Health (NIH)
the treatment of ARS
HAIFA, Israel, April 23, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded a $2.5 million grant to Indiana University to conduct studies of Pluristem’s PLX-R18 cell therapy in the treatment of acute radiation syndrome (ARS).
The goal of this project is to extend the PLX-R18 ARS studies to include examination of survival efficacy in additional populations, such as geriatric and pediatric, and to compare the effectiveness and examine interactions with other drugs, such as Granulocyte-Colony Stimulating Factor (G-CSF). Data collected during the first year of this 5-year research agreement will support Pluristem’s Biologics License Application (BLA) filing with the U.S. Food and Drug Administration (FDA) for marketing approval of PLX- R18 in the treatment of ARS.
The $2.5 million, 5-year research collaboration agreement will be performed in conjunction with Indiana University researchers led by Prof. Christie M. Orschell. As part of this agreement, Pluristem will be reimbursed for supplying PLX-R18 cells for these studies.
Following previous positive results from a Phase II-equivalent study in non-human primates, sponsored by NIAID, Pluristem is now in discussions with the FDA and several U.S. governmental agencies to clear the path and funding for a pivotal study of PLX-R18 in the treatment of ARS.
“We are very pleased to receive NIH support through this important grant to Indiana University for advancing PLX-R18 towards becoming an approved countermeasure for ARS. Pluristem looks forward to working with the researchers at Indiana University who have broad expertise in this field of research,” stated Pluristem Co-CEO and President Yaky Yanay. “We expect to collect data from these studies to support the initiation of the pivotal study protocol, an essential step in the PLX-R18 product development.”
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late- stage trials in several indications.
Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses collaboration with Indiana University, allocation of grants, reimbursement to Pluristem for supplying PLX-R18 cells for the studies conducted with Indiana University, discussions with the FDA and governmental agencies to clear the path and funding for a pivotal study of PLX-R18, that data collected from the studies will support the initiation of a pivotal study protocol and Pluristem’s BLA with the FDA for marketing approval of PLX-R18. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward- looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Jeffs led United Therapeutics from its founding until 2016 and led Amgen’s Neupogen clinical programs
HAIFA, Israel, March 26, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that Dr. Roger Jeffs has joined Pluristem’s strategic advisory board. Dr. Jeffs, a highly accomplished biopharma executive, will advise Pluristem on clinical and commercial strategies for the Company’s cell therapy programs.
Dr. Jeffs joined United Therapeutics Corporation during its start-up phase in 1998 as director of research, development, and medical and led the company as its President and CEO from 2001 to 2014 and President & co-CEO from 2015 to 2016. During his successful 18-year tenure at United Therapeutics, Dr. Jeffs helped lead the company’s initial public offering, oversaw the clinical development and regulatory approval of six products, and managed the commercial effort that lead to a significant increase in revenues. Prior to his time at United Therapeutics, Dr. Jeffs was previously at Amgen Inc. where he helped lead the clinical program for Neupogen. Dr. Jeffs holds an undergraduate degree in chemistry from Duke University and a Ph.D. in pharmacology from the University of North Carolina School of Medicine. He served on the Board of Directors for United Therapeutics from 2001 to 2016, and currently serves on the Boards of five public companies. Dr. Jeffs is also the co-founder and co-owner of Bull City Select Investments.
Dr. Jeffs commented, “Pluristem’s placental cell therapies, currently being evaluated in multiple advanced clinical trials, could significantly advance regenerative medicine and make a change in the way patients are treated today, by delivering a safe and effective off-the-shelf cell therapy. The Company’s manufacturing assets are a key to its commercialization capabilities. I look forward to working with Pluristem’s management team to move the clinical programs forward towards marketing.”
“Dr. Jeffs brings tremendous expertise and vision to Pluristem, from business aspects, to clinical development, marketing approval and commercialization.
His work in developing Neupogen is directly relevant to our PLX-R18 clinical program in the treatment of bone marrow deficiencies,” stated Pluristem Chairman and Co-CEO Zami Aberman. “Pluristem is now forming a senior strategic advisory board in t preparing the Company toward expansion and commercialization.
We are honored and pleased that Dr. Jeffs is joining us at this important time.”
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late-stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses Pluristem’s clinical trials, that its placental cell therapies could significantly advance regenerative medicine and make a change in the way patients are treated, and when it discusses the potential safety and effectiveness of Pluristem’s cell therapy and potential expansion and commercialization. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Findings support Pluristem’s ongoing Phase I study of PLX-R18 in hematopoietic recovery following hematopoietic cell transplantation
HAIFA, Israel, February 27, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, announced today that Frontiers in Medicine has published key findings from a study of PLX-R18 that demonstrate the cells’ efficacy in improving human hematopoietic engraftment. The article titled, “Posttransplant Intramuscular Injection of PLX-R18 Mesenchymal-Like Adherent Stromal Cells Improves Human Hematopoietic Engraftment in A Murine Transplant Model” was published in the peer-reviewed journal’s February 2018 issue.
In the published study, mice were injected intramuscularly (IM) with PLX-R18 following human hematopoietic cell transplantation (HCT). Significant improvement was observed in the peripheral blood counts as measured by CD45+ cell recovery at weeks 6 (8.4 vs. 24.1%, p < 0.001) and 8 (7.3 vs. 13.1%, p < 0.05) and in the bone marrow at week 8 (28 vs. 40.0%, p < 0.01) in the PLX-R18 treated groups versus the control, placebo groups. Superiority of PLX-R18 treatment over the control groups was also reported for recovery of CD19+ cells at weeks 6 (12.6 vs. 3.8%) and 8 (10.1 vs. 4.1%). These findings support Pluristem’s clinical development of PLX-R18 for a variety of hematological indications.
Pluristem is currently conducting a Phase I clinical trial in the U.S. and Israel of PLX-R18 to treat incomplete hematopoietic recovery following HCT. HCT is used to treat bone marrow failure associated with cancers of the blood and/or chemotherapy. When HCT fails to fully engraft, it poses dangers to the patient. The Phase I study is evaluating the safety of IM injections of PLX-R18 cells in 24 people with incomplete hematopoietic recovery persisting for at least 4 months following HCT.
Prof. Hillard M. Lazarus, Department of Medicine, Case Western Reserve University, co-author of the article, and Principal Investigator of Pluristem’s Phase I study of PLX-R18 in HCT recovery, commented: “The published preclinical study directly supports the current Phase I study of PLX-R18 in HCT. The preclinical data clearly suggest that PLX-R18 may have a therapeutic role in improving incomplete engraftment following HCT.
We hypothesize that PLX-R18 cells’ secreted proteins, cytokines and chemokines are stimulating the marrow microenvironment, leading to improved reproduction of the progenitor cells and increasing peripheral blood counts.”
“Through the publication of this study, we are pleased to add to the growing body of knowledge and data on PLX-R18 cells’ role following IM injection to improve hematopoietic cell engraftment. These data support not only our Phase I study of PLX-R18 in HCT, but may also support current and potential studies of PLX-R18 in a broad range of hematologic indications,” stated Pluristem Chairman and Co-CEO Zami 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 cells and is entering late- stage trials in several indications.
Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses its Phase I clinical trial of PLX-R18 generally as well as when it states that PLX-R18 may have a therapeutic role in improving incomplete engraftment following HCT or that the data from its Phase I clinical trial of PLX-R18 to treat incomplete hematopoietic recovery following HCT may support current and potential studies of PLX-R18 in a broad range of hematologic indications. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward- looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, Israel, February 07, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today reported financial results for the second quarter of fiscal 2018 ended December 31, 2017 and issued a letter to its shareholders from its Co-CEOs, Zami Aberman and Yaky Yanay.
Pluristem had a very busy 2017, filled with significant achievements. Our management team has been working hard to ensure that we reach our milestones. This year, most milestones were met, others unfortunately were not, but we were pleasantly surprised to achieve other, unexpected milestones throughout the year as well. While we can’t address all the details, we are hopeful that this letter will provide valuable updates and insight, on some of our programs.
We are witnessing a growing change in how regulators approach treatment of patients suffering from unmet medical conditions, through various new expedited approval pathways. Pluristem has been pursuing these regulatory pathways, allowing us to accelerate the development of our cell therapy products.
As part of this acceleration, we are well positioned towards marketing with regulatory assets including U.S. Food and Drug Administration (FDA) “Fast Track Designation”, European Medicines Agency (EMA) “Adaptive pathways program”, Japanese Pharmaceuticals and Medical Devices Agency (PMDA) “Accelerated regulatory pathway for regenerative therapies” and recently received clearance by the FDA for our Expanded Access Program to treat patients unsuitable for inclusion in our ongoing Critical Limb Ischemia (CLI) Phase III trial.
We have also received much interest in the past year in collaboration and partnerships, including the launch of physician-initiated trials, such as the Phase I/II Graft-versus-host disease (GvHD) trial being conducted in the Tel Aviv Sourasky Medical Center in Israel.
These types of trials will be conducted and funded by the participating hospital or medical center, so it is important to note that we will only be able to share the data once it has been provided to Pluristem. These new paths of development are a true vote of confidence in our PLX (PLacental eXpanded) cell therapy from key regulators and physicians worldwide, and additionally provide potential opportunities to treat patients while collecting real-world data (in parallel to our clinical programs), to support our clinical advancement.
We were very proud to publish the promising results in anti-cancer treatment from our new product, PLX- Immune, which may open new possibilities in the field of oncology to treat solid tumors and offer new paths to help millions of patients around the world. The new findings, published in Nature journal, have generated significant interest from investors as well as potential pharmaceutical partners.
These results demonstrate the capabilities of our PLX cells and the advantage of our technology. Today we hold a technology that enables us to develop the ability of our cells to secrete a variety of therapeutic proteins in response to different medical conditions. We now intend to start discussions with the regulators to begin clinical development of this potentially groundbreaking product.
In our Acute Radiation Syndrome (ARS) program, following the positive results from the Phase II- equivalent study in non-human primates, which was conducted by the National Institutes of Health (NIH), we are in discussions with the FDA and several U.S. governmental agencies to clear the path for a pivotal study.
This process includes several complementary studies, the majority of which are funded and conducted by the NIH, which will also provide additional data to support future milestones. We expect to collect the complementary data during the first half of 2018 and to clear the pivotal study protocol and funding during the second half of 2018.
We are also collaborating with the U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI), to examine the effectiveness of PLX-R18 as a treatment for ARS prior to, and within the first 24 hours of exposure to radiation.
These studies are conducted and funded by AFRRI and we expect to receive data from these studies in 2018.
A Phase III study of our PLX-PAD cells in the treatment of CLI is up and running and recruiting patients in clinical sites around the world including the U.S, U.K., Germany, Austria, Hungary, Poland and the Czech Republic. We are gearing up and preparing for an additional Phase III study to begin during 2018 in the U.S. and Europe in the treatment of recovery from hip fractures.
Another exciting, early-stage study is our Phase I study in incomplete hematopoietic recovery following hematopoietic cell transplantation which is ongoing and open for patient recruitment at clinical sites in the U.S. and Israel.
As this is a Phase I trial, designed to test the safety of PLX-R18, we are carefully enrolling patients under the study protocol. So far, no safety issues were seen in patients enrolled in the trial.
With regards to the Japanese CLI trial, Pluristem previously signed a term sheet with Sosei CVC and partners to form a joint venture (JV) to conduct a pivotal study of CLI in Japan. As this JV includes not only financial aspects but clinical ones as well, it involves discussions with several partners which is one of the reasons why reaching a final agreement is taking longer than initially expected. Pluristem is working hard to negotiate the best possible terms for a Japanese JV and will provide an update upon reaching an agreement.
In 2018, Pluristem is expected to carry out three pivotal studies, all supported by non-dilutive funds from 3rd parties, that will advance our PLX cell products towards commercialization. This year should also provide Pluristem with our largest amount of clinical data yet, and with the publishing of the results from the 172-patient multinational Phase II Intermittent Claudication study, which is expected during the second quarter of 2018.
We are focused on our mission to bring our cell therapy products to patients in need, while continuing to build our business and be a leader in our industry. Thank you for your continued support of Pluristem.
Sincerely,
Zami Aberman Yaky Yanay
Chairman and Chief Executive Officer President and Chief Executive Officer
As of December 31, 2017, Pluristem had $35.9 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities.
The Company’s net cash used for operating activities for the quarter ended December 31, 2017 was $4.8 million.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late- stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This letter contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the timing and funding sources of its various studies and trials, that new regulatory pathways potentially give it opportunities, the potential for PLX-Immune to open new possibilities in the field of oncology and offer new paths to help millions of patients, that PLX-Immune has generated interest from potential pharmaceutical partners and that Pluristem intends to start discussions with regulators to officially begin a clinical pathway for this potentially groundbreaking product, it discusses the proposed path for a pivotal study for its ARS program and the timing of the collection of complementary data and the pivotal study protocol and funding, when it discusses that it is gearing up and preparing for an additional Phase III study to begin in 2018 relating to the treatment of the recovery from hip fractures, the ongoing Phase I study in incomplete hematopoietic recovery following hematopoietic cell transplantation, the timing and negotiation relating to the proposed Japanese joint venture, that Pluristem intends to conduct three pivotal studies in 2018 and that 2018 should provide Pluristem with its largest amount of clinical data yet relating to its proposed publishing of clinical data from its multinational Phase II intermittent claudication study and the proposed timing of such publication. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, ISRAEL, JANUARY 12, 2018 — Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced the publication of a peer-reviewed article in the journal Scientific Reports, from the publisher of Nature, titled, “Human Placental-Derived Adherent Stromal Cells Co-Induced with TNF-a and IFN-g Inhibit Triple-Negative Breast Cancer in Nude Mouse Xenograft Models.”
The article is based on studies which examined the effect of PLX cells that had been induced with tumor necrosis factor alpha (TNF-a) and interferon-gamma (IFN-g), on the proliferation of over 50 lines of human cancerous cells. The induction of the cells was carried out by adjusting their manufacturing process in order to transiently alter their secretion profile.
Data from the first study showed that the modified PLX cells exhibited an anti-proliferative effect on 45% of the tested cancer cell lines, with a strong inhibitory effect on various lines of breast, colorectal, kidney, liver, lung, muscle and skin cancers.
Comprehensive bioinformatics analysis identified common characteristics of the cancer cell lines inhibited by PLX cells. This knowledge could potentially be used in the future for screening patients’ tumors to identify those patients most likely to show a positive response to treatment with PLX cells.
Based on these promising results, Pluristem conducted a pre-clinical study of female mice harboring human triple negative breast cancer (TNBC). TNBC is an aggressive form of breast cancer that does not respond to standard hormonal therapy due to a lack of estrogen and progesterone receptors. Current treatment for TNBC consists of a combination of surgery, radiation therapy, and chemotherapy, and yet the prognosis remains poor for patients with this type of breast cancer. In this study, weekly intramuscular (IM) injections of the induced PLX cells produced a statistically significant reduction (p= 0.025) in mean tumor size in the treated group compared with the untreated group, with 30% of the treated mice exhibiting complete tumor remission. In addition, a statistically significant reduction (p=0.003) was seen in the percentage of proliferating tumor cells as well as in the level of blood vessels within the tumors.
“The findings of this study published in a peer-reviewed journal are the outcome of over two years of research as well as the vast knowledge of PLX cell properties we have developed over the last 10 years. We believe the findings show promise for the utilization of our induced PLX cells in slowing and reversing the growth of cancer cells, particularly for some cancers that don’t have viable treatment options,” stated Zami Aberman, Chairman and Co-CEO of Pluristem. “The findings also confirm the effectiveness of IM administration and support a mechanism of action involving immunomodulation and inhibition of angiogenesis and cell proliferation in cancerous conditions. Our unique patented manufacturing platform allows us to alter our cells’ secretion profile in correlation with the targeted cancer cells, which may open new possibilities in the field of oncology to treat solid tumors and may also offer new paths to help millions of patients around the world.
As in immunotherapy technology, PLX cells potentially have the ability to communicate with the body and to secrete biological components that enhance regeneration processes and support the body in fighting cancer cells.”
Pluristem has filed patent applications relating to the technology for the induction of PLX cells and the use of these cells for the treatment of cancer.
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. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses that comprehensive bioinformatics analysis, which identified common characteristics of the cancer cell lines inhibited by PLX cells, could potentially be used in the future for screening patients’ tumors, that the study findings show promise for the utilization of Pluristem’s induced PLX cells in slowing and reversing the growth of cancer cells, that Pluristem’s PLX cells may open new possibilities to treat solid tumors and may also offer new paths to help millions of patients around the world. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
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, January 9, 2018 — Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Food & Drug Administration (FDA) has cleared the Company’s Expanded Access Program (EAP) for the use of its PLX- PAD cell treatment in patients with Critical Limb Ischemia (CLI). EAP allows the use of an investigational medical product outside of clinical trials and is usually granted in cases where patients are unsuitable for inclusion under the study protocol and the patient’s condition is life-threatening with an unmet medical need.
As part of the program, Pluristem’s PLX-PAD cell therapy will be made available to a limited number of Rutherford Category 5 CLI patients in the U.S. who are unsuitable for revascularization and cannot take part in the Company’s ongoing Phase III clinical study, which is currently enrolling patients in the U.S. and Europe. The Company’s PLX-PAD program has already been selected for accelerated approval pathways in both regions, including the FDA’s Fast Track Designation and the European Medicines Agency’s (EMA) Adaptive Pathways program.
“This is a true vote of confidence by the FDA in our cell therapy and a landmark achievement for Pluristem and its shareholders. It gives us the ability to begin treatments using our cell product, offering treatment to certain CLI patients who have poor therapeutic options, while also collecting real-world data alongside our ongoing Phase III clinical study,” said Yaky Yanay, Co-CEO and President of Pluristem. “We are hopeful that the FDA may also allow us to be compensated for the costs of treatment, which can support our work developing effective cell therapies for millions of patients worldwide.”
CLI is an advanced stage of peripheral artery disease where fatty deposits block arteries in the legs, leading to pain, non-healing ulcers, and gangrene. Patients with CLI have a high risk of amputation and death, and those unsuitable for revascularization are left with no adequate treatment options. Pluristem’s PLX-PAD cell therapy utilizes placental cells to secrete a range of therapeutic proteins that trigger the body’s own repair mechanisms, allowing it to grow blood vessels, bring oxygenated blood to damaged tissue, and heal itself faster.
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. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses that its PLX-PAD cell therapy will be made available to a limited number of Rutherford Category 5 CLI patients in the U.S. and that the FDA may allow it to be compensated for the costs of treatment, which can support the Pluristem’s work to develop effective cell therapies for millions of patients worldwide.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, ISRAEL, December 12, 2017 — Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today it received a GMP certification and manufacturer/importer authorization from Israel’s Ministry of Health (MOH). The GMP certificate was granted upon successful audit of Pluristem’s facilities.
The MOH approval is required for Pluristem to continue manufacturing its cell therapies for use in ongoing pivotal studies and will also facilitate readiness of manufacturing for marketing of Pluristem’s placental cell therapies worldwide.
This MOH authorization fulfills the requirements set by the World Health Organization (WHO) and also falls under the provision of the CAA agreement between Israel and the EU, which will also serve to qualify Pluristem’s facilities for marketing in the EU as well.
The approval supports the readiness of Pluristem’s manufacturing capabilities as the company advances in its pivotal-stage studies. Pluristem is currently enrolling patients in a global Phase III trial of PLX-PAD cells for the treatment of critical limb ischemia and expects to commence a phase III study of PLX-PAD for the treatment of hip fracture following surgery.
The company maintains close relationships with key regulators worldwide relating to the quality expectations for marketing and has already secured Chemistry, Manufacturing, and Controls (CMC) approval from key regulators including the U.S. Food and Drug Administration (FDA), Japan’s Pharmaceutical and Medical Devices Agency (PMDA,) and the European Medicines Agency (EMA).
“We are delighted to receive this GMP certification from the Israeli Ministry of Health,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “We believe that this authorization affirms our ability to abide by the strict requirements demanded from advanced pharmaceutical companies while being the gold standard in cell therapy manufacturing and development.”
Pluristem Therapeutics is a leading developer of placenta-derived cell therapy products with patented PLX (PLacental eXpanded) cells entering late-stage trials in several indications. Our PLX cell products each release a different range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the company’s proprietary 3D expansion technology and can be administered to patients without tissue matching or immunosuppression.
Pluristem has company-owned and operated, GMP-certified manufacturing and research facilities, a strong intellectual property position, and strategic relationships with major research and U.S. government institutions.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses that the GMP certification supports the manufacturing of Pluristem’s pivotal stage studies and readiness for future marketing as well as complying with future EU marketing purposes, Pluristem’s expectation to commence a phase III study in PLX-PAD for the treatment of hip fracture following surgery and its belief that the GMP certification affirms its ability to abide by the strict requirements demanded from advanced pharmaceutical companies while being the gold standard in cell therapy manufacturing and development. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward- looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Investor and Public Relations Manager 972-74-7108600
HAIFA, ISRAEL, December 07, 2017 — Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today the company will present data from its Phase II-equivalent study of PLX-R18 cells for the treatment of acute radiation syndrome (ARS) at the American Society of Hematology’s (ASH) 59th Annual Meeting to be held in Atlanta, Georgia, on December 9-12, 2017.
The results of the study will be presented during Program Session 506: Hematopoiesis and Stem Cells: Microenvironment, Cell Adhesion, and Stromal Stem Cells.
The poster, “Intramuscular Administration of Placenta-Derived Stromal Cells Enhances Survival of Rhesus Macaque Monkeys Exposed to Total Body Irradiation,” will describe data from a recently announced Phase II-equivalent study under the U.S. Food and Drug Administration (FDA) Animal Rule. The data demonstrate improved survival and hematological recovery of NHPs exposed to different levels of radiation. This study was conducted and funded by the
U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The poster abstract will be published online in the supplemental volume of Blood, a peer-reviewed medical journal published by ASH.
“We are excited to present these promising data on our PLX-R18 cells in the treatment of ARS to the world’s thought leaders in hematology at this year’s ASH conference,” said Yaky Yanay, President and Co- CEO of Pluristem. “We believe that there is a crucial need for a therapy capable of effectively treating populations in case of nuclear or radioactive incidents.
These findings, which show recovery of the hematologic system, suggest that PLX-R18 has the potential to treat a large population exposed to different levels of radiation and might also be used for additional hematologic indications.”
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 is currently enrolling patients in a U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation. PLX-R18’s first animal studies in ARS were performed in collaboration with Prof. Gorodetsky at Hadassah Medical Center. Further preclinical data from trials conducted by the U.S. National Institutes of Health, Hadassah, the Charite in Berlin 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. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses that PLX-R18 has the potential to treat a large population exposed to different levels of radiation and might also be used for additional hematologic indications, and the potential market for such indications. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Data supports advanced PLX-PAD clinical studies including dosing regimen, systemic therapeutic effects and superiority of the cells over cytokines
HAIFA, ISRAEL, November 29, 2017 — Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced the publication of a peer-reviewed article in Cytotherapy, the official journal of the International Society for Cellular Therapy, titled, “Placenta- Derived PLX-PAD Mesenchymal-Like Stromal Cells are Efficacious in Rescuing Blood Flow in Hind Limb Ischemia Mouse Model by a Dose- and Site-Dependent Mechanism of Action (MOA).” The article is based on the Company’s preclinical findings and will be published in the December 2017 issue of Cytotherapy.
The study utilized a mouse model of hind limb ischemia (HLI) to study the efficacy and MOA of PLX-PAD cells in the treatment of peripheral artery disease (PAD). Pluristem is currently conducting a global, pivotal Phase III study in critical limb ischemia (CLI), and is expecting clinical data from its Phase II study in intermittent claudication (IC). Both are forms of peripheral artery disease. In both conditions, blood supply to the legs is obstructed, leading to impaired blood flow and tissue ischemia.
Data from this study showed that intramuscularly (IM) administered PLX-PAD cells restored blood flow to the lower limbs of mice with HLI, in a dose- and site-dependent manner. IM administration of PLX-PAD cells had a systemic effect, thereby restoring blood flow to parts of the limb in need even when injected to the contralateral leg. Administration of a second dose was found to boost the effect of a single administration and lead to greater improvement in blood flow. The study demonstrated the cells’ MOA: secreting therapeutic proteins systemically that promote the creation of new blood vessels.
“We are pleased to share these findings, which suggest the potential of our cells to secrete an adaptive, slow-release cocktail of therapeutic proteins via their interaction with tissue surrounding the area in need of healing and repair,” stated Zami Aberman, Chairman and Co-CEO of Pluristem. “We believe this data supports our current pivotal trial in CLI by affirming our dosing methods and quantities. The data is also valuable in understanding the therapeutic role of PLX products in additional medical indications. We believe these important findings also provide additional support for the scientific rationale behind our unique mechanism of action, and for the systemic effect and therapeutic benefits of injecting the cells intramuscularly.”
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. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses the various studies relating to its cell therapy products, Pluristem’s belief that the findings of the preclinical HLI study support its dosing methods and quantities, the scientific rationale of its unique MOA and the positive influence of IM Injections on the systemic therapeutic effect of the cells as well as its understanding of the therapeutic role of PLX products in additional medical indications. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, ISRAEL, November 22, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Patent and Trademark Office (USPTO) has issued a patent titled, “Skeletal muscle regeneration using mesenchymal system cells.” This key patent, which has already been granted in Europe, Hong Kong and Israel, addresses the use of MSCs for skeletal muscle regeneration used either directly after, or shortly after, post-surgical muscle injury.
The Company received positive feedback from the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA) for the proposed study design and endpoints of its Phase III trial for the treatment of muscle recovery following arthroplasty for hip fracture. This planned study was recently awarded an $8.7 million grant by the Horizon 2020 program, the European Union’s largest research and innovation program. If successful, Pluristem plans to use the study results to achieve marketing approval in both the U.S. and Europe.
Previous clinical studies using PLX-PAD cells demonstrated significant muscle regeneration following arthroplasty, including a 300% improvement in muscle volume (p=0.004) and a 500% (p=0.0067) boost in muscle force when observed six months after surgery compared to the control group.
“This very important patent comes at the right time, just ahead of our planned Phase III study in muscle regeneration following hip fracture,” stated Zami Aberman, Chairman and Co-CEO of Pluristem. “The patent substantially strengthens our intellectual property around muscle regeneration, particularly as it pertains to repair and regeneration following surgery. In an industry that demands constant technological and scientific advances, a robust patent portfolio covering our core innovations strengthens Pluristem’s competitive edge.”
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. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when its discusses the positive feedback it received from regulatory authorities and the potential that such feedback will result in approval to conduct clinical trials, the actual receipt of grants, the initiation and successful completion of planned clinical trials, the potential to receive marketing approval for Pluristem’s products and the potential of the patent reported above to and other intellectual property rights Pluristem owns to support Pluristem’s competitive edge. . These forward- looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
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