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HAIFA, Israel, June 4, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that the top-line results of the company’s multinational Phase II clinical trial of PLX-PAD cells in the treatment of Intermittent Claudication (IC) will be released on June 12, 2018.
Pluristem’s Phase II IC trial is evaluating the safety and efficacy of PLX-PAD cells as compared to placebo in 172 patients with IC, Rutherford category 2-3. Enrollment took place at 30 clinical sites in the U.S., Germany, South Korea and Israel. Patients received either two courses of 150 ×106 PLX-PAD cells, two courses of 300 ×106 cells, two courses of placebo, or one course of 300 ×106 cells followed by placebo. In each of these study arms, the two courses were given intramuscularly, 3 months apart. The primary efficacy endpoint is the change in maximal walking distance one year after the first administration. Other endpoints include rate of revascularization and other hemodynamic and clinical parameters.
IC is a subset of peripheral artery disease (PAD). It is caused by obstruction to arterial flow in the legs and is characterized by muscle pain, cramping, numbness or a sense of fatigue, classically in the calf muscle, which occurs during walking or similar exercise and is relieved by a period of rest. Almost fifth of the population over the age of 65 has IC and as a result of demographic changes in many developed countries, its prevalence in the general population is likely to rise dramatically over the next 20 years. PLX-PAD cells may offer a non-surgical procedure that may contributed significantly to the quality of life of PAD patients as well as provide additional treatment possibilities to the angioplasty and vascular medical communities.
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 cells and is entering late- stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
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 express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses the expected date for the release of the results of its Phase II clinical trial of PLX-PAD cells in the treatment of IC and that PLX-PAD cells may offer a non-surgical procedure that may contributed significantly to the quality of life of PAD patients as well as provide additional treatment possibilities to the angioplasty and vascular medical communities.
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; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; 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; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, Israel, May 10, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today reported financial results and corporate developments for its third quarter of fiscal 2018 ended March 31, 2018.
“The past few months brought several significant milestones which we believe are key to our continued development”, stated Pluristem Chairman and Co-CEO Zami Aberman. “The U.S. Food and Drug Administration (FDA) has cleared our Investigational New Drug application (IND) for the use of PLX-R18 in treating victims who may have been acutely exposed to high dose radiation (ARS) due to nuclear attack or accident. Following this IND approval, and as an additional step to prepare for marketing, we will now start the necessary preparations in order to keep an emergency stock of PLX-R18 on hand for use in such events. We were also cleared by the FDA to start our Phase III study in PLX-PAD in the treatment of muscle injury following hip fracture surgery. This marks the second Phase III study in Pluristem’s clinical pipeline, and we intend to have an additional Phase III study in the treatment of ARS cleared by the FDA by the end of this year.”
“Pluristem is well positioned to be a significant market leader in the cell therapy and regenerative medicine industries”, stated Pluristem President and Co-CEO Yaky Yanay.
“We expect to publish top line data from our Phase II study in intermittent claudication (IC) in June, which will be the largest clinical data set we have published to date. With these data and the latest IND approvals, we are moving closer to market. In support of this process we have announced that we are forming a strategic advisory board, composed of highly accomplished executives, such as Roger Jeffs, former CEO of United Therapeutics and who led Amgen’s Neupogen clinical programs. We believe that this strategic board will bring tremendous expertise and vision to Pluristem, and support our strategic development, clinical progress and commercialization. The company is well financed and has multiple non-dilutive grants to supports its clinical development, including a $2.5 million grant from the U.S. National Institutes of Health (NIH) for a research project in ARS which should provide bridging data for the final pivotal study.”
As of March 31, 2018, Pluristem had $34.1 million in cash and cash equivalents, bank deposits and short- term restricted deposits.
The Company’s net cash used for operating activities for the quarter ended March 31, 2018 was $5.6 million.
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 cells and is entering late- stage trials in several indications.
Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
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 express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses its belief that the recent milestones are key to Pluristem’s continued development and that Pluristem is heading towards a significant time period, its intention to make necessary preparations to keep an emergency stock of PLX-R18, that it expects to publish top line data from its Phase II study in IC within the coming weeks, its belief that with the data from the Phase II study in IC, and the latest IND approvals, it is moving closer to market, that the data developed from its ARS studies should provide data for its final pivotal study and its belief that it is in a strong position to become a significant market leader in the cell therapy and regenerative medicine industries. 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; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; 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; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, Israel, April 30, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its PLX-R18 cell therapy in the treatment of acute radiation syndrome (ARS). The IND allows Pluristem to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident. With this IND in place, Pluristem will now start the necessary preparations in order to keep an emergency stock of PLX-R18 on hand for use in such events.
The U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) sponsored and completed a successful Phase II-equivalent study of PLX-R18 in the treatment of ARS via the FDA’s animal rule pathway. PLX-R18 is also being studied by the U.S. Department of Defense (DOD) to support the needs of the armed forces and study PLX-R18 as a treatment prior to, or within the first 24 hours of, radiation exposure. Pluristem is currently in discussions with the FDA and several U.S. governmental agencies to clear the path for its proposed pivotal study of PLX-R18 in ARS.
Per the IND protocol, PLX-R18 will be provided up to 96 hours following radiation exposure. The approved dosage for treatment in humans is 4 million cells per kilogram, the optimal dosage that was determined in the Phase II-equivalent non-human primate pilot study. PLX-R18 cells demonstrated a dramatic increase in survival of population exposed to high dose of radiation and enhancement of blood lineages recovery.
“We are proud to have PLX-R18 join the exclusive club of IND approved medical countermeasures for the treatment of ARS. This FDA clearance is one of the most significant milestones in the development of PLX- R18 to date and should provide Pluristem with significant support in advancing its off-the-shelf cell therapy into a pivotal trial. The fact that we are now able to treat human casualties in the case of a nuclear event provides us with the ability to protect from severe health consequences, saving lives of population in need,” stated Pluristem Chairman and Co-CEO Zami Aberman.
Acute Radiation Syndrome occurs following acute exposure to very high levels of radiation, and involves severe, potentially lethal injury to the bone marrow as well as to other organs and systems within the body. High doses of radiation can destroy the bone marrow’s ability to produce white blood cells, red blood cells and platelets; without these cells patients are at high risk of death.
PLX-R18 is Pluristem’s second cell therapy product in development.
It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure.
PLX-R18’s first animal studies in ARS were performed in collaboration with Prof.
Gorodetsky at Hadassah Medical Center. Further preclinical data from trials conducted by the U.S. National Institutes of Health, Hadassah, the Charité in Berlin and other prominent research institutions, have shown that PLX-R18 cells secrete a range of specific proteins that salvage and trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production. With its capabilities, PLX-R18 could potentially be used in several indications to treat a broad range of hematologic disorders, which together constitute a substantial global market.
Pluristem is currently enrolling patients in a multinational Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation.
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 cells and is entering late- stage trials in several indications. Our PLX cell products release a range of therapeutic proteins following intramuscular administration, in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. 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 express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses its intention to keep an emergency stock of PLX-R18 on hand for use in a nuclear event, its proposed pivotal study of PLX-R18 in ARS, its belief that the approved IND may provide it with the potential to help populations in need as well as support its ARS program and its belief that the IND approval will provide it with significant support in advancing its off-the-shelf cell therapy into a pivotal trial. 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; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; 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; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Multinational study expected to include clinical sites in U.S. Israel and Europe, where study has been awarded an $8.7 million grant from European Horizon 2020 Program
HAIFA, Israel, April 25, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Food and Drug Administration (FDA) has cleared Pluristem’s Investigational Drug Application (IND) for a Phase III study of its PLX-PAD cell therapy in the treatment of muscle injury following surgical repair (arthroplasty) of the hip joint due to fracture. Pluristem is in discussions with several EU countries to approve this study in Europe as well and expects to begin patient enrollment in both regions during 2018. Non-dilutive funding totaling $8.7 million (7.4 million Euro) has been granted to this study from Horizon 2020, the European Union’s largest research and innovation program.
The Phase III study follows positive results from a Phase I/II trial which demonstrated significant muscle regeneration when using PLX-PAD cells in total hip arthroplasty patients. The study demonstrated a 300% change in muscle volume (p=0.004) and a 500% (p=0.0067) change in muscle force at 6 months post- surgery, compared to the control group.
The Phase III, multinational, randomized, double-blind, placebo-controlled study will assess the efficacy and safety of intramuscular (IM) administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture, as compared to placebo treatment. Through clinical sites in the U.S. and Europe, 240 patients will be randomized on a 1:1 allocation to be dosed with 150 million PLX- PAD cells or placebo on the day of surgery. The primary endpoint is the change in the short physical performance battery (SPPB) score at week 26 after treatment.
“The FDA’s clearance marks the second Phase III study for Pluristem in the U.S. for our PLX-PAD cell therapy and we look forward to begin patient enrollment in 2018,” stated Pluristem’s President and Co- CEO, Yaky Yanay. “We are encouraged by our prior Phase I/II study results that showed PLX-PAD supported muscle regeneration and we are hopeful that PLX-PAD will be similarly effective for patients in our Phase III study. I am pleased to see the successful execution of our clinical development plan with a series of Phase III multinational studies, which we believe positions Pluristem as one of the most advanced and mature companies in the regenerative medicine industry.”
Dr. Tobias Winkler of the Berlin-Brandenburg Center for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery, the principal investigator of the study, commented, “We look forward to evaluating PLX-PAD’s ability to aid muscle regeneration in patients recovering from arthroplasty for hip fracture. Following surgery, many patients do not fully recover and suffer considerable morbidity due to poor muscle regeneration and impaired mobility. If the results of the study show efficacy, then one simple procedure administering an IM dose of PLX-PAD on the day of surgery may significantly reduce recovery time and recovery costs, while improving quality of life for these patients.”
Femoral neck fracture is the most common form of hip fracture, with mortality rates of up to 36%, and annual treatment costs estimated to be between $10-$15 billion in the U.S. alone.
Following surgery, many patients do not fully recover due to poor muscle regeneration, leading to significant morbidity, loss of the ability to live independently, and an overall decline in quality of life.
The incidence of hip fracture is expected to increase as populations age.
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 cells and is entering late- stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. 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 express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses its Phase III clinical trial of PLX-PAD cells generally as well as its expectation that it will begin patient enrollment in the U.S. and Europe in 2018, its belief that the successful execution of its clinical development plan with a series of Phase III multinational studies positions Pluristem as one of the most advanced and mature companies in the regenerative medicine industry and the possibility that PLX-PAD may significantly reduce recovery time and recovery costs and improve quality of life. 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; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; 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; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Health (NIH)
the treatment of ARS
HAIFA, Israel, April 23, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded a $2.5 million grant to Indiana University to conduct studies of Pluristem’s PLX-R18 cell therapy in the treatment of acute radiation syndrome (ARS).
The goal of this project is to extend the PLX-R18 ARS studies to include examination of survival efficacy in additional populations, such as geriatric and pediatric, and to compare the effectiveness and examine interactions with other drugs, such as Granulocyte-Colony Stimulating Factor (G-CSF). Data collected during the first year of this 5-year research agreement will support Pluristem’s Biologics License Application (BLA) filing with the U.S. Food and Drug Administration (FDA) for marketing approval of PLX- R18 in the treatment of ARS.
The $2.5 million, 5-year research collaboration agreement will be performed in conjunction with Indiana University researchers led by Prof. Christie M. Orschell. As part of this agreement, Pluristem will be reimbursed for supplying PLX-R18 cells for these studies.
Following previous positive results from a Phase II-equivalent study in non-human primates, sponsored by NIAID, Pluristem is now in discussions with the FDA and several U.S. governmental agencies to clear the path and funding for a pivotal study of PLX-R18 in the treatment of ARS.
“We are very pleased to receive NIH support through this important grant to Indiana University for advancing PLX-R18 towards becoming an approved countermeasure for ARS. Pluristem looks forward to working with the researchers at Indiana University who have broad expertise in this field of research,” stated Pluristem Co-CEO and President Yaky Yanay. “We expect to collect data from these studies to support the initiation of the pivotal study protocol, an essential step in the PLX-R18 product development.”
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 cells and is entering late- stage trials in several indications.
Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
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 express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses collaboration with Indiana University, allocation of grants, reimbursement to Pluristem for supplying PLX-R18 cells for the studies conducted with Indiana University, discussions with the FDA and governmental agencies to clear the path and funding for a pivotal study of PLX-R18, that data collected from the studies will support the initiation of a pivotal study protocol and Pluristem’s BLA with the FDA for marketing approval of PLX-R18. 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; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; 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; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Jeffs led United Therapeutics from its founding until 2016 and led Amgen’s Neupogen clinical programs
HAIFA, Israel, March 26, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that Dr. Roger Jeffs has joined Pluristem’s strategic advisory board. Dr. Jeffs, a highly accomplished biopharma executive, will advise Pluristem on clinical and commercial strategies for the Company’s cell therapy programs.
Dr. Jeffs joined United Therapeutics Corporation during its start-up phase in 1998 as director of research, development, and medical and led the company as its President and CEO from 2001 to 2014 and President & co-CEO from 2015 to 2016. During his successful 18-year tenure at United Therapeutics, Dr. Jeffs helped lead the company’s initial public offering, oversaw the clinical development and regulatory approval of six products, and managed the commercial effort that lead to a significant increase in revenues. Prior to his time at United Therapeutics, Dr. Jeffs was previously at Amgen Inc. where he helped lead the clinical program for Neupogen. Dr. Jeffs holds an undergraduate degree in chemistry from Duke University and a Ph.D. in pharmacology from the University of North Carolina School of Medicine. He served on the Board of Directors for United Therapeutics from 2001 to 2016, and currently serves on the Boards of five public companies. Dr. Jeffs is also the co-founder and co-owner of Bull City Select Investments.
Dr. Jeffs commented, “Pluristem’s placental cell therapies, currently being evaluated in multiple advanced clinical trials, could significantly advance regenerative medicine and make a change in the way patients are treated today, by delivering a safe and effective off-the-shelf cell therapy. The Company’s manufacturing assets are a key to its commercialization capabilities. I look forward to working with Pluristem’s management team to move the clinical programs forward towards marketing.”
“Dr. Jeffs brings tremendous expertise and vision to Pluristem, from business aspects, to clinical development, marketing approval and commercialization.
His work in developing Neupogen is directly relevant to our PLX-R18 clinical program in the treatment of bone marrow deficiencies,” stated Pluristem Chairman and Co-CEO Zami Aberman. “Pluristem is now forming a senior strategic advisory board in t preparing the Company toward expansion and commercialization.
We are honored and pleased that Dr. Jeffs is joining us at this important time.”
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 cells and is entering late-stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
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 express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses Pluristem’s clinical trials, that its placental cell therapies could significantly advance regenerative medicine and make a change in the way patients are treated, and when it discusses the potential safety and effectiveness of Pluristem’s cell therapy and potential expansion and commercialization. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; 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; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Findings support Pluristem’s ongoing Phase I study of PLX-R18 in hematopoietic recovery following hematopoietic cell transplantation
HAIFA, Israel, February 27, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that Frontiers in Medicine has published key findings from a study of PLX-R18 that demonstrate the cells’ efficacy in improving human hematopoietic engraftment. The article titled, “Posttransplant Intramuscular Injection of PLX-R18 Mesenchymal-Like Adherent Stromal Cells Improves Human Hematopoietic Engraftment in A Murine Transplant Model” was published in the peer-reviewed journal’s February 2018 issue.
In the published study, mice were injected intramuscularly (IM) with PLX-R18 following human hematopoietic cell transplantation (HCT). Significant improvement was observed in the peripheral blood counts as measured by CD45+ cell recovery at weeks 6 (8.4 vs. 24.1%, p < 0.001) and 8 (7.3 vs. 13.1%, p < 0.05) and in the bone marrow at week 8 (28 vs. 40.0%, p < 0.01) in the PLX-R18 treated groups versus the control, placebo groups. Superiority of PLX-R18 treatment over the control groups was also reported for recovery of CD19+ cells at weeks 6 (12.6 vs. 3.8%) and 8 (10.1 vs. 4.1%). These findings support Pluristem’s clinical development of PLX-R18 for a variety of hematological indications.
Pluristem is currently conducting a Phase I clinical trial in the U.S. and Israel of PLX-R18 to treat incomplete hematopoietic recovery following HCT. HCT is used to treat bone marrow failure associated with cancers of the blood and/or chemotherapy. When HCT fails to fully engraft, it poses dangers to the patient. The Phase I study is evaluating the safety of IM injections of PLX-R18 cells in 24 people with incomplete hematopoietic recovery persisting for at least 4 months following HCT.
Prof. Hillard M. Lazarus, Department of Medicine, Case Western Reserve University, co-author of the article, and Principal Investigator of Pluristem’s Phase I study of PLX-R18 in HCT recovery, commented: “The published preclinical study directly supports the current Phase I study of PLX-R18 in HCT. The preclinical data clearly suggest that PLX-R18 may have a therapeutic role in improving incomplete engraftment following HCT.
We hypothesize that PLX-R18 cells’ secreted proteins, cytokines and chemokines are stimulating the marrow microenvironment, leading to improved reproduction of the progenitor cells and increasing peripheral blood counts.”
“Through the publication of this study, we are pleased to add to the growing body of knowledge and data on PLX-R18 cells’ role following IM injection to improve hematopoietic cell engraftment. These data support not only our Phase I study of PLX-R18 in HCT, but may also support current and potential studies of PLX-R18 in a broad range of hematologic indications,” stated Pluristem Chairman and Co-CEO Zami Aberman.
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 cells and is entering late- stage trials in several indications.
Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
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 express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses its Phase I clinical trial of PLX-R18 generally as well as when it states that PLX-R18 may have a therapeutic role in improving incomplete engraftment following HCT or that the data from its Phase I clinical trial of PLX-R18 to treat incomplete hematopoietic recovery following HCT may support current and potential studies of PLX-R18 in a broad range of hematologic indications. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward- looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; 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; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, Israel, February 07, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today reported financial results for the second quarter of fiscal 2018 ended December 31, 2017 and issued a letter to its shareholders from its Co-CEOs, Zami Aberman and Yaky Yanay.
Pluristem had a very busy 2017, filled with significant achievements. Our management team has been working hard to ensure that we reach our milestones. This year, most milestones were met, others unfortunately were not, but we were pleasantly surprised to achieve other, unexpected milestones throughout the year as well. While we can’t address all the details, we are hopeful that this letter will provide valuable updates and insight, on some of our programs.
We are witnessing a growing change in how regulators approach treatment of patients suffering from unmet medical conditions, through various new expedited approval pathways. Pluristem has been pursuing these regulatory pathways, allowing us to accelerate the development of our cell therapy products.
As part of this acceleration, we are well positioned towards marketing with regulatory assets including U.S. Food and Drug Administration (FDA) “Fast Track Designation”, European Medicines Agency (EMA) “Adaptive pathways program”, Japanese Pharmaceuticals and Medical Devices Agency (PMDA) “Accelerated regulatory pathway for regenerative therapies” and recently received clearance by the FDA for our Expanded Access Program to treat patients unsuitable for inclusion in our ongoing Critical Limb Ischemia (CLI) Phase III trial.
We have also received much interest in the past year in collaboration and partnerships, including the launch of physician-initiated trials, such as the Phase I/II Graft-versus-host disease (GvHD) trial being conducted in the Tel Aviv Sourasky Medical Center in Israel.
These types of trials will be conducted and funded by the participating hospital or medical center, so it is important to note that we will only be able to share the data once it has been provided to Pluristem. These new paths of development are a true vote of confidence in our PLX (PLacental eXpanded) cell therapy from key regulators and physicians worldwide, and additionally provide potential opportunities to treat patients while collecting real-world data (in parallel to our clinical programs), to support our clinical advancement.
We were very proud to publish the promising results in anti-cancer treatment from our new product, PLX- Immune, which may open new possibilities in the field of oncology to treat solid tumors and offer new paths to help millions of patients around the world. The new findings, published in Nature journal, have generated significant interest from investors as well as potential pharmaceutical partners.
These results demonstrate the capabilities of our PLX cells and the advantage of our technology. Today we hold a technology that enables us to develop the ability of our cells to secrete a variety of therapeutic proteins in response to different medical conditions. We now intend to start discussions with the regulators to begin clinical development of this potentially groundbreaking product.
In our Acute Radiation Syndrome (ARS) program, following the positive results from the Phase II- equivalent study in non-human primates, which was conducted by the National Institutes of Health (NIH), we are in discussions with the FDA and several U.S. governmental agencies to clear the path for a pivotal study.
This process includes several complementary studies, the majority of which are funded and conducted by the NIH, which will also provide additional data to support future milestones. We expect to collect the complementary data during the first half of 2018 and to clear the pivotal study protocol and funding during the second half of 2018.
We are also collaborating with the U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI), to examine the effectiveness of PLX-R18 as a treatment for ARS prior to, and within the first 24 hours of exposure to radiation.
These studies are conducted and funded by AFRRI and we expect to receive data from these studies in 2018.
A Phase III study of our PLX-PAD cells in the treatment of CLI is up and running and recruiting patients in clinical sites around the world including the U.S, U.K., Germany, Austria, Hungary, Poland and the Czech Republic. We are gearing up and preparing for an additional Phase III study to begin during 2018 in the U.S. and Europe in the treatment of recovery from hip fractures.
Another exciting, early-stage study is our Phase I study in incomplete hematopoietic recovery following hematopoietic cell transplantation which is ongoing and open for patient recruitment at clinical sites in the U.S. and Israel.
As this is a Phase I trial, designed to test the safety of PLX-R18, we are carefully enrolling patients under the study protocol. So far, no safety issues were seen in patients enrolled in the trial.
With regards to the Japanese CLI trial, Pluristem previously signed a term sheet with Sosei CVC and partners to form a joint venture (JV) to conduct a pivotal study of CLI in Japan. As this JV includes not only financial aspects but clinical ones as well, it involves discussions with several partners which is one of the reasons why reaching a final agreement is taking longer than initially expected. Pluristem is working hard to negotiate the best possible terms for a Japanese JV and will provide an update upon reaching an agreement.
In 2018, Pluristem is expected to carry out three pivotal studies, all supported by non-dilutive funds from 3rd parties, that will advance our PLX cell products towards commercialization. This year should also provide Pluristem with our largest amount of clinical data yet, and with the publishing of the results from the 172-patient multinational Phase II Intermittent Claudication study, which is expected during the second quarter of 2018.
We are focused on our mission to bring our cell therapy products to patients in need, while continuing to build our business and be a leader in our industry. Thank you for your continued support of Pluristem.
Sincerely,
Zami Aberman Yaky Yanay
Chairman and Chief Executive Officer President and Chief Executive Officer
As of December 31, 2017, Pluristem had $35.9 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities.
The Company’s net cash used for operating activities for the quarter ended December 31, 2017 was $4.8 million.
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 cells and is entering late- stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
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 letter contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the timing and funding sources of its various studies and trials, that new regulatory pathways potentially give it opportunities, the potential for PLX-Immune to open new possibilities in the field of oncology and offer new paths to help millions of patients, that PLX-Immune has generated interest from potential pharmaceutical partners and that Pluristem intends to start discussions with regulators to officially begin a clinical pathway for this potentially groundbreaking product, it discusses the proposed path for a pivotal study for its ARS program and the timing of the collection of complementary data and the pivotal study protocol and funding, when it discusses that it is gearing up and preparing for an additional Phase III study to begin in 2018 relating to the treatment of the recovery from hip fractures, the ongoing Phase I study in incomplete hematopoietic recovery following hematopoietic cell transplantation, the timing and negotiation relating to the proposed Japanese joint venture, that Pluristem intends to conduct three pivotal studies in 2018 and that 2018 should provide Pluristem with its largest amount of clinical data yet relating to its proposed publishing of clinical data from its multinational Phase II intermittent claudication study and the proposed timing of such publication. 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; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; 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; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, ISRAEL, JANUARY 12, 2018 — Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced the publication of a peer-reviewed article in the journal Scientific Reports, from the publisher of Nature, titled, “Human Placental-Derived Adherent Stromal Cells Co-Induced with TNF-a and IFN-g Inhibit Triple-Negative Breast Cancer in Nude Mouse Xenograft Models.”
The article is based on studies which examined the effect of PLX cells that had been induced with tumor necrosis factor alpha (TNF-a) and interferon-gamma (IFN-g), on the proliferation of over 50 lines of human cancerous cells. The induction of the cells was carried out by adjusting their manufacturing process in order to transiently alter their secretion profile.
Data from the first study showed that the modified PLX cells exhibited an anti-proliferative effect on 45% of the tested cancer cell lines, with a strong inhibitory effect on various lines of breast, colorectal, kidney, liver, lung, muscle and skin cancers.
Comprehensive bioinformatics analysis identified common characteristics of the cancer cell lines inhibited by PLX cells. This knowledge could potentially be used in the future for screening patients’ tumors to identify those patients most likely to show a positive response to treatment with PLX cells.
Based on these promising results, Pluristem conducted a pre-clinical study of female mice harboring human triple negative breast cancer (TNBC). TNBC is an aggressive form of breast cancer that does not respond to standard hormonal therapy due to a lack of estrogen and progesterone receptors. Current treatment for TNBC consists of a combination of surgery, radiation therapy, and chemotherapy, and yet the prognosis remains poor for patients with this type of breast cancer. In this study, weekly intramuscular (IM) injections of the induced PLX cells produced a statistically significant reduction (p= 0.025) in mean tumor size in the treated group compared with the untreated group, with 30% of the treated mice exhibiting complete tumor remission. In addition, a statistically significant reduction (p=0.003) was seen in the percentage of proliferating tumor cells as well as in the level of blood vessels within the tumors.
“The findings of this study published in a peer-reviewed journal are the outcome of over two years of research as well as the vast knowledge of PLX cell properties we have developed over the last 10 years. We believe the findings show promise for the utilization of our induced PLX cells in slowing and reversing the growth of cancer cells, particularly for some cancers that don’t have viable treatment options,” stated Zami Aberman, Chairman and Co-CEO of Pluristem. “The findings also confirm the effectiveness of IM administration and support a mechanism of action involving immunomodulation and inhibition of angiogenesis and cell proliferation in cancerous conditions. Our unique patented manufacturing platform allows us to alter our cells’ secretion profile in correlation with the targeted cancer cells, which may open new possibilities in the field of oncology to treat solid tumors and may also offer new paths to help millions of patients around the world.
As in immunotherapy technology, PLX cells potentially have the ability to communicate with the body and to secrete biological components that enhance regeneration processes and support the body in fighting cancer cells.”
Pluristem has filed patent applications relating to the technology for the induction of PLX cells and the use of these cells for the treatment of cancer.
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, and is entering late-stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
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 express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses that comprehensive bioinformatics analysis, which identified common characteristics of the cancer cell lines inhibited by PLX cells, could potentially be used in the future for screening patients’ tumors, that the study findings show promise for the utilization of Pluristem’s induced PLX cells in slowing and reversing the growth of cancer cells, that Pluristem’s PLX cells may open new possibilities to treat solid tumors and may also offer new paths to help millions of patients around the world. 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; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; 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; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, ISRAEL, January 9, 2018 — Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Food & Drug Administration (FDA) has cleared the Company’s Expanded Access Program (EAP) for the use of its PLX- PAD cell treatment in patients with Critical Limb Ischemia (CLI). EAP allows the use of an investigational medical product outside of clinical trials and is usually granted in cases where patients are unsuitable for inclusion under the study protocol and the patient’s condition is life-threatening with an unmet medical need.
As part of the program, Pluristem’s PLX-PAD cell therapy will be made available to a limited number of Rutherford Category 5 CLI patients in the U.S. who are unsuitable for revascularization and cannot take part in the Company’s ongoing Phase III clinical study, which is currently enrolling patients in the U.S. and Europe. The Company’s PLX-PAD program has already been selected for accelerated approval pathways in both regions, including the FDA’s Fast Track Designation and the European Medicines Agency’s (EMA) Adaptive Pathways program.
“This is a true vote of confidence by the FDA in our cell therapy and a landmark achievement for Pluristem and its shareholders. It gives us the ability to begin treatments using our cell product, offering treatment to certain CLI patients who have poor therapeutic options, while also collecting real-world data alongside our ongoing Phase III clinical study,” said Yaky Yanay, Co-CEO and President of Pluristem. “We are hopeful that the FDA may also allow us to be compensated for the costs of treatment, which can support our work developing effective cell therapies for millions of patients worldwide.”
CLI is an advanced stage of peripheral artery disease where fatty deposits block arteries in the legs, leading to pain, non-healing ulcers, and gangrene. Patients with CLI have a high risk of amputation and death, and those unsuitable for revascularization are left with no adequate treatment options. Pluristem’s PLX-PAD cell therapy utilizes placental cells to secrete a range of therapeutic proteins that trigger the body’s own repair mechanisms, allowing it to grow blood vessels, bring oxygenated blood to damaged tissue, and heal itself faster.
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, and is entering late-stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
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 express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses that its PLX-PAD cell therapy will be made available to a limited number of Rutherford Category 5 CLI patients in the U.S. and that the FDA may allow it to be compensated for the costs of treatment, which can support the Pluristem’s work to develop effective cell therapies for millions of patients worldwide.
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; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; 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; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
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