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
Safety clearance is another step towards the start of Phase II CLI trial via Japan’s accelerated approval pathway
HAIFA, ISRAEL, August 12, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has cleared the Company’s PLX-PAD cells for use in clinical trials in Japan. This clearance is required in order to apply for approval to conduct a Phase II study of PLX-PAD in critical limb ischemia (CLI) through Japan’s accelerated regulatory pathway for regenerative medicine. This regulatory pathway generally allows for conditional, time- limited marketing approval after a single successful Phase II trial.
“We are very pleased to receive this important safety clearance to administer PLX-PAD to Japanese patients during our anticipated clinical trial in Japan. Our next step is to conclude the discussion of the clinical protocol with the PDMA for our proposed Phase II CLI study. We expect to talk with the PDMA during the last quarter of 2015, and are anticipating that we will receive permission to begin the trial by the end of 2015,” stated Pluristem CEO Zami Aberman. “This approval would enable us to potentially start a trial in early 2016.”
Safety clearance is the second of three authorizations required by the PMDA prior to commencement of a Phase II trial. Pluristem announced that it received the first of these in May 2015, when the Agency accepted PLX-PAD cells’ quality standards and large- scale manufacturing methods. The third and final step, yet to be achieved, is approval of the clinical study design.
Japan’s Act on the Safety of Regenerative Medicines went into effect in November 2014. It effectively fast-tracks the approval of cellular therapies and other regenerative medicine treatments for marketing. According to the law, these therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety and a signal of effectiveness but prior to verification of efficacy. Safety and efficacy need to be confirmed via collection of observational data after the conditional approval. No formal Phase III trial is expected to be required.
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 whether the PDMA will allow us to conduct a Phase II clinical study of PLX-PAD in CLI, the expected timing for the approval of our Phase II protocol for CLI by the PDMA, the expected timing for starting a Phase II trial for CLI and whether a Phase III clinical trial will be required. 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; changes in legislation, 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
Pluristem also presented plans to develop accelerated clinical programs for PLX cells in ischemic stroke, muscle wasting and hip fracture
HAIFA, ISRAEL, August 10, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that it has conducted detailed discussions with the European Adaptive Pathways Discussion Group regarding the clinical development plan for PLX cells in Critical Limb Ischemia (CLI) patients, and received guidance on the planned design of the initial Phase II trial of PLX cells in a subgroup of patients with severe CLI. Positive results from this trial could be sufficient for conditional approval to market PLX cells in this indication. Pluristem is receiving this in-depth guidance from European regulatory officials following the selection of this clinical program for the European Medicine Agency’s Adaptive Pathways project in May 2015.
In the discussions Pluristem also presented other indications for potential development through the Adaptive Pathways project; these were ischemic stroke, muscle wasting, hip fracture and additional subgroups of CLI.
The Adaptive Pathways project is part of the European Medicine Agency’s (EMA) efforts to improve timely access for patients to new therapies. It targets treatments with the potential to heal serious conditions with an unmet medical need, and may reduce the time to a medicine’s approval or to its reimbursement for targeted patient groups.
“We are very pleased with the invaluable guidance we are receiving from EMA regulatory officials as we design our clinical trial protocol in a subgroup of CLI with particularly high unmet medical need,” stated Pluristem CEO Zami Aberman. “As we previously announced, we plan to apply to expand our program in CLI to include additional subgroups of the disease for development via the Adaptive Pathways, and expect to apply for consideration of other important indications with large potential markets. We are also benefiting from high-level guidance on these initiatives. Development of indications via the Pathways project could potentially provide patients earlier access to our therapies, while creating value to our shareholders by shortening time to market. In parallel, we continue to advance our clinical development programs for PLX cells in the U.S.”
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 regarding the formal regulatory processes that precede a trial targeting early 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 that a successful phase II study could potentially be sufficient to receive early regulatory approval for marketing of PLX cells to treat CLI, when we discuss our plans to apply to expand our program in CLI to include additional subgroups of the disease, and in parallel to apply specifically to each of the other indications we presented to the EMA with large potential markets, or that this expansion allow us to optimize our long range planning for our [European?]clinical development side by side with our US clinical development plan and potentially cut time to market significantly or when we discuss that early regulatory approval after a successful Phase II trial could provide patients earlier access to our therapies, while creating value to our shareholders by shortening time to market. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Study results published in peer-reviewed scientific journal
HAIFA, ISRAEL, July 27, 2015 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI , TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced the publication of a scientific study regarding PLacental eXpanded (PLX) cells in the prominent peer-reviewed journal Stem Cells. The paper, titled “Mesenchymal stromal cells prevent allostimulation in vivo and control checkpoints of Th1 priming: migration of human DC to lymph nodes and NK cell activation”, describes the findings of a recent mechanism of action study conducted by independent scientists at the Berlin-Brandenburg Center for Regenerative Therapy at Charité – University Medicine Berlin. The paper was co-authored by scientists from the Charité and Pluristem.
The study demonstrated mechanisms by which PLX cells and other mesenchymal stromal cells (MSC) influence the immune system in order to modulate immune reactions and to prevent immune reactions against the cells when they are administered as an off-the-shelf product (unmatched). It was demonstrated in vitro that MSC, and in particular PLX cells, control the induction of an immune response at several points. The main target for MSC and PLX cells in this process are dendritic cells, which are the key player in inducing a T-cell immune response. Moreover, in vivo data from patients suffering from critical limb ischemia who were treated with PLX cells in a phase I/II study confirmed that HLA-unmatched PLX cells did not provoke an immune response in immunocompetent patients.
These findings confirm the feasibility of using PLX cells in an off-the-shelf manner, and explain the mechanisms that make this possible.
“Our findings in this study provide novel evidence for the regulation of several checkpoints of T- cell priming by PLX cells and other MSC, via modulation of the crosstalk between myeloid dendritic cells and natural killer cells. While the complete mechanism of immunomodulation by PLX cells requires further investigation, this study demonstrates how PLX cells might inhibit the immune responses of Type 1 T helper cell,” stated the study’s Principal Investigator, Dr. Hans- Dieter Volk, Director of the Berlin-Brandenburg Center for Regenerative Therapy and head of the Institute of Medical Immunology at the Charité.
“The investigation of the interaction between unmatched PLX cells and patient immune systems is central to Pluristem’s clinical research. This research may lead to a new understanding of how PLX cells influence, and potentially heal, the immune system, thereby possibly expanding the use of PLX cells for new indications,” stated Pluristem CEO Zami Aberman. “By modulating a patient’s immune response, PLX cells could potentially help treat severe diseases of the immune system such as aplastic anemia, which has been designated as an orphan indication, autoimmune diseases such as multiple sclerosis and lupus, as well as graft versus host disease (GVHD),” Aberman added.
PLX cells, and other MSC, affected complex pathways in order to prevent the priming of Type 1 T helper cell (Th1) responses towards major histocompatibility complex mismatches. The study utilized both in vitro and ex vivo data from PLX cells and other MSC. In vivo evidence came from patients in a study of PLX cells for critical limb ischemia. Peripheral blood mononuclear cells (PBMC), collected from the patients at different time points after PLX injection, were re- stimulated with the corresponding PLX-PAD cells or unrelated third party donor PBMC. The in vivo induced memory Th1 response was measured by using the IFN-g Elispot test. There was no, or only very marginal, Th1 priming specific for the MHC-mismatch even after application of high-dose allogeneic PLX cells. Collectively, the study data indicated that MSC, and in particular PLX cells, inhibit the priming of Th1-driven immune responses via modulation of myeloid dendritic cell (mDC). The maturation, migration to stimulatory chemokines, and the release of NK and T-cell stimulating cytokines of mDC are inhibited by PLX cells and some other MSC. For example, mDC exposed to PLX/MSC secreted reduced levels of IL-12p70and IL-1b and increased levels of IL-10 and IL-1Ra, representing a cytokine profile typical for tolerogenic dendritic cells (TolDC), which are required for the development and maintenance of immunological tolerance.
The Berlin-Brandenberg Center for Regenerative Therapy was established as an interdisciplinary translational center with the aim of enhancing endogenous regeneration by cells, biomaterials, and factors which can be used to develop and implement innovative therapies and products.
The primary focus of the Center is on diseases of the immune system, the musculoskeletal system and the cardiovascular system for which only insufficient treatment options are available.
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 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). 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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