HAIFA, ISRAEL, September 18, 2017 — Pluristem Therapeutics, Inc. (NASDAQ:PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s ongoing Phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization. The FDA’s Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs. With Fast Track Designation, there is an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.
“We are extremely pleased with the FDA’s decision to grant Fast Track Designation to PLX-PAD in the treatment of CLI. Up to 40% of patients with CLI are ineligible for revascularization and are at high risk of amputation and death within the first year of diagnosis. This disease takes a heavy toll on patients and their families, while the cost of treating CLI in the U.S. alone is estimated at over $25 billion per year. We are working tirelessly to provide a cell therapy that will address this severe unmet medical need” said Zami Aberman, Chairman and Co-CEO of Pluristem.
“Regulators in some of the largest healthcare markets in the world are now in alignment regarding the need for accelerated approval pathways for our cell therapy product in the treatment of CLI. Programs like the Fast Track Designation offer real hope for patients battling this disease and we look forward to accelerating the path to market for PLX-PAD,” stated Pluristem President and Co-CEO, Yaky Yanay.
Pluristem’s Phase III CLI study is ongoing and actively enrolling patients in the U.S. and Europe.
The European Medicines Agency (EMA) has included PLX-PAD in its Adaptive Pathways program. Positive results from an interim analysis following treatment of half (125) of the study’s population may lead to early conditional marketing authorization.
In Japan, the Pharmaceuticals and Medical Devices Agency (PDMA) has accepted PLX-PAD for the treatment of CLI into its accelerated regulatory pathway for regenerative therapies and has agreed on the design of a single study (N=75) that may lead to early conditional marketing approval and reimbursement.
In Critical Limb Ischemia (CLI), fatty deposits block arteries in the leg, leading to greatly reduced blood flow. This causes leg pain at rest, non-healing ulcers and gangrene.
Patients with CLI are at immediate risk for limb amputation and death. It is estimated that 5-6 million people in the U.S. and Europe suffer from CLI, and this number is projected to grow with the increasing rate of diabetes. While some non- surgical treatments exist to relieve pain and provide local ulcer care, most patients will ultimately need revascularization with vascular bypass surgery or an endovascular procedure to try to prevent major limb amputation and prolong survival.
However, up to 40% of patients are unsuitable for revascularization and experience up to a 40% amputation rate at 1 year.
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. 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 the Fast Track Designation of its Phase III study of PLX-PAD cells for the treatment of CLI may increase the possibility of a priority review by the FDA, its belief that regulators in some of the largest healthcare markets in the world are now in alignment on the need for accelerated approval pathways for its cell therapy product in the treatment of CLI, that positive results from an interim analysis of its Phase III CLI study in Europe may lead to early conditional marketing authorization and that its single study in Japan, which has been approved by the PDMA, may lead to early conditional marketing approval and reimbursement in Japan. 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 goodresults 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, September 13, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that the company has been issued two new patents by Hong Kong Patents Registry for its cell therapy products relating to two of the company’s leading indications, Critical Limb Ischemia (CLI) and muscle regeneration.
The first patent addresses the use of mesenchymal stem cells for the treatment of skeletal muscle damage or injury. The second is for the use of adherent cells to treat ischemia and for connective tissue regeneration and repair.
Pluristem holds over 100 patents globally, including 19 approved patents in China and Hong Kong, that cover various innovations, including the application of Pluristem’s proprietary PLacental eXpanded (PLX) cells, to a wide variety of medical indications like Intermittent Claudication (IC), CLI, hematological disorders such as Acute Radiation Syndrome (ARS), and recovery and repair of injured skeletal muscle.
The approval for the patents follows a recent “Smart Money” grant from Israel’s Ministry of Economy and Industry to support marketing activities in Hong Kong and China. Pluristem’s progress in these markets reflects the company’s goal of offering accessible cell therapy treatments to Asia’s growing healthcare market.
“Receiving approval for these patents strengthens our position in Asia, where we believe our PLX cells can have a lasting and beneficial impact on the way millions of patients are treated for prevalent medical conditions,” noted Yaky Yanay, President and Co-CEO of Pluristem. “We view these patent approvals as a vote of confidence in our innovative treatments and intellectual property, as our cell therapies move closer to commercialization.”
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. 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 strategy is to penetrate Asian markets and offer accessible cell therapy treatments to patients, its belief that the Asian continent’s aging populations and growing healthcare market make it ripe for cell therapy treatments and its belief that PLX cells can have a lasting and beneficial impact on the way millions of patients are treated for prevalent medical conditions. 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, September 11, 2017– 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 fourth quarter and fiscal year ended June 30, 2017.
“Fiscal 2017 has marked a significant advancement in our clinical development pipeline,” stated Pluristem Chairman and Co-CEO Zami Aberman. “We have completed patient enrollment in our Phase II Trial of PLX-PAD in Intermittent Claudication (IC) and expect clinical data from this study in the first half of 2018. We are currently in Phase III trials, with an ongoing pivotal Phase III study in Critical Limb Ischemia (CLI), and another Phase III planned for hip fracture. Our pipeline has been awarded non-dilutive funding of over
$19 million, which we believe will cover significant portion of the costs of these studies. Our PLX-R18 development has had significant progress and is heading towards a pivotal trial as a countermeasure for Acute Radiation Syndrome (ARS) as the U.S. National Institutes of Health (NIH) concludes a successful Phase II equivalent animal dosing study, enabling the selection of optimal dosage for the Pivotal study. The NIH’s promising results have led to an additional agreement with the U.S. Department of Defense (DOD) to evaluate PLX-R18 based on the scope needed for the U.S. armed forces, thereby broadening PLX-R18’s potential to protect troops and civilians before and after a nuclear incident.”
Pluristem Co-CEO and President Yaky Yanay commented, “Looking ahead to fiscal 2018, we look forward to meeting our enrollment target for our Phase III CLI trial, which may put us in a position to apply for conditional marketing approval of PLX-PAD for the treatment of CLI in Europe through the Adaptive Pathways project. We intend to continue our work with U.S. agencies on PLX-R18, including the NIH and DOD, towards approval that would qualify PLX-R18 for stockpiling. Pluristem has worked diligently throughout the fiscal year to bring the benefits of cell therapies closer to the patients and healthcare systems that need them.”
PLX-R18 Advances Towards Pivotal Trial in Treatment of ARS; Investigated by the NIH and DOD as ARS Antidote Both Before and After Radiation Exposure- During fiscal 2017, the U.S. NIH released data from a successful large animal study that evaluated PLX-R18 as an antidote for ARS when administered 24 hours after exposure to radiation. Study results showed that all three doses of PLX-R18 demonstrated improved survival rates compared to placebo. The PLX-R18-treated groups also showed better and faster recovery of blood lineages, a major component of recovery after radiation-induced damage to bone marrow. Safety data showed that PLX-R18 cells can be safely administered without determining an individual’s level of exposure to radiation and without any matching or blood tests, offering a significant and time-critical advantage when treating a mass casualty disaster.
In August 2017, we announced that the U.S. DOD will examine whether PLX-R18 administered prior to, or within the first 24 hours of, exposure to radiation will mitigate ARS. The DOD studies will be conducted in parallel with the NIH studies, allowing for a broader understanding of the potential therapeutic effects of PLX-R18 as a novel medical countermeasure for ARS. This announcement enjoyed broad media coverage, including features in media outlets such as CNN, I24 News and more.
Additional Regulatory Approvals for Pivotal Phase III CLI Trial; Actively Enrolling Patients with Goal of 40 Active Sites Worldwide by the End of 2017– Pluristem’s multinational Phase III study of PLX-PAD cells in the treatment of CLI is currently enrolling in the U.S., U.K., Germany and Austria. An interim efficacy analysis is planned based on data from the first 125 patients. Positive results are expected to lead to early conditional marketing approval in Europe via the Adaptive Pathways project. Following completion of the study, data from all 250 patients will be submitted to the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA) for full marketing approval.
Total of $19 million in Non-Dilutive Funding Awarded to PLX Programs- Pluristem’s planned Phase III study to support recovery following surgery for hip fracture was awarded an $8.7 million non-dilutive grant from the European Union’s Horizon 2020 program. Previously, Horizon 2020 awarded $8 million for Pluristem’s Phase III study in the treatment of CLI. The two grants are expected to cover a significant portion of the costs of these Phase III studies.
Pluristem also received approval for a $1.5 million grant from the Israel Innovation Authority within the Israeli Ministry of Economy to support its PLX-PAD program and was also awarded a “Smart Money” grant from Israel’s Ministry of Economy and Industry to advance its product candidates towards marketing in China-Hong Kong markets.
The PLX-R18 Program also received $900,000 in funding from the Israel-U.S. Binational Industrial Research and Development Foundation (BIRD) for a collaborative study with the New York Blood Center on umbilical cord blood transplantation.
As of June 30, 2017, Pluristem had $26.7 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. During the fiscal year, Pluristem conducted a public offering for aggregate net proceeds of $15.7 million. The Company’s net cash used for operating activities for the quarter ended June 30, 2017 was $6.4 million and $21.6 million during the fiscal year.
“Throughout our history, Company management has evaluated financing opportunities and market conditions in the best interest of our shareholders to ensure that we are able to execute on our business strategy. This year, we enjoyed major successes as our PLX programs were awarded $19 million through non-dilutive grants, most recently in the amount of $8.7 million by the E.U. to support our Phase III hip fracture trial. We continue to evaluate additional financing options available also through strategic and licensing opportunities,” stated Yaky Yanay, Pluristem President and Co-CEO.
“We expect to meet significant milestones in the coming 12 months that will position Pluristem as a global leading cell therapy company,” stated Zami Aberman and Yaky Yanay. “These milestones include completion of a partnership deal in Asia, continued development of our ARS project including 3rd party funding of pivotal studies from the
U.S. government, expected data readouts from several clinical trials, launch of our phase III study for hip fracture, preparations for Biological License Application (BLA) submission in ARS and meeting enrollment goals for our CLI study.
We look forward to leveraging our PLX platform technology for new and exciting business partnerships and opportunities, strengthening our balance sheet and bringing significant value to our shareholders.
Over the past 12 months, we’ve made significant progress building our pipeline and technology platform. This year’s upcoming milestones will enable us to monetize our capabilities for the benefit of the company and its shareholders.”
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 cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage.
PLX cell products are grown using the Company’s proprietary three- dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains 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 it expects clinical data from its Phase II trial of PLX-PAD in IC during the first half of 2018, when it discusses its planned Phase III trial in hip fractures, when it discusses its goal of having 40 active sites worldwide by the end of 2017 for its Phase III CLI trial, the expected recruitment plan in its Phase III CLI trial and possibly being in a position to apply for conditional marketing approval of PLX-PAD for the treatment of CLI in Europe through the Adaptive Pathways project, that the DOD studies relating to PLX-R18 as a treatment for ARS will be conducted in parallel with the NIH studies and that data from all 250 participants planned for the study will be submitted to the FDA and the EMA for full marketing approval and that the two grants provided by the Horizon 2020 program are expected to cover significant portion of the costs of these Phase III studies.
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
karinek@pluristem.com 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations efratk@pluristem.com 972-74-7108600
HAIFA, ISRAEL, September 05 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that its Phase III study of PLX-PAD cells to support recovery following surgery for femoral neck fracture has been awarded an $8.7 million (7.4 million Euro) non-dilutive grant from the Horizon 2020 program, the European Union’s largest research and innovation program. Final approval of the grant is subject to the finalization of the consortium and Horizon 2020 grant agreements. This marks the second grant awarded to a Pluristem Phase III trial by Horizon 2020, following an $8 million (7.6 million Euro) award for its ongoing Phase III study of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI), which was awarded in August 2016.
The Phase III trial of PLX-PAD cells in the treatment of femoral neck fracture will be a collaborative effort between Pluristem and an international consortium led by the Charité – Universitätsmedizin Berlin, under the leadership of Dr. Tobias Winkler, Principal Investigator at the Berlin-Brandenburg Center for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery. Dr. Winkler also served as Senior Scientist for Pluristem’s completed Phase I/II study of PLX-PAD for hip surgery. That trial demonstrated that patients treated with Pluristem’s PLX-PAD cells during total hip arthroplasty experienced significant muscle regeneration compared to the control group with an improvement in muscle force and in muscle volume six months after surgery.
Dr. Winkler commented, “Following the impressive results from the Phase I/II study of PLX-PAD cells in a similar orthopedic indication, we are excited to advance PLX-PAD cell therapy into a Phase III study to aid in muscle regeneration in patients recovering from femoral neck fracture. If similar results are achieved in this Phase III trial, it could show that PLX-PAD cells can improve outcomes in these procedures and change the way recovery is managed worldwide.”
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. The number of surgeries performed annually to treat femoral neck fractures is increasing as populations age. Following surgery, many patients do not regain their baseline capabilities due to poor muscle healing and regeneration, which leads to significantly increased morbidity and a lower quality of life.
“We are honored to receive this second grant from the Horizon 2020 program,” stated Pluristem Chairman and Co-CEO Zami Aberman. “We believe this grant reflects a vote of confidence by the European Union and signals the need for cell therapy solutions to enable patients to lead healthier lives and to relieve health systems’ financial burdens. We are confident that this grant will help us move towards rapid entry into the European and U.S. markets.”
Pluristem’s PLX-PAD program is one of only a handful to be accepted into Europe’s Adaptive Pathway program, the purpose of which is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. Pluristem plans to enroll patients at clinical sites throughout Europe and the U.S. The study is expected to serve as a pivotal trial for regulatory approval in both regions.
The Berlin-Brandenburg Center for Regenerative Therapies (BCRT) was founded as a cooperative research institution of the Charité University Hospital in Berlin, which is one of the largest university hospitals in Europe, and Germany’s largest research association, the Helmholtz Association. The goal of the BCRT is to enhance endogenous regeneration by cells, biomaterials, and factors which can be used to develop and implement innovative therapies and products. The primary focus of the BCRT is on diseases of the immune system, the musculoskeletal system and the cardiovascular system for which currently only unsatisfactory 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, 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 Phase III Studies of PLX-PAD cells and possible results, that the final approval of the Horizon 2020 grant is subject to finalizing the consortium and Horizon 2020 grant agreements, that Pluristem believes the grant is a vote of confidence by the European Union and signals the need for cell therapy solutions to enable patients to lead healthier lives and to relieve health systems’ financial burdens, when Pluristem states it is confident that the grant will help it move towards rapid entry into the European and U.S. markets and that the Phase III femoral neck fracture study is expected to serve as a pivotal trial for regulatory approval in the European Union and the U.S. 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, August 16, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that a pilot study of the company’s PLX-R18 cell therapy will be initiated by the U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI), part of the Uniformed Services University of Health Sciences (USU). The study will examine the effectiveness of PLX-R18 as a treatment for Acute Radiation Syndrome (ARS) prior to, and within the first 24 hours of exposure to radiation.
ARS results from exposure to high levels of radiation, such as in the case of a nuclear accident or attack, and can lead to severe health consequences including death. Pluristem recently reported positive data from studies of PLX-R18 cells as a treatment for ARS conducted by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), U.S. Department of Health and Human Services (DHHS). Data demonstrated improvement in survival rates and enhancement of blood lineages recovery.
A key difference in the NIAID study and the upcoming DOD study is the timeframe of exposure that is being examined: in the NIAID study, PLX-R18 was administered to subjects 24 hours post exposure, while the new DOD study will be designed to support the needs of the U.S. Armed Forces and examine subjects receiving treatment prior to, or within the first 24 hours of radiation exposure. The DOD studies will be conducted in parallel with the NIH/DHHS studies, allowing broader understanding of the potential therapeutic effects of PLX-R18 as a novel medical countermeasure for ARS.
The study will be conducted in accordance with the FDA Animal Rule pathway, the regulatory pathway followed when human efficacy trials are not feasible, in this case due to the ethics of exposing humans to nuclear radiation. Product approval via this pathway is granted following large animal efficacy studies and human safety data.
“We are pleased to see increased interest from US governmental agencies in our PLX-R18 cell therapy,” noted Zami Aberman, Chairman and Co-CEO of Pluristem. “In view of the therapeutic effects of our product and the current geopolitical situation, governments can potentially shield their citizens from the dire health effects arising from exposure to nuclear radiation, saving many lives in the process, which is our ultimate goal.”
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. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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.
Pluristem received FDA clearance to initiate a U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation.
Preclinical data from trials conducted by the NIH, Hadassah Medical Center, and other prominent research institutions have shown that PLX-R18 cells secrete a range of specific proteins that trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production.
With its capabilities, PLX-R18 could potentially treat a broad range of hematologic indications, which together constitute a substantial global market.
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 cells, red cells and platelets; without these cells patients are at high risk of death.
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, we are using forward-looking statements when we discuss how the proposed DOD study will be conducted and the various phases of the study, as well as when we discuss that governments can potentially shield their citizens from the dire health effects arising from exposure to nuclear radiation, saving many lives in the process, while using our products. 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.
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, August 09, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that it has been awarded a “Smart Money” grant from Israel’s Ministry of Economy and Industry to help penetrate the Chinese market, including Hong Kong, with its advanced cell therapy products.
The Smart Money program’s aim is to help companies expand their business to growing international markets. The Israeli government will fund half of Pluristem’s marketing activities in the China-Hong Kong markets, with certain limitations, supporting promotion of the company’s advanced cell therapy products. Pluristem will also receive close support from Israel’s trade representatives stationed in China, including Hong Kong, along with experts appointed by the Smart Money program.
“We are grateful for the Israeli government’s generous support, which will help us introduce our cell therapy products to key markets such as China and Hong Kong,” stated Pluristem President and Co-CEO Yaky Yanay. “In the last two years, we have been very active in Asian markets, and strong governmental support is important in helping us continue building these relationships and potential partnerships. The recent changes in the Chinese Food and Drug Administration (CFDA) guidelines, which accelerate the regulatory approval process for regenerative medicine technologies, represents an opportunity for Pluristem and its strategic partners to address the needs of Asia’s rapidly growing healthcare market and aging populations. Economic and trade activity between Israel and China is reaching new heights, fostering increased partnerships between the Israeli hi-tech sector and Chinese companies. We are honored to be part of these growing partnerships and to contribute to both countries. We look forward to providing better treatment options for millions of patients worldwide.”
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 conducting late-stage trials in several indications.
The PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss the funding and assistance Pluristem will receive through the Smart Money program, our belief that PLX cell therapy products have the ability to play an important role in addressing the needs of Asia’s rapidly growing healthcare markets and aging population and our looking forward to providing better treatment options 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; 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.
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, JULY 26, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today presented new data at the RITN (Radiation Injury Treatment Network) conference from a recent study evaluating PLX-R18 as a treatment for Acute Radiation Syndrome (ARS).
Pluristem recently announced positive data from a Phase II-equivalent study under the FDA Animal Rule demonstrating improved survival and hematological recovery of non-human primates (NHP) exposed to high levels of radiation. The study was conducted and funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH).
New data from the study focuses on 12 additional NHPs that were exposed to lower radiation levels than those in the initial study. In a radioactive or nuclear incident, many victims will suffer from health effects resulting from low radiation exposure and not necessarily from the more dire impact of exposure to high radiation levels. The findings suggest that even though low radiation exposure is not lethal, it can lead to serious hematological deficiencies and to long-term health problems that result from such damage.
Neutrophil, lymphocyte, and platelet counts of the 12 PLX-R18-treated subjects showed faster recovery than those of the study’s control group. This finding indicates that PLX-R18 could potentially be used as a treatment for additional indications relating to bone marrow deficiencies, such as those that may occur due to radiotherapy, chemotherapy, adverse drug reaction and some genetic conditions.
These new findings also strengthen the safety profile of PLX-R18 in subjects exposed to different levels of radiation and even to subjects not exposed to radiation at all. This is a critical factor in case of disasters where screening of victims for exposure levels would delay treatment and potentially reduce its efficacy.
In addition, a thorough analysis of the initial group of 24 NHPs exposed to high doses of ionizing radiation showed that PLX-R18 treatment shortened the length of time spent below severe blood count thresholds, thus avoiding serious infections, hemorrhaging, and anemia.
“There is a crucial need for a therapy to effectively treat populations in case of nuclear or radioactive incidents. These positive results strengthen our confidence in the safety profile and treatment potential of PLX-R18 for different levels of radiation exposure. These new findings, showing improvement in the hematologic system at lower radiation levels, suggest that PLX-R18 has the potential to treat the broader population exposed to different levels of radiation and might also be used for additional indications such as mitigating the negative effects of cancer treatments like chemotherapy,” said Yaky Yanay, president and Co-CEO of Pluristem. “With the knowledge that applications of PLX-R18 could go far beyond treating victims of nuclear incidents, we are one step closer to fulfilling our goal of providing better treatment options for millions of patients worldwide.”
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. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss that the findings of the PLX-R18 study indicate the potential for PLX-R18 to be used as a treatment for additional indications and to be effective in treating radiation exposure, as well as when we discuss that the findings of the PLX- R18 study strengthens the safety profile of PLX-R18 administered to subjects exposed to different levels of radiation or even to subjects not exposed to radiation at all. 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.
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, July 10, 2017— Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that Austria’s regulatory health agency, the Austrian Agency for Health and Food Safety (AGES), has cleared Pluristem to begin enrollment in Austria for its pivotal Phase III trial of PLX-PAD cells to treat Critical Limb Ischemia (CLI). The trial is currently enrolling patients in the U.S., U.K., and Germany.
Pluristem’s PLX-PAD cell therapy is one of a few therapies in the world to have been selected to take part in the European Medicines Agency’s (EMA) Adaptive Pathways pilot project, which goal is to streamline development for promising innovative medicines to allow for early access in patients with serious conditions that lack adequate treatment. An interim efficacy analysis is planned to be conducted based on data from the first 125 patients. Positive results are expected to lead to early conditional marketing approval in Europe.
The Phase III CLI trial has received an $8 million grant from the European Union’s Horizon 2020 program, which will cover a significant portion of the costs of the multinational trial. Following the completion of the study, data from all 250 participants will be submitted to the EMA to apply for full marketing approval and will be reviewed by the U.S. FDA for a Biologics License Application (BLA) targeting commercialization.
“CLI is a severely debilitating and life-threatening disease that affects tens of millions of patients around the world. Approval for this trial and its innovative time-to-event endpoint by regulatory bodies worldwide reinforces our belief that our PLX-PAD cell therapy has great potential to successfully treat these patients and enable them to lead long and healthy lives,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “The potential for early marketing approval is of key importance for us and we plan to continue our mission to utilize cell therapies to help combat devastating medical conditions.”
CLI is an advanced stage of peripheral artery disease, where fatty deposits block arteries in the legs, severely reducing blood flow and causing pain, non-healing ulcers, and gangrene.
Patients with CLI are at a high risk of amputation and death, and those unsuitable for revascularization are left with no adequate treatment options.
The Phase III trial will enroll a total of 250 patients across an estimated 40 clinical sites to evaluate PLX-PAD in the treatment of CLI in a double-blind, randomized, placebo-controlled trial. The patients will all have CLI Rutherford Category 5 – making them unsuitable candidates for revascularization. The patients will be injected twice intramuscularly (IM), two months apart, with 300 million cells or a placebo. The primary endpoint will be time to amputation or death, allowing for a survival analysis and increased data collection to reduce the number of patients required while still enabling statistically significant results for the trial.
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 different cell products each release their own range 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. No tissue matching is required to administration of PLX cell products.
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, we are using forward-looking statements when we discuss our pivotal Phase III trial of PLX- PAD cells, the expected interim efficacy analysis planned to be conducted based on data from the first 125 patients, our expectations that positive results from the Phase III CLI trial, if achieved, are expected to lead to early conditional marketing approval in Europe, the expected submission of study data from all 250 participants to the EMA in relation to the application for full marketing approval and a BLA to the FDA targeting commercialization, when we discuss the potential for PLX-PAD cells to treat CLI and when we discuss our plan to continue our mission to utilize cell therapies to help combat devastating medical conditions. 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor & Public Relations 972-74-710-8600
HAIFA, ISRAEL, June 29, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI), (TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that new data from its non-human primates (NHP) pilot study evaluating PLX-R18 as a treatment for Acute Radiation Syndrome (ARS), will be presented at the RITN (Radiation Injury Treatment Network) conference next month. The company recently reported positive data from the study, which was conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Racheli Ofir, Ph.D., VP Research, will give a presentation titled “Placenta-Derived PLX- R18 Stromal Cells as Mitigators of H-ARS” at the RITN conference on July 26th at 1pm. The RITN conference provides comprehensive evaluation and treatment for victims of radiation exposure or other marrow toxic injuries and will take place on July 25-26 in Rockville, Maryland.
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. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss exploring potential partnership opportunities in Japan in order to take full advantage of the new regulatory landscape. 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.
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 22, 2017 — Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today reported financial results and corporate and clinical developments for the third quarter of fiscal 2017 ended March 31, 2017.
“In this quarter, we achieved significant progress in the development of our PLX-R18 product as a medical counter measure in the treatment of Acute Radiation Syndrome (ARS). Additionally, we continued to build our intellectual property portfolio and are very proud to have reached a milestone of 100 granted patents, including coverage of leading indications in major markets. We look forward to finalizing our joint venture for the commercialization of PLX-PAD in Japan and are confident in our ability to execute on multiple fronts to bring the most innovative and effective cell therapies to market,” stated Pluristem President and Co-CEO, Yaky Yanay.
The objective of the pilot study, conducted and funded by the U.S. National Institutes of Health (NIH), was to evaluate survival, hematological and safety parameters, in both irradiated and non-irradiated non-human primates (NHPs).
Study results showed that all three doses of PLX-R18 improved survival rates compared to control group. Doses of 4, 10 and 20 million cells per kilogram resulted in survival rates of 83%, 86% and 67% respectively, compared to 50% in the control group. All surviving animals fully recovered from ARS. This pilot study also demonstrated a trend towards enhanced neutrophil and lymphocyte recovery.
Safety data showed that PLX-R18 cells did not affect non-irradiated animals. This indicates that individuals can be treated without determining their degree of exposure to radiation. Dosing without the need to test for the level of exposure could offer a significant and time-critical treatment advantage in a mass-casualty disaster.
“The positive data show that PLX-R18 was effective at increasing survival rates and accelerating full recovery in NHPs exposed to radiation. Achievement of this milestone brings us one step closer to potential marketing approval of PLX-R18 as a first line medical countermeasure for ARS,” stated Pluristem Chairman and Co-CEO, Zami Aberman.
“We believe that PLX-R18 cells have the potential to become an alternative to existing treatments for ARS due to their significant advantages. Existing treatments available today have limited efficacy, focusing mainly on regeneration of subpopulations of blood cells. Studies have shown that PLX-R18 cells could potentially trigger regeneration of all blood lineages and lead to higher survival rates.”
“We are now focusing on advancing this important treatment and continuing our discussions with U.S. government agencies regarding their continued support for the final pivotal study, as well as potential initial stockpiling of PLX-R18 cells,” Aberman concluded.
On March 29, 2017, Pluristem announced two senior executive appointments to support the company’s growth and ensure continued success as it enters advanced stages of clinical development for its PLX products.
Yaky Yanay, President of Pluristem and formerly Chief Operating Officer, joined current Chairman and Chief Executive Officer, Zami Aberman as Co-Chief Executive Officer and retained his title of President of the company.
Erez Egozi was appointed to the position of Chief Financial Officer of the company. Previously, Mr. Egozi served as the company’s Vice President of Finance and Secretary.
Pluristem is advancing discussions with Sosei Corporate Venture Capital Ltd. (Sosei CVC) towards establishing a new corporation to pursue the clinical development and commercialization of Pluristem’s PLX-PAD cell therapy product in Japan. Pluristem and Sosei CVC currently anticipate definitive agreements will be finalized in the coming months.
On April 19, 2017, Pluristem announced that it had been granted its 100th patent. Pluristem’s 100 approved patents and over 110 pending patent applications cover over 30 different innovations, including: Pluristem’s proprietary PLX cells and the pharmaceutical composition containing them; methods of expanding and harvesting the cells; uses of the cells in treating a wide variety of indications; and advanced devices developed for expanding and thawing the cells.
During the last few months we have seen an increased interest from Asia. This was particularly evident in China, where the Chinese Food and Drug Administration (CFDA) updated their regulations in order to accelerate the medical regulatory approval process for regenerative medicine companies. The recent notice states that the CFDA would grant fast-track status to innovative products that address unmet medical needs in the country.
Following the Chinese monetary Policy, Pluristem does not expect the necessary clarifications regarding the agreement with Innovative Medical to be provided by the end of H1/2017. Company will update upon developments, if any.
Pluristem believes that PLX cell therapy products have the ability to play an important role in addressing the needs of Asia’s rapidly growing healthcare markets and aging population. The company is confident in its ability to collaborate with strategic Asian partners.
As of March 31, 2017, Pluristem had $33.1 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities.
During this quarter, Pluristem conducted a public offering for aggregate net proceeds of $15.7 million. The company’s net cash used for operating activities was $5.5 million for this quarter.
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 cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the company’s proprietary three- dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when the company discusses Pluristem’s plans to finalize its joint venture for the commercialization of PLX-PAD in Japan, the establishment of a Japanese new corporation, Pluristem and Sosei CVC’s plan to enter into definitive agreements and the proposed timing of execution of such definitive agreements, Pluristem’s ability to collaborate with a strategic Asian partner, Pluristem’s confidence in its ability to execute on multiple fronts to bring the most innovative and effective cell therapies to market, Pluristem’s belief that PLX-R18 cells have the potential to become an alternative to existing treatments for ARS due to their significant advantages, that PLX-R18 cells could potentially trigger regeneration of all blood lineages and lead to higher survival rates and Pluristem’s discussions with U.S. government agencies regarding continued support for a pivotal trial and potential initial stockpiling of PLX-R18 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.
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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