HAIFA, ISRAEL, March 11, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced that Company executives will present at two upcoming financial conferences:
Barclays Global Healthcare Conference Date: March 11, 2014 at 8:30 am Location: Miami, Florida
Presenter: Boaz Gur-Lavie, Chief Financial Officer
RegenMed Investor Day
Date: March 26, 2014 at 2:15 pm Location: New York, New York
Presenter: Karine Kleinhaus, Divisional VP, North America
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
Aberman to discuss collaborative models and partnerships that enable successful commercialization of gene and cell therapies
HAIFA, ISRAEL, March 7, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced the Company’s Chief Executive Officer Zami Aberman will deliver a brief presentation and be a panelist at BIO- Europe Spring 2014 on March 10, 2014 at 4pm. BIO-Europe Spring 2014 will take place on March 10-12 in Turin, Italy.
Mr. Aberman will join four other industry participants from GE Healthcare, Novartis, Oxford BioMedica, and Progenitor Cell Therapy on a panel discussion titled: “Gene therapy and gene modified cell therapies: What are the collaborative models and partnerships that will enable successful commercialization of these products?”
The panel will discuss the burgeoning interest in gene therapy as evidenced by a large number of new companies being formed in the sector, pharma investment in a variety of gene therapy programs, and the growing interest in gene-modified therapies to harness the immune system in the treatment of cancer and other diseases. Mr. Aberman will provide his expertise on how cell therapy and gene therapy intersect, as well as successful partnership strategies.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, M.D., M.P.H. Director of Investor Relations
1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
Pluristem fortifies leadership position in cell therapy following multiple regulatory approvals of its new PLX cell mass production facility
HAIFA, ISRAEL, March 06, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced that the United States Food and Drug Administration (FDA) has reviewed Pluristem’s comparability studies of its PLacental eXpanded (PLX) cell products and granted approval for the Company to manufacture these products in its new commercial-scale cell manufacturing facility.
“We believe we have the largest, scalable, most efficient, most consistent and controlled process for manufacturing cell therapies,” stated Zami Aberman, Chairman and CEO of Pluristem. “Knowing that the ‘Process is the Product’ in cell therapy, we have established our leadership position in the industry by focusing on our 3D commercial scale cell manufacturing processes. To be a successful company in the industry, we believe it is imperative to possess and control the manufacturing processes we have developed at Pluristem. We believe this FDA approval, combined with the approval given by the Paul-Ehrlich-Institute (PEI) of Germany announced on January 23, 2014, is an indication that these regulatory bodies see our proprietary 3D manufacturing process as a valid and sustainable commercial scale solution for potential cell therapies.”
At its new state-of-the-art GMP manufacturing facility, Pluristem has implemented its proprietary, fully automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment. Pluristem’s facility has the ability to efficiently produce approximately150,000 doses of PLX cells annually, with batch-to- batch consistency, which potentially translates into significant economic value.
Pluristem’s state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including US Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements and International Conference on Harmonization (ICH) quality guidelines. Pluristem believes that controlling the process is the key to success and invests significantly in developing highly efficient, cutting-edge culturing systems for its PLX cell therapy products.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements, when we discuss what it takes to be a successful company in our industry, or that regulatory bodies see our proprietary 3D manufacturing process as a valid and sustainable commercial scale solution for cell therapies, or when we discuss the capabilities of our new facility and how they potentially translate into significant economic value. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North-America 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
Orphan Drug Designation may provide benefits including 7 year market exclusivity, tax credits, and FDA’s guidance on clinical studies
HAIFA, ISRAEL, February 20, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced it is submitting its application to the United Stated Food and Drug Administration requesting the Company to be granted Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells in the treatment of severe preeclampsia.
Orphan Drug Designation may qualify a company for several benefits under the Orphan Drug Act of 1983 (ODA), as amended. These benefits may include a 7-year period of orphan drug exclusivity upon product approval, a tax credit for certain clinical testing expenses for the orphan drug, written guidance on the non-clinical and clinical studies needed to obtain marketing approval of an orphan drug, and orphan drug grants.
“Having just recently established our Preeclampsia Steering Committee comprised of key medical opinion leaders, this Orphan Drug application submission is an important step in advancing our preeclampsia development program,” stated Pluristem Chairman and CEO Zami Aberman. “The tremendous unmet medical need makes this indication one of our top priorities. We look forward to advancing into human trials and we are hopeful that the very strong preclinical data for PLX cells will translate into similar results at the clinical level.”
Pluristem has successfully received Orphan Drug Designation from the FDA for its PLX cells in two other indications: the treatment of aplastic anemia; and the treatment of Buerger’s disease.
About Preeclampsia
Preeclampsia is one of the most common medical complications of pregnancy, and one of the leading known causes of premature births, stillbirths and early neonatal and maternal deaths. If left untreated it can progress to eclampsia, the life-threatening occurrence of seizures during pregnancy. The only definitive treatment for preeclampsia is abortion or delivery. The disease occurs after the 20th week of pregnancy, and is characterized by high blood pressure and significant amounts of protein in the urine or end-organ dysfunction. According to the World Health Organization, preeclampsia occurs in approximately 6%–8% of pregnancies worldwide. It is estimated that preeclampsia costs the global health care system $3 billion annually.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements, when we discuss the orphan drug submission and receipt of orphan drug status, the potential of receipt certain benefits in case we receive orphan drug status, and our statements regarding the status of the human trials we are conducting and potential success thereof, or when we discuss advancing our cell therapies to serve unmet medical needs, or that we are ready and set to meet the significant opportunities ahead. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Director of Investor Relations 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
Covers commercial rights for 3D manufacturing methods and composition of matter for placental or fat cells
HAIFA, ISRAEL, February 18, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced it has been granted a new patent by the Australian Patent Office. Patent #2007228341 covers the method and composition of matter for three-dimensional (3D) expansion of placental or adipose (fat) stromal cells, Pluristem’s key technology platform. Patent claims also include methods of treatment using placental cells for numerous diseases including graft vs. host disease (GvHD), heart disease, stroke, burns, loss of tissue, loss of blood, anemia, and autoimmune disorders. Patents with similar claims have also been granted to Pluristem in Russia and in South Africa. This marks Pluristem’s third patent issued in Australia and its 28th patent issued worldwide.
Pluristem’s PLacental eXpanded (PLX) PAD cells have been approved for a Phase I study in Australia for the treatment of Pulmonary Arterial Hypertension (PAH). United Therapeutics will be conducting the trial under a licensing agreement with Pluristem.
“Australia represents a significant and attractive healthcare market for the largest biotech and pharmaceutical companies. Because this patent covers manufacturing methods for producing commercial quantities of cells, it is very valuable intellectual property for Pluristem and the patent can be a key asset for potential partnership and licensing opportunities for us in Australia,” stated Zami Aberman, Chairman and CEO of Pluristem.
Pluristem’s Australian patent announced on January 8, 2014 covers the use of adherent placental cells for the treatment of ischemia, which is a restriction of blood supply to tissues, and for treatments of conditions requiring connective tissue repair or regeneration.
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 that PLX-PAD cells may be helpful in treating certain medical conditions, that United Therapeutics may conduct clinical trials under a license agreement with Pluristem. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Director of Investor Relations 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
Panel: Disrupting the Pharma Model with Allogeneic Stem Cell Therapies
HAIFA, ISRAEL, February 13, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced that its CEO and Chairman, Zami Aberman, will be a speaker on a panel titled, “Disrupting the Pharma Model with Allogeneic Stem Cell Therapies – Part I” at the 9th Annual Stem Cell Summit. The summit will take place in New York on Tuesday, February 18th, 2014.
The Stem Cell Summit has set the following agenda for Mr. Aberman’s panel:
The Pharma model may be broken. Can allogeneic stem cell therapies save it? Traditional drug development means screening 10,000 compounds to get to 250 animal study candidates to get to 10 human study candidates to market 2 drugs. It takes so long that patents expire and costs can reach $500 million. Could stem cell therapies turn the Pharma model on its head?
The summit convenes more than 30 of the world’s leaders in the stem cell industry. The Stem Cell Summit’s aim is to bring the future of this dynamic industry to life for investors, industry, practitioners, and analysts.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Director of Investor Relations 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
PLX-PAD cells offer promising potential treatment for preeclampsia; currently no treatment exists other than early delivery
HAIFA, ISRAEL, February 11, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced it has formed a Preeclampsia Steering Committee to advance its PLacental eXpanded (PLX) cell therapies for the treatment of preeclampsia.
“Preeclampsia is an important indication for our PLX-PAD cells. Based on the dire need for a treatment and the potential of our cell therapy in this indication, we have made it a key priority to enter clinical trials for preeclampsia in the near future,” stated Pluristem Chairman and CEO Zami Aberman. “The caliber of medical and scientific thought leaders who have joined our Preeclampsia Steering Committee is a testament to the promise of our PLX cell therapy as a potential treatment for this disease.”
Preeclampsia Steering Committee Member, Dr. Sibai, who was a moderator on the preeclampsia scientific forum, “Debate and Consensus: Preeclampsia Biomarkers in Clinical Practice, Are we ready?” at the Society for Maternal Fetal Medicine in New Orleans on Feb 5, 2014, commented, “For almost a thousand years, physicians have had no therapy to offer women with preeclampsia. A safe and effective therapy is needed to treat these women and prolong gestation. Pluristem’s PLX cells are a unique potential therapy because they originate from the placenta, which plays a key role in preeclampsia.”
Pluristem’s Preeclampsia Steering Committee:
Prof. James M. Roberts, M.D. University of Pittsburgh
Professor, Department of Obstetrics, Gynecology and Reproductive Sciences Professor of Epidemiology, Senior Scientist, Magee-Women’s Research Institute
Prof. George R. Saade, M.D. University of Texas Medical Branch
Professor, Division Chief Obstetrics & Gynecology
Prof. Baha M. Sibai, M.D. University of Texas Medical School
Visiting Professor
Dr. David Williams, PhD FRCP University College London
Honorary Senior Lecturer, Maternal & Fetal Medicine, Institute for Women’s Health, Faculty of Population Health Sciences
Prof. Simcha Yagel, M.D. Hadassah Medical Center, Israel
Head Division of Obstetrics and Gynecology at Hadassah Medical Center Head of the Israeli Association of Placental Study
The Preeclampsia Steering Committee will guide Pluristem’s preeclampsia program including advising on various stages of clinical trials, from the design of the study protocol through processing patient feedback up to the final study report. Committee members have vast knowledge of preeclampsia and a commitment to finding a treatment.
In preclinical studies, PLX cells have been shown to be safe and an effective treatment for preeclampsia. In November 2013, Pluristem announced that PLX cells proved to be safe in an animal study assessing maternal and fetal toxicity. The Company announced in May 2013 that PLX cells improved several parameters of preeclampsia in animal models of the disease.
About Preeclampsia
Preeclampsia is one of the most common medical complications of pregnancy, and one of the leading known causes of premature births, stillbirths and early neonatal and maternal deaths. If left untreated it can progress to eclampsia, the life-threatening occurrence of seizures during pregnancy. The only known treatment for preeclampsia is abortion or delivery. The disease occurs after the 20th week of pregnancy, and is characterized by high blood pressure and significant amounts of protein in the urine or end-organ dysfunction. According to the World Health Organization, preeclampsia occurs in approximately 6–8% of pregnancies worldwide. It is estimated that preeclampsia costs the global health care system $3 billion annually.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements, when we discuss the potential of our PLX- PAD cells to provide therapy for preeclampsia, conducting clinical trials in preeclampsia and the Preeclampsia Steering Committee meeting its expected goals. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Director of Investor Relations 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
HAIFA, ISRAEL, February 5, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced the appointments of two of its senior executives. These executive appointments support the Company’s growth and opportunities both on the clinical development front and with its big-pharma corporate partnerships. This comes at a time when Pluristem is advancing its cell therapies for numerous indications through global clinical trials.
Yaky Yanay has been promoted to President and Chief Operating Officer. Mr. Yanay joined Pluristem in 2006, serving as the Company’s Chief Financial Officer in charge of financial strategy. Since March of 2012, Mr. Yanay has also served as the Company’s Executive Vice President. Mr. Yanay is a member of the board of directors of Israel Advanced Technologies Industries, the largest umbrella organization in Israel for companies, organizations, and individuals in the high tech and life science sectors. Mr. Yanay holds a bachelor’s degree with honors in business administration and accounting, and he is a Certified Public Accountant in Israel.
Boaz Gur-Lavie has been appointed to the position of Chief Financial Officer and Secretary. Mr. Gur-Lavie recently joined Pluristem, serving as the Company’s Vice President of Finance. Prior to joining Pluristem, Mr. Gur-Lavie was CFO of Abbott Informatics Division, responsible for different Abbott informatics brands and STARLIMS, a global software organization which helps laboratories optimize data accessibility, integrity, defensibility and long-term value. Before that, he served as VP Finance of STARLIMS, a software company traded on the NASDAQ and Tel- Aviv stock exchange prior to being acquired by Abbott. Mr. Gur-Lavie previously served as assistant controller at ECI. Prior to which he served as a senior manager on the ERS team of Deloitte Israel. He has also served as a lecturer at Ben Gurion University. Mr. Gur-Lavie holds a master’s degree in finance and a bachelor’s degree in economy and accounting from the University of Ben-Gurion. He is a Certified Public Accountant in Israel.
“Both Yaky and Boaz bring tremendous value to the Company and these appointments are very well-deserved. Their proven leadership skills, their strategic choices and their implementation of operational goals will take Pluristem to the next level of achievement,” stated Zami Aberman, Chairman and CEO of Pluristem. “Our entire scientific, manufacturing, and operational team has done a phenomenal job of advancing our cell therapies to serve unmet medical needs.”
Yaky Yanay, Pluristem’s President and COO commented, “In the last year we were focused on building our manufacturing capabilities and our technology’s competitive advantages. Now, following the strengthening of our executive and management team, our Company is ready and set to meet the significant opportunities ahead for the benefit of our shareholders, business partners and our employees.”
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 that the executive appointments support the Company’s growth and opportunities, taking Pluristem to the next level of achievement, or when we discuss advancing our cell therapies to serve unmet medical needs, or that we are ready and set to meet the significant opportunities ahead. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated
events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Director of Investor Relations 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
NIAID’s next study of PLX-RAD cells to be initiated in February
HAIFA, ISRAEL, February 3, 2014- Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced that the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), will commence a mechanism-of-action study of Pluristem’s PLacental eXpanded RAD (PLX-RAD) cells for the treatment of acute radiation syndrome (ARS). The study aims to investigate the effect of PLX-RAD cells on body weight, blood count parameters, cytokine concentrations and bone marrow or spleen cellularity at various time points following the administration of PLX-RAD cells to animals receiving total body irradiation. The study is scheduled to begin in February 2014.
Following positive data from NIAID’s first study of PLX-RAD cells on irradiated animals’ hematological systems, Pluristem had announced on July 18th, 2013 NIAID’s intention to expand the scope of its PLX-RAD research. NIAID’s initial work showed that the overall survival of irradiated rodents treated with PLX-RAD cells significantly increased compared to that of the control group.
“In this study, NIAID will expand the focus of its work to better understand the mechanism-of- action of PLX-RAD cells. We are pleased that NIAID has recognized the therapeutic potential of these cells in treating ARS,” stated Zami Aberman, Chairman and CEO of Pluristem.
Pluristem has a preclinical hematology program in which the company is evaluating PLX-RAD cells in the treatment of bone marrow failure following radio- or chemotherapy. Data from the NIAID studies are expected to be beneficial to our hematology program.
ARS studies of PLX-RAD cells also have been conducted by Prof. Raphael Gorodetsky, lead investigator of the study and head of the Biotechnology and Radiobiology Laboratory at the Sharett Institute of Oncology at the Hadassah Hebrew University Medical Center. Those studies showed an up to four-fold increase in the survival rate of irradiated animals treated with PLX cells versus those treated with placebo, as well as improvements in additional parameters. The preclinical results for PLX-RAD cells have been published in peer reviewed journal PLOS ONE.
ARS represents a constellation of signs and symptoms that occur between several minutes and several weeks after exposure to high doses of ionizing radiation. ARS involves multiple organs, including the hematological and gastrointestinal systems. The hematological syndrome follows damage to the bone marrow and is characterized by severe decreases in red and white blood cell and platelet counts, which can lead to infection, bleeding and death. The gastrointestinal syndrome follows radiation-induced damage of the gastrointestinal tract and results in infection, dehydration and electrolyte imbalance, which can lead to death within two weeks.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team.
For more information visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements, when we discuss the schedule of the NIAID study of our PLX-RAD cells, when we discuss the therapeutic potential of our cells in treating ARS, or that data from NIAID studies are expected to be beneficial for Pluristem’s preclinical hematology program. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Director of Investor Relations 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
HAIFA, Israel, January 30, 2014 — Pluristem Therapeutics Inc. (NASDAQCM: PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today issued a Letter to Shareholders from its CEO, Zami Aberman. The company also announced that it has launched a revised corporate website, www.pluristem.com, the content of which is not part of this press release, where investors and other interested parties can find extensive information about Pluristem and its cell therapies.
Dear Pluristem Shareholders,
We are proud to have begun 2014 with the announcement of top-line results of our Phase I/II muscle injury study. The study demonstrated safety and, with respect to the subjects treated with 150 million PLX-PAD cells, showed statistically significant improvements in its primary and secondary efficacy end points of increased muscle volume and strength when PLX-PAD cells were compared to placebo. Pluristem intends to build on these results as we plan further development of PLX-PAD cells for the orthopedic and sports injury markets. The company has also been in discussions with representatives of orthopedic companies about potential collaborations for the use of PLX-PAD in these markets.
The results of our muscle injury trial are in line with the successful outcome of our two Phase I/II clinical trials in critical limb ischemia (CLI). That trial demonstrated a significant improvement in its primary end point of amputation-free survival (AFS) when compared to historical data.
The results from these multiple clinical trials suggest that PLX-PAD cells are safe and can significantly improve patients’ health. They also validate the superiority of our PLX cells and proprietary 3D culturing technology over current standard of care treatments.
2013 saw Pluristem achieve the following milestones:
Bio&Diostech for the South Korean market
the US market
In January 2013 we took possession of our new state-of-the-art, good manufacturing practices (GMP) facility. This facility has the capacity to produce over 150,000 doses of PLX cells utilizing a totally automated manufacturing process that contains at its core our proprietary 3D bioreactor technology. Additionally, our new facility allows for the development of different PLX cells products, such as PLX-PAD and PLX-RAD. In 2013 we completed the comparability studies between our old and new facilities and we are currently awaiting the U.S. Food and Drug Administration’s (FDA) response on our submissions. This January, Germany’s health authority approved our new facility. We can now supply cells produced with our advanced, fully automated and proprietary 3D technology platform for clinical trials or commercialization of cell products, once approved, in Germany.
We recently consummated our second out-licensing and partnership agreement with a healthcare company. Pluristem’s agreement with South Korean-based CHA Bio&Diostech creates an opportunity for us to accelerate the clinical activity of our PLX cells.
The first indication agreed upon by Pluristem and CHA is in the area of Peripheral Artery Disease (PAD). CHA bears the entire cost of developing PLX cells for the indication of PAD in South Korea while Pluristem provides the cells. Upon commercialization, Pluristem and CHA Bio&Diostech will establish a 50/50 joint venture (JV) for marketing to South Korea.
We view our cooperation with CHA Bio&Diostech as long term strategic partnership. Based on the size and the opportunities of the South Korean market for PAD-related indications, we strive to expand our presence and activity in this dynamic territory. According to the research firm Clearstate, 1 million people in South Korea have PAD and the growth forecast of the disease is estimated to be moderate-to-high.
CHA will participate in our multinational Phase II IC trial which recently has been approved by the South Korean Ministry of Food and Drug Safety (MFDS). Additionally, an advanced CLI clinical trial is anticipated with CHA in South Korea.
Pluristem signed this out-licensing and partnership agreement with United Therapeutics in 2011 for the use of PLX-PAD cells in the treatment of Pulmonary Arterial Hypertension (PAH).
Following favorable preclinical studies, United Therapeutics received approval in April 2013 to perform a human Phase I dose escalation study in Australia using our PLX-PAD cells in patients diagnosed with PAH. The study is currently enrolling patients.
In addition to the human Phase I and Phase II trials for the indications mentioned above, in 2013 we identified and documented potential efficacy in preclinical trials using our PLX cells for three important new indications: preeclampsia, tendon injury, and graft versus host disease (GvHD).
Independent studies conducted at the Texas A&M College of Medicine using our PLX- PAD cells in preclinical animal models of preeclampsia effectively improved several parameters of the disease. The study results were subsequently presented in May 2013 at the Society for Gynecological Investigation Summit held in Jerusalem. The potential for PLX-PAD cells to be used as a novel therapeutic for the treatment of preeclampsia is very exciting because there is currently no acceptable treatment for this potentially lethal disease, save terminating the pregnancy.
Orthopedic researchers at New York’s Hospital for Special Surgery (HSS) conducted an independent study using our PLX cells in animal models of tendon injury. These studies validated our strategy to pursue the development of PLX cells for tendon injuries and represent an expansion of our orthopedic and sports injury franchise.
PLX cells have also demonstrated efficacy in the treatment of GvHD in animal models, an often lethal complication of bone marrow transplantation (BMT), with our PLX cells demonstrating a statistically significant improvement in the GvHD score versus controls. We are in discussions with a leading U.S. hematology cancer research center involving a Phase I clinical trial using our PLX-PAD cells in GvHD.
Our intellectual property portfolio is a critical asset to our company. Pluristem was issued several U.S. and non-U.S. patents, which bring our patent count to 27 issued patents and over 100 patent applications.
Based on the achievements in the past year, we believe that Pluristem’s cell therapies has the potential to become the cell therapy medicine breakthrough of the 21st century. The scientific community agrees that cell therapies hold great promise in the future of medicine. We believe that our 3D cell manufacturing platform that can produce large, commercial scale consistent batches of cells, when combined with the efficacy our cells have demonstrated to date, create a powerful combination unique to Pluristem. We’ve built a stronger team and a stronger company in 2013 and we look forward to achieving additional milestones and continuing to build value in 2014. The entire Pluristem team wishes you and your families a happy, healthy and prosperous 2014.
Thank you very much for your continued support. Zami Aberman
Chairman and CEO
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 plans to further develop PLX-PAD cells for the orthopedic and sports injury markets, when we discuss PLX-PAD cells being safe and can significantly improve patients’ health, or the superiority of our PLX cells and proprietary 3D culturing technology over current standard of care treatments, when we discuss our relationship with CHA bio, how we strive to expand our presence and activity in South Korea and our planned CLI clinical trial, when we discuss our plans to pursue the development of PLX cells for new indications, when we discuss our belief that our cell therapies have the potential to become the cell therapy medicine breakthrough of the 21st century, when we discuss the powerful combination our 3D cell manufacturing platform create together with the efficacy our cells have demonstrated to date, or when we discuss our anticipation for 2014. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Director of Investor Relations 1-914-512-4109
Daya Lettvin
Investor & Media Relations Director
+972-54-674-5580
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.