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
HAIFA, Israel, June 4, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that the top-line results of the company’s multinational Phase II clinical trial of PLX-PAD cells in the treatment of Intermittent Claudication (IC) will be released on June 12, 2018.
Pluristem’s Phase II IC trial is evaluating the safety and efficacy of PLX-PAD cells as compared to placebo in 172 patients with IC, Rutherford category 2-3. Enrollment took place at 30 clinical sites in the U.S., Germany, South Korea and Israel. Patients received either two courses of 150 ×106 PLX-PAD cells, two courses of 300 ×106 cells, two courses of placebo, or one course of 300 ×106 cells followed by placebo. In each of these study arms, the two courses were given intramuscularly, 3 months apart. The primary efficacy endpoint is the change in maximal walking distance one year after the first administration. Other endpoints include rate of revascularization and other hemodynamic and clinical parameters.
IC is a subset of peripheral artery disease (PAD). It is caused by obstruction to arterial flow in the legs and is characterized by muscle pain, cramping, numbness or a sense of fatigue, classically in the calf muscle, which occurs during walking or similar exercise and is relieved by a period of rest. Almost fifth of the population over the age of 65 has IC and as a result of demographic changes in many developed countries, its prevalence in the general population is likely to rise dramatically over the next 20 years. PLX-PAD cells may offer a non-surgical procedure that may contributed significantly to the quality of life of PAD patients as well as provide additional treatment possibilities to the angioplasty and vascular medical communities.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late- stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses the expected date for the release of the results of its Phase II clinical trial of PLX-PAD cells in the treatment of IC and that PLX-PAD cells may offer a non-surgical procedure that may contributed significantly to the quality of life of PAD patients as well as provide additional treatment possibilities to the angioplasty and vascular medical communities.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward- looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, Israel, May 10, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today reported financial results and corporate developments for its third quarter of fiscal 2018 ended March 31, 2018.
“The past few months brought several significant milestones which we believe are key to our continued development”, stated Pluristem Chairman and Co-CEO Zami Aberman. “The U.S. Food and Drug Administration (FDA) has cleared our Investigational New Drug application (IND) for the use of PLX-R18 in treating victims who may have been acutely exposed to high dose radiation (ARS) due to nuclear attack or accident. Following this IND approval, and as an additional step to prepare for marketing, we will now start the necessary preparations in order to keep an emergency stock of PLX-R18 on hand for use in such events. We were also cleared by the FDA to start our Phase III study in PLX-PAD in the treatment of muscle injury following hip fracture surgery. This marks the second Phase III study in Pluristem’s clinical pipeline, and we intend to have an additional Phase III study in the treatment of ARS cleared by the FDA by the end of this year.”
“Pluristem is well positioned to be a significant market leader in the cell therapy and regenerative medicine industries”, stated Pluristem President and Co-CEO Yaky Yanay.
“We expect to publish top line data from our Phase II study in intermittent claudication (IC) in June, which will be the largest clinical data set we have published to date. With these data and the latest IND approvals, we are moving closer to market. In support of this process we have announced that we are forming a strategic advisory board, composed of highly accomplished executives, such as Roger Jeffs, former CEO of United Therapeutics and who led Amgen’s Neupogen clinical programs. We believe that this strategic board will bring tremendous expertise and vision to Pluristem, and support our strategic development, clinical progress and commercialization. The company is well financed and has multiple non-dilutive grants to supports its clinical development, including a $2.5 million grant from the U.S. National Institutes of Health (NIH) for a research project in ARS which should provide bridging data for the final pivotal study.”
As of March 31, 2018, Pluristem had $34.1 million in cash and cash equivalents, bank deposits and short- term restricted deposits.
The Company’s net cash used for operating activities for the quarter ended March 31, 2018 was $5.6 million.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late- stage trials in several indications.
Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses its belief that the recent milestones are key to Pluristem’s continued development and that Pluristem is heading towards a significant time period, its intention to make necessary preparations to keep an emergency stock of PLX-R18, that it expects to publish top line data from its Phase II study in IC within the coming weeks, its belief that with the data from the Phase II study in IC, and the latest IND approvals, it is moving closer to market, that the data developed from its ARS studies should provide data for its final pivotal study and its belief that it is in a strong position to become a significant market leader in the cell therapy and regenerative medicine industries. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward- looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, Israel, April 30, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its PLX-R18 cell therapy in the treatment of acute radiation syndrome (ARS). The IND allows Pluristem to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident. With this IND in place, Pluristem will now start the necessary preparations in order to keep an emergency stock of PLX-R18 on hand for use in such events.
The U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) sponsored and completed a successful Phase II-equivalent study of PLX-R18 in the treatment of ARS via the FDA’s animal rule pathway. PLX-R18 is also being studied by the U.S. Department of Defense (DOD) to support the needs of the armed forces and study PLX-R18 as a treatment prior to, or within the first 24 hours of, radiation exposure. Pluristem is currently in discussions with the FDA and several U.S. governmental agencies to clear the path for its proposed pivotal study of PLX-R18 in ARS.
Per the IND protocol, PLX-R18 will be provided up to 96 hours following radiation exposure. The approved dosage for treatment in humans is 4 million cells per kilogram, the optimal dosage that was determined in the Phase II-equivalent non-human primate pilot study. PLX-R18 cells demonstrated a dramatic increase in survival of population exposed to high dose of radiation and enhancement of blood lineages recovery.
“We are proud to have PLX-R18 join the exclusive club of IND approved medical countermeasures for the treatment of ARS. This FDA clearance is one of the most significant milestones in the development of PLX- R18 to date and should provide Pluristem with significant support in advancing its off-the-shelf cell therapy into a pivotal trial. The fact that we are now able to treat human casualties in the case of a nuclear event provides us with the ability to protect from severe health consequences, saving lives of population in need,” stated Pluristem Chairman and Co-CEO Zami Aberman.
Acute Radiation Syndrome occurs following acute exposure to very high levels of radiation, and involves severe, potentially lethal injury to the bone marrow as well as to other organs and systems within the body. High doses of radiation can destroy the bone marrow’s ability to produce white blood cells, red blood cells and platelets; without these cells patients are at high risk of death.
PLX-R18 is Pluristem’s second cell therapy product in development.
It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure.
PLX-R18’s first animal studies in ARS were performed in collaboration with Prof.
Gorodetsky at Hadassah Medical Center. Further preclinical data from trials conducted by the U.S. National Institutes of Health, Hadassah, the Charité in Berlin and other prominent research institutions, have shown that PLX-R18 cells secrete a range of specific proteins that salvage and trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production. With its capabilities, PLX-R18 could potentially be used in several indications to treat a broad range of hematologic disorders, which together constitute a substantial global market.
Pluristem is currently enrolling patients in a multinational Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late- stage trials in several indications. Our PLX cell products release a range of therapeutic proteins following intramuscular administration, in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses its intention to keep an emergency stock of PLX-R18 on hand for use in a nuclear event, its proposed pivotal study of PLX-R18 in ARS, its belief that the approved IND may provide it with the potential to help populations in need as well as support its ARS program and its belief that the IND approval will provide it with significant support in advancing its off-the-shelf cell therapy into a pivotal trial. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Multinational study expected to include clinical sites in U.S. Israel and Europe, where study has been awarded an $8.7 million grant from European Horizon 2020 Program
HAIFA, Israel, April 25, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Food and Drug Administration (FDA) has cleared Pluristem’s Investigational Drug Application (IND) for a Phase III study of its PLX-PAD cell therapy in the treatment of muscle injury following surgical repair (arthroplasty) of the hip joint due to fracture. Pluristem is in discussions with several EU countries to approve this study in Europe as well and expects to begin patient enrollment in both regions during 2018. Non-dilutive funding totaling $8.7 million (7.4 million Euro) has been granted to this study from Horizon 2020, the European Union’s largest research and innovation program.
The Phase III study follows positive results from a Phase I/II trial which demonstrated significant muscle regeneration when using PLX-PAD cells in total hip arthroplasty patients. The study demonstrated a 300% change in muscle volume (p=0.004) and a 500% (p=0.0067) change in muscle force at 6 months post- surgery, compared to the control group.
The Phase III, multinational, randomized, double-blind, placebo-controlled study will assess the efficacy and safety of intramuscular (IM) administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture, as compared to placebo treatment. Through clinical sites in the U.S. and Europe, 240 patients will be randomized on a 1:1 allocation to be dosed with 150 million PLX- PAD cells or placebo on the day of surgery. The primary endpoint is the change in the short physical performance battery (SPPB) score at week 26 after treatment.
“The FDA’s clearance marks the second Phase III study for Pluristem in the U.S. for our PLX-PAD cell therapy and we look forward to begin patient enrollment in 2018,” stated Pluristem’s President and Co- CEO, Yaky Yanay. “We are encouraged by our prior Phase I/II study results that showed PLX-PAD supported muscle regeneration and we are hopeful that PLX-PAD will be similarly effective for patients in our Phase III study. I am pleased to see the successful execution of our clinical development plan with a series of Phase III multinational studies, which we believe positions Pluristem as one of the most advanced and mature companies in the regenerative medicine industry.”
Dr. Tobias Winkler of the Berlin-Brandenburg Center for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery, the principal investigator of the study, commented, “We look forward to evaluating PLX-PAD’s ability to aid muscle regeneration in patients recovering from arthroplasty for hip fracture. Following surgery, many patients do not fully recover and suffer considerable morbidity due to poor muscle regeneration and impaired mobility. If the results of the study show efficacy, then one simple procedure administering an IM dose of PLX-PAD on the day of surgery may significantly reduce recovery time and recovery costs, while improving quality of life for these patients.”
Femoral neck fracture is the most common form of hip fracture, with mortality rates of up to 36%, and annual treatment costs estimated to be between $10-$15 billion in the U.S. alone.
Following surgery, many patients do not fully recover due to poor muscle regeneration, leading to significant morbidity, loss of the ability to live independently, and an overall decline in quality of life.
The incidence of hip fracture is expected to increase as populations age.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late- stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses its Phase III clinical trial of PLX-PAD cells generally as well as its expectation that it will begin patient enrollment in the U.S. and Europe in 2018, its belief that the successful execution of its clinical development plan with a series of Phase III multinational studies positions Pluristem as one of the most advanced and mature companies in the regenerative medicine industry and the possibility that PLX-PAD may significantly reduce recovery time and recovery costs and improve quality of life. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
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