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HAIFA, Israel and San Francisco, CA, October 16, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, and WideTrial Inc., a privately-held third-party sponsor of authorized Expanded Access Programs (EAPs), today announced that the parties have entered into agreement to initiate an FDA- cleared EAP for Pluristem’s cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI). The parties further announced that the FDA has authorized WideTrial to charge payment for the PLX-PAD EAP treatment. Under the terms of the EAP, an initial 100 Rutherford-5 CLI patients who are ineligible for inclusion under Pluristem’s ongoing Phase 3 study protocol, and whose condition is life-threatening, will be enrolled.
“Patients suffering from critical limb ischemia are often unsuitable for revascularization and therefore experience poor clinical outcomes, including amputation. The condition can be fatal if left untreated,” said Yaky Yanay, Co-CEO and President of Pluristem. “We believe the FDA’s decision to approve this Expanded Access Program with cost-recovery for this novel and potentially life-saving cell therapy reflects the Agency’s comfort with the safety profile of PLX-PAD, and recognition of its potential use in treating CLI patients who have few remaining treatment options. As we progress through the EAP, we look forward to generating valuable real world data concurrent with our ongoing 246-patient Phase 3 study that we are currently enrolling in U.S., Europe and Israel. Together, these clinical initiatives are expected to yield a significant body of evidence that we believe will support the safety and efficacy of PLX-PAD and may represent a significant advancement in the treatment of CLI.”
“We are pleased to make PLX-PAD more widely available to CLI patients in need while allowing Pluristem’s management to stay focused on its ongoing Phase 3 clinical study,” said Jess Rabourn, Chief Executive Officer of WideTrial. “Expanded Access Programs allow pre-market treatment use of new medicines by patients who suffer from severe conditions and who cannot enroll in regular clinical studies. These programs can also generate real world data from a wider range of patients in the target population, insights from which could help inform further development of this particular study drug.”
Pluristem’s PLX-PAD program has been selected for accelerated approval pathways in both the U.S. and Europe, including the FDA’s Fast Track Designation and the European Medicines Agency’s (EMA) Adaptive Pathways program.
CLI is an advanced stage of peripheral artery disease where fatty deposits block arteries in the legs, leading to pain, non-healing ulcers, and gangrene. Patients with CLI, particularly later stages of the disease (Rutherford Categories 5 and 6) have a high risk of amputation and death, and those unsuitable for revascularization are left with no adequate treatment options. Pluristem’s PLX-PAD cell therapy utilizes placental cells to secrete a range of therapeutic proteins that trigger the body’s own repair mechanisms, allowing it to grow blood vessels, bring oxygenated blood to damaged tissue, and heal itself faster.
WideTrial is a third-party sponsor of small-group and large-group Expanded Access programs for patients who do not meet the enrollment criteria of traditional research studies. The company uses its scalable platform to make pre-market access more attractive to drug developers and to improve the inclusiveness of the overall drug development process.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical study data in multiple indications for its patented PLX cells and is entering late stage studies in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the timing, description and parameters of its EAP with Widetrial, its belief that the FDA’s approval of the EAP reflects its comfort with the safety profile of PLX- PAD and may lead to recognition of its potential use in treating CLI patients who have few remaining treatment options and that the results of the EAP are expected to yield a significant body of evidence that it believes will support the safety and efficacy of PLX-PAD and may represent a significant advancement in the treatment of CLI.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Ian Manger, PhD
Director of Clinical Sciences WideTrial, Inc.
(415) 691-4556
HAIFA, Israel, October 10, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that two-year follow-up data from its Phase I/II clinical study evaluating its allogeneic placenta-derived cell therapy product, PLX-PAD, for the treatment of muscle injury following hip replacement was published in the peer-reviewed Journal of Cachexia, Sarcopenia and Muscle.
Pluristem also announced that its ongoing Phase III study in the treatment of muscle injury following hip fracture, which is underway in the U.S. and Israel, has been cleared to enroll additional patients in Denmark, Germany and the United Kingdom. The study is being funded in part by an $8.7 million grant from the European Horizon 2020 Program.
“Hip fracture surgeries often result in serious ongoing complications, including pain, disability, functional decline and even death, and there are currently no treatments approved for the post-operative regeneration of injured skeletal muscle,” said Dr. Tobias Winkler, at the Berlin-Brandenburg Center for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery, and principal investigator of the Phase I/II and Phase III studies. “The published study is the first to successfully show the potential of an allogeneic cell therapy in treating patients with skeletal muscle injury, and we eagerly await data from the ongoing Phase III study as this promising therapy advances towards commercialization.”
“The ongoing Phase III study has been precisely designed based on the results of the published Phase I/II study,” added Dr. Winkler. “Based on our results of a reduction of postoperative stress by PLX-PAD, the indication has been adapted to hip fracture patients, who suffer even more due to the surgery-induced stress of hip arthroplasty. In addition, we included in the Phase III study endpoints which measure the systemic effect of PLX-PAD, which we observed in the earlier study, such as increase of contralateral gluteal muscle force and pro-regenerative immunological changes. Taken together, we believe the Phase III study design greatly supports the likelihood of its success.”
The data published also supports PLX-PAD potential in treating additional muscle injuries. “The observations on postoperative stress reduction indicate that using PLX-PAD cells in cases where perioperative stress is highly relevant, such as in sports injuries, traumatic muscle injuries, rotator cuff injuries and other surgical approach related injuries, in spine or knee surgeries, could lead to better outcomes in these patient groups”, states Dr. Winkler. “In addition, since hip fracture patients suffer widely from a condition of general muscle loss, called sarcopenia, leading to frailty and a reduction of mobility, we expect the data from the Phase III study to support the potential use of PLX-PAD in these patients as well.
We believe that the Phase III study design will allow us to identify treatment parameters for both acute muscle injuries as well as general muscle loss.”
“The two-year follow-up data from our Phase I/II study demonstrate once again the safety and efficacy of PLX-PAD cell therapy product and further suggest that PLX-PAD is a highly versatile cell therapy with potential utility in multiple indications,” said Yaky Yanay, Co-CEO and president of Pluristem. “We continue to advance our Phase III programs and plan to open additional clinical sites in Europe to advance the recruitment of patients.
The incidence of hip fracture is expected to increase markedly as the global population ages, and we believe PLX-PAD has the potential to significantly improve outcomes for patients in need of a novel treatment option following surgery.”
The Phase I/II study was a randomized, double blind, placebo controlled study conducted at the Charité Universitätsmedizin Berlin jointly with the Berlin- Brandenburg Center for Regenerative Therapies and the Julius Wolff Institute under the auspices of the Paul-Ehrlich Institute (PEI), Germany’s health authority.
The injured muscle studied was the gluteus medius muscle, which is intentionally cut during total hip arthroplasty. 20 patients were randomized into one of three cohorts: 150 million cell dose of PLX-PAD, 300 million cell dose of PLX-PAD or placebo.
PLX-PAD or placebo was administered directly to the injured gluteus medius muscle during surgery. The primary efficacy endpoint was the change in the strength of the gluteus medius muscle six months after surgery. The key secondary endpoint was the change in the muscle volume of the gluteus medius six months after surgery, as measured by MRI. The results of the study showed that PLX-PAD demonstrated significant muscle regeneration including a highly significant improvement in muscle volume (p=0.004) and muscle force (p=0.0067) when observed six months after surgery compared to the control group.
A copy of the Journal of Cachexia, Sarcopenia and Muscle paper can be found here.
Femoral neck fracture is the most common form of hip fracture, with mortality rates of up to 36%, and annual treatment costs estimated to be between $10-$15 billion in the U.S. alone. Following surgery, many patients do not fully recover due to poor muscle regeneration, leading to significant morbidity, loss of the ability to live independently, and an overall decline in quality of life. The incidence of hip fracture is expected to increase as the population ages.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical study data in multiple indications for its patented PLX cells and is entering late stage studies in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its belief that its PLX-PAD therapy is advancing toward commercialization, its belief that the Phase III study design greatly supports the likelihood of success of the Phase III study, its belief that the published data supports PLX-PAD’s potential in treating additional muscle injuries, its expectation that the data from the Phase III study will support the potential use of PLX- PAD in patients with sarcopenia, its plan to open additional clinical sites in Europe with respect to its Phase III programs and its believe that PLX-PAD has the potential to significantly improve outcomes for patients in need of a novel treatment option following surgery. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical studies; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical studies; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109
HAIFA, Israel, September 27, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today reported financial results for its fourth quarter and fiscal year ended June 30, 2018 and provided a corporate update.
“The indications we are pursuing for our novel cell therapy products, PLX-PAD and PLX-R18, target underserved medical conditions for which there are no viable treatment options today,” stated Yaky Yanay, Co-Chief Executive Officer and President of Pluristem. “With our two ongoing pivotal Phase III trials for PLX-PAD in critical limb ischemia (CLI) and muscle recovery following hip fracture surgery, both collectively supported by over $16 million in non-dilutive grants, we are progressing toward our goal of offering patients a new, innovative, regenerative medicine option that can improve mobility, shorten hospitalization time and ultimately save lives.”
Mr. Yanay continued, “During the fiscal fourth quarter, we achieved a number of significant milestones across both of our development programs. In PLX-PAD, we reported positive data from our Phase II clinical study for the treatment of Intermittent Claudication (IC), an earlier stage of PAD. In PLX-R18, we entered into an additional collaboration agreement with the U.S. Department of Defense to study PLX-R18 for the treatment of long term lung injury following exposure to mustard gas. We also reported positive data from our ongoing collaboration with Fukushima Medical University evaluating PLX-R18 as a treatment for radiation damage to the gastrointestinal (GI) tract and bone marrow. Finally, we announced a strategic collaboration agreement with Thermo Fisher Scientific to advance fundamental knowledge of cell therapy industrialization and to improve quality control of the end-to-end supply chain.”
“September is Peripheral Artery Disease (PAD) awareness month.
Pluristem is committed to developing a viable medical solution for this troubling condition and we are proud to be on the cutting edge of regenerative medicine through which we aim to give hope to millions of PAD patients around the world,” Mr. Yanay concluded.
As of June 30, 2018, Pluristem had $30.6 million in cash and cash equivalents, bank deposits and restricted deposits.
The Company’s net cash used for operating activities during the fourth quarter was $5.8 million.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late-stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its belief that it is progressing toward its goal of offering patients a new, innovative, regenerative medicine option that can improve mobility, shorten hospitalization time and ultimately save lives and its aim to give hope to millions of PAD patients around the world.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Tim McCarthy LifeSci Advisors, LLC 212-915-2564
HAIFA, Israel, September 25, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company’s PLX cell therapy for the treatment of graft failure and incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).
“We believe the FDA’s decision to grant Orphan Drug Designation to PLX cell therapy for the treatment of graft failure and incomplete hematopoietic recovery reflects the potential of this regenerative therapy to improve outcomes in this underserved patient population,” said Yaky Yanay, Co-CEO and President of Pluristem. “We look forward to data from our ongoing Phase 1 clinical trial as we work to efficiently advance this novel therapy through clinical development for this and other hematopoietic indications.”
Pluristem’s product PLX-R18 is currently being evaluated for the treatment of insufficient hematopoietic recovery following bone marrow transplantation in an ongoing Phase 1 clinical trial in the U.S. and Israel.
The trial is designed to evaluate the safety of intramuscular (IM) injections of PLX-R18 cells in 24 subjects with incomplete hematopoietic recovery persisting for at least 4 months after HCT, with a 12-month follow-up period.
The primary endpoint is safety. Exploratory endpoints include changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, changes in quality of life, and changes in the serum immunological parameters.
The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders. Orphan drug designation provides to the Company certain benefits, including market exclusivity upon regulatory approval, if received, exemption of FDA application fees and tax credits for qualified clinical trials.
The FDA previously granted pluristem’s regenerative medicine PLX cell product Orphan Drug Designation for the treatment of Pre-eclampsia, Aplastic Anemia, Berger disease and Acute Radiation Syndrome (ARS).
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward- looking statements when we discuss our belief that the FDA’s decision to grant Orphan Drug Designation to PLX-R18 for the treatment of graft failure and incomplete hematopoietic recovery reflects the potential of this regenerative therapy to improve outcomes in this underserved patient population.
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
Tim McCarthy LifeSci Advisors, LLC 212-915-2564
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Numerous Clinical Sites in Israel to join sites in the U.S. and Europe for Pivotal Phase III Studies of PLX-PAD Cell Therapy in the Treatment of Critical Limb Ischemia and Muscle Injury Following Hip Fracture
HAIFA, Israel, August 8, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that Israel’s Ministry of Health has cleared the Company to commence patient recruitment in Israel for two ongoing pivotal Phase III trials of PLX-PAD cell therapy, one for the treatment of Critical Limb Ischemia (CLI) and another for the treatment of muscle injury following hip fracture surgery.
Both trials have been accepted to accelerated approval pathways and have received a total of $16.7 million in grants from the European Union’s Horizon 2020 Program.
“We are pleased to open clinical sites in Israel for both of our ongoing pivotal Phase III studies. These sites may enable Pluristem to apply for marketing approval in Israel for both indications, aligning with potential regulatory approvals in the U.S. and Europe and expedite the completion of recruitment of both pivotal trials,” stated Pluristem Chairman and Co-CEO, Zami Aberman.
Pluristem’s pivotal Phase III study of PLX-PAD cells in the treatment of CLI, which has received an $8 million grant from the European Union’s Horizon 2020 program, and is currently recruiting patients in the U.S., U.K., Germany, Poland, Czech Republic, Hungary, Bulgaria and Macedonia. PLX-PAD has received the U.S. Food and Drug Administration’s (FDA) Fast Track designation for the treatment of CLI and has been included in the European Medicines Agency (EMA) Adaptive Pathways program, which may lead to early conditional marketing authorization based on an interim analysis following treatment of half of the total 246 patients to be enrolled in the study. The FDA recently cleared PLX-PAD for its Expanded Access Program (EAP) for the treatment of patients with CLI who are not eligible for Pluristem’s Phase III study. EAP allows the use of an investigational medical product outside of clinical trials and is usually granted in cases where patients are unsuitable for inclusion under the study protocol and the patient’s condition is life-threatening with an unmet medical need.
Pluristem’s pivotal Phase III study in the treatment of muscle injury following arthroplasty for hip fracture was awarded an $8.7 million grant by the European Horizon 2020 Program. This study will recruit 240 patients through clinical sites in the U.S., Europe and Israel.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late- stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its intent to apply for marketing approval for CLI and treatment of muscle injury following hip fracture surgery, the potential for Pluristem to obtain early conditional marketing authorization from the FDA and EMA relating to its PLX-PAD cells and its description of the recruitment and timing of its studies.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
exposure
HAIFA, Israel, July 26, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that the Japan Patent Office has granted Pluristem a patent for the treatment of Acute Radiation Syndrome (ARS) and its impact on the gastrointestinal tract. The patent titled “Methods for Treating Radiation or Chemical Injury” relates to intramuscular (IM) administration of adherent stromal cells, cultured under three-dimensional culturing conditions, for mitigating intestinal damage in patients that have been exposed to radiation or chemotherapy.
“The patent is a particularly meaningful asset for our Company in Japan, due to recently published findings from pre-clinical studies conducted at Fukushima Medical University, showing that following radiation exposure PLX-R18 cells significantly increase survival rates, preserve GI stem cell activity, enhance the recovery of the GI system and prevent severe damage to the intestinal lining,” stated Pluristem Chairman and Co-CEO Zami Aberman.
“We believe PLX-R18 is the optimal therapy available today for acute radiation injury. ARS includes injury to multiple organs, with its lethality stemming from radiation-induced damage mainly to the bone marrow and GI tract. The Fukushima University studies demonstrate PLX-R18’s potential ability to treat multiple organs affected by ARS,” Aberman added.
Pluristem’s PLX-R18 cells are in late-stage development as a treatment for ARS in a program conducted and funded by the U.S. National Institutes of Health (NIH) and are also being studied by the U.S. Department of Defense (DOD) and Fukushima University. A PLX-R18 investigational new drug (IND) application for ARS was recently cleared by the U.S. Food and Drug Administration (FDA), allowing Pluristem to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident. Pluristem’s PLX-R18 ARS program has also received an orphan drug designation by the FDA.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late- stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. ֿ
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses PLX-R18 cells’ potential to treat multiple organs affected by ARS. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, Israel, July 09, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that it has entered into a strategic collaboration with Thermo Fisher Scientific to advance fundamental knowledge of cell therapy industrialization and to improve quality control of the end-to-end supply chain.
The collaboration combines Thermo Fisher’s experience in cell therapy development and bioproduction scaleup with Pluristem’s expertise in cell therapy manufacturing, clinical development and quality control.
Together, the companies hope to transform cell therapy manufacturing into a large-scale, high capacity industry that will enable the production of millions of therapeutic doses of regenerative medicines.
Currently, over 850 companies worldwide are developing regenerative medicine and advanced therapies. There are more than 900 clinical trials underway, with several approved and marketed products worldwide. This sector holds the promise of addressing many unmet medical needs, but requires a change in the supply chain of equipment, consumables, reagents and storage systems to enable the treatment of millions of patients.
Bryan Poltilove, General Manager of Cell and Gene Therapy at Thermo Fisher, commented, “The cell therapy industry is expanding at an explosive pace, and Thermo Fisher provides total solutions for cell therapy research, development, and manufacturing. We look forward to advancing our relationship with Pluristem to further enable commercial manufacturing and benefit the broader global industry.”
“From early on, our strategy was to build an in-house manufacturing facility. Having achieved that, we are now in a unique position within the industry, and have a broad understanding of its needs. Thermo Fisher, known for its biopharmaceutical infrastructure, materials supply, logistics, and manufacturing expertise is a perfect partner for Pluristem. This initiative has the potential to advance the industry significantly, allowing regenerative medicine to realize its potential, treating millions of patients globally while reducing healthcare spending. We look forward to a long-term, mutually beneficial partnership,” stated Pluristem President and Co-CEO Yaky Yanay.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late- stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses its collaboration with Thermo Fisher generally as well as its belief that such collaboration will advance fundamental knowledge of cell therapy industrialization and improve quality control of the end-to-end supply chain, that the companies hope to transform cell therapy manufacturing into a large-scale, high capacity industry that will enable the production of millions of therapeutic doses of regenerative medicines. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, Israel, June 25, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today reported positive data from studies conducted in collaboration with Fukushima Medical University evaluating PLX-R18 cells as a treatment for radiation damage to the gastrointestinal (GI) tract and bone marrow. Data from these studies showed that PLX-R18 cells significantly increase survival rates, preserve GI stem cells activity that enhance the recovery of the GI system and prevents severe damage to the intestinal lining, suggesting PLX-R18 potential as a multi- organ therapy for acute radiation syndrome (ARS).
Under a Memorandum of Understanding (MOU) with Pluristem, Fukushima University, Fukushima Global Medical Science Center, has been developing targeted animal models of ARS and has been testing these models in studies to evaluate the efficacy of PLX-R18 in treating radiation damage to the GI tract and bone marrow of mice.
In these preclinical studies, data showed that treatment with PLX-R18 following exposure to high level of ionizing radiation (14 Gy) with partial shielding of the bone marrow, led to a 50% increase in survival, significantly reduced weight loss and increased white blood cell and platelet counts as compared to the control groups. GI tract damage in ARS typically includes damage to, or reduction of, local stem cells, as well as a breach of the lining of the GI tract, leading to life threatening diarrhea and sepsis. Histopathological analysis from these studies showed that PLX-R18 cells mitigate severe damage to the intestinal lining, preserve survival and enhance regeneration of local stem cells, thus preventing breaches and support recovery of the GI tissue following exposure to high levels of ionizing radiation.
Akihiro Inano, Ph.D. of Fukushima University stated, “We were impressed by PLX-R18’s ability to increase survival by mitigating the damage of high levels of radiation on these organ systems. The development of this animal model enabled us to evaluate the efficacy of treating ARS in both the GI system and bone marrow simultaneously. Lethality in ARS originates mainly from radiation-induced injuries to bone marrow and the GI tract, highlighting the importance of the study’s purpose and results. We are now conducting a more extensive analysis of the data and plan to present these findings at the 18th World Congress of Basic and Clinical Pharmacology at Kyoto, Japan (July 1-6, 2018).
Pluristem Chairman and Co-CEO Zami Aberman commented, “We are very happy with the results and the expert research done by Fukushima University.
A 50% Increase in survival is particularly impressive given the very high level of radiation exposure in these subjects and the damages that follow such radiation, especially to the bone marrow and the GI tract. The findings show, for the first time, that PLX-R18 has the ability to treat ARS as a multi-organ therapy. There is advancing scientific understanding that ARS is a multi-organ system injury and needs to be treated as such.
We believe these findings position PLX-R18 as the ultimate therapy available today for acute radiation injuries.”
Pluristem’s PLX-R18 cells are in late-stage development as a treatment for ARS in a program conducted and funded by the U.S. National Institutes of Health (NIH) and are also being studied by the U.S. Department of Defense (DOD) to support the needs of the U.S. armed forces. PLX-R18 investigational new drug (IND) application for ARS was recently cleared by the U.S. Food and Drug Administration (FDA), allowing Pluristem to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident. Pluristem’s PLX-R18 ARS program has also received an orphan drug designation by the FDA.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late- stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses that PLX-R18 may have potential as a multi-organ therapy for ARS and its belief that the study’s findings position PLX-R18 as the ultimate therapy available today for acute radiation injuries. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Studies to be funded by the U.S. NIH
Marks the second project for DOD with PLX-R18 cell therapy product
HAIFA, Israel, June 19, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today it has entered into an additional collaboration agreement with the U.S. Department of Defense (DOD) and its United States Army Medical Research Institute of Chemical Defense (USAMRICD) to study the Company’s PLX-R18 cell therapy product in the treatment of long term lung injuries following exposure to mustard gas. These studies will be funded by the U.S. National Institutes of Health (NIH) and mark the second project selected by the DOD for PLX-R18. The DOD is also studying the effectiveness of PLX-R18 as a novel medical countermeasure for Acute Radiation Syndrome (ARS) prior to exposure to high levels of radiation, designed to support the needs of the U.S. Armed Forces. These two DOD projects are in addition to the NIH-funded late stage development of PLX-R18 to treat the injuries from acute exposure to high levels of radiation.
Sulfur mustard, also known as mustard gas, is a chemical warfare agent, causing severe chemical burns in multiple organs and can also lead to long term damage to the lungs. Currently, supportive care is the only treatment available for people exposed to mustard gas and there is no antidote available.
In multiple studies conducted by several agencies, including the NIH, PLX-R18 has been shown to be effective in recovering the bone marrow, leading to regeneration of progenitor cells and the three blood lineages, including white blood cells, red blood cells and platelets. We believe that these data, together with the results from additional studies conducted with PLX-R18 on lung fibrosis, demonstrate the cells’ potential to counteract injuries from sulfur mustard gas.
“Mustard gas injuries have both acute and long-term consequences. We believe that PLX-R18 has the potential to alleviate or prevent the devastating effects of both the acute and chronic injuries following mustard gas exposure,” stated Pluristem Co-CEO and President, Yaky Yanay. “Mustard gas is also known as a radio-mimetic agent, with injuries similar to those appearing following exposure to ionizing radiation. Following the positive results with PLX-R18 in ARS we believe that the cells have the potential to mitigate the deleterious effects of mustard gas. Positive results from these studies may establish PLX-R18 as a medical countermeasure against a wide range of chemical, biological, radiological and nuclear (CBRN) threat agents.”
The DOD is already studying the effectiveness of PLX-R18 as a novel medical countermeasure for Acute Radiation Syndrome (ARS) prior to exposure to high levels of radiation, designed to support the needs of the U.S. Armed Forces.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late- stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses PLX-R18 cells’ potential to counter injuries and deleterious effects from sulfur mustard gas and its belief that positive results from these studies may establish PLX- R18 as a medical countermeasure against a wide range of chemical, biological, radiological and nuclear threat agents. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, Israel, June 14, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, is delighted to announce that it has been invited by the Tel Aviv Stock Exchange (TASE) to open the weekly trading of the Israeli market, following the announcement of its positive study results.
Pluristem recently announced positive top-line results from its multinational Phase II clinical study of PLX- PAD cells in the treatment of Intermittent Claudication, where treatment was found to reduce the incidence of revascularization, improve patients’ mobility and validate the design of the company’s ongoing multinational Phase III study in Critical Limb Ischemia.
The event will take place at the TASE on Sunday, June 17, 2018 at 9:30am Israel time. Pluristem welcomes its partners, investors and friends to join the event.
Registration is required at: Investor.relations@pluristem.com.
Contact:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
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