Menu
HAIFA, ISRAEL, JULY 26, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today presented new data at the RITN (Radiation Injury Treatment Network) conference from a recent study evaluating PLX-R18 as a treatment for Acute Radiation Syndrome (ARS).
Pluristem recently announced positive data from a Phase II-equivalent study under the FDA Animal Rule demonstrating improved survival and hematological recovery of non-human primates (NHP) exposed to high levels of radiation. The study was conducted and funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH).
New data from the study focuses on 12 additional NHPs that were exposed to lower radiation levels than those in the initial study. In a radioactive or nuclear incident, many victims will suffer from health effects resulting from low radiation exposure and not necessarily from the more dire impact of exposure to high radiation levels. The findings suggest that even though low radiation exposure is not lethal, it can lead to serious hematological deficiencies and to long-term health problems that result from such damage.
Neutrophil, lymphocyte, and platelet counts of the 12 PLX-R18-treated subjects showed faster recovery than those of the study’s control group. This finding indicates that PLX-R18 could potentially be used as a treatment for additional indications relating to bone marrow deficiencies, such as those that may occur due to radiotherapy, chemotherapy, adverse drug reaction and some genetic conditions.
These new findings also strengthen the safety profile of PLX-R18 in subjects exposed to different levels of radiation and even to subjects not exposed to radiation at all. This is a critical factor in case of disasters where screening of victims for exposure levels would delay treatment and potentially reduce its efficacy.
In addition, a thorough analysis of the initial group of 24 NHPs exposed to high doses of ionizing radiation showed that PLX-R18 treatment shortened the length of time spent below severe blood count thresholds, thus avoiding serious infections, hemorrhaging, and anemia.
“There is a crucial need for a therapy to effectively treat populations in case of nuclear or radioactive incidents. These positive results strengthen our confidence in the safety profile and treatment potential of PLX-R18 for different levels of radiation exposure. These new findings, showing improvement in the hematologic system at lower radiation levels, suggest that PLX-R18 has the potential to treat the broader population exposed to different levels of radiation and might also be used for additional indications such as mitigating the negative effects of cancer treatments like chemotherapy,” said Yaky Yanay, president and Co-CEO of Pluristem. “With the knowledge that applications of PLX-R18 could go far beyond treating victims of nuclear incidents, we are one step closer to fulfilling our goal of providing better treatment options for millions of patients worldwide.”
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 and is entering late-stage trials in several indications. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss that the findings of the PLX-R18 study indicate the potential for PLX-R18 to be used as a treatment for additional indications and to be effective in treating radiation exposure, as well as when we discuss that the findings of the PLX- R18 study strengthens the safety profile of PLX-R18 administered to subjects exposed to different levels of radiation or even to subjects not exposed to radiation at all. 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.
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 10, 2017— Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that Austria’s regulatory health agency, the Austrian Agency for Health and Food Safety (AGES), has cleared Pluristem to begin enrollment in Austria for its pivotal Phase III trial of PLX-PAD cells to treat Critical Limb Ischemia (CLI). The trial is currently enrolling patients in the U.S., U.K., and Germany.
Pluristem’s PLX-PAD cell therapy is one of a few therapies in the world to have been selected to take part in the European Medicines Agency’s (EMA) Adaptive Pathways pilot project, which goal is to streamline development for promising innovative medicines to allow for early access in patients with serious conditions that lack adequate treatment. An interim efficacy analysis is planned to be conducted based on data from the first 125 patients. Positive results are expected to lead to early conditional marketing approval in Europe.
The Phase III CLI trial has received an $8 million grant from the European Union’s Horizon 2020 program, which will cover a significant portion of the costs of the multinational trial. Following the completion of the study, data from all 250 participants will be submitted to the EMA to apply for full marketing approval and will be reviewed by the U.S. FDA for a Biologics License Application (BLA) targeting commercialization.
“CLI is a severely debilitating and life-threatening disease that affects tens of millions of patients around the world. Approval for this trial and its innovative time-to-event endpoint by regulatory bodies worldwide reinforces our belief that our PLX-PAD cell therapy has great potential to successfully treat these patients and enable them to lead long and healthy lives,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “The potential for early marketing approval is of key importance for us and we plan to continue our mission to utilize cell therapies to help combat devastating medical conditions.”
CLI is an advanced stage of peripheral artery disease, where fatty deposits block arteries in the legs, severely reducing blood flow and causing pain, non-healing ulcers, and gangrene.
Patients with CLI are at a high risk of amputation and death, and those unsuitable for revascularization are left with no adequate treatment options.
The Phase III trial will enroll a total of 250 patients across an estimated 40 clinical sites to evaluate PLX-PAD in the treatment of CLI in a double-blind, randomized, placebo-controlled trial. The patients will all have CLI Rutherford Category 5 – making them unsuitable candidates for revascularization. The patients will be injected twice intramuscularly (IM), two months apart, with 300 million cells or a placebo. The primary endpoint will be time to amputation or death, allowing for a survival analysis and increased data collection to reduce the number of patients required while still enabling statistically significant results for the trial.
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 different cell products each release their own 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. No tissue matching is required to administration of PLX cell products.
Pluristem has a strong intellectual property position; company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss our pivotal Phase III trial of PLX- PAD cells, the expected interim efficacy analysis planned to be conducted based on data from the first 125 patients, our expectations that positive results from the Phase III CLI trial, if achieved, are expected to lead to early conditional marketing approval in Europe, the expected submission of study data from all 250 participants to the EMA in relation to the application for full marketing approval and a BLA to the FDA targeting commercialization, when we discuss the potential for PLX-PAD cells to treat CLI and when we discuss our plan to continue our mission to utilize cell therapies to help combat devastating medical conditions. 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor & Public Relations 972-74-710-8600
HAIFA, ISRAEL, June 29, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI), (TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that new data from its non-human primates (NHP) pilot study evaluating PLX-R18 as a treatment for Acute Radiation Syndrome (ARS), will be presented at the RITN (Radiation Injury Treatment Network) conference next month. The company recently reported positive data from the study, which was conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Racheli Ofir, Ph.D., VP Research, will give a presentation titled “Placenta-Derived PLX- R18 Stromal Cells as Mitigators of H-ARS” at the RITN conference on July 26th at 1pm. The RITN conference provides comprehensive evaluation and treatment for victims of radiation exposure or other marrow toxic injuries and will take place on July 25-26 in Rockville, Maryland.
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 and is entering late-stage trials in several indications. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss exploring potential partnership opportunities in Japan in order to take full advantage of the new regulatory landscape. 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.
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 22, 2017 — Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today reported financial results and corporate and clinical developments for the third quarter of fiscal 2017 ended March 31, 2017.
“In this quarter, we achieved significant progress in the development of our PLX-R18 product as a medical counter measure in the treatment of Acute Radiation Syndrome (ARS). Additionally, we continued to build our intellectual property portfolio and are very proud to have reached a milestone of 100 granted patents, including coverage of leading indications in major markets. We look forward to finalizing our joint venture for the commercialization of PLX-PAD in Japan and are confident in our ability to execute on multiple fronts to bring the most innovative and effective cell therapies to market,” stated Pluristem President and Co-CEO, Yaky Yanay.
The objective of the pilot study, conducted and funded by the U.S. National Institutes of Health (NIH), was to evaluate survival, hematological and safety parameters, in both irradiated and non-irradiated non-human primates (NHPs).
Study results showed that all three doses of PLX-R18 improved survival rates compared to control group. Doses of 4, 10 and 20 million cells per kilogram resulted in survival rates of 83%, 86% and 67% respectively, compared to 50% in the control group. All surviving animals fully recovered from ARS. This pilot study also demonstrated a trend towards enhanced neutrophil and lymphocyte recovery.
Safety data showed that PLX-R18 cells did not affect non-irradiated animals. This indicates that individuals can be treated without determining their degree of exposure to radiation. Dosing without the need to test for the level of exposure could offer a significant and time-critical treatment advantage in a mass-casualty disaster.
“The positive data show that PLX-R18 was effective at increasing survival rates and accelerating full recovery in NHPs exposed to radiation. Achievement of this milestone brings us one step closer to potential marketing approval of PLX-R18 as a first line medical countermeasure for ARS,” stated Pluristem Chairman and Co-CEO, Zami Aberman.
“We believe that PLX-R18 cells have the potential to become an alternative to existing treatments for ARS due to their significant advantages. Existing treatments available today have limited efficacy, focusing mainly on regeneration of subpopulations of blood cells. Studies have shown that PLX-R18 cells could potentially trigger regeneration of all blood lineages and lead to higher survival rates.”
“We are now focusing on advancing this important treatment and continuing our discussions with U.S. government agencies regarding their continued support for the final pivotal study, as well as potential initial stockpiling of PLX-R18 cells,” Aberman concluded.
On March 29, 2017, Pluristem announced two senior executive appointments to support the company’s growth and ensure continued success as it enters advanced stages of clinical development for its PLX products.
Yaky Yanay, President of Pluristem and formerly Chief Operating Officer, joined current Chairman and Chief Executive Officer, Zami Aberman as Co-Chief Executive Officer and retained his title of President of the company.
Erez Egozi was appointed to the position of Chief Financial Officer of the company. Previously, Mr. Egozi served as the company’s Vice President of Finance and Secretary.
Pluristem is advancing discussions with Sosei Corporate Venture Capital Ltd. (Sosei CVC) towards establishing a new corporation to pursue the clinical development and commercialization of Pluristem’s PLX-PAD cell therapy product in Japan. Pluristem and Sosei CVC currently anticipate definitive agreements will be finalized in the coming months.
On April 19, 2017, Pluristem announced that it had been granted its 100th patent. Pluristem’s 100 approved patents and over 110 pending patent applications cover over 30 different innovations, including: Pluristem’s proprietary PLX cells and the pharmaceutical composition containing them; methods of expanding and harvesting the cells; uses of the cells in treating a wide variety of indications; and advanced devices developed for expanding and thawing the cells.
During the last few months we have seen an increased interest from Asia. This was particularly evident in China, where the Chinese Food and Drug Administration (CFDA) updated their regulations in order to accelerate the medical regulatory approval process for regenerative medicine companies. The recent notice states that the CFDA would grant fast-track status to innovative products that address unmet medical needs in the country.
Following the Chinese monetary Policy, Pluristem does not expect the necessary clarifications regarding the agreement with Innovative Medical to be provided by the end of H1/2017. Company will update upon developments, if any.
Pluristem believes that PLX cell therapy products have the ability to play an important role in addressing the needs of Asia’s rapidly growing healthcare markets and aging population. The company is confident in its ability to collaborate with strategic Asian partners.
As of March 31, 2017, Pluristem had $33.1 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities.
During this quarter, Pluristem conducted a public offering for aggregate net proceeds of $15.7 million. The company’s net cash used for operating activities was $5.5 million for this quarter.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the company’s proprietary three- dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when the company discusses Pluristem’s plans to finalize its joint venture for the commercialization of PLX-PAD in Japan, the establishment of a Japanese new corporation, Pluristem and Sosei CVC’s plan to enter into definitive agreements and the proposed timing of execution of such definitive agreements, Pluristem’s ability to collaborate with a strategic Asian partner, Pluristem’s confidence in its ability to execute on multiple fronts to bring the most innovative and effective cell therapies to market, Pluristem’s belief that PLX-R18 cells have the potential to become an alternative to existing treatments for ARS due to their significant advantages, that PLX-R18 cells could potentially trigger regeneration of all blood lineages and lead to higher survival rates and Pluristem’s discussions with U.S. government agencies regarding continued support for a pivotal trial and potential initial stockpiling of PLX-R18 cells.
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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations
972-74-7108600
Pluristem recently reported positive results from its pilot study in nonhuman primates, for treatment of acute radiation syndrome.
You are welcome to enter the following link for a short video on the
study results: https://youtu.be/i4nRUESNAXk
HAIFA, ISRAEL, May 3, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI), (TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today the promising results of its non-human primates (NHP) pilot study for PLX-R18 as a treatment for Acute Radiation Syndrome (ARS). The study, conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), was designed to assess the safety and efficacy of PLX-R18 following intramuscular injection into irradiated and non-irradiated NHPs. Efficacy measures included survival as well as level of bone marrow function, which is affected by exposure to high levels of radiation as may occur in a nuclear accident or attack.
While this pilot study was not powered to demonstrate statistical significance, all cohorts treated with PLX-R18 showed improved survival compared to cohorts that received placebo. The two lower dosages, 4 and 10 million cells per kilogram body weight, resulted in an 85% survival rate in irradiated NHPs compared to a 50% survival rate in the placebo treated control group. This pilot study also demonstrated a trend towards enhanced neutrophil and lymphocyte recovery.
No serious adverse reactions were observed in non-irradiated NHPs , suggesting that in scenarios requiring the rapid treatment of large populations, such as in the case of a nuclear emergency, no determination of an individual’s level of exposure would be required prior to treatment.
These data will help inform a pivotal study designed to meet the requirements for a Biologics License Application (BLA) submission under the FDA’s Animal Rule regulatory pathway.
“These findings are in line with what we’ve seen in previous studies and strengthen our commitment to delivering a ready-to-use treatment to counteract the devastating effects of ARS,” said Zami Aberman, Co-CEO and Chairman of Pluristem.
“The transition from small to large animals has always been a challenge in therapeutic product development, and the success of this study marks a significant milestone. Our unique, multifactorial PLX-R18 cell therapy was developed to repair the body’s ability to produce all three blood lineages in a timely manner. This therapy would protect patients from severe infection, anemia and hemorrhage, saving lives in the case of a nuclear event. We are pleased that these findings support this treatment’s efficacy and are looking forward to results from further studies,” added Aberman.
“Following this successful trial, we look forward to continuing our discussions with U.S. government agencies regarding continued support for a pivotal trial” said Yaky Yanay, Co- CEO and President of Pluristem. “We are confident that PLX-R18 can serve as a powerful tool for governments to protect their citizens against the devastating health impact of potential exposure to nuclear radiation. We are proud to have developed a treatment that could save many lives.”
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 cells, red cells and platelets; without these cells patients are at high risk of death.
The objective of the study was to evaluate survival and hematology parameters as well as safety parameters in irradiated (target LD30/45) and non-irradiated male and female NHPs (total 48 animals), following intramuscular treatment with 3 doses (4.0, 10.0 and 20.0 million cells per Kg) of PLX-R18 as compared to non-treated controls.
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 U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation.
Preclinical data from trials conducted by the NIH, Hadassah Medical Center, and other prominent research institutions have shown that PLX-R18 cells secrete a range of specific proteins that trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production. 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 (PLacental eXpanded) cells and is entering late-stage trials in several indications. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss Pluristem’s belief that the data from the NHP pilot study of PLX-R18 will pave the way for a pivotal study designed to meet the requirements for a BLA submission under the FDA’s Animal Rule regulatory pathway, Pluristem’s discussions with U.S. government agencies regarding continued support for a pivotal trial and Pluristem’s confidence that PLX-R18 can serve as a powerful tool for governments to protect their citizens against the devastating health impact of potential exposure to nuclear radiation. 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.
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 19, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI), (TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that it has been issued its 100th patent, an important milestone attesting to the significant accomplishments of its scientists and engineers, and its enduring commitment to innovative research and development.
The milestone reflects Pluristem’s continued efforts to develop accessible and effective placental cell therapies. Pluristem’s 100 approved patents and over 110 pending patent applications cover over 30 different innovations, including Pluristem’s proprietary Placental Expanded (PLX) cells and the pharmaceutical composition containing them; methods of expanding and harvesting the cells; uses of the cells in treating a wide variety of indications; and advanced devices developed for expanding and thawing the cells. Therapeutic areas covered by the patent portfolio include ischemic disorders such as intermittent claudication (IC), critical limb ischemia (CLI), ischemic stroke, acute myocardial infarction and ischemic kidney injury. Also covered are hematological disorders such as acute radiation syndrome (ARS), graft vs. host disease (GvHD), and incomplete engraftment of hematopoietic cell transplants (partially unsuccessful bone marrow transplantation). Other therapeutic areas include muscle and tendon injury; inflammatory bowel disorders and other autoimmune diseases; heart failure and cardiomyopathy.
“In an industry that demands constant technological and scientific advances, a robust patent portfolio covering our core innovations strengthens Pluristem’s competitive edge,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “We believe that our patented technologies allow us to deliver truly distinct and scientifically superior products, while fulfilling our vision of creating successful cell therapies that we believe will change the way patients are treated.”
Pluristem is currently in advanced-stage, pre-marketing clinical trials for several of its cell therapy products. The patents cover Pluristem’s leading indications such as CLI, with patents in over 10 jurisdictions, including major markets such as the United States, Europe, Japan and China.
“Our patent portfolio is a valuable asset that serves our marketing strategy. We are pleased that our competitive advantage in technology and manufacturing will be secured by patent protection for many years to come,” said Yaky Yanay, Co-CEO and President of Pluristem. “These patented innovations created by our outstanding teams of researchers and engineers pave the way towards a better future for healthcare that leverages advanced technology to increase treatment efficacy and patient access, we look forward to the fulfillment of this vision.”
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 and is entering late-stage trials in several indications. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage.
PLX cell products are grown using the company’s proprietary three-dimensional expansion technology.
They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss Pluristem maintaining a competitive edge due to its robust patent portfolio covering its core innovations, Pluristem’s belief that its patented technologies allow it to deliver truly distinct and scientifically superior products that it believes will change the way patients are treated for various medical conditions and Pluristem’s patented innovations paving the way towards a better future for healthcare that leverages advanced technology to increase treatment efficacy and patient access. 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.
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, March 30, 2017- Pluristem Therapeutics Inc. (NASDAQ: PSTI), (TASE: PSTI), a leading developer of placenta-based cell therapy products today announced advancement in discussions with Sosei Corporate Venture Capital Ltd. (Sosei CVC) towards establishing a new corporation to pursue the clinical development and commercialization of Pluristem’s PLX-PAD cell therapy product in Japan.
Pluristem and Sosei CVC currently anticipate definitive agreements are to be finalized in the coming months, rather than by March 31, 2017 as previously announced.
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss the establishment of a Japanese new corporation; when we discuss the parties’ plan to enter into definitive agreements and the proposed timing of execution of such agreements; and when we discuss the pursuit of clinical development and commercialization in Japan. Further, although Pluristem has signed a binding term sheet with Sosei CVC, it may not be successful in negotiating definitive documentation by the date expected or at all, and even if successful, the transaction may not be completed if the conditions to closing are not met. 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.
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, March 29, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI), (TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today two senior executive appointments to support the company’s growth and ensure continued success as it enters advanced stages of clinical development for its PLX products.
Yaky Yanay, President of Pluristem and formerly Chief Operating Officer, will join current Chairman and Chief Executive Officer Zami Aberman as Co-Chief Executive Officer and retain his title of President of the company. Mr. Yanay will no longer serve as the company’s Chief Financial Officer and Chief Operating Officer. Mr. Yanay joined Pluristem in 2006 as Chief Financial Officer and Secretary, before being promoted to Executive Vice President in 2013 and then to President and Chief Operating Officer in 2014. Previously, Mr. Yanay was the Chief Financial Officer of Elbit Vision Systems, Ltd. He is also Co-Chairman of Israel Advanced Technology Industries, the largest umbrella organization representing Israel’s hi-tech and life science industries and has served on its Board of Directors for three years.
In addition, Erez Egozi has been appointed to the position of Chief Financial Officer of the company. Previously, Mr. Egozi served as the company’s Vice President of Finance and Secretary. Prior to joining Pluristem, Mr. Egozi held several senior financial positions at Verint Systems Inc. including senior director of finance-worldwide finance controller of Verint’s Communications and Cyber Intelligence Solutions division.
From 2003 to 2007, Mr. Egozi held several financial positions at Intel Corporation. From 2000 to 2003, Mr. Egozi served as an auditor in the hi-tech technology sector at Deloitte & Touche.
“It’s a very exciting time for Pluristem, as we move forward in our mission to deliver PLX cell therapies to patients suffering from severe conditions,” said Mr Yanay. “I look forward to continue working with Zami to shape Pluristem’s strategic direction and leverage our vast wealth of intellectual property and innovation to bring the company closer to global marketing for our products to provide much-needed treatments.”
“As we near the critical juncture of pivotal-stage clinical trials for our cell therapy products, broadening our expertise and experience at the senior-most level will enable us to deliver even better results and opportunities for the company, investors, and potentially many patients who can benefit from our therapies,” noted Mr. Aberman.
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 and is entering late-stage trials in several indications. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the company’s proprietary three-dimensional expansion technology.
They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, the company is using forward-looking statements when we discuss Pluristem entering advanced stages of clinical development for its PLX products, leveraging Pluristem’s wealth of intellectual property and innovation to bring Pluristem closer to global marketing for its products and that broadening Pluristem’s expertise and experience at the senior-most level will enable Pluristem to deliver even better results and opportunities for the company, investors and the potentially many patients who can benefit from the company’s therapies. 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; the company may encounter delays or obstacles in launching and/or successfully completing its clinical trials; the company’s products may not be approved by regulatory agencies, the company’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; the company 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 the company’s process; the company’s products may wind up being more expensive than the company 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; the company’s patents may not be sufficient; the company’s 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.
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, February 13, 2017 — Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today reported financial update and corporate and clinical developments for the second quarter of fiscal 2017, ended December 31, 2016.
“Driven by our commitment to help patients with serious, unmet medical needs, we are continuously working towards our goals for 2017 which will advance our cell therapy products towards commercialization, bring significant value to our shareholders and make an important difference in millions of patients’ lives,” stated Pluristem Chairman and CEO Zami Aberman.
“While we move multiple indications into advanced stage clinical studies, we continue to maintain a significant advantage in the field with our commercial-grade cell production capacity, ground-breaking manufacturing technology, and proprietary GMP manufacturing facility that we own and operate.
“Regenerative medicine in general, and PLX cell therapy in particular will have tremendous benefits on healthcare economics based on efficacy, the treatments’ non-invasive nature, and our production capacity enabling us to supply allogeneic cells to a broad population.”
“Pluristem is well positioned to progress towards commercialization, and with a strong balance sheet for upcoming negotiations with potential commercial partners,” Aberman concluded.
Clinical and Corporate Highlights and Upcoming Milestones Include:
Pluristem achieved significant strides towards marketing approval of PLX-PAD in the treatment of critical limb ischemia (CLI). Study initiation of the pivotal Phase III trial in CLI received clearance from regulatory authorities in the United States, United Kingdom and Germany. Based on these clearances, the Company expects to begin enrolling patients in this study in the first half of 2017.
An interim analysis of data collected on the first half of recruited patients is planned, potentially leading to early conditional marketing approval in Europe via the EMA adaptive pathway pilot project. Full enrollment is to be completed as planned to pursue full marketing approval in the U.S and Europe.
In January 2017 Pluristem completed enrollment of all 172 patients in a multinational Phase II trial of PLX-PAD in the treatment of intermittent claudication (IC), an early stage of peripheral artery disease (PAD). Data from this study, expected in the first half of 2018, may also support the planned Biologics License Application (BLA) for PLX-PAD in the treatment of CLI in the U.S.
Pluristem signed a term sheet with Sosei Corporate Venture Capital LTD., a Japanese pharmaceutical company, to form a joint venture for the development and commercialization of PLX-PAD for the treatment of CLI in Japan. Pursuant to the executed term sheet, Sosei and its partners will invest $11 million into the joint venture to support a pivotal trial of PLX-PAD in CLI in Japan. This 75-patient trial was previously cleared by the Japanese regulatory authority. Results could potentially serve as the basis for conditional marketing approval under the PMDA accelerated pathway, for which Pluristem has already been accepted. Finalization of the definitive agreement with Sosei is anticipated by March 31, 2017.
The U.S. National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) is completing the dose-selection trials for PLX-R18 in the treatment of acute radiation syndrome (ARS). The results of these studies, conducted and funded by the NIAID, are intended to serve as the basis for a final pivotal trial in large animals, which will provide the evidence of efficacy for approval under the FDA’s Animal Rule. Pluristem is pursuing a government contract to stockpile the product for use in the case of a nuclear catastrophe.
In the first quarter of 2017, Pluristem expects to initiate patient enrollment in its FDA-cleared, open- label Phase I trial of PLX-R18 to treat incomplete engraftment of hematopoietic cell transplant. Data will be available on an ongoing basis as this is an open label study.
Pluristem plans to obtain clearance of its protocol for a Phase III trial of PLX-PAD cells in recovery after surgery for hip fracture, from both U.S. and European regulators, during the second half of 2017.
Financial Update:
As of December 31, 2016, Pluristem had $21.9 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities.
The Company’s net cash used for operating activities was $5.8 million for this quarter. In January 2017, the Company completed a public offering of common stock and warrants with gross proceeds of $17.25 million. Pluristem also signed a binding term sheet for a $30M investment from Innovative Medical, a subsidiary of ZSVC. Finalization of the term sheet was delayed due to a new Chinese monetary policy.
The parties continue the discussions with respect to the definitive agreement until they have received further clarification about such policies, which is expected during the first half of 2017.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products entering pivotal trials in 2017.
Pluristem has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells.
The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage.
PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic partnerships; 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 financial position, the timing of execution of definitive agreements with Innovative Medical and the closing of their $30 million investment, the timing of the execution of definitive agreements with Sosei, the sufficiency of capital resources, our plans with respect to our existing and future preclinical and clinical trials, including initiation, enrollment, successful completion reporting of results and timing of all of the above, discussions with regulatory agencies and receipt of favorable outcomes from such discussions. Further, although Pluristem has signed binding term sheets with each of Innovative Medical and Sosei, respectively, it may not be successful in negotiating definitive documentation with either party by the date expected or at all, and even if successful, the transactions may not be completed if the conditions to closing are not met. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.