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Second collaboration agreement for new PLX-RAD cell therapy product
HAIFA, ISRAEL, December 4, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that it has entered into a long-term collaboration agreement with Hadassah Medical Center in Jerusalem. The medical center’s Department of Bone Marrow Transplantation and Cancer Immunotherapy, headed by Professor Reuven Or, will use preclinical models to assess the potential efficacy of PLX-RAD cells for treatment and prevention of hematological deficiencies and complications of bone marrow and umbilical cord blood transplantation. PLX-RAD cells are Pluristem’s second cell therapy product candidate.
“Hadassah is one of the leading medical centers in the world and we are honored to work with Dr. Or and his team. The preclinical studies to be conducted at Hadassah are expected to yield important data about the use of PLX-RAD cells in the treatment of hematological diseases. These data may help Pluristem to direct future clinical trials,” stated Pluristem CEO Zami Aberman. “This is our second collaboration with an academic institution to study PLX-RAD cells since announcing in October that we have the capability to manufacture this product candidate on a large scale.”
The Company’s development plan for PLX-RAD cells includes potential indications such as:
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, hematological disorders, radiation damage, and ischemia. PLX cells are grown using the Company’s proprietary three- dimensional expansion 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, forward-looking statements are used in this press release when we discuss the PLX- RAD preclinical studies to be conducted at Hadassah, the data they are expected to yield about PLX-RAD cells, that such data may help us to direct future clinical trials, or when we discuss the potential indications for PLX-RAD.
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, December 1, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today it has been granted a patent in Singapore titled “Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced Thereby for Therapy.”
Patent No. 170761 is Pluristem’s second granted patent in Singapore, and relates to methods of expanding adherent stromal cells from human placental or adipose tissue using Pluristem’s three-dimensional technology. Patents from the same family have previously been granted in Australia, India, Russia, and South Africa. Pluristem’s intellectual property portfolio now includes 33 patents issued and approximately 120 more pending worldwide.
“Singapore is a significant healthcare market and is a manufacturing center in the cell therapy space. We are happy to continue to build our relationship with its governmental agencies while strengthening our 3D technology-based competitive advantage in this important territory. We believe the regulatory environment for cell therapy to be advantageous and supportive of accelerated commercialization pathways in a number of Asian countries. For this reason we are actively seeking partners in Japan, and have already established a partnership with CHA Bio, a major biotechnology company in South Korea,” stated Pluristem CEO Zami Aberman.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, hematological disorders, radiation damage, and ischemia. PLX cells are grown using the Company’s proprietary three- dimensional expansion 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, forward-looking statements are used in this press release when we discuss our belief that regulatory environment for cell therapy is advantageous and supportive of accelerated commercialization pathways in a number of Asian countries.
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
Presentations to focus on Pluristem’s industry-leading expertise in 3D cell culturing and cell expansion technologies
HAIFA, ISRAEL, November 25th, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that Dr. Ohad Karnieli, the Company’s vice president of development and manufacturing, will present at two scientific conferences on the latest advancements in large-scale cell therapy manufacturing.
On November 25, 2014 at the 11th Annual bioProcessUK Conference Dr. Karnieli will give a presentation titled, “The Road Not Taken-Challenges and Possible Solutions in Moving Cell Therapy from Bench Top to Industry.” The bioProcessUK conference will take place in Liverpool, England on November 25-26, 2014 and is organized by the UK BioIndustry Association.
At the Cell Therapy Manufacturing conference on December 4, 2014 Dr. Karnieli will give a presentation titled, “Challenges and Possible Solutions for Optimizing Cell Therapy Manufacturing and its Influence on Quality and Cost of the Product.” He will also be a presenter and panelist for the panel titled, “Top Tips When Moving a Process from Phase I to Phase II to Phase III.” The conference will take place from December 3- 4, 2014 in Brussels, Belgium, in association with the International Society for Cellular Therapy.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, hematological disorders, radiation damage, and ischemia. PLX cells are grown using the Company’s proprietary three- dimensional expansion 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
Indications include orthopedic, nerve injury and neurodegenerative diseases
HAIFA, ISRAEL, November 12, 2014 — Pluristem Therapeutics Inc. (Nasdaq: PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that it has been granted a patent in both Australia and New Zealand for the use of a specified population of placental cells for treating several medical indications. The patent, titled “Adherent cells from placenta and use of same in disease treatment” has been issued in Australia, Patent No. 2010322808, and in New Zealand, Patent No. 600651.
The patents’ claims include the use of the population of placental cells in the treatment of muscle trauma, muscle defect, neuropathic pain, peripheral nerve injury, and neurodegenerative diseases.
“These patents, which cover multiple indications and bring the Company’s total to 32 granted patents, are timely, as we’ve demonstrated Pluristem’s ability to use its technology platform to develop distinct cell therapy product lines for the potential treatment of different conditions. We continue to evaluate additional indications for PLX- PAD and PLX-RAD, our first two cell therapy products,” stated Pluristem CEO Zami Aberman.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, hematological disorders, radiation damage, and ischemia. PLX cells are grown using the Company’s proprietary three- dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
In addition to its strong intellectual property position, Pluristem has 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 in this press release when we discuss the potential of our product candidates to treat different conditions or that we continue to evaluate additional indications for PLX-PAD and PLX-RAD. 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
London Regenerative Medicine Network Meeting
Alliance for Regenerative Medicine’s 2nd Annual European Advanced Therapies Investor Day
HAIFA, ISRAEL, November 10th, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that the Company’s CEO, Zami Aberman, has been invited to present at two regenerative medicine conferences in London regarding Pluristem’s cell therapy platform, large-scale manufacturing methods, and intellectual property strategy.
At the London Regenerative Medicine Network’s (LRMN) November 12 meeting, Mr. Aberman will deliver a presentation titled, “Maturing adherent-cell therapies for commercialization: strategies, technology barriers and possible solutions.” Mr. Aberman is one of three international speakers invited to present on the topic of scalable manufacturing therapies, which will be the focus of LRMN’s November 2014 meeting sponsored by Thermo Fisher Scientific.
Mr. Aberman will also present at the Alliance for Regenerative Medicine’s (ARM) 2nd Annual European Advanced Therapies Investor Day on November 13. His presentation, entitled “The Placenta as a superior source for cell therapy products – strategy and implementation”, will focus on Pluristem’s proprietary three-dimensional cell expansion technology platform, and the Company’s unique methods for developing and manufacturing distinct cell therapy products to treat specific diseases. Mr. Aberman will also discuss Pluristem’s successful intellectual property strategy, which serves as a model for IP protection in the regenerative medicine industry.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, hematological disorders, radiation damage, and ischemia. PLX cells are grown using the Company’s proprietary three- dimensional expansion 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, forward-looking statements are used in this press release when we discuss our potential to develop cell therapy products to treat specific diseases, and that Pluristem’s IP assets will in fact protect its position in the regenerative medicine industry.
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
The study will determine whether Pluristem’s second major product line may help cord blood cells to successfully replace damaged bone marrow
HAIFA, ISRAEL, October 27, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-derived cell therapy products, announced today that researchers at Case Western Reserve University will conduct a preclinical study of the Company’s PLacental eXpanded (PLX)-RAD cells. The study will evaluate whether PLX-RAD cells increase the success rate of human umbilical cord blood transplantation.
Umbilical cord blood cells are transplanted to replace a patient’s unhealthy bone marrow cells. When successful, a transplant can treat bone marrow failure, which can result from immune system disorders, genetic diseases, and leukemia treatment. When cord blood cells are administered to a patient, they travel to the bone marrow and produce healthy white and red blood cells and platelets after the patient’s own abnormal cells have been eliminated. Sometimes, however, the cord blood cells fail to take hold and the transplant fails. The study at Case Western Reserve will research the feasibility of using PLX-RAD cells to help the cord blood to engraft more effectively, resulting in higher rates of successful transplantation and treatment.
“Case Western Reserve is one of the top research institutes in the U.S. and we are delighted to work with them. Pluristem will provide the PLX-RAD cells and the university’s researchers will conduct the study,” stated Pluristem’s Chairman and CEO Zami Aberman.
“If animal data show that PLX-RAD cells increase the success rate of umbilical cord blood transplants, this would motivate us to apply to conduct human clinical trials for bone marrow reconstitution following radiation in a number of life-threatening diseases including leukemia, where development of new, healthy bone marrow is the only available cure,” Aberman concluded.
PLX-RAD cells are also being studied by the U.S. National Institutes of Health (NIH) for the treatment of acute radiation syndrome (ARS), which involves bone marrow failure after exposure to high levels of radiation, as can happen after a nuclear catastrophe.
The primary objective of the study at Case Western Reserve is to determine the benefits of administering PLX-RAD cells at the time of transplantation of human hematopoietic CD34+ cells collected from umbilical cord blood. Scientists will compare the success rates of transplant engraftment in the control arm versus those treated with PLX-RAD cells. The secondary objective is to determine if there are any histologic changes in the liver, lung, spleen and intestine in the control versus treated groups. The preclinical study will be conducted in an immunodeficient mouse model that has undergone non-lethal radiation to destroy its own bone marrow cells. There will be three arms in the study: 1) IV (intravenous) injection of human Hematopoietic Cells (hHC) alone for the control; 2) IV injection of hHC plus IV injection of 1 million PLX-RAD cells; 3) IV injection of hHC plus intramuscular (IM) injection of 1 million PLX RAD cells. At 8 weeks bone marrow of the mice will be analyzed.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release 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, forward looking statements are used in this press release when we discuss the feasibility of PLX-RAD cells to help cord blood cells to successfully replace damaged bone marrow, or when we discuss the PLX-RAD study we are going to conduct at Case Western Reserve University, or when we discuss the possibility of applying to conduct human clinical trials in a number of life-threatening diseases. 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 be 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
Marks second major cell therapy product line developed on Company’s PLX platform; PLX-RAD cells address multiple indications associated with bone marrow deficiency
HAIFA, ISRAEL, October 21, 2014– Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that it has completed development of its second major product line, and can now begin manufacturing the cells on a large-scale at its state-of-the art facility in order to meet demand for anticipated studies in a range of hematologic conditions. This second cell product candidate, called PLX-RAD, was created using Pluristem’s proprietary three dimensional cell expansion technology platform. The Company’s first product, PLX- PAD, is already in clinical trials for the treatment of peripheral artery disease, muscle injury and pulmonary arterial hypertension.
Pluristem’s development plan for the PLX-RAD cells considers numerous potential clinical indications such as: 1) enhancement of engraftment of transplanted hematopoietic stem cells for the treatment of bone marrow deficiency, which can result from immune system disorders, genetic diseases, and treatment of leukemia and other blood cancers; 2) treatment of bone marrow deficiency in patients who have undergone chemotherapy; 3) treatment of acute radiation syndrome (ARS) in conjunction with the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases.
“We’ve just completed a two-year development cycle for our PLX-RAD cells, and have also developed new manufacturing equipment, methods and know-how. We believe that our state-of-the-art technology platform can be used to create additional cell products from the placenta, tailored to potentially deliver targeted treatments for a variety of new indications,” stated Zami Aberman, Chairman and CEO of Pluristem.
“Our technology platform, robust manufacturing capabilities and broad IP portfolio open the door for potential institutional and commercial partners, and we’re pleased with the level of interest we have received in our technology platform. Pluristem is in a unique position to be a leader in the cell therapy industry,” Aberman concluded.
Data from a study of PLX-RAD cells conducted at Hadassah Medical Center were published in the peer-reviewed journal, PLOS ONE.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation or ischemia. PLX cells are grown using the Company’s proprietary three dimensional expansion 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, forward-looking statements are used in this press release when we discuss our development plan for the PLX-RAD and anticipated studies in a range of hematologic conditions; when we discuss our belief that our technology platform can be used to create additional cell products from the placenta, tailored to potentially deliver targeted treatments for a variety of new indications; when we discuss the feasibility of potential institutional and commercial new partnerships, or that we are in a unique position to lead the cell therapy industry. 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 08, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that its licensee, United Therapeutics Corporation, has completed the dosing of the first cohort of patients in its Phase I study using Pluristem’s PLacental eXpanded (PLX-PAD) cells in patients diagnosed with pulmonary arterial hypertension (PAH). PAH, with a global market estimated at approximately $3 billion, is characterized by abnormally high blood pressure in the arteries of the lungs; it can disrupt lung and heart function, leading to debilitating conditions such as heart failure.
The Phase I study, being conducted in Australia, is an open-label, dose-escalation study designed to enroll 9 patients diagnosed with PAH. The first cohort of 3 patients has received 0.5 million PLX cells per kilogram body weight. An independent Data Safety Monitoring Board recommended advancement to the second cohort. The second cohort will receive 1 million cells per kilogram, while the third cohort is planned to be administered 2 million cells per kilogram. The primary endpoint of the study is the safety of PLX-PAD cells, which will be evaluated at 12 weeks and one year after dosing. Secondary efficacy endpoints are to be measured at six weeks post-treatment in order to assess changes in the ability to exercise, disease severity and cardio-respiratory function; measures include six-minute walk distance and cardio-pulmonary hemodynamic parameters evaluated via right heart catheterization and echocardiogram.
“We look forward to preliminary results for this trial in 2015, after completion of dosing in all three cohorts,” stated Pluristem Chairman and CEO Zami Aberman. “This Phase I study is important to the development of our PAH program in conjunction with United Therapeutics, and we are delighted to work with United Therapeutics in advancing the promise of cell therapy to treat pulmonary diseases.”
The Phase I study is being conducted as part of a 2011 licensing agreement between United Therapeutics and Pluristem. Pursuant to the agreement, United Therapeutics will develop, market and sell Pluristem’s PLX-PAD cells for PAH. Pluristem is eligible to receive up to $55 million based on successful achievement of clinical milestones and commercialization, and reimbursement of certain R&D costs. Following
commercialization, United Therapeutics will purchase commercial supplies of PLX-PAD cells from Pluristem at a specified margin over Pluristem’s cost, and will pay royalties at a percentage of its gross profits.
PAH is characterized by abnormally high blood pressure in the arteries of the lungs which leads to an increased workload on the right side of the heart; this can lead to heart failure and other negative health outcomes. It is a serious illness that becomes progressively worse and is sometimes fatal. PAH isn’t curable, although treatments are available that can help lessen symptoms and improve quality of life.
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. Forward-looking statements include statements about future progress and completion of the Phase 1 study of PLX-PAD in PAH patients, milestone payments based on further clinical development, the possible commercialization of PLX-PAD by United Therapeutics and royalty payments and supply arrangements upon commercialization. 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, October 7th, 2014 – Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that its European Patent No. EP2200622, titled, “ADHERENT CELLS FROM ADIPOSE OR PLACENTA TISSUES AND USE THEREOF IN THERAPY”, was upheld by the European Patent Office in amended form, affirming its validity
Pluristem’s patent went through Opposition Proceedings before the Opposition Division of the European Patent Office, as a result of a challenge from a cell therapy company. The European Patent Office concluded that Pluristem’s patent, whose claims cover treatment of ischemia with adherent placental cells which are propagated using a 3D culture, is valid.
“With a portfolio of 30 issued patents and another 120 pending, intellectual property is a core asset for Pluristem. We will continue to invest in and defend our patents,” stated Zami Aberman, Chairman and CEO of Pluristem.
“We believe this case, which was brought to the Opposition Division of the European Patent Office from a cell therapy company, afforded Pluristem a clear opportunity. We have proven that we are determined to protect our IP assets that cover our unique, proprietary inventions, and that we are committed to protect our patents from any challenge,” Aberman concluded.
EPO Opposition Proceedings are post-grant adversarial proceedings in which interested third parties can challenge the validity of all the national parts of a European patent via a single centralized procedure. The decision of the Opposition Division to uphold Pluristem’s EP2200622 in amended form is open to an appeal to one of the EPO’s Technical Boards of Appeal for all parties involved.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation or ischemia. PLX cells are grown using the Company’s proprietary three dimensional expansion 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 investing in and defending our patents. 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 end 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 16, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today it is evaluating strategic opportunities to co-develop and commercialize its PLacental eXpanded (PLX) cell therapies in Japan.
Recent changes in Japan’s laws governing regenerative medicine and the approval of stem cell therapies indicate the country may now offer the fastest track to commercialization in the world for regenerative medicine treatments. As part of Pluristem’s strategy in Japan, on September 16, 2014, Company executives presented to a group of Japanese pharmaceutical executives in Tokyo, and conducted a series of one-on- one meetings with Japanese companies exploring a potential partnership with Pluristem.
To support its strategy in Japan, Pluristem is working with The Sage Group, a consulting firm specializing in healthcare industry transactions and business strategy, and Sage’s partner Waterfield HealthCom, a Japan-based firm managed by Yoshi Mizuta. Mr. Mizuta is a highly experienced pharmaceutical industry executive with more than 40 years in the business of financial healthcare transactions in the Japanese arena.
Japan’s government passed a bill in 2013, which goes into effect in November of this year, effectively fast-tracking the approval of stem cell therapies for marketing. According to the law, stem cell regenerative medicine therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety but prior to verification of efficacy; safety and effectiveness need to be confirmed after the conditional approval.
Waterfield HealthCom’s Mr. Mizuta commented, “With its broad portfolio of indications and its commercial scale 3D cell manufacturing capabilities, Pluristem is a very desirable partner for Japanese pharmaceutical companies looking to bring cell therapies to the market in the near term.”
“As a result of Japan’s favorable new law, cell therapies like Pluristem’s PLX cells can receive market approval in Japan upon completion of Phase II trials when good safety and efficacy data is available. This could potentially reduce approval time down to two or three years,” Mr. Mizuta concluded.
Pluristem CEO Zami Aberman added, “The opportunity in Japan opens an accelerated path for the global regenerative medicine industry to prove the efficacy of cell therapies in a broad patient population in Japan. Japan has one of the most advanced healthcare systems, and the second largest healthcare market in the world.”
Pluristem currently has co-development and out-licensing partnership agreements with United Therapeutics (NASDAQ: UTHR) and South-Korea-based CHA Bio&Diostech (KOSDAQ: CHA).
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, forward-looking statements are used in this press release when we discuss the opportunity in Japan including receiving market approval in Japan for our products upon completion of phase II which could potentially reduce approval time. 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
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