Medical Key Opinion Leaders in Preeclampsia Join Pluristem’s Steering Committee
PLX-PAD cells offer promising potential treatment for preeclampsia; currently no treatment exists other than early delivery
HAIFA, ISRAEL, February 11, 2014 - Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced it has formed a Preeclampsia Steering Committee to advance its PLacental eXpanded (PLX) cell therapies for the treatment of preeclampsia.
“Preeclampsia is an important indication for our PLX-PAD cells. Based on the dire need for a treatment and the potential of our cell therapy in this indication, we have made it a key priority to enter clinical trials for preeclampsia in the near future,” stated Pluristem Chairman and CEO Zami Aberman. “The caliber of medical and scientific thought leaders who have joined our Preeclampsia Steering Committee is a testament to the promise of our PLX cell therapy as a potential treatment for this disease.”
Preeclampsia Steering Committee Member, Dr. Sibai, who was a moderator on the preeclampsia scientific forum, “Debate and Consensus: Preeclampsia Biomarkers in Clinical Practice, Are we ready?” at the Society for Maternal Fetal Medicine in New Orleans on Feb 5, 2014, commented, “For almost a thousand years, physicians have had no therapy to offer women with preeclampsia. A safe and effective therapy is needed to treat these women and prolong gestation. Pluristem’s PLX cells are a unique potential therapy because they originate from the placenta, which plays a key role in preeclampsia.”
Pluristem’s Preeclampsia Steering Committee:
Prof. James M. Roberts, M.D.
University of Pittsburgh
Professor, Department of Obstetrics, Gynecology and Reproductive Sciences
Professor of Epidemiology, Senior Scientist, Magee-Women’s Research Institute
Prof. George R. Saade, M.D.
University of Texas Medical Branch
Professor, Division Chief Obstetrics & Gynecology
Prof. Baha M. Sibai, M.D.
University of Texas Medical School
Dr. David Williams, PhD FRCP
University College London
Honorary Senior Lecturer, Maternal & Fetal Medicine, Institute for Women's Health, Faculty of Population Health Sciences
Prof. Simcha Yagel, M.D.
Hadassah Medical Center, Israel
Head Division of Obstetrics and Gynecology at Hadassah Medical Center
Head of the Israeli Association of Placental Study
The Preeclampsia Steering Committee will guide Pluristem’s preeclampsia program including advising on various stages of clinical trials, from the design of the study protocol through processing patient feedback up to the final study report. Committee members have vast knowledge of preeclampsia and a commitment to finding a treatment.
In preclinical studies, PLX cells have been shown to be safe and an effective treatment for preeclampsia. In November 2013, Pluristem announced that PLX cells proved to be safe in an animal study assessing maternal and fetal toxicity. The Company announced in May 2013 that PLX cells improved several parameters of preeclampsia in animal models of the disease.
Preeclampsia is one of the most common medical complications of pregnancy, and one of the leading known causes of premature births, stillbirths and early neonatal and maternal deaths. If left untreated it can progress to eclampsia, the life-threatening occurrence of seizures during pregnancy. The only known treatment for preeclampsia is abortion or delivery. The disease occurs after the 20th week of pregnancy, and is characterized by high blood pressure and significant amounts of protein in the urine or end-organ dysfunction. According to the World Health Organization, preeclampsia occurs in approximately 6–8% of pregnancies worldwide. It is estimated that preeclampsia costs the global health care system $3 billion annually.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visitwww.pluristem.com, the content of which is not part of this press release.
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, we are using forward-looking statements, when we discuss the potential of our PLX-PAD cells to provide therapy for preeclampsia, conducting clinical trials in preeclampsia and the Preeclampsia Steering Committee meeting its expected goals. 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 surgical 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.
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH
Director of Investor Relations
Investor & Media Relations Director