of Vascular Medicine in Dresden, Germany which will be attended by approximately 1,700 attendees from 16 different countries. The company recently announced receiving an $8 million grant from the European Union’s Horizon 2020 program to support the European trial.
One of the key topics of the conference is to discuss the advanced treatments of peripheral vascular disease. Physicians and researchers from specialties including angiology, phlebology, internal medicine, interventional radiology and vascular surgery will be attending the conference. Pluristem will also be holding a meeting with investigators for the CLI study, to review the study with them in more details.
“This is an opportunity time for Pluristem to interact with the leading vascular specialists in Europe. Given the potential of our PLX-PAD cells to offer a unique and much needed treatment solution for CLI, we believe there will be strong interest amongst attendees to take part in our upcoming Phase III CLI trial,” stated Pluristem CEO Zami Aberman.
Professor Norbert Weiss, President of the Conference and Principal Investigator of Pluristem’s Phase II Intermittent Claudication (IC) trial commented, “This conference is an ideal venue through which Pluristem can have a very meaningful exchange with the vascular healthcare decision makers of Europe. As the Principal Investigator of Pluristem’s Phase II IC trial, I believe PLX-PAD cells have the potential to address difficult to treat peripheral artery disease patients with a non-invasive and potentially highly effective solution.”
Professor Nikol Sigrid, Principal Investigator of Pluristem’s upcoming Phase III CLI trial, added, “We look forward to commencing this important Phase III CLI trial. Among the physicians attending this conference are some of the most active specialists assessing and implementing new methods of treatment. Upon regulatory approval in Europe, we believe these physicians may be among the first to prescribe PLX-PAD for the benefit of their patients.”
About the Phase III Trial in CLI
The pivotal study for 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 major amputation or 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 the U.S. and Europe. PLX-PAD cells could potentially address the $12 billion global CLI market.
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 cell products 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 the upcoming Phase III trial of Pluristem’s PLX-PAD cells, the potential for PLX-PAD cells to be used in the treatment of Critical Limb Ischemia (CLI) and a range of peripheral artery diseases, the description of the proposed Phase III trial relating to PLX-PAD cells in the treatment of CLI, including the number of estimated patients, the method of treatment and the proposed locations for such clinical trial, the potential for European physicians to be among the first to prescribe PLX-PAD for the benefit of their patients and the potential for PLX-PAD cells to address the $12 billion global CLI market. 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.
Contact: Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109 karinek@pluristem.com
