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Company can expand into, and advance its clinical trials, in any European Union member nation
HAIFA, ISRAEL, April 28, 2014 — Pluristem Therapeutics Inc. (NasdaqCM:PSTI; TASE: PLTR) today announced that its new manufacturing facility has received the European Union’s Qualified Person Declaration. With this declaration, Pluristem is now approved to use cell therapies manufactured at its state-of-the-art facility located in Haifa, Israel, in all phases of its clinical trials conducted in the European Union, including Phase I, Phase II and Phase III.
The Qualified Person inspection was conducted in line with the European Union’s Good Manufacturing Practice (GMP) legislation, directives and guidelines. The audit focused on the design, construction and validation of Pluristem’s new facility, equipment, utilities, and quality management systems. Pluristem’s manufacturing and cell expansion operations were deemed compliant with EU GMP requirements.
“This Qualified Person declaration enables us to expand our clinical site locations into any European Union member nation through each phase of our trials,” stated Zami Aberman, Chairman and CEO of Pluristem. “We believe Pluristem’s advanced, commercial scale cell manufacturing facility is one of our Company’s key strategic assets and gives us significant competitive advantage in the industry as we move our clinical development pipeline forward.”
At its new state-of-the-art GMP manufacturing facility, Pluristem has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment. Pluristem’s facility has the ability to efficiently produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value.
Pluristem’s state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements and International Conference on Harmonization (ICH) quality guidelines. Pluristem believes that controlling the process is the key to success and invests significantly in developing highly efficient, cutting-edge culturing systems for its PLX cell therapy products. Pluristem’s manufacturing facility and its commercial scale manufacturing process have received approval from the U.S. Food and Drug Administration and the Paul-Ehrlich-Institute (PEI), Germany’s health authority.
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 visit www.pluristem.com, the content of which is not part of this press release.
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 expanding our clinical trials into any European Union nation member, or that our facility gives us significant competitive advantage in the industry as we move our clinical development pipeline forward. 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
HAIFA, ISRAEL, April 22, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, announced today that Company executives are actively participating in a series of meetings in Washington D.C. regarding proposed legislation that may impact the future of cell therapy and regenerative medicine in the U.S.
“These initiatives are a very important effort by Pluristem, in collaboration with other industry thought leaders, to help bring about a legislative, funding, and reimbursement environment that can accelerate the commercialization of breakthrough cell therapies which have the potential to transform the lives of patients in need,” stated Pluristem CEO, Zami Aberman.
Dr. William Prather, Senior Vice President Corporate Development, and Dr. Karine Kleinhaus, Divisional Vice President North America, will join fellow ARM members including patient advocacy organizations, research institutions and other regenerative medicine-focused companies at the organization’s annual Legislative Fly-In. This event is dedicated to meeting with key members of Congress and Administration officials to describe the immense near-term potential of regenerative medicine and the need for legislation and policies that support the development of life saving therapies. ARM supports an important bipartisan bill, the Regenerative Medicine Promotion Act of 2014, which has been introduced in the Senate and calls for a U.S. national strategy to support regenerative medicine. Dr. Prather currently serves on ARM’s Committee for Government Relations & Policy, Committee for Reimbursement, and the Sub-committee for Centers for Medicare & Medicaid Services Reimbursement. Dr. Kleinhaus serves on ARM’s Committee for Capital Formation.
Michael Werner, Executive Director of ARM, stated, “Regenerative medicine represents the single most promising new approach to mitigating the human and economic costs of disease, and changing the course of human health. Pluristem, which pioneered promising cell therapies for a number of indications, has played a vital role in advocating for regenerative medicine within the biotech community and we are pleased that they are actively involved with ARM to move the entire industry forward. To date, ARM has worked with the White House, the U.S. Food & Drug Administration, National Institutes of Health, National Institute of Standards & Technology and members of Congress to further define and promote adoption of a national strategy for regenerative medicine.”
Dr. Ohad Karnieli, Pluristem’s Vice President of Development and Manufacturing met with representatives of the U.S. Food and Drug Administration at a public workshop titled, “Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products.” Participants in this meeting included key opinion leaders from industry as well as organizations advocating for standards and guidelines that can advance regenerative medicine, including Pluristem. Advocacy Organizations participating in the meeting included Alliance for Regenerative Medicine (ARM), International Society for Cellular Therapy (ISCT), American Association of Blood Banks (AABB), National Institute of Standards and Technologies (NIST), and The United States Pharmacopeial Convention (USP). Dr. Karnieli currently serves on ARM’s Science and Technology Committee and is Chair of the ISCT’s Process and Product Development Committee.
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 visit www.pluristem.com, the content of which is not part of this press release.
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 proposed legislation that may accelerate brining cell therapies to the market, its adoption, if adopted at all and affect on the Company. 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 Divisional VP, North America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
HAIFA, ISRAEL, April 16, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, announced today that Dr. Ohad Karnieli, Vice President of Development and Manufacturing, and Lena Pinzur, Basic and Preclinical Research Manager, will deliver presentations at the International Society for Cellular Therapy (ISCT) 2014 Conference which will take place in Paris, France on April 23rd through 26th, 2014. Additionally, Racheli Ofir, Vice President of Research & IP will be participating in ISCT’s Industry Education Subcommittee. The ISCT is a global society of clinicians, regulators, technologists, and industry partners with a shared vision to translate cellular therapy into safe and effective treatments to improve patients’ lives. Pluristem supports the advancement of cell therapy not only through its breakthrough technologies, but also through active participation in industry organizations like ISCT that play a key role in shaping the future of the industry.
Dr. Ohad Karnieli was recently confirmed as Chair of ISCT’s Process and Product Committee for a two-year post.
“I am honored to serve as Chair of ISCT’s Process and Product Committee. The committee acts as a leading force in the cell therapy industry by bringing together industry and academia to set standards and best practices that move cell therapy forward into commercialization for the benefit of patients. I look forward to making key contributions towards the committee’s goals,” stated Dr. Karnieli.
Dr. Karnieli will co-chair a presentation and panel discussion with Dr. Knut Niss of Novartis titled, “Process and Product Development Innovation,” during the Strategies for Commercialization track on April 26th from 1:15 pm – 2:45 pm.
On April 25th from 5:00 pm – 6:30 pm, Ms. Pinzur will present a poster titled, “PLX-PAD Cell Treatment Mitigates Toll-Like Receptor Agonist-Induced Preeclampsia Symptoms in Mice.” The research findings are based on pre-clinical studies conducted in conjunction with the Department of Internal Medicine, Division of Nephrology & Hypertension, Texas A&M Health Science Center and Scott & White Healthcare. Data from the study suggest that Pluristem’s PLX-PAD cell treatment exerts beneficial effects by reducing inflammation and placental injury and demonstrate that PLX-PAD cells may be a potential novel therapeutic approach for the treatment of preeclampsia.
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 visit www.pluristem.com, the content of which is not part of this press release.
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. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions or that historic results referred to in this press release would be interpreted differently in light of additional research and clinical and preclinical trials results. 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 Divisional VP, North America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
HAIFA, ISRAEL, March 26, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, announced today that a delegation from the UK made an official visit to Pluristem on March 25, 2014. Officials visiting Pluristem included the UK’s Minister for Universities and Science, David Willetts, whose responsibilities include overseeing the Department of Business Innovation and Skills (BIS), and Dr. Stephen Ward, Chief Operating Officer of the Cell Therapy Catapult, a non-profit organization which aims to grow the UK cell therapy industry.
British Prime Minster David Cameron recently launched a call for ground breaking collaborative research between Britain and Israel into Alzheimer’s, Type 1 Diabetes, heart disease, and Parkinson’s. British delegates including Mr. Willetts and Mr. Ward were in Israel to participate in the 2nd UK-Israel Regenerative Medicine Conference (BIRAX), which is being held on March 25th and 26th, 2014 in Haifa.
Minister David Willets stated, “In recent years, Israel has emerged as a leading player in the biomedical arena and in particular in the cell therapy space .Our objective is to deepen cooperation in scientific and clinical trials between Israel and the United Kingdom by establishing strategic partnerships with leading medical centers in the UK and Israeli companies.”
“It was an honor to host Minister Willetts, Dr. Ward, and members of their delegation here at Pluristem. We look forward to further talks regarding cooperation and collaboration with the British government and UK-based companies. As we accelerate our clinical pipeline, we are evaluating various locations for our clinical trials as well as other business partnership initiatives. We see the UK as an attractive territory that potentially enables a shorter path to market for our PLX products, particularly if the UK approves the Promising Innovation Medicine legislation that would speed up patients’ access to innovative new therapies,” commented, Pluristem CEO Zami Aberman.
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 visit www.pluristem.com, the content of which is not part of this press release.
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 possible cooperation and collaboration with the British government and UK companies, when we discuss acceleration of our clinical pipeline, or when we discuss the UK being an attractive territory that potentially enables a shorter path to market for our PLX products. 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
HAIFA, ISRAEL, March 25, 2014 – Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced its participation in the 2nd UK-Israel Regenerative Medicine Conference (BIRAX), which is being held on March 25th and 26th, 2014 in Haifa at the Ruth and Bruce Rappaport Faculty of Medicine, Technion – Israel Institute of Technology.
Ohad Karnieli, Pluristem’s Vice President of Development & Manufacturing will be a panelist on a session focused on commercialization of regenerative medicine titled, “Road to Clinical Translation – The viewpoint from Industry,” on March 26th, at 4:20 pm.
Shani Raveh, Ph.D., Pluristem’s Scientist will present a scientific poster titled, “Prevention of GvHD by PLX-PAD Cells via intravenous (IV) or intramuscular (IM) Administration”. Preliminary results from Pluristem’s preclinical study of its Placental eXpanded cells (PLX) in the prevention of graft versus host disease (GvHD) were announced in October, 2013. Dr. Raveh will present this data. Conclusions of the preclinical study include:
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 visit www.pluristem.com, the content of which is not part of this press release.
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 our preclinical study conclusions that PLX-PAD may be an effective and novel prophylactic treatment for GvHD or that the systemic effect of PLX-PAD can be achieved also by local administration. 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North-America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
HAIFA, ISRAEL, March 12, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced that Dr. Scott Rodeo of New York’s Hospital for Special Surgery (HSS) presented his research findings in a scientific poster titled, “Use of Human Placental-Derived Adherent Stromal Cells Improves Tendon Healing in a Preclinical Model of Tendon Injury,” at the American Academy of Orthopedic Surgeons’ (AAOS) Annual Meeting, on March 11-15 in New Orleans.
At the AAOS meeting, Dr. Rodeo’s poster presentation concluded that: a) placental-expanded cell therapy appeared to have an early beneficial effect on tendon healing following collagenase injury in this preclinical model; b) since these cells are immunoprivileged and are expanded ex vivo, its potential for “off-the-shelf” use is attractive relative to existing cell-based therapies; and
“Although our findings should be considered preliminary, adherent stromal cells derived from human placenta appear promising as a readily available cell source to aid tendon healing and regeneration,” stated Dr. Rodeo.
“These detailed preclinical results, as well as the favorable top-line results we announced from our Phase I/II muscle injury study in January, both validate our strategy to pursue advanced clinical studies of our PLX cells for the sports and orthopedic market,” stated Pluristem CEO Zami Aberman.
Dr. Rodeo and his orthopedic research team at HSS studied the effects of Pluristem’s PLacental eXpanded (PLX)-PAD cells in a preclinical model of patellar tendons that had sustained collagenase-induced injuries. Favorable results from the study were announced by Pluristem on August 14, 2013. Dr. Rodeo, the Principal Investigator for this study is Professor of Orthopedic Surgery at Weill Cornell Medical College; Co-Chief of the Sports Medicine and Shoulder Service at HSS; Associate Team Physician for the New York Giants Football Team; and Physician for the U.S.A. Olympic Swimming Team.
About the Study:
The biomechanical analysis of the study results showed that PLX-PAD treated tendons had significantly higher load-to-failure at the 2-week time point following injection when compared to saline-treated patellar tendons (p < 0.05). While PLX-PAD treated tendons had a higher mean tendon load-to-failure and stiffness (31.44 ± 6.06 N/mm versus 27.91 ± 6.57 N/mm) at a 4-week time point, these differences were not statistically significant.
Gross specimen and histological analysis of the tissue found: a) no consistent differences in severity of inflammation were seen between saline and tendons treated with placental cells at 2 and 4 weeks; b) no adverse soft tissue reaction was seen in placental cell-treated samples; c) CFSE-labeled placental cells were identified in the patellar tendon tissues out to 4 weeks following injection on fluorescent microscopy; and d) there was greater area of collagen content and metachromasia on ploraized-light picrosirius-red and safranin-O in tendons treated with placental-expanded cells, respectively.
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 visit www.pluristem.com, the content of which is not part of this press release.
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 research findings related to the use of our PLX-PAD cells in tendon injury, or that adherent stromal cells derived from human placenta appear promising as a readily available cell source to aid tendon healing and regeneration, or when we discuss our strategy to pursue advanced clinical studies of our PLX cells for the sports and orthopedic 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 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 Divisional VP, North-America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
HAIFA, ISRAEL, March 11, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced that Company executives will present at two upcoming financial conferences:
Barclays Global Healthcare Conference Date: March 11, 2014 at 8:30 am Location: Miami, Florida
Presenter: Boaz Gur-Lavie, Chief Financial Officer
RegenMed Investor Day
Date: March 26, 2014 at 2:15 pm Location: New York, New York
Presenter: Karine Kleinhaus, Divisional VP, North America
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 visit www.pluristem.com, the content of which is not part of this press release.
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. 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
Aberman to discuss collaborative models and partnerships that enable successful commercialization of gene and cell therapies
HAIFA, ISRAEL, March 7, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced the Company’s Chief Executive Officer Zami Aberman will deliver a brief presentation and be a panelist at BIO- Europe Spring 2014 on March 10, 2014 at 4pm. BIO-Europe Spring 2014 will take place on March 10-12 in Turin, Italy.
Mr. Aberman will join four other industry participants from GE Healthcare, Novartis, Oxford BioMedica, and Progenitor Cell Therapy on a panel discussion titled: “Gene therapy and gene modified cell therapies: What are the collaborative models and partnerships that will enable successful commercialization of these products?”
The panel will discuss the burgeoning interest in gene therapy as evidenced by a large number of new companies being formed in the sector, pharma investment in a variety of gene therapy programs, and the growing interest in gene-modified therapies to harness the immune system in the treatment of cancer and other diseases. Mr. Aberman will provide his expertise on how cell therapy and gene therapy intersect, as well as successful partnership strategies.
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 visit www.pluristem.com, the content of which is not part of this press release.
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. 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, M.D., M.P.H. Director of Investor Relations
1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
Pluristem fortifies leadership position in cell therapy following multiple regulatory approvals of its new PLX cell mass production facility
HAIFA, ISRAEL, March 06, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced that the United States Food and Drug Administration (FDA) has reviewed Pluristem’s comparability studies of its PLacental eXpanded (PLX) cell products and granted approval for the Company to manufacture these products in its new commercial-scale cell manufacturing facility.
“We believe we have the largest, scalable, most efficient, most consistent and controlled process for manufacturing cell therapies,” stated Zami Aberman, Chairman and CEO of Pluristem. “Knowing that the ‘Process is the Product’ in cell therapy, we have established our leadership position in the industry by focusing on our 3D commercial scale cell manufacturing processes. To be a successful company in the industry, we believe it is imperative to possess and control the manufacturing processes we have developed at Pluristem. We believe this FDA approval, combined with the approval given by the Paul-Ehrlich-Institute (PEI) of Germany announced on January 23, 2014, is an indication that these regulatory bodies see our proprietary 3D manufacturing process as a valid and sustainable commercial scale solution for potential cell therapies.”
At its new state-of-the-art GMP manufacturing facility, Pluristem has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment. Pluristem’s facility has the ability to efficiently produce approximately150,000 doses of PLX cells annually, with batch-to- batch consistency, which potentially translates into significant economic value.
Pluristem’s state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including US Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements and International Conference on Harmonization (ICH) quality guidelines. Pluristem believes that controlling the process is the key to success and invests significantly in developing highly efficient, cutting-edge culturing systems for its PLX cell therapy products.
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 visit www.pluristem.com, the content of which is not part of this press release.
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 what it takes to be a successful company in our industry, or that regulatory bodies see our proprietary 3D manufacturing process as a valid and sustainable commercial scale solution for cell therapies, or when we discuss the capabilities of our new facility and how they potentially translate into significant economic value. 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North-America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
Orphan Drug Designation may provide benefits including 7 year market exclusivity, tax credits, and FDA’s guidance on clinical studies
HAIFA, ISRAEL, February 20, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced it is submitting its application to the United Stated Food and Drug Administration requesting the Company to be granted Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells in the treatment of severe preeclampsia.
Orphan Drug Designation may qualify a company for several benefits under the Orphan Drug Act of 1983 (ODA), as amended. These benefits may include a 7-year period of orphan drug exclusivity upon product approval, a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug, and orphan drug grants.
“Having just recently established our Preeclampsia Steering Committee comprised of key medical opinion leaders, this Orphan Drug application submission is an important step in advancing our preeclampsia development program,” stated Pluristem Chairman and CEO Zami Aberman. “The tremendous unmet medical need makes this indication one of our top priorities. We look forward to advancing into human trials and we are hopeful that the very strong preclinical data for PLX cells will translate into similar results at the clinical level.”
Pluristem has successfully received Orphan Drug Designation from the FDA for its PLX cells in two other indications: the treatment of aplastic anemia; and the treatment of Buerger’s disease.
About Preeclampsia
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 definitive 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.
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 visit www.pluristem.com, the content of which is not part of this press release.
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 orphan drug submission and receipt of orphan drug status, the potential of receipt certain benefits in case we receive orphan drug status, and our statements regarding the status of the human trials we are conducting and potential success thereof, or when we discuss advancing our cell therapies to serve unmet medical needs, or that we are ready and set to meet the significant opportunities ahead. 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Director of Investor Relations 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
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