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HAIFA, ISRAEL, July 11, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced it has advanced its Phase I trial of PLX-R18 cells to treat insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT) by contracting with a leading global clinical research organization (CRO).
The trial received clearance from the U.S. Food and Drug Administration earlier this year and enrollment is planned to begin in the coming months. The multi-center, open-label, dose-escalating Phase I trial will evaluate the safety of intramuscular injections of PLX-R18 cells in 30 patients with incomplete hematopoietic recovery persistent for 6 months or more after HCT.
“Data from this trial will inform the potential of PLX-R18 to treat a wide range of indications including blood cancers and radiation therapy-related blood diseases. The CRO we chose has extensive experience working with leading pharmaceutical and biotech companies to successfully manage clinical trials. We are excited to move forward to bring clinical sites online and begin enrolling patients,” said Pluristem Chairman and CEO Zami Aberman.
Data from multiple preclinical studies conducted by world-class research institutions, including the U.S. National Institutes of Health and Hadassah Medical Center, have shown that PLX-R18 cells secrete a range of specific proteins that support the regeneration of bone marrow and the recovery of its ability to produce normal amounts of all three blood cell types. PLX-R18 is designed to be administered without matching, and using a standard syringe to inject the cells intramuscularly.
Hematopoietic cell transplantation is a standard treatment for a range of conditions, including malignant diseases such as multiple myeloma, non-Hodgkin’s lymphoma, Hodgkin’s disease, and acute myeloid leukemia, as well as non-malignant diseases and autoimmune disorders such as aplastic anemia and thalassemia. The hematopoietic cells for HCT can come from a donor (allogeneic) or from the patient (autologous), and can be harvested from peripheral blood, bone marrow or umbilical cord blood.
In a number of cases, complete hematopoietic recovery following HCT is not reached, and patients are at increased risk of bleeding, infection, poor general function and death for months afterwards.
Current treatments include administration of factors stimulating growth of specific blood cell types, such as granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony- stimulating factor (GM-CSF), and erythropoietin.
However, a significant number of patients do not respond to growth factors and may require frequent transfusions, which expose them to transfusion-related risks such as allo-sensitization and infections, without providing a curative solution. These are also associated with significant costs.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off- the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss our Phase I trial of PLX-R18 cells to treat incomplete hematopoietic recovery following HCT, its expected commencement, the data we expect to discover as a result of this trial. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
HAIFA, ISRAEL, June 22, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI/ PLTR), a leading developer of placenta-based cell therapy products, today reported positive data from preclinical studies of its PLX-PAD cells in the treatment of Duchenne muscular dystrophy. The studies were conducted in conjunction with ADI, the Association Duchenne Israel, whose members are parents of children with Duchenne. They are committed to helping to find a cure for Duchenne muscular dystrophy through research, clinical trials, and advocacy.
Duchenne muscular dystrophy is the most common neuromuscular disorder, and affects roughly one in 3,500 boys. The disease causes progressive muscle weakness, and leads to severe disability and death. There is currently no cure.
Following Pluristem’s announcement of positive results from a Phase II clinical trial of PLX-PAD as a treatment for muscle injury, the Association Duchenne Israel approached Pluristem with a request to study PLX-PAD cells in Duchenne muscular dystrophy. Pluristem donated PLX-PAD cells for the preclinical studies, and the association supported the research in cooperation with Science in Action Ltd.
The studies demonstrated that, in a mouse model of muscular dystrophy, PLX-PAD cells reduced creatine phosphokinase (CPK), a marker of muscle degeneration or injury, by approximately 50% as compared to placebo. CPK levels were measured via a blood sample taken 5 days after each intramuscular PLX-PAD injection made at day 15 and day 29 of the study. Histological analyses of quadriceps and diaphragm muscles show PLX-PAD reduced levels of inflammation and necrosis, a type of cell death, and induced regeneration of muscle tissue.
Hila Krupsky, CEO of ADI, the Association Duchenne Israel, stated, “These preclinical data suggest that PLX-PAD cells could possibly be a breakthrough therapy to help treat symptoms of Duchenne muscular dystrophy. We are thankful for Pluristem’s donation of PLX-PAD and are eager to continue studying the cells since new therapeutic approaches are needed to manage this disease, save children’s lives, and give them hope and a chance for the future.”
“Because PLX-PAD cells have already displayed efficacy in muscle regeneration in a Phase II muscle injury study, we believe our cell therapy may potentially be beneficial in Duchenne muscular dystrophy in human clinical trials,” said Pluristem Chairman and CEO Zami Aberman. “We admire the commitment of the Association Duchenne Israel to find a cure for Duchenne muscular dystrophy, and we will work closely with them in an effort to develop a treatment for the children around the world who suffer from this disease.”
Duchenne muscular dystrophy (DMD) is a genetic disorder characterized by progressive muscle degeneration and weakness. It is caused by a shortage of dystrophin, a protein that helps keep muscle fibers intact as they contract and relax. This shortage is due to a mutation in the gene that controls the production of dystrophin. Muscle weakness can begin as early as age 3, and by the early teens the heart and respiratory muscles also are affected. Average life expectancy for people with DMD is 27 years, though there is significant individual variability. Although girls can be carriers and mildly affected, the disease typically affects boys, and there is currently no cure.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells.
The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage.
PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off- the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the findings of the study of our cell therapy and its potential to treat symptoms of, or be part of a possible cure for, DMD and that we will work closely with the Association Duchenne Israel in an effort to develop a treatment to this disease. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
HAIFA, ISRAEL, May 10, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, today reported financial highlights for its fiscal third quarter ended March 31, 2016, and provided clinical and corporate updates.
“In the third quarter we achieved significant progress in the development of our PLX-R18 product, both as a treatment for a broad range of hematologic indications and as a medical counter measure in the treatment of Acute Radiation Syndrome (ARS). We received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase I study in patients suffering from insufficient hematopoietic recovery following hematopoietic cell transplant. The National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), notified us that they will initiate studies in large animals to evaluate the dosing of PLX-R18 for the treatment of ARS. The first NIAID study is expected to start in the second quarter of 2016,” stated Pluristem Chairman and CEO Zami Aberman.
“In Japan, we received two patents and licensed another key patent from Tokyo University that covers the treatment of ischemic diseases with placental cell therapy in Japan. We believe that our strong IP position in Japan will help in the completion of a PLX-PAD out-licensing deal with a Japanese pharma company,” Aberman added. “Japan’s Pharmaceuticals and Medical Devices Agency cleared the protocol for the trial we anticipate could lead to conditional marketing approval of PLX-PAD in the treatment of Critical Limb Ischemia, and Japanese pharmaceutical companies are expressing strong interest in cooperating with Pluristem. We have hosted a number of delegations at our factory in Israel, including the Japanese Ambassador, who visited in March.”
Financial Update:
As of March 31, 2016, Pluristem had a strong balance sheet with over $38 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. In addition, on May 9, 2016 the Company announced that it was awarded a $3.3 million grant from the Israeli government. The Company’s net cash used for operating activities was $5.6 million for the third quarter. As a result, Pluristem anticipates being well capitalized to conduct the clinical trials that are planned for initiation in 2016, as well as ongoing R&D efforts to support development of future products.
Clinical and Corporate Highlights for the Third Quarter of Fiscal 2016 Include:
The FDA granted Pluristem clearance to initiate a clinical trial of PLX-R18 in the treatment of insufficient hematopoietic recovery following hematopoietic cell transplantation (e.g. bone marrow or peripheral blood or umbilical cord blood transplants). An open-label Phase I trial is expected to begin in 2016, which will allow for the possibility of interim data analysis. Pluristem intends to pursue early market access for PLX-R18 in the U.S. via a Fast Track Designation.
The NIAID will initiate studies in large animals to evaluate dosing for Pluristem’s PLX-R18 as a medical counter measure in the treatment of the hematologic component of ARS. This condition is caused by exposure to extremely high levels of radiation, such as those that are due to a nuclear disaster. Once the optimal dose is determined in large animals, a pivotal trial could be conducted and the results could be used to support a Biologics License Application (BLA) submission of PLX-R18 for this indication under the Animal Rule regulatory pathway.
The Japan Patent Office recently granted two additional patents to Pluristem. One addresses Pluristem’s core technology of three-dimensional expansion methods for producing therapeutic cell products derived from placental or fat cells. Another covers the use of placenta-derived cells grown with this three-dimensional technology to treat disorders of the hematopoietic system, such as disorders caused by exposure to radiation or chemotherapy, and failed engraftment of hematopoietic stem cell transplants. Pluristem also licensed an important patent in Japan from TES Holdings Co., Ltd., a venture company derived from the University of Tokyo, to cover the treatment of ischemic diseases with placental cell therapy, thereby rounding out the Company’s IP coverage in that country.
Pluristem is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage.
PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology.
They require no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the expected timing for the initiation of a Phase I trial in patients suffering from insufficient hematopoietic recovery following hematopoietic cell transplant and the possibility of interim data analysis, when we discuss the possibility of a PLX-PAD out-licensing deal with a Japanese pharma company and other possible collaborations with us, when we discuss the possibility of a conditional marketing approval of PLX-PAD in the treatment of Critical Limb Ischemia, when we discuss our anticipation to be well capitalized to conduct the clinical trials that are planned for initiation in 2016, as well as ongoing R&D efforts to support development of future products, when we discuss our intention to pursue early market access for PLX-R18 in the United States via a Fast Track Designation, and when we discuss the possibility of conducting a pivotal trial and using its results to support a Biologics License Application submission of PLX-R18 for the treatment of the hematologic component of ARS under the Animal Rule regulatory pathway. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
HAIFA, ISRAEL, May 16, 2016 – Pluristem Therapeutics Inc. (NasdaqCM: PSTI , TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced it has completed the planned enrollment of 150 patients in a global Phase II trial of its PLacental eXpanded, PLX-PAD, cells for the treatment of intermittent claudication (IC), a peripheral artery disease (PAD). The double blind, randomized, placebo controlled trial enrolled 50 patients since last October in the U.S., Germany, Israel, and South Korea.
Pluristem has expanded the trial to enroll 20 additional patients to be randomized in order to preserve the study’s original design to administer two injections to each of 150 patients. Twenty of the 150 patients originally enrolled did not complete the trial with two injections. Previous findings in clinical and preclinical studies of PLX cells demonstrated the superior efficacy of two injections vs. a single injection in certain indications.
“We have seen a significant increase in the enrollment rate in the last six months, and I eagerly anticipate the final results of this study. As there is significant suffering of patients with peripheral artery disease, the medical field must advance in offering treatment strategies in addition to revascularization or supervised exercise training, which is not suitable for all patients,” stated the study’s Principal Investigator, Prof. Dr. Norbert Weiss, of the Dresden Division of Angiology, Center for Vascular Medicine and Department of Internal Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden in Germany.
“In the last two years we significantly advanced our understanding of the mechanisms of action of PLX cells, and established the importance of repeat injections to stimulate tissue regeneration in certain acute and chronic indications. Based on our recruitment rate in the last half year, we anticipate quickly completing enrollment of the additional patients,” said Pluristem Chairman and CEO Zami Aberman.
IC is a subset of peripheral artery disease, caused by atherosclerosis of the lower extremity arteries. IC is characterized by muscle pain, cramping, numbness or a sense of fatigue, classically in the calf muscle, which occurs during walking or similar exercise and is relieved by a period of rest. The prevalence of IC in the United States alone is approximately 14 million patients, representing a cost of approximately $2.5 billion annually to the national health care system.
Pluristem’s Phase II trial is evaluating the safety and efficacy of two doses of PLX-PAD cells versus placebo, administered via intramuscular injections. The study protocol is now comprised of approximately 170 patients with IC, Fontaine class IIb, Rutherford category 2-3. In addition to the primary efficacy endpoint of change in the maximal walking distance from baseline during an exercise treadmill test, secondary endpoints of the study are hemodynamic and quality of life measurements. Safety parameters are also being assessed.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss our plan to enroll 20 additional patients to our Phase II trial of our PLX-PAD cells for the treatment of IC, the expected enrollment rate and timing of completion of the enrollment. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
HAIFA, ISRAEL, May 9, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced that its wholly owned subsidiary, Pluristem Ltd., has been awarded 12.7 million New Israeli Shekels (approximately $3.3 million) from the Israel Innovation Authority (Previously the Office of the Chief Scientist ‘OCS’) of the Israeli Ministry of Economy & Industry. The grant will support Clinical trials and R&D activities for calendar year 2016.
“We are delighted to receive the Israeli Innovation Authority Grant this year,” stated Zami Aberman, Chairman and CEO. “The continued backing of the Israeli Innovation Authority is a vote of confidence in Pluristem technology and strategy and support the execution of our plans.”
The Israeli Innovation Authority, empowered by the Law for the Encouragement of Industrial Research & Development – 1984, oversees all government sponsored support of R&D in the Israeli hi-tech and bio-tech industries. This broad-spectrum support stimulates the development of innovative, state-of-the-art technologies, enhances the competitive power of the industry in the global hi-tech market, and creates employment opportunities.
According to the Israeli Innovation Authority grant terms, Pluristem Ltd. is required to pay royalties of 3% – 4% on sales of products and services derived from technology developed using this and other Israeli Innovation Authority grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment is required.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cells are grown using the Company’s proprietary three- dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information, visit www.pluristem.com, the content of which is not part of this press release.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the receipt and use of the Israeli Innovation Authority grant. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
HAIFA, ISRAEL, April 21, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-derived cell therapy products, today announced that it has entered into a licensing agreement with TES Holdings Co., Ltd., a venture company derived from the University of Tokyo, to obtain a key patent in Japan to cover the treatment of ischemic diseases with placental cell therapy rounding out the Company’s IP coverage. This license follows Pluristem’s recent announcement that the Japan Patent Office granted the Company two key patents addressing three-dimensional methods for expanding placental and adipose cells, and specified cell therapies produced from placental tissue using these methods.
The Japanese Patent No. 4554940 is titled “Drug containing human placenta-derived mesenchymal cells and process for producing VEGF employing said cells”. The patent covers use of all placenta-derived mesenchymal cells that are able to produce VEGF, a signaling protein that promotes the growth of new blood vessels, which the body needs to address the damage in ischemic tissue in the heart, brain, skeletal muscle, or elsewhere in the body. The listed inventors of the patent are Dr. Naohide Yamashita, Professor at the Department of Advanced Medical Science, University of Tokyo, Dr. Takashi Nakaoka, and Dr. Toshihide Nishishita. The patent is valid through 2023 and may be eligible for up to five years of patent term extension. Ischemic indications covered by the patent include the two leading causes of death worldwide – ischemic heart disease and stroke – as ranked by the World Health Organization, in addition to peripheral artery disease. Pluristem recently received clearance of its protocol for a Japanese pre-marketing trial in critical limb ischemia, a type of peripheral artery disease.
Akio Hayashi, President of TES Holdings, which manages the commercialization of this IP, commented, “Placenta-derived cell therapies may significantly improve the health and wellbeing of millions of people who suffer from ischemic disease. We are pleased that Pluristem, which is a leading player in the world’s regenerative medicine space, has licensed this patent because their unique experience with placental cell therapies make them optimally positioned to use knowledge developed at the University of Tokyo which demonstrates Japan’s strong capabilities in this space. We hope that this cooperation will advance the regenerative medicine industry and benefit the people with unmet medical needs.”
“The University of Tokyo is well known in for its cutting edge research in the field of cell therapy, and we are happy to expand our cooperation with this world class academic institution. As we prepare to initiate a clinical trial in critical limb ischemia targeting conditional marketing approval via Japan’s new accelerated regulatory pathway for regenerative medicine, our patents addressing placental cell therapies remain a core asset and important to our current negotiations with large pharmaceutical companies regarding potential partnerships in Japan,” stated Pluristem Chairman and CEO Zami Aberman.
“This latest Japanese patent covers the use of placental treatments in any ischemic indication, including heart disease and stroke, which are multi-billion dollar markets. We are securing the IP landscape for placental cell therapies in Japan, which is particularly important because Japan is a large potential market for our cell products, together with the U.S. and Europe, and the world’s leader in facilitating the commercialization of regenerative medicines,” Aberman concluded.
Ischemia is an insufficient supply of blood to an organ or tissue, usually due to a blocked artery. Myocardial ischemia can lead to a heart attack, which is the leading cause of death in the United states and Japan. Cerebral ischemia occurs when arteries are blocked in the brain, and can lead to a stroke, brain damage and death. About 80-85% of all strokes are ischemic. When cholesterol blocks the arteries in the leg, patients develop peripheral artery disease, which includes intermittent claudication and critical limb ischemia. The latter condition often leads to severe illness, amputation and death, and over a million patients suffer from it in the U.S. alone.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off- the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the duration of the IP protection provided by the Japanese patent, when we discuss potential partnerships for the development and commercialization of our PLX cells in Japan, when we discuss our plan to obtain marketing approval in Japan via Japan’s accelerated regulatory pathway for regenerative medicines and when we discuss the market size with respect to heart disease and stroke. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
IP addresses both 3D growth of placental and fat cells and the use of placental cells grown with 3D technology for the treatment of hematopoietic disorders
HAIFA, ISRAEL, April 13, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI , TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced that the Japan Patent Office has granted the Company two key patents addressing: 1) Pluristem’s core technology of three-dimensional expansion methods for producing therapeutic cell products derived from placental or fat cells; 2) the use of placenta-derived cells grown with this 3D technology to treat disorders of the hematopoietic system, such as disorders caused by exposure to radiation or chemotherapy, and failed engraftment of hematopoietic stem cell transplants. Pluristem continues to strengthen its IP position in order to support the current negotiations with pharmaceutical companies in Japan regarding potential partnerships for the development and commercialization of its PLacental eXpanded (PLX) cells. Pluristem recently received clearance for its protocol for a Phase 2 trial in critical limb ischemia targeting marketing approval in Japan, via Japan’s accelerated regulatory pathway for regenerative medicines.
Patent No. 5733894, titled “Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced Thereby for Therapy”, covers three-dimensional methods of growing adherent placental or adipose cells, and the cells produced by the claimed methods.
Patent No. 5766041, titled “Pharmaceutical Composition for Enhancing Subject Hematopoietic System”, addresses pharmaceutical compositions containing placental stromal cells grown using 3D culturing methods for supporting engraftment of hematopoietic progenitor cells, thus enabling treatment of disorders of the hematopoietic system by promoting the recovery of the immune system and bone marrow function.
“These latest patent grants in Japan fortify our intellectual property position globally, and specifically in the Japanese market, where we are in active negotiations with potential pharmaceutical partners,” stated Pluristem Chairman and CEO Zami Aberman. “Our proprietary process and technology for growing placenta-derived cells within a 3D microenvironment make large scale, cost effective cell therapy production a reality, and IP protection of these methods in Japan is a key asset. The use of these cells to treat disorders of the hematopoietic system is an important indication for PLX cells that is now protected in Japan.”
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off- the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss potential partnerships for the development and commercialization of our PLX cells in Japan, when we discuss our plan to obtain marketing approval in Japan via Japan’s accelerated regulatory pathway for regenerative medicines and the statement that our proprietary process and technology for growing placenta-derived cells within a 3D microenvironment make large scale, cost effective cell therapy production a reality. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Second Hematologic Indication Being Developed in the U.S. for PLX-R18
HAIFA, ISRAEL, February 16, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), will initiate studies in large animals to evaluate dosing for Pluristem’s PLX-R18 as a medical counter measure in the treatment of the hematologic components of Acute Radiation Syndrome (ARS). Once the optimal dose is determined in large animals, a pivotal trial could be conducted and the results used to support a Biologics License Application (BLA) submission of PLX-R18 for this indication under the Animal Rule regulatory pathway. In September 2015, the FDA had confirmed that data from earlier trials conducted by NIAID were sufficient for the future design of studies in Pluristem’s development path for PLX-R18. NIAID is supporting and collaborating on the dosing studies, and Pluristem is supplying PLX-R18.
ARS is caused by exposure to very high levels of radiation, such as those that could occur in a nuclear catastrophe. The syndrome can cause severe illness or death. When human trials are not ethical or feasible, as in this indication, the FDA’s Animal Rule regulatory pathway allows for the determination of the efficacy of drugs using animal efficacy studies and human safety data.
“We are very pleased to receive the support and collaboration of the NIH for the development of PLX-R18 as a medical countermeasure in the treatment of ARS, which is the first indication we are targeting in the defense technology space,” stated Pluristem Chairman and CEO Zami Aberman.
Pluristem recently received FDA clearance to initiate a Phase I trial of PLX-R18 to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT). This trial is scheduled to begin in the first half of 2016 in the U.S. Additionally, Pluristem has entered into a Memorandum of Understanding (MOU) with Japan’s Fukushima Medical University, Fukushima Global Medical Science Center to develop PLX-R18 for the treatment of ARS and for morbidities following radiotherapy in cancer patients.
The NIH has supported and completed two mouse studies of PLX-R18 as a potential treatment of the component of ARS that affects bone marrow function. ARS involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells and platelets, as well as to other systems and organs. Severe damage to bone marrow quickly makes victims vulnerable to life- threatening hemorrhage, infection and anemia. A recently concluded NIH/NIAID study showed that administration of PLX-R18 resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation, and described the treatment’s mechanism of action. The NIH/NIAID’s first study of PLX-R18 showed a substantial, statistically significant improvement in 30-day survival and overall survival of irradiated rodents given PLX-R18 versus a control group.
PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure. Pluristem received FDA clearance to initiate a Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation. With its capabilities, PLX-R18 could potentially treat a broad range of hematologic indications, which together constitute a substantial global market.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage.
PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws.
For example, we are using forward-looking statements when we discuss the expected NIAID study, continued support of the NIH, when we discuss the results of the study and its potential use to apply for marketing authorization PLX-R18, the possibility to use results of the study in question to conduct a pivotal study and facilitating the development of PLX-R18 in other hematologic indications, when we discuss our plan to begin a Phase I trial to treat incomplete hematopoietic recovery following HCT in the first half of 2016, and when we discuss PLX-R18’s potential to treat a broad range of hematologic indications, which together constitute a substantial global market. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
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