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Data show the mechanism of action by which PLX-R18 treats radiation-induced bone marrow damage
HAIFA, ISRAEL, November 17, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI , TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that Dr. Racheli Ofir, Vice President Research & Intellectual Property, will present new data on PLX-R18 cells at the American Society of Hematology’s (ASH) 57th Annual Meeting to be held in Orlando, Florida, from December 5-8, 2015.
The poster presentation titled “Mechanism of Action of PLX-R18, a Placental-Derived Cellular Therapy for the Treatment of Radiation-Induced Bone Marrow Failure”, will be delivered during Program Session 508: Bone Marrow Failure, on December 6, 2015, at 8:00 PM. The poster will describe data from preclinical studies on irradiated mice showing the mechanism of action by which PLX-R18 cells mitigate the damage to bone marrow caused by exposure to high levels of radiation, such as could occur in a nuclear catastrophe. The poster abstract will be published online in the December 3, 2015 supplemental volume of Blood, a peer-reviewed medical journal published by ASH.
The mechanism of action was revealed through a series of trials conducted in conjunction with Charité Universitätsmedizin Berlin Institute of Medical Immunology, the Brandenburg Center of Regenerative Therapy in Berlin, the Sharett Institute of Oncology, Hadassah Hebrew University Medical Center in Jerusalem, and Indiana University; the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), provided support for the research conducted at Indiana University. A previously published article has already described the improved survival overall as well as restoration of bone marrow function in irradiated animals treated with PLX-R18 cells.
“We have a growing body of preclinical evidence demonstrating PLX-R18’s profound capacity to generate and regulate an adaptive cell response to in vivo chemical signals from damaged tissue; this response, a tailored, time-dependent secretion of a broad array of cytokines that contribute to the healing of the hematopoietic and immune systems, was shown to protect and restore bone marrow function,” stated Pluristem CEO Zami
Aberman. “We are pleased to present this latest data on the mechanism of action of our cells to the world’s thought leaders in hematology and bone marrow failure at this year’s ASH conference.”
PLX-R18 is Pluristem’s second off-the-shelf cell therapy in development. It is designed to treat bone marrow that is unable to produce blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, and immune-mediated bone marrow failure. Pluristem is preparing to initiate a Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation, and, in collaboration with the NIH, a late-stage trial in ARS. With its capabilities, PLX-R18 could potentially treat a broad range of indications related to bone marrow function, which together constitute a substantial global market.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring 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.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss our plan to initiate a Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation and, in collaboration with the NIH, a late- stage trial in ARS, and when we discuss PLX-R18’s potential to treat a broad range of indications related to bone marrow function, which together constitute a substantial global market. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical 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.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, November 9, 2015 —Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, reported financial results for its fiscal first quarter ended September 30, 2015, and provided financial and corporate highlights for the quarter.
“We made significate progress in the last quarter with U.S FDA, EMA and PMDA regulatory agencies, implementing our strategy of early access to markets. We are well capitalized to continue executing our strategy and achieving multiple meaningful milestones in the coming months, and look forward to sharing the accomplishments with our shareholders”, said Zami Aberman, Pluristem’s Chairman and CEO.
As of September 30, 2015, Pluristem had $47.2 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. The Company’s net cash used for operating activities was $3.8 million for this first quarter. As a result, Pluristem anticipates being well capitalized to conduct the clinical trials that are planned for initiation in 2016, as well as ongoing R&D efforts to support future products approval.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off- the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 capitalization allowing us to continue executing our strategy and achieving our milestones, when we discuss our anticipation to achieve multiple meaningful milestones in the coming months, when we discuss our anticipation to be well capitalized to conduct two clinical trials that are planned for initiation in 2016, as well as ongoing R&D efforts towards development of a third distinct product, when we discuss our development plan for initiation of late-stage trials of PLX-R18 in the treatment of ARS, when we discuss our intention, together with Charité, to advance the development of PLX- PAD cells in those orthopedic indications that could be eligible for Europe’s Adaptive Pathways Project, and when we discuss our plan to submit a Phase II trial protocol via a European rapid regulatory pathway. 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 clinical 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
BioEurope 2015, EU Advanced Therapies Investor Day, & Berlin Dialogue
HAIFA, ISRAEL, October 27, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that Company executives will be participating in three upcoming conferences in Europe.
Pluristem recently reported its PLX-PAD cells have been selected for the European Medicines Agency’s Adaptive Pathways Project, which is designed to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment option. The Company also recently expanded its Collaboration Research Agreement with the Berlin-Brandenburg Center for Regenerative Therapy at Charité – University Medicine Berlin.
BioEurope 2015
Date: November 2-5, 2015 Location: Munich, Germany
Hillit Mannor Shachar MD, MBA, Vice President Business Development, will participate in meetings with potential partners at BioEurope, which is Europe’s largest partnering conference serving pharma, biotech, and medical device companies.
Date: November 12, 2015 Location: London, England
Zami Aberman, Chairman and CEO, will be a speaker on the panel “Cell Therapy Commercialization”. The conference is hosted by the Alliance for Regenerative Medicine.
Date: November 17, 2015 Location: Berlin, Germany
Zami Aberman, Chairman and CEO, will participate in a dialogue session between the Berlin Senator of Economics, Technology and Research, representatives of academia and companies from the field of life sciences on the topic of “Furthering the Innovative Co-
Operation Models between Industry and Academia on the Way to a Strategically Laid Out Long-Term Partnership in the Field of Life Sciences and Medicine”.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring 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.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, October 12, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced it has expanded its five-year Collaborative Research Agreement with the Berlin-Brandenburg Center for Regenerative Therapy at Charité – University Medicine Berlin. The expanded agreement, which was executed on October 11th at the Berlin-Tel Aviv Business Forum in Tel Aviv, broadens the parties’ cooperation to include identification of orthopedic indications that may be eligible for development under Europe’s Adaptive Pathways and conditional marketing approval in the European Union. Pluristem’s program to develop PLX cells in critical limb ischemia is already under discussion with the EMA and other European Stakeholders under the Adaptive Pathways.
Under the five-year Collaborative Research Agreement, Pluristem and Charité have jointly completed a successful orthopedic Phase I/II study using PLacental eXpanded (PLX) cells in muscle injury. The parties have also collaborated on a variety of other indications, including kidney diseases such as acute kidney injury, cardiovascular indications such as inflammatory cardiomyopathy, and comprehensive immunological research for Pluristem’s Peripheral Artery Disease clinical programs.
Dr. Tobias Winkler of the Center for Musculoskeletal Surgery & Julius Wolff Institute Berlin, Charité, who served as Senior Scientist on the completed Phase I/II orthopedic study, commented, “In our studies PLX cells demonstrated the potential to improve overall muscle functionality, with an impressive magnitude of effect. An additional orthopedic PLX indication has a promising potential.”
“Pluristem has enjoyed a very productive relationship with European regulators and our PLX cells have already been selected for the Adaptive Pathways in critical limb ischemia. Working with the prestigious Charité, we look forward to advancing an orthopedic indication through Adaptive Pathways as well,” stated Pluristem Chairman and CEO, Zami Aberman.
The Berlin-Brandenburg Center for Regenerative Therapies was founded as a cooperative research institution of the Charité University Hospital in Berlin and Germany’s largest research association, the Helmholtz Association. The mission of the BCRT is to develop a translational platform for Regenerative Therapies from bench-to-bedside. The five clinical platforms–Immune, musculoskeletal, hepatic, neuronal, and cardiovascular system–are cross-linked by technology platforms (basic science, bio-engineering, translational technologies).
The purpose of Europe’s Adaptive Pathways is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only.
After a therapy is selected for the program, the Adaptive Pathways Discussion Group provides detailed guidance to the applicant previous to the formal regulatory processes that precede a trial targeting early or conditional approval and further expansion of the indications.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring 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.
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 PLX cells’ potential to improve overall muscle functionality with an impressive magnitude of effect, when we discuss the potential of the orthopedic PLX indication to be a promising clinical program and when we discuss our plans to continue to work with Charité to advance an orthopedic indication through Adaptive Pathways as well. For example. we are using forward-looking statements when we discuss the findings of the scientific study and the evidence they provide, that the research may lead to a new understanding of how PLX cells influence and potentially heal the immune system through paracrine and endocrine effects, and opens the window for the use of PLX cells for new indications, or that the data from the study suggest the potential for PLX cells to treat a range of severe conditions related to immune function, or that PLX cells could potentially help treat diseases of the immune system such as aplastic anemia, and autoimmune diseases such as multiple sclerosis, lupus and graft versus host disease (GVHD). 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 clinical settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward- looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
ARM is the preeminent global advocate for the advancement of regenerative medicine
HAIFA, ISRAEL, October 7, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that its Chairman and CEO, Zami Aberman, has been elected to serve on the Board of Directors of the Alliance for Regenerative Medicine (ARM). Based in Washington, D.C., ARM promotes research, development, investment and commercialization of regenerative medicine technologies. Pluristem has been a member of ARM for 3 years and has actively supported the organization’s goals. Mr. Aberman joins other prominent leaders in the field of regenerative medicine who are currently serving on the board.
Dr. Karine Kleinhaus, Divisional Vice President, North America, will present at 10:45
a.m. on October 7 at the Stem Cell Meeting on the Mesa to be held October 7-9, 2015 in La Jolla, California. Co-hosted by ARM, the California Institute for Regenerative Medicine (CIRM) and the Sanford Consortium for Regenerative Medicine, the 2015 Stem Cell Meeting on the Mesa is attended by leading cell therapy, gene therapy and tissue engineering companies, large pharma and biotech, industry investors and major academic research institutions. A live video webcast of the presentation will be available at: http://stemcellmeetingonthemesa.com/webcast/ and will also be published on ARM’s website shortly after the event.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring 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.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, September 10, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, reported yesterday financial results for its fiscal year ended June 30, 2015, and provides corporate and financial highlights for fiscal year 2015.
“During fiscal 2015 we executed our strategy to shorten the time to commercialization for PLX-PAD, our lead product, and significantly advanced the development of PLX- R18, our second product,” said Zami Aberman, Pluristem’s Chairman and CEO.
“We achieved a major milestone when our clinical development program for PLX-PAD in critical limb ischemia (CLI) was selected for Europe’s Adaptive Pathways pilot project. Only a handful of programs were chosen worldwide. Pending a single successful Phase II trial, PLX-PAD could enter the European market in 2018 with conditional approval to treat a type of CLI. Another important milestone was safety clearance of PLX-PAD cells for use in clinical trials in Japan.”
“We also advanced our U.S. program for PLX-R18 in the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation. This year we also announced an important new clinical finding from our Phase I/II trial in muscle injury, suggesting that treatment with PLX-PAD could also significantly strengthen muscle force in the contralateral leg.
“During fiscal 2015, we strengthened our valued partnerships with United Therapeutics, Cha Bio and the U.S. National Institutes of Health, and finished the fiscal year with a robust balance sheet. We look forward to a very productive fiscal 2016 on all fronts,” Mr. Aberman concluded.
During fiscal 2015, Pluristem raised net cash of $17.2 million from issuance of common stock, and from exercises of outstanding warrants and options. The fundraise marked the accomplishment of a goal to increase US institutional ownership. In addition, the Company was awarded $2.9 million grant from the Office of the Chief Scientist (OCS) of Israel’s Ministry of Economy to support R&D programs, as well as a “Smart Money” grant from Israel’s Ministry of the Economy to support marketing activities in Japan. As of June 30, 2015, Pluristem had $35.1 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. The Company expects this will support its activities for the next two years.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring 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.
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 PLX-PAD’s potential to enter the European market in 2018 with conditional approval to treat a type of CLI, when we discuss our preparation for submission of an Investigational New Drug application to FDA for PLX-R18 in the treatment of incomplete hematopoietic recovery following hematopoietic cell transplant, when we discuss PLX-R18’s potential to improve the outcome of bone marrow transplantation, and when we discuss our expectation that our current cash and cash equivalents, bank deposits, restricted deposits and marketable securities will support its activities for the next two years. 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 clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward- looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, September 9, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that it has completed a successful meeting with the U.S. Food and Drug Administration (FDA) regarding the initiation of a Phase I clinical trial for its PLX-R18 cells in the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation. Hematopoietic stem cells, which produce the body’s blood cells, are transplanted in various settings to facilitate regeneration of the hematopoietic system, for example in the context of certain cancers or immune-mediated bone marrow failure.
During Pluristem’s meeting with the FDA, the regulatory agency communicated that the preclinical data presented by the company would support an Investigational New Drug (IND) application to test PLX-R18 in humans. The Company also presented the design of its proposed Phase I study to the FDA. Pluristem anticipates initiating the Phase I trial in the U.S. in early 2016.
“We were very pleased with the positive outcome of our recent FDA meeting. The timeline for our IND submission and anticipated clearance by the FDA are in line with the timetable and strategy we outlined earlier this year regarding the development of PLX-R18,” stated Pluristem CEO Zami Aberman.
Incomplete hematopoietic recovery following hematopoietic cell transplantation marks the first indication to be pursued in human trials for PLX-R18, Pluristem’s second cell therapy product in development. PLX-R18 is also being developed, in partnership with the U.S. National Institutes of Health, as a potential treatment for Acute Radiation Syndrome.
Hematopoietic stem cells, which can be obtained from bone marrow, peripheral blood, or umbilical cord blood, are transplanted into patients with damaged, dysfunctional or ablated bone marrow in order to restore normal production of white and red blood cells and platelets. Successful engraftment of transplanted hematopoietic cells can take weeks, but in some cases recovery of the bone marrow can be delayed for many months, or remain insufficient indefinitely.
During that time, patients are at substantial risk of death from hemorrhage, infection, or even severe anemia.
Building on the positive preclinical data showing that PLX-R18 can significantly increase the production of all blood cell types, Pluristem believes that PLX-R18 may become a transformative treatment option for patients with insufficient hematopoietic function.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells.
The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring 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.
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 expected timing for submitting our IND application to the FDA and commencing a Phase I/II multi-site trial in the U.S. for our PLX-R18 cells in the treatment of insufficient engraftment of transplanted hematopoietic cells, when we discuss the anticipated clearance by the FDA to our expected IND submission, and when we discuss our belief that PLX-R18 may become a transformative treatment option for patients with insufficient engraftment of hematopoietic stem cells. 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 clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
IATI is the largest umbrella organization for Israel’s high tech and life science industries
HAIFA, ISRAEL, September 6, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI. TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced its President and Chief Operating Officer, Yaky Yanay, has been elected as Co-Chairman of the largest umbrella organization representing Israel’s high tech and life science industries, Israel Advanced Technology Industries (IATI). Representing Israel’s life sciences industry, Yanay will serve alongside his Co-Chariman, Erez Tsur, CEO of EMC Israel, who represents the country’s high-tech industry. Yanay has served on the Board of Directors of the IATI for the past three years.
“I am honored to be elected as IATI’s Co-Chairman and for the trust placed in Pluristem by the IATI members. The life science and high-tech industries can and should join hands to make a significant change in employment and education in Israel. As co-chair on behalf of the life science industry I will strive to continue the establishment and growth of high-tech industries in Israel, as a goal to bring thousands of additional employees into the work force in Israeli companies. Success in this mission will improve the quality of life for hundreds of thousands of workers and their families, “Yanay stated.
IATI CEO, Karin Mayer Rubinstein commented, “The two incoming IATI Chairmen bring with them expertise and a deep knowledge of the sectors they represent, along with a real willingness to act in favor of the industry.”
The IATI includes about 600 members who belong to every level and sector of the industry, including R&D centers of multi-national companies, local and international venture capital funds, incubators, accelerators, private investors, tech transfer companies, municipalities and service providers.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells.
The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage.
PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology.
They are off-the-shelf, requiring 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.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
PLX-R18 for use in Acute Radiation Syndrome (ARS) is being developed under the Animal Rule regulatory pathway with the NIAID’s support
HAIFA, ISRAEL, September 21, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that Pluristem and the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), completed a successful meeting with the U.S. Food and Drug Administration (FDA) regarding the development program for PLX-R18 cells in the treatment of Acute Radiation Syndrome (ARS). ARS is caused by exposure to dangerously high levels of radiation, such as those that could occur in a nuclear catastrophe. The FDA communicated that the data presented at the meeting allow for the design of large animal studies, which are the only studies required to prove efficacy for FDA approval under the Animal Rule; this is the regulatory pathway followed when human efficacy trials are not ethical or feasible. The FDA also offered to assist Pluristem with the design of these trials. The NIAID, which has supported and conducted two earlier studies of PLX-R18 in a mouse model of ARS, communicated its interest in supporting and completing trials in large animals as well, pending protocol review by the FDA.
The FDA advised Pluristem to conduct a pilot study in large animals to determine the optimal dose of PLX-R18 as a treatment for the hematologic component of ARS. Once the optimal dose schedule is determined, a pivotal trial in large animals could commence. If successful, this trial would provide sufficient efficacy data for an application to the FDA for approval of PLX-R18 as a treatment for ARS.
“This positive meeting with the FDA is a major step forward for our PLX-R18 program, and we expect to submit a protocol to the FDA for the dosing trial in large animals as soon as possible,” said Pluristem Chair and CEO Zami Aberman. “FDA approval of PLX-R18 for ARS could generate U.S. government interest in stockpiling it for use in the case of a nuclear disaster, since PLX cell products are ideally suited for rapid initiation of treatment of large populations. Our cells do not require tissue matching prior to administration and can be administered quickly via intramuscular injection.” Mr. Aberman added, “We value our close working relationship with the NIH/NIAID, and look forward to continuing to collaborate with them.”
The NIH has supported and completed two mouse studies of PLX-R18 as a potential treatment of the component of ARS that affects bone marrow function. ARS involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells and platelets, as well as to other systems and organs. Severe damage to bone marrow quickly makes victims vulnerable to life-threatening hemorrhage, infection and anemia. A recently concluded NIH/NIAID study showed that administration of PLX-R18 resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation, and described the cells’ mechanism of action. The NIH/NIAID’s first study of PLX-R18 showed a substantial, statistically significant improvement in 30-day survival and overall survival of irradiated rodents given PLX-R18 versus a control.
PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce blood cells due to a variety of causes including ARS, certain cancers, or immune-mediated bone marrow failure. Pluristem is preparing to initiate a Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation. With its capabilities, PLX-R18 could potentially treat a broad range of indications related to bone marrow function, which together constitute a substantial global market.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring 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.
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 expected timing for submitting a protocol to the FDA for the dosing trial of PLX-R18 in large animals, when we discuss potential U.S. government interest in stockpiling our PLX-R18 for use in the case of a nuclear disaster, when we discus initiating a Phase I trial of PLX-R18, when we discuss PLX-R18’s potential to treat a broad range of indications related to bone marrow function, and when we discuss PLX-R18’s potential substantial global market. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward- looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Addresses indications including Peripheral Artery Disease for which PLX cells are currently in clinical trials; Reinforces Company’s leadership position in large-scale manufacturing of cell therapies
HAIFA, ISRAEL, August 17, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that the U.S. Patent and Trademark Office has issued to the Company patent #9,096,827 titled “Adherent Cells From Placenta Tissue and Use Thereof in Therapy”.
The patent protects specific methods of culturing placental adherent stromal cells, and use of these cells for the treatment of a wide variety of diseases. Indications covered by the patent include a wide range of ischemic conditions such as heart disease, stroke, peripheral arterial disease (which includes critical limb ischemia and intermittent claudication), graft-versus-host disease, solid organ transplantation, hematopoietic stem cell transplantation, diabetes, autoimmune diseases, neuropathic pain and cancer.
“The U.S. is a very significant market for us and the protection of our IP in this market is a top priority for us. We are pleased to have been granted this patent covering both manufacturing methods and treatment indications. This patent contribute to our IP position we are building in the USA to support our clinical development strategy and future manufacturing and marketing in the USA,” stated Pluristem CEO Zami Aberman.
Pluristem has been issued over 40 patents worldwide, and has approximately 150 more patents pending.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring 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.
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 significance of the U.S. market for us.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
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