Findings from first two cohorts show primary safety endpoint met and early signals of efficacy
HAIFA, Israel, March 12, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the Company has fully enrolled the second cohort of six patients in its ongoing Phase I clinical study evaluating PLX-R18 for the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT), and has received Data and Safety Monitoring Board (DSMB) approval to continue to the final cohort of the study.
Results from the first two cohorts demonstrate PLX-R18 is safe and well tolerated, with early signals of efficacy in improving blood counts. The third and final cohort will be comprised of 15 patients that will receive two administrations of four million PLX-R18 cells/kg, one week apart, considered as the target dose for these patients.
“We are highly encouraged by the findings from the first two cohorts in this study, and we are pleased to receive DSMB approval to continue with the study as planned, as we look to efficiently advance PLX-R18 through clinical development,” commented Zami Aberman, Chairman and Co- Chief Executive Officer of Pluristem. “Incomplete hematopoietic recovery poses a significant risk to HCT recipients who fail to respond to the usual standards of care, making them vulnerable to severe complications and potentially resulting in their incurring significant related costs. We believe PLX-R18 can address the unmet need in this patient population by reviving the regenerative potential of the bone marrow and blood cell growth where other treatments have proven ineffective, and we look forward to final results from this study.”
This Phase I study is designed as a multi-center, open-label, dose-escalating study to evaluate the safety of intra-muscular (IM) injections of PLX-R18 cells in 24 patients with incomplete hematopoietic recovery persisting for at least four months after HCT. The follow up period for safety is 12 months. Patients in the study are enrolled into three chronological treatment groups: two administrations of 1 million PLX-R18 cells/kg (n=3), two administrations of 2 million PLX-R18 cells/kg (n=6) and two administrations of 4 million PLX-R18 cells/kg (n=15). The primary endpoint is safety which is assessed, at the end of each cohort, by an external DSMB. In addition, exploratory evaluations are made, including changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, changes in quality of life and changes in the serum immunological parameters.
PLX-R18 cell therapy for the treatment of incomplete hematopoietic recovery following HCT was granted Orphan Drug Designation by the U.S. Food and Drug Administration.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical study data in multiple indications for its patented PLX cells and is entering late stage clinical studies in several indications.
PLX cell product candidates are believed to 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; a Company-owned and operated, GMP- certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the proposed final cohort of its Phase I study and the belief that PLX-R18 can revive the regenerative potential of the bone marrow and blood cell growth in patients suffering from incomplete hematopoietic recovery.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, February 11, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading regenerative medicine company developing novel placenta-based cell therapy product candidates, today announced that the large-scale research initiative, RESTORE, of which Pluristem is a member, is nominated to be one of two finalists competing to be awarded up to €1 billion over the next 10 years by the EC for the development and advancement of transformative therapeutics.
RESTORE will receive initial funding of €1 million from the EC in order to fully develop its concept.
As a member of the RESTORE consortium, if RESTORE wins the award, Pluristem could receive a portion of the award, the amount of which is not yet determinable.
Led by Charité-Universitätsmedizin Berlin, and coordinated by Professor Hans-Dieter Volk from the BIH-Center for Regenerative Therapies in Berlin, RESTORE aims to promote groundbreaking research, drive Europe to the forefront in advanced therapies and deliver a pipeline of transformative cures to patients in need.
“We believe that this potential investment made by the EC is a testament to Europe’s ongoing commitment of advancing solutions for patients in need of transformative therapies,” said Zami Aberman, Chairman & Co-CEO of Pluristem. “Pluristem’s late-stage clinical trials and capacity for large-scale manufacturing technologies makes us committed to the RESTORE consortium with the collective vision of collaborating with world-class experts in a variety of roles within the life sciences industry to bring patients regenerative solutions as quickly as possible. We believe this potential funding, if awarded, will help advance multiple promising programs in development.”
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is entering late stage clinical trials in several indications. Based on nonclinical research, PLX cell product candidates are believed to 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 facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential for RESTORE to be awarded a grant by the EC for development of advanced therapeutics and for Pluristem to win a portion of the award, and its belief that such funding, if awarded, will help advance multiple promising programs in 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: whether or not RESTORE is awarded the grant by the EC, and the amount, if any, awarded to Pluristem thereafter, changes in technology and market requirements; development of unforeseen scientific difficulties with Pluristem’s development programs; as well as the other factors discussed in the “Risk Factors” section in Pluristem’s most recently filed Annual Report on Form 10-K, as well as other risks detailed in Pluristem’s subsequent filings with the Securities and Exchange Commission. There can be no assurance that the actual results or developments anticipated by Pluristem will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Pluristem.
All information in this press release is as of the date of the release and 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 unless required by law.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, January 22, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today reported the receipt of a joint grant awarded by the Israeli Ministry of Defense and the Israel Innovation Authority for the development of the company’s PLX cells for the treatment of burn injuries. This project entails collaboration between the Company, the Israeli Defense Forces (IDF) medical corps and professionals who specialize in burn injuries from Israeli hospitals.
The provision of the grant is based on Pluristem’s previously published clinical trial data, which demonstrated successful regeneration of muscle tissue and blood vessels as a result of PLX administration, as well as the anti-inflammatory ability of the cells. Proceeds from the grant will support studies of the effects of PLX cells in expediting burn wound healing.
“Today, there is a significant need for improved methods of treating burn injuries, with approximately 25 percent of battlefield casualties suffering from burns.
Given the multiple potential comorbidities associated with burns, including risk of infection, time to wound closure, associated healthcare costs and overall recovery, we believe that it is imperative that we identify new ways of caring for these patients,” said Zami Aberman, Chairman & Co-CEO of Pluristem. “We have already demonstrated our technology’s positive impact with promising data in a variety of indications where regenerative medicine has been applied. Our team has allotted significant resources to refine our technology and we are delighted to collaborate on this project with professionals who specialize in burn injuries from both Israeli hospitals and the IDF medical corps.”
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its proposed joint project with respect to the study of the effects of PLX cells in expediting burn wound healing and the expected use of proceeds from the grant.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Meeting included representatives from NIH and BARDA
HAIFA, Israel, January 3, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced it has concluded a positive meeting with the U.S. Food and Drug Administration (FDA) regarding the ongoing development of PLX-R18 for the treatment of Acute Radiation Syndrome (ARS). The FDA provided Pluristem with feedback on the progress and data collected on PLX-R18 to date and gave guidance towards advancing the development of PLX-R18 with respect to the treatment of ARS. The meeting also included representatives from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the U.S. Biomedical Advanced Research and Development Authority (BARDA).
“We are pleased to have completed a positive meeting with the FDA and U.S. government agencies representatives, which we believe has provided us with a clear and efficient path towards advancing the development of PLX-R18, targeting approval in the treatment of ARS,” said Mr. Yaky Yanay, Co-Chief Executive Officer and President of Pluristem. “For several years, we have successfully cooperated with the NIAID, which has supported and conducted studies of PLX-R18 in ARS. These studies demonstrated PLX- R18 potential to increase survival rates after radiation exposure, as well as protect and regenerate the bone marrow’s ability to produce blood cells, crucial for victims exposed to high levels of radiation. We are pleased to see interest from key governmental agencies such as NIAID, the U.S Department of Defense and BARDA in our novel regenerative medical countermeasure for radiation injuries and look forward to potentially supporting such medical needs of the U.S. government.”
PLX-R18 has been studied in Phase I and II-equivalent studies conducted and funded by NIAID via the FDA Animal Rule Pathway. Results from these studies showed that PLX-R18 supports the recovery of the bone marrow and increases survival rates. PLX-R18 has been granted an Investigational New Drug application (IND) and an orphan drug designation by the FDA for the treatment of ARS.
ARS involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells, as well as to other systems and organs. Severe damage to bone marrow renders victims vulnerable to life- threatening hemorrhage, infection and anemia.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it states its belief that, as a result of its meeting with the FDA, it has a clear and efficient path towards advancing the development of PLX-R18 in the treatment of ARS and its potential support of the U.S. government with respect to its medical needs relating to radiation injuries.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward- looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109