ARM is the Preeminent Global Advocate for the Advancement of Regenerative Medicine
HAIFA, ISRAEL, October 13, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced its Chairman and CEO, Zami Aberman, has been re-elected as Member of the Board of Directors of the Alliance for Regenerative Medicine (ARM). This is Mr. Aberman’s second year serving on the Board of the Washington, D.C.-based, international organization that represents the gene therapy, cell therapy and tissue engineering sector. Pluristem has been a member of ARM for 4 years and has actively supported the organization’s goals.
Mr. Aberman will work with fellow board members, officers and executive committee members of ARM who come from the leading companies and institutions in regenerative medicine, to set the overall vision and direction of ARM.
“I am honored to be re-elected to the Board of ARM. Over the past year, Pluristem has made a meaningful contribution to this very important organization, which advances the regenerative medicine industry for the benefit of patients and healthcare systems around the globe,” stated Pluristem CEO Zami Aberman.
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 225 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit http://www.alliancerm.org.
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.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, September 14, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced the appointment of Dr. Hillard Lazarus of Case Western Reserve University as the Principal Investigator of the Company’s Phase I trial of its PLacental eXpanded (PLX)-R18 cells to treat incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).
Enrollment for the Phase I trial, which was recently cleared by the U.S. Food and Drug Administration, is expected to begin in the coming months at multiple clinical sites in the U.S. The open label, dose escalating study will evaluate the safety of intramuscular injections of PLX-R18 in 30 patients with incomplete hematopoietic recovery following HCT. Additional endpoints will include changes in platelet and hemoglobin levels, transfusion frequency, frequency of shift from transfusion dependence to transfusion independence, quality of life, and various immunological parameters in the blood.
Dr. Lazarus is a Professor of Medicine at Case Western Reserve University and doctor of Hematology-Oncology at University Hospitals Case Medical Center. He is the George & Edith Richman Professor and Distinguished Scientist in Cancer Research and Director of Novel Cell Therapy.
He was Director of the Blood and Marrow Transplant Program for over 25 years. For the past decade, he has been the Principal Investigator of the Case Consortium of the Blood & Marrow Transplant Clinical Trials Network.
Having developed many new anti-cancer therapies and sophisticated supportive care technologies, Dr. Lazarus is internationally recognized for his contributions in several areas, including mesenchymal stem cell transplantation and allogeneic blood and marrow transplantation for malignancies. Dr. Lazarus has over 600 publications to his name and is the Editor-in-Chief of both Bone Marrow Transplantation and Blood Reviews.
He is a member of Pluristem’s clinical advisory board for the development of PLX-R18 in hematology, and was actively involved in both the selection of the indication and the study design.
“We are pleased and honored that Dr. Lazarus will lead our Phase I trial as Principal Investigator. His extensive experience in the field of hematologic-oncology is an asset to our PLX-R18 development program” stated Pluristem Chairman and CEO Zami Aberman.
“Having previously studied the potential of PLX-R18 in pre-clinical settings to improve outcomes for umbilical cord blood stem cell transplantation, I am eager to lead a clinical trial to explore PLX-R18’s benefits in hematologic recovery following HCT,” commented Dr. Lazarus. “Positive clinical data could support further development of PLX-R18 to increase the success rates of transplants used to treat a broad range of indications.”
PLX-R18 is Pluristem’s second cell therapy product cleared for clinical studies by the U.S. FDA. It has already been studied in preclinical models of acute radiation syndrome, support of hematopoietic cell transplants, and side effects of radiotherapy and chemotherapies used to treat cancers. Preclinical data from trials conducted by the U.S. National Institutes of Health, 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.
By this mechanism of action, PLX-R18 could potentially treat a broad range of hematologic indications.
Hematopoietic cell transplantation (HCT) is a standard treatment for a range of conditions, including malignant diseases such as multiple myeloma, non-Hodgkin’s lymphoma, Hodgkin’s disease, and acute myeloid leukemia, as well as non-malignant diseases and autoimmune disorders such as aplastic anemia and thalassemia. The hematopoietic cells for HCT can come from a donor (allogeneic) or from the patient (autologous), and can be harvested from peripheral blood, bone marrow or umbilical cord blood.
In a number of cases, complete hematopoietic recovery following HCT is not reached, and patients are at increased risk of bleeding, infection, anemia, and poor general function. Current treatments include administration of factors stimulating growth of specific blood cell types, such as granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), and erythropoietin. However, a significant number of patients do not respond to growth factors and may require frequent transfusions, which expose them to transfusion-related risks such as allo-sensitization and infections, without providing a curative solution. These are also associated with significant costs.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells.
The cells release a 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, we are using forward-looking statements when we discuss the expected timing for enrollment for the Phase I trial, when we discuss the planned trial design and its endpoints, when we discuss the potential of positive clinical data to support further development of PLX-R18 to increase the success rates of transplants, and when we discuss the potential of PLX-R18 to treat 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, September 12, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, reported financial results and summarized corporate and clinical developments for its fiscal year ended June 30, 2016.
“Over the past twelve months, Pluristem has made major progress in executing its long-term strategy to target accelerated regulatory pathways and shortening the time to market for its products. These achievements position us to launch a series of multinational pivotal phase III trials, targeting major markets with significant unmet needs,” stated Pluristem Chairman and CEO Zami Aberman.
“The potential of PLX cells has been acknowledged by regulators and innovation programs from around the globe. Our clinical development programs have been selected for accelerated regulatory pathways to market, and we have been awarded massive grants that enable us to move quickly and efficiently towards pivotal studies.”
“We are now entering an exciting and very meaningful stage for the company and are extremely confident in Pluristem’s ability to execute on multiple fronts to bring the most innovative and effective cell therapies to market,” concluded Aberman.
In the coming quarters, Pluristem plans to commence enrolling an estimated 250 patients through clinical sites in the U.S. and Europe for its Phase III trial of PLX-PAD cells in the treatment of CLI, a $12 billion global market. The Company intends to utilize this study as a single pivotal trial for regulatory approval in both regions. The FDA has given Pluristem positive feedback on the proposed Phase III trial. The EU has accepted Pluristem’s PLX-PAD cells for the treatment of CLI in its Adaptive Pathways pilot project, making PLX-PAD cells eligible for conditional market clearance following one pivotal trial. The EU is providing monetary support for the Phase III CLI trail through an approximately $8 million grant from its Horizon 2020 program, which will cover a significant portion of the trial costs.
In Japan, Pluristem intends to conduct a 75-patient pivotal trial for PLX-PAD in the treatment of CLI, via Japan’s accelerated regulatory pathway for regenerative medicine. Pluristem’s strategic plan is to partner with a Japanese partner to conduct this study.
The National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. NIH, is conducting dose selection studies in large animals to determine optimal dosing for Pluristem’s PLX-R18 as a medical counter measure in the treatment of the hematologic components of Acute Radiation Syndrome (ARS). Upon determining the optimal dose, a pivotal trial in large animals is planned and the results will be used to support a Biologics License Application (BLA) submission of PLX-R18 for this indication under the Animal Rule regulatory pathway.
In January 2016, the U.S. FDA cleared Pluristem’s Investigational New Drug (IND) application to begin its Phase I trial of PLX-R18 cells in the treatment of incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT).
Pluristem intends to conduct a Phase III trial of PLX-PAD to evaluate its efficacy to improve recovery following surgery for femoral neck fracture, which is the most common form of hip fracture. Pluristem has already submitted the study protocol to the EMA for a single pivotal trial in this indication through the Adaptive Pathways Project and plans to meet with the FDA later this year.
The Company expects to complete enrollment of all 170 patients in its global Phase II trial of PLX- PAD in the treatment of Intermittent Claudication (IC) within the next couple of months and to report trial results in 2017.
As of June 30, 2016 Pluristem had approximately $33 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. During the fiscal year, Pluristem received a $3.3 million grant to support clinical trials and R&D activities from the Israeli Innovation Authority of the Israeli Ministry of Economy and Industry. The Company’s net cash used for operating activities was $18.5 million during the fiscal year. After the end of the fiscal year, in August 2016, Pluristem was awarded a grant of approximately $8 million from the EU’s Horizon
2020 program to fund its upcoming Phase III trial of PLX-PAD in the treatment of CLI. Pluristem anticipates being well capitalized to conduct the clinical trials planned for initiation in the coming quarters, as well as ongoing R&D efforts to support development of future products.
Pluristem Therapeutics Inc., a late-stage biotechnology company, 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 Pluristem’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the potential for our cell therapies with respect to the treatment of peripheral artery disease and a range of hematologic and orthopedic indications, the description, timing and method of treatment and the proposed locations for our proposed clinical trials, our expectations regarding the possibility of accelerated regulatory approvals, our expected timing and ability to bring our cell therapies to market, our plans to partner with third parties to conduct studies and our anticipation of being well capitalized to conduct the clinical trials planned for initiation in the coming quarters as well ongoing R&D efforts to support development of future 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.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, September 8, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that the Company is conducting a Symposium on the potential for its placental expanded (PLX)PAD cells in the treatment of peripheral artery disease. Pluristem’s upcoming Phase III trial in Critical Limb Ischemia patients will be presented as well. Pluristem’s Symposium is scheduled to take place on Thursday, September 8, 2016 at the Third National Conference of the German, Austrian and Swiss Societies of Vascular Medicine in Dresden, Germany which will be attended by approximately 1,700 attendees from 16 different countries. The company recently announced receiving an $8 million grant from the European Union’s Horizon 2020 program to support the European trial.
One of the key topics of the conference is to discuss the advanced treatments of peripheral vascular disease. Physicians and researchers from specialties including angiology, phlebology, internal medicine, interventional radiology and vascular surgery will be attending the conference. Pluristem will also be holding a meeting with investigators for the CLI study, to review the study with them in more details.
“This is an opportunity time for Pluristem to interact with the leading vascular specialists in Europe. Given the potential of our PLX-PAD cells to offer a unique and much needed treatment solution for CLI, we believe there will be strong interest amongst attendees to take part in our upcoming Phase III CLI trial,” stated Pluristem CEO Zami Aberman.
Professor Norbert Weiss, President of the Conference and Principal Investigator of Pluristem’s Phase II Intermittent Claudication (IC) trial commented, “This conference is an ideal venue through which Pluristem can have a very meaningful exchange with the vascular healthcare decision makers of Europe. As the Principal Investigator of Pluristem’s Phase II IC trial, I believe PLX-PAD cells have the potential to address difficult to treat peripheral artery disease patients with a non-invasive and potentially highly effective solution.”
Professor Nikol Sigrid, Principal Investigator of Pluristem’s upcoming Phase III CLI trial, added, “We look forward to commencing this important Phase III CLI trial. Among the physicians attending this conference are some of the most active specialists assessing and implementing new methods of treatment. Upon regulatory approval in Europe, we believe these physicians may be among the first to prescribe PLX-PAD for the benefit of their patients”.
The pivotal study for PLX-PAD cells in the treatment of CLI is a double blind, randomized, placebo controlled trial in an estimated 250 patients with CLI Rutherford Category 5 who are unsuitable candidates for revascularization.
Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM), with the second dose administered two months after the first. The primary endpoint will be time to major amputation or death.
Patients will be enrolled in clinical sites located throughout Europe and the U.S. Pluristem’s intention is to utilize this study as a single pivotal trial for regulatory approval in both the U.S. and Europe. PLX-PAD cells could potentially address the $12 billion global CLI market.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells.
The 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 the upcoming Phase III trial of Pluristem’s PLX-PAD cells, the potential for PLX-PAD cells to be used in the treatment of Critical Limb Ischemia (CLI) and a range of peripheral artery diseases, the description of the proposed Phase III trial relating to PLX-PAD cells in the treatment of CLI, including the number of estimated patients, the method of treatment and the proposed locations for such clinical trial, the potential for European physicians to be among the first to prescribe PLX-PAD for the benefit of their patients and the potential for PLX-PAD cells to address the $12 billion global CLI market. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, August 9, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that its critical limb ischemia (CLI) program in the European Union has been awarded an $8 million grant. The grant is part of the European Union’s Horizon 2020 program, which is its largest Research and Innovation program. The Phase III study of PLX-PAD in CLI will be a collaborative project carried out by an international consortium led by the Berlin-Brandenburg Center for Regenerative Therapies (BCRT) under the leadership of Prof. Hans-Dieter Volk and Prof. Petra Reinke together with Pluristem.
The consortium, which will include leading European research institutes and clinical sites, will undertake an extensive scientific program in parallel to the trial, using in-depth immunological, endocrine, and molecular analyses to better understand the mechanism of action of PLX-PAD in CLI.
As previously announced, Pluristem’s PLX-PAD development program has been selected for the EU’s Adaptive Pathways project, whose goal is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options.
“We are honored to have been awarded this Horizon 2020 grant designed to support the manufacturing and development of our cell products for potential commercialization. This grant is a vote of confidence and an expression of hope by the European Union that we may be able to provide a regenerative therapy for millions of CLI patients around the world. Pluristem is committed to developing PLX-PAD for patients with peripheral artery disease, and this grant will help us move towards our goal of rapid entry into the European and U.S. markets, given positive results,” stated Pluristem Chairman and CEO Zami Aberman.
The pivotal study for Pluristem’s PLacental eXpanded (PLX) PAD cells in the treatment of CLI is a double blind, randomized, placebo controlled trial in an estimated 250 patients with CLI Rutherford Category 5 who are unsuitable candidates for revascularization. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM), with the second dose administered two months after the first. The primary endpoint will be time to amputation and death.
Patients will be enrolled in clinical sites located throughout Europe and the U.S. Pluristem’s intention is to utilize this study as a single pivotal trial for regulatory approval in both regions. PLX-PAD cells are designed to address the $12 billion global CLI market.
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.
The purpose of Europe’s Adaptive Pathways is to shorten the time it takes for innovative medicines to reach patients with serious conditions that lack adequate treatment options. The pathway is open to clinical programs in early stages of development only.
After a therapy is selected for the program, the Adaptive Pathways group conducts high level discussions and provides guidance to the applicant regarding the formal regulatory processes that precede a trial targeting early approval and further expansion of the indications.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a 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 obtaining the $8 million grant as a part of the EU’s Horizon 2020 program, the estimated use of the grant, the potential for obtaining conditional marketing approval in Europe in the event of positive results of our pivotal CLI trial and Pluristem’s intention to utilize the results of the CLI trial in applying for regulatory approval in both the Europe 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
HAIFA, ISRAEL, August 2, 2016 — Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on the proposed Phase III trial of its PLX-PAD cells in the treatment of critical limb ischemia (CLI). This Phase III trial is intended to support a biologics license application (BLA).
The Phase III study is a double blind, randomized, placebo controlled trial in an estimated 250 patients with CLI Rutherford Category 5 who are unsuitable candidates for revascularization. Patients will be treated with 300 million cells or placebo, injected twice intramuscularly (IM), with the second dose administered two months after the first. The primary endpoint will be time to amputation and death (amputation free survival). Clinical sites will enroll patients in the U.S. and Europe. In parallel, the study protocol has been submitted as a single pivotal trial to European national competent authorities, following scientific advice from the European Medicines Agency (EMA), and approval is expected in the upcoming months. Pluristem’s intention is to utilize this 250 patient trial as a single pivotal trial to apply for regulatory approval in both the U.S. and Europe.
In Critical Limb Ischemia (CLI) fatty deposits block arteries in the leg, leading to greatly reduced blood flow, pain at rest, non-healing ulcers, and gangrene. Patients with CLI are at an immediate risk for limb amputation and death. With poor treatment options, CLI patients who cannot undergo revascularization procedures have a high unmet medical need.
“This is a significant leap forward for Pluristem, as we prepare to enter into a U.S. Phase III trial with our cell therapy for the treatment of CLI. There are few treatment options for this serious cardiovascular condition, which too often leads to amputation and death. We look forward to starting this trial by early 2017,” stated Pluristem Chairman and CEO Zami Aberman. “Concurrent with this U.S. FDA process, we are also moving the CLI indication forward in Europe and Japan. Our PLX-PAD cells address a $12 billion global market in the treatment of CLI.”
As part of its global strategy, Pluristem intends to conduct a pivotal trial Japan in addition to the pivotal trial planned in the U.S. and Europe. Pluristem reached an agreement with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the protocol of a pivotal trial in 75 patients for PLX-PAD in CLI via Japan’s accelerated regulatory pathway for regenerative medicine. Pluristem’s strategic decision is to partner with a Japanese partner to conduct this study. In May 2015, the EMA’s Adaptive Pathways Pilot Project selected the PLX-PAD program for the accelerated pathway, which may lead to conditional marketing approval following a single successful pivotal study.
The design of the Phase III study protocol is based on two successful Phase I trials in CLI. Patients in the Phase I studies were Rutherford categories 4 and 5, and not suitable candidates for leg revascularization. Data from the two Phase I studies showed a favorable safety profile and promising data on amputation free survival one year post-treatment, improved tissue perfusion, and a reduction of ischemic pain at rest. An ongoing Phase II trial in intermittent claudication is expected to complete enrollment of its target of 170 patients by the end of 2016. Intermittent claudication is an earlier stage of peripheral artery disease that can precede CLI.
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 high risk for limb amputation and death within a year of diagnosis. While some conservative treatments exist to relieve pain and provide local ulcer care, most patients will ultimately need a revascularization procedure. Many, however, are not suitable candidates for revascularization, and have high rates of major amputations (up to 40% at 6 months from diagnosis in patients with Rutherford category 4 or 5).
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells.
The cells release a 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 the intention for the Phase III trial to support Pluristem’s biologics license application with the FDA, the expected reply of the European Medicines Agency of the protocol for the European trial in CLI Rutherford Category 5, the potential for conditional marketing approval by the European Medicines Agency following a single successful pivotal study relating to the clinical development program for PLX-PAD and the timing and approvals of the pivotal CLI trials in U.S, Europe and 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
HAIFA, ISRAEL, July 27, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced it intends to conduct a Phase III trial assessing its PLX-PAD cells in recovery following surgery for femoral neck fracture, which is the most common form of hip fracture. The trial protocol is now being designed by Pluristem and its Clinical Advisory Board (CAB), which is comprised of world- leading orthopedic surgeons, and experts in rehabilitation. Pluristem is planning to meet with the FDA later this year to discuss the Phase III protocol. The Company has already submitted this protocol to the European Medicines Agency (EMA) following consultation with the Adaptive Pathways Project Group. Pluristem’s program in critical limb ischemia is already being developed via the Adaptive Pathways Project.
The Phase III study design builds upon positive data from a Phase II trial which showed that PLX- PAD cells induced significant muscle regeneration in patients who had undergone total hip replacement surgery. Patients treated with PLX-PAD at the time of surgery showed a 500% improvement in muscle force and a 300% improvement in muscle volume six months after surgery, as compared to the placebo group.
Muscle injury related to surgery, or to immobilization following surgery, may impact effective rehabilitation, and can lead to the loss of the ability to live independently, severe morbidity, and increased mortality. In the U.S., according to different sources, the lifetime prevalence of a hip fracture is 20% for women and 10% for men. Annual treatment costs in the U.S. are estimated to be between $10 to $15 billion, and are expected to rise because of the aging population.
“PLX-PAD’s proven ability to regenerate muscles could play a critical role in improving the outcomes of the growing number of surgeries for femoral neck fracture,” stated Pluristem Chairman and CEO Zami Aberman. “We are eager to move into Phase III trial in the U.S. and Europe in this important orthopedic indication. We look forward to working with the FDA and EMA to receive clearance to commence the trials.”
Experts present at the meeting:
Fractures of the hip are relatively common in adults and are associated with substantial morbidity and mortality.
Most hip fractures occur in elderly individuals as a result of minimal trauma, such as a fall from the standing position.
One-year mortality rates have been reported to range from 12 to 37 percent, and approximately half of patients are unable to regain their ability to live independently.
In 2003, there were 310,000 individuals hospitalized with hip fractures in the U.S., according to data from the United States Agency for Healthcare Research and Quality (AHRQ), accounting for 30 percent of all hospitalized patients. As the U.S. population ages, the annual number of hip fractures is expected to increase significantly.
The estimated cost for treatment of hip fracture is approximately $10 to $15 billion per year in the United States.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a 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, we are using forward-looking statements when we discuss moving forward to a Phase III trial in the U.S. and Europe to asses PLX-PAD cells in recovery following surgery for femoral neck fracture, when we discuss working with the FDA and EMA to receive clearance to commence the trials and when we discuss that PLX-PAD’s proven ability to regenerate muscles could play a critical role in improving the outcomes of the growing number of surgeries for femoral neck fracture. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
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