Sharing insights and knowledge of the unique immune-privileged properties and mechanism of action of PLX cells
HAIFA, ISRAEL, September 10, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that the Company’s Vice President of Research & Intellectual Property, Racheli Ofir, Ph.D., and its Basic and Preclinical Research Manager, Lena Pinzur, M.Sc., will each deliver a presentation at the International Placenta Stem Cell Society’s 3rd IPLASS Meeting which will take place on September 10-12, 2014 in Granada, Spain.
Dr. Ofir’s presentation titled, “The Therapeutic Value of Placental Cells–What Makes the Difference?” will be delivered at 10:30 a.m. on Friday, September 12th during Session IV, which is focused on cell therapy approaches using placenta cells or derivatives.
Dr. Ofir’s presentation will describe the unique immune-privileged properties of placental cells, mechanism of action (MoA) and the use of the placenta as a potential source for different products.
Lena Pinzur’s presentation titled, “Toll-Like Receptor Agonist-Induced Preeclampsia Symptoms in Mice are Treatable with Placental Expanded (PLX)-PAD Cells,” will be given at 11:00 a.m. on Friday, September 12th during Session IV.
The International Placenta Stem Cell Society is an independent and non-profit organization that promotes advances in placenta-derived stem cell research and development with the goal of applying these cells for cell therapy.
“We have focused on the placenta as an optimal source of cells for almost a decade, and are eager to share our knowledge about the placenta’s therapeutic value,” said Zami Aberman, Pluristem’s Chairman and CEO. “The NIH’s initiation of the Human Placental Project earlier this year highlights the growing recognition of the importance of this organ as we continue to develop our placenta-derived cell therapy products.”
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to inflammation or ischemia. 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 placenta’s therapeutic value, or that we continue to develop our placenta-derived cell therapy 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
HAIFA, ISRAEL, September 4, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today its executives will present at two financial conferences in New York City during the month of September. The Company’s Divisional Vice President, North America, Dr. Karine Kleinhaus will present at the Rodman & Renshaw 16th Annual Global Investment Conference at the New York Palace Hotel on Wednesday, September 10th at 3:20 pm. Pluristem’s President and Chief Operating Officer, Yaky Yanay will present at The East Coast Family Office & Wealth Management Annual Conference at the Union League Club on Wednesday, September 17th at 10:05 am.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to inflammation or ischemia. 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
This follows clearances from U.S., E.U., German, and South Korean regulators
HAIFA, ISRAEL, July 31, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapies, announced today that it has completed the approval process and received final clearance from a fifth regulatory agency for its 3D cell therapy manufacturing processes in use at its new facility in Haifa. The latest approval comes from Israel’s Ministry of Health and follows similar clearances from the U.S. Food and Drug Administration, the European Union’s Qualified Person, Germany’s Paul Ehrlich Institute, and the South Korean Ministry of Food and Drug Safety.
“This latest regulatory clearance further validates our proprietary cell manufacturing processes, which we believe are state-of-the-art and unmatched in the cell therapy arena. Our Haifa facility has the capacity to produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value” stated Pluristem CEO Zami Aberman. “This latest approval also exemplifies our strategy of working with multiple regulatory bodies in order to establish Pluristem as a leading developer of cell therapies and to set the standards for this area of manufacturing,” added Aberman.
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 in sufficient quantities to support late-phase clinical trials and commercial demand at time of regulatory approval. Pluristem manufactures its products in full compliance with the U.S. Food and Drug Administration (FDA) and European Medicines Agencies (EMA) current Good Manufacturing Practices (cGMP). Pluristem believes that control of the production process is critical for the successful manufacture of cell therapies and invests significantly in developing highly efficient, cutting-edge culturing systems for its range of PLX cell products.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to inflammation or ischemia. 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
Key Opinion Leader Dr. Baha Sibai will discuss preeclampsia, a disease that costs the
U.S. $7 billion annually
HAIFA, ISRAEL, July 22, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, announced today that it will host an investor breakfast on Wednesday, July 23 in New York City. Prof. Baha M. Sibai, MD, a renowned expert in preeclampsia, will present an overview of this disorder, a leading cause of maternal deaths and premature births. Pluristem’s CEO, Zami Aberman, will then speak about the potential of Pluristem’s cells to treat this unmet medical need.
The presentations, followed by a question-and-answer session, will be webcast live beginning at 8am Eastern Time. The webcast and accompanying presentation materials will be accessible live at http://lifesci.rampard.com/20140723/.
Preeclampsia is 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 other signs of organ dysfunction. According to the American Society of Hypertension, preeclampsia costs the U.S. alone more than $7 billion annually, and globally it causes between 50-70,000 maternal and approximately 500,000 infant deaths each year.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to inflammation or ischemia. 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 potential of Pluristem’s cells to treat preeclampsia. 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
Trial now active in 13 clinical centers in 4 countries
HAIFA, ISRAEL, July 8, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, today announced the initiation of South Korean sites in the Phase II study assessing PLacental eXpanded (PLX) cells in the treatment of intermittent claudication (IC). Patient screening is now underway at three clinical centers, making South Korea the fourth country to participate in this randomized, double-blind, placebo-controlled Phase II trial. The trial has been ongoing at clinical sites in the U.S., Israel and Germany with an enrollment target of 150 patients.
The South Korean part of the study is being conducted by CHA Bio & Diostech (Kosdaq: CHA) under an exclusive licensing agreement for the use of PLX cells for peripheral artery disease (PAD) in South Korea. Under the terms of Pluristem’s licensing agreement with CHA, if there is regulatory approval for a PLX product in South Korea Pluristem and CHA will establish a joint venture (JV) co-owned by the parties; they will share the revenues and income generated through sales of PLX cell therapies in the South Korean market. It is estimated that one million people in South Korea suffer from PAD and this number is expected to grow.
“We have a very productive partnership with CHA, as evidenced by our joint clinical program. Initiating our first trial in South Korea is a major milestone. We look forward to reporting further progress on our Phase II IC trial in the South Korean market,” stated Pluristem CEO Zami Aberman.
In May, Pluristem received clearance from the South Korean Ministry of Food and Drug Safety (MFDS) to use PLX cells in South Korean trials.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to inflammatory or ischemic conditions. 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 receiving regulatory approval for PLX products in South Korea, or when we discuss reporting further progress on our Phase II IC trial in the South Korean 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Pluristem to share insights on emerging markets and its industry-leading cell manufacturing methods with audience of bio-manufacturing experts
HAIFA, ISRAEL, June 30, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, today announced its VP of Development & Manufacturing, Ohad Karnieli, Ph.D., will give a plenary talk at the Bio-Process Systems Alliance’s (BPSA) 4th Annual International Single-Use Summit (ISUS 2014), which will be held on July 9-11, 2014 in Washington, D.C.
Speakers at this year’s ISUS 2014 event will offer insight on building bio-manufacturing venues tailored to single-use technologies, new markets for single-use (disposable) biopharmaceutical manufacturing equipment, and a host of other technical topics facing this fast-evolving industry.
On Thursday, July 10th from 11:45 a.m. to 12:30 p.m., during his presentation on behalf of the ISCT titled, “Emerging Markets for Single-Use: Cell Therapy and Regenerative Medicine,” Dr. Karnieli will speak about process and product development and innovation in single-use manufacturing of cell therapy and regenerative medicine products.
Pluristem is currently the only company manufacturing large quantities of homogeneous, clinical-grade, placenta-based cell products using a 3D bioreactor. Driving this achievement are research, development and manufacturing teams dedicated to shaping the future of placenta-based cell therapies.
The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led trade association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies for the production of biopharmaceuticals and vaccines. BPSA facilitates education, sharing of best practices, development of consensus guides and business-to-business networking opportunities among its members.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a protein 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
PLX cells offer potential as first off-the-shelf product for muscle and tendon regeneration
HAIFA, ISRAEL, June 25, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, today announced it has selected rotator cuff repair as the second indication in its orthopedic clinical program. The Company’s PLacental eXpanded (PLX) cells offer potential as the first off-the-shelf cell therapy product for muscle and tendon regeneration that can be used to enhance repair after rotator cuff surgery. There are currently no FDA-approved therapies using engineered cells for the treatment of rotator cuff injuries.
According to the American Academy of Orthopaedic Surgeons (AAOS), nearly 2 million patients in the U.S. seek help for their rotator cuff injuries. The incidence of these injuries increases with age, so as the U.S. population ages the prevalence and potential cost burden is likely to grow.
“Following the favorable results of our Phase I/II trial in our first orthopedic indication, the treatment of injured gluteal muscle after total hip replacement, we, together with Key Opinion Leaders in orthopedic surgery, selected rotator cuff repair as an important indication in need of a novel cell therapy solution. We are progressing with our study design, and are considering the addition of a third orthopedic indication,” stated Pluristem CEO Zami Aberman.
“There is a clear and unmet need for a new kind of therapy that can improve the outcome of orthopedic surgery for rotator cuff tears. Our PLX cells can be administered as a simple office procedure. The team of Key Opinion Leaders advising us is particularly excited by the potential of a non-invasive, effective cell therapy for orthopedic indications,” added 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 our plan to enter into clinical trials for rotator cuff repair indication, or that our PLX cells offer potential as the first off-the- shelf cell therapy product for muscle and tendon regeneration that can be used to enhance repair after rotator cuff surgery, or that we are considering the addition of a third orthopedic indication, or when we discuss the potential of a non-invasive, effective cell therapy for orthopedic indications . 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
PLX cells shown to be a potentially effective treatment
HAIFA, ISRAEL, June 19, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, today announced that Russia’s Federal Service for Intellectual Property has granted to Pluristem Patent No. 2515156 titled, “Methods of Treating Inflammatory Colon Diseases”. The patent covers methods for treating ulcerative colitis or Crohn’s disease using placenta-derived cells. This patent has already been issued to Pluristem in South Africa and is currently pending in several other jurisdictions.
“Pre-clinical studies have demonstrated that PLX cells are potentially effective in treating inflammatory bowel disease, and we may consider advancing into clinical trials with this indication in future,” stated Pluristem CEO Zami Aberman. “This patent issued in Russia is the latest in a series of patents we’ve been granted across the globe for the use of placenta-derived cell therapies in a variety of different indications.”
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 protein delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic conditions. 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.
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 that PLX cells are potentially effective in treating inflammatory bowel disease and that we may consider advancing inflammatory bowel disease and Crohn’s disease indications into clinical trials in future.
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
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, June 16, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, today announced it has been granted Patent No. 261087 from India’s Office of the Controller General of Patents, Designs & Trade Marks for a patent titled, “Methods for Cell Expansion and Conditioned Media Produced Thereby for Therapy.”
The patent, which has also been granted to Pluristem in Australia, Russia and South Africa, covers the Company’s key technology platform, its method for 3-dimensional expansion of placental and adipose (fat) derived cells. It also covers the composition of cells derived using this method.
“We believe Pluristem is the global leader in the commercial-scale production of placenta-derived cells. In our manufacturing facility, we use proprietary 3-dimensional cell expansion technology that gives us the ability to precisely control cell growth based on the intended indication to be treated. Our ability to do this on a large scale is one of our key assets,” stated Pluristem CEO Zami Aberman.
“This patent issued by India is an important part of our global IP strategy to protect our breakthrough cell production methods in high-value and emerging healthcare markets where we see future potential for growth,” Aberman added.
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 being a global leader in the commercial-scale production of placenta-derived cells, or our ability to precisely control cell growth based on the intended indication to be treated and do it on a large scale. 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
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.