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.
Pluristem’s PLX-R18 is being studied by NIAID for Acute Radiation Syndrome (ARS), and following pharmacodynamics, safety and efficacy trials, the company plans to initiate a pivotal study to gain approval for ARS via the FDA Animal Rule.
HAIFA, ISRAEL, July 20, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced its participation in the Radiation Injury Treatment Network’s meeting titled, “Medical Management of Radiation Casualties: Where Research and Usage Meet”. The meeting, which took place on July 18-19, 2016, was organized jointly by the Radiation Injury Treatment Network and the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID).
Racheli Ofir, Ph.D., Pluristem’s Vice President of Research & Intellectual Property, shared her expertise in studying the treatment of Acute Radiation Syndrome (ARS) in a variety of animal models.
“We are pleased to have been invited to participate in this important event. It highlights our continued collaboration with the NIH’s NIAID to develop PLX-R18 as a treatment for the hematologic component of ARS,” said Zami Aberman, Chairman and CEO of Pluristem Therapeutics.
Pluristem’s scientists, together with researchers at several academic institutions, Hadassah Medical Center and at the NIAID, have studied the Company’s PLX-R18 cells as a potential treatment for the hematologic subsyndrome of ARS. They have also used animal and in vitro models to delineate the unique mechanism of action of PLX-R18 in this indication. Data have demonstrated that PLX- R18 cells release a spectrum of therapeutic proteins in response to inflammatory cytokines secreted by animals with acutely damaged bone marrow caused by exposure to high levels of radiation. The therapeutic proteins from PLX-R18 cells work to stimulate recovery of hematopoietic function, addressing production of all three blood cell lineages.
As previously announced, the U.S. FDA recently cleared Pluristem’s Phase I trial of PLX-R18 in the treatment of insufficient hematopoietic recovery following hematopoietic cell transplantation.
PLX-R18 cells sense the inflammatory cytokines that are secreted by the body following hematopoietic failure, and respond by releasing a spectrum of therapeutic proteins such as G-CSF (induces HSC mobilization), MCP-1 (induces chemotaxis of monocytes and basophils) and IL-6 (assists in renewal and differentiation of hematopoietic cells). Preclinical studies showed that the proteins released by PLX-R18 attained peak levels before accelerated cellularity and progenitor cell recovery were detected within the bone marrow. Treatment with PLX-R18 was associated with 98% survival versus 30% survival in a control group that was treated with a placebo. Intramuscular injection of PLX-R18 into naïve mice induces only a negligible response, in contrast to the reaction in irradiated mice, suggesting detection of ARS-related signals by PLX-R18.
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 PLX-R18 cells as a potential treatment for the hematologic subsyndrome of ARS, prior models and data relating to the Company’s PLX-R18 cells and the Company’s Phase I trial of PLX-R18 in the treatment of insufficient hematopoietic recovery following hematopoietic cell transplantation. 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 11, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced it has advanced its Phase I trial of PLX-R18 cells to treat insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT) by contracting with a leading global clinical research organization (CRO).
The trial received clearance from the U.S. Food and Drug Administration earlier this year and enrollment is planned to begin in the coming months. The multi-center, open-label, dose-escalating Phase I trial will evaluate the safety of intramuscular injections of PLX-R18 cells in 30 patients with incomplete hematopoietic recovery persistent for 6 months or more after HCT.
“Data from this trial will inform the potential of PLX-R18 to treat a wide range of indications including blood cancers and radiation therapy-related blood diseases. The CRO we chose has extensive experience working with leading pharmaceutical and biotech companies to successfully manage clinical trials. We are excited to move forward to bring clinical sites online and begin enrolling patients,” said Pluristem Chairman and CEO Zami Aberman.
Data from multiple preclinical studies conducted by world-class research institutions, including the U.S. National Institutes of Health and Hadassah Medical Center, have shown that PLX-R18 cells secrete a range of specific proteins that support the regeneration of bone marrow and the recovery of its ability to produce normal amounts of all three blood cell types. PLX-R18 is designed to be administered without matching, and using a standard syringe to inject the cells intramuscularly.
Hematopoietic cell transplantation 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, poor general function and death for months afterwards.
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 our Phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following HCT, its expected commencement, the data we expect to discover as a result of this trial. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; 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, June 22, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI/ PLTR), a leading developer of placenta-based cell therapy products, today reported positive data from preclinical studies of its PLX-PAD cells in the treatment of Duchenne muscular dystrophy. The studies were conducted in conjunction with ADI, the Association Duchenne Israel, whose members are parents of children with Duchenne. They are committed to helping to find a cure for Duchenne muscular dystrophy through research, clinical trials, and advocacy.
Duchenne muscular dystrophy is the most common neuromuscular disorder, and affects roughly one in 3,500 boys. The disease causes progressive muscle weakness, and leads to severe disability and death. There is currently no cure.
Following Pluristem’s announcement of positive results from a Phase II clinical trial of PLX-PAD as a treatment for muscle injury, the Association Duchenne Israel approached Pluristem with a request to study PLX-PAD cells in Duchenne muscular dystrophy. Pluristem donated PLX-PAD cells for the preclinical studies, and the association supported the research in cooperation with Science in Action Ltd.
The studies demonstrated that, in a mouse model of muscular dystrophy, PLX-PAD cells reduced creatine phosphokinase (CPK), a marker of muscle degeneration or injury, by approximately 50% as compared to placebo. CPK levels were measured via a blood sample taken 5 days after each intramuscular PLX-PAD injection made at day 15 and day 29 of the study. Histological analyses of quadriceps and diaphragm muscles show PLX-PAD reduced levels of inflammation and necrosis, a type of cell death, and induced regeneration of muscle tissue.
Hila Krupsky, CEO of ADI, the Association Duchenne Israel, stated, “These preclinical data suggest that PLX-PAD cells could possibly be a breakthrough therapy to help treat symptoms of Duchenne muscular dystrophy. We are thankful for Pluristem’s donation of PLX-PAD and are eager to continue studying the cells since new therapeutic approaches are needed to manage this disease, save children’s lives, and give them hope and a chance for the future.”
“Because PLX-PAD cells have already displayed efficacy in muscle regeneration in a Phase II muscle injury study, we believe our cell therapy may potentially be beneficial in Duchenne muscular dystrophy in human clinical trials,” said Pluristem Chairman and CEO Zami Aberman. “We admire the commitment of the Association Duchenne Israel to find a cure for Duchenne muscular dystrophy, and we will work closely with them in an effort to develop a treatment for the children around the world who suffer from this disease.”
Duchenne muscular dystrophy (DMD) is a genetic disorder characterized by progressive muscle degeneration and weakness. It is caused by a shortage of dystrophin, a protein that helps keep muscle fibers intact as they contract and relax. This shortage is due to a mutation in the gene that controls the production of dystrophin. Muscle weakness can begin as early as age 3, and by the early teens the heart and respiratory muscles also are affected. Average life expectancy for people with DMD is 27 years, though there is significant individual variability. Although girls can be carriers and mildly affected, the disease typically affects boys, and there is currently no cure.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells.
The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage.
PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off- the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the findings of the study of our cell therapy and its potential to treat symptoms of, or be part of a possible cure for, DMD and that we will work closely with the Association Duchenne Israel in an effort to develop a treatment to this disease. 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, May 10, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, today reported financial highlights for its fiscal third quarter ended March 31, 2016, and provided clinical and corporate updates.
“In the third quarter we achieved significant progress in the development of our PLX-R18 product, both as a treatment for a broad range of hematologic indications and as a medical counter measure in the treatment of Acute Radiation Syndrome (ARS). We received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase I study in patients suffering from insufficient hematopoietic recovery following hematopoietic cell transplant. The National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), notified us that they will initiate studies in large animals to evaluate the dosing of PLX-R18 for the treatment of ARS. The first NIAID study is expected to start in the second quarter of 2016,” stated Pluristem Chairman and CEO Zami Aberman.
“In Japan, we received two patents and licensed another key patent from Tokyo University that covers the treatment of ischemic diseases with placental cell therapy in Japan. We believe that our strong IP position in Japan will help in the completion of a PLX-PAD out-licensing deal with a Japanese pharma company,” Aberman added. “Japan’s Pharmaceuticals and Medical Devices Agency cleared the protocol for the trial we anticipate could lead to conditional marketing approval of PLX-PAD in the treatment of Critical Limb Ischemia, and Japanese pharmaceutical companies are expressing strong interest in cooperating with Pluristem. We have hosted a number of delegations at our factory in Israel, including the Japanese Ambassador, who visited in March.”
Financial Update:
As of March 31, 2016, Pluristem had a strong balance sheet with over $38 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. In addition, on May 9, 2016 the Company announced that it was awarded a $3.3 million grant from the Israeli government. The Company’s net cash used for operating activities was $5.6 million for the third quarter. As a result, Pluristem anticipates being well capitalized to conduct the clinical trials that are planned for initiation in 2016, as well as ongoing R&D efforts to support development of future products.
Clinical and Corporate Highlights for the Third Quarter of Fiscal 2016 Include:
The FDA granted Pluristem clearance to initiate a clinical trial of PLX-R18 in the treatment of insufficient hematopoietic recovery following hematopoietic cell transplantation (e.g. bone marrow or peripheral blood or umbilical cord blood transplants). An open-label Phase I trial is expected to begin in 2016, which will allow for the possibility of interim data analysis. Pluristem intends to pursue early market access for PLX-R18 in the U.S. via a Fast Track Designation.
The NIAID will initiate studies in large animals to evaluate dosing for Pluristem’s PLX-R18 as a medical counter measure in the treatment of the hematologic component of ARS. This condition is caused by exposure to extremely high levels of radiation, such as those that are due to a nuclear disaster. Once the optimal dose is determined in large animals, a pivotal trial could be conducted and the results could be used to support a Biologics License Application (BLA) submission of PLX-R18 for this indication under the Animal Rule regulatory pathway.
The Japan Patent Office recently granted two additional patents to Pluristem. One addresses Pluristem’s core technology of three-dimensional expansion methods for producing therapeutic cell products derived from placental or fat cells. Another covers the use of placenta-derived cells grown with this three-dimensional technology to treat disorders of the hematopoietic system, such as disorders caused by exposure to radiation or chemotherapy, and failed engraftment of hematopoietic stem cell transplants. Pluristem also licensed an important patent in Japan from TES Holdings Co., Ltd., a venture company derived from the University of Tokyo, to cover the treatment of ischemic diseases with placental cell therapy, thereby rounding out the Company’s IP coverage in that country.
Pluristem 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 require 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 the initiation of a Phase I trial in patients suffering from insufficient hematopoietic recovery following hematopoietic cell transplant and the possibility of interim data analysis, when we discuss the possibility of a PLX-PAD out-licensing deal with a Japanese pharma company and other possible collaborations with us, when we discuss the possibility of a conditional marketing approval of PLX-PAD in the treatment of Critical Limb Ischemia, when we discuss our anticipation to be well capitalized to conduct the clinical trials that are planned for initiation in 2016, as well as ongoing R&D efforts to support development of future products, when we discuss our intention to pursue early market access for PLX-R18 in the United States via a Fast Track Designation, and when we discuss the possibility of conducting a pivotal trial and using its results to support a Biologics License Application submission of PLX-R18 for the treatment of the hematologic component of ARS under the Animal Rule regulatory pathway. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
HAIFA, ISRAEL, May 16, 2016 – Pluristem Therapeutics Inc. (NasdaqCM: PSTI , TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced it has completed the planned enrollment of 150 patients in a global Phase II trial of its PLacental eXpanded, PLX-PAD, cells for the treatment of intermittent claudication (IC), a peripheral artery disease (PAD). The double blind, randomized, placebo controlled trial enrolled 50 patients since last October in the U.S., Germany, Israel, and South Korea.
Pluristem has expanded the trial to enroll 20 additional patients to be randomized in order to preserve the study’s original design to administer two injections to each of 150 patients. Twenty of the 150 patients originally enrolled did not complete the trial with two injections. Previous findings in clinical and preclinical studies of PLX cells demonstrated the superior efficacy of two injections vs. a single injection in certain indications.
“We have seen a significant increase in the enrollment rate in the last six months, and I eagerly anticipate the final results of this study. As there is significant suffering of patients with peripheral artery disease, the medical field must advance in offering treatment strategies in addition to revascularization or supervised exercise training, which is not suitable for all patients,” stated the study’s Principal Investigator, Prof. Dr. Norbert Weiss, of the Dresden Division of Angiology, Center for Vascular Medicine and Department of Internal Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden in Germany.
“In the last two years we significantly advanced our understanding of the mechanisms of action of PLX cells, and established the importance of repeat injections to stimulate tissue regeneration in certain acute and chronic indications. Based on our recruitment rate in the last half year, we anticipate quickly completing enrollment of the additional patients,” said Pluristem Chairman and CEO Zami Aberman.
IC is a subset of peripheral artery disease, caused by atherosclerosis of the lower extremity arteries. IC is characterized by muscle pain, cramping, numbness or a sense of fatigue, classically in the calf muscle, which occurs during walking or similar exercise and is relieved by a period of rest. The prevalence of IC in the United States alone is approximately 14 million patients, representing a cost of approximately $2.5 billion annually to the national health care system.
Pluristem’s Phase II trial is evaluating the safety and efficacy of two doses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol is now comprised of approximately 170 patients with IC, Fontaine class IIb, Rutherford category 2-3. In addition to the primary efficacy endpoint of change in the maximal walking distance from baseline during an exercise treadmill test, secondary endpoints of the study are hemodynamic and quality of life measurements. Safety parameters are also being assessed.
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 our plan to enroll 20 additional patients to our Phase II trial of our PLX-PAD cells for the treatment of IC, the expected enrollment rate and timing of completion of the enrollment. 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.
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