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HAIFA, Israel, October 7, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that it has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for the Company’s COVID-19 Phase II clinical trial, under the protocol that was approved by the Paul Ehrlich Institute (PEI), Germany’s regulatory agency.
A total of 40 patients hospitalized with severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled at clinical sites in Israel and Germany.
The Phase II COVID-19 European clinical trial that is being expanded to Israel is in addition to Pluristem’s other COVID-19 clinical programs, including a Phase II study and an Expanded Access Program in the U.S., both under the U.S. Food and Drug Administration’s (FDA) approved protocol, and a per-patient compassionate use program in Israel.
The primary efficacy endpoint of the Phase II European study titled, “A Randomized, Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of severe COVID-19” is the number of ventilator free days during the 28 days from day 1 through to day 28 of the study. Safety and survival follow-up will be conducted up to week 52.
“We believe that the approval from the Israeli Ministry of Health will enable us to advance the treatment of severe COVID-19 patients. As the pandemic continues in Israel, we see it as our mission to treat those severe patients in need. With our broad COVID-19 clinical programs in Europe and the U.S., we are committed to advancing our research and developing a treatment that may help save lives,” stated Pluristem CEO and President Yaky Yanay.
PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, which we believe offers a key advantage in addressing a global pandemic. PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may potentially reverse the dangerous overactivation of the immune system. Accordingly, PLX cells may potentially reduce the severity of COVID-19 pneumonia, leading hopefully to a better prognosis for the patients. Previous pre-clinical findings of PLX cells revealed therapeutic benefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury which are potential complications of the severe COVID-19 infection. Clinical data using PLX cells demonstrated the strong immunomodulatory potency of PLX cells in patients post major surgery.
Initial clinical data on COVID-19 ICU patients, treated under a Compassionate Use Program, at the conclusion of a 28 day follow up were previously published.
Taken together, PLX cells’ potential capabilities with the safety profile observed from clinical trials involving hundreds of patients worldwide potentially position them as a therapy for mitigating the tissue-damaging effects of COVID-19.
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 currently conducting late stage clinical trials 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 its proposed study in Israel, its belief that the approval from the Israeli Ministry of Health will enable it to advance the treatment of severe COVID-19 patients, its belief that the ability to manufacture PLX cells in large scale quantities offers a key advantage in addressing a global pandemic, the potential of PLX cells in preventing or reversing the dangerous overactivation of the immune system, that PLX cells may potentially reduce the fatal symptoms of COVID-19 induced pneumonia, and PLX cells’ position as a therapy for mitigating the tissue-damaging effects of COVID-19.
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.
Dana Rubin
Director of Investor Relations 972-74-7107194
The Malta Conferences address the shared desire to improve quality of life and political stability in the Middle East through scientific collaboration
HAIFA, Israel, October 1, 2020 – On Wednesday, September 30, 2020, Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading Israeli regenerative medicine company developing a platform of novel biological products, and the Abu Dhabi Stem Cells Center (ADSCC) unveiled their first joint projects in a presentation at the Malta Conferences Foundation, a global conference supported by the kENUP Foundation, a global promoter of research-based innovation with public and societal benefit.
Pluristem and ADSCC presented the new projects, part of the recently signed Memorandum of Understanding (MOU) aimed at harnessing the power of regenerative medicine.
The first joint project brings together the expertise and knowledge of Pluristem and ADSCC to advance a potential COVID-19 treatment. The project will involve the first-time administration of Pluristem’s PLX cells via a nebulizer, a drug delivery device that helps a patient inhale a medication through a mask or mouthpiece, to COVID-19 patients.
The collaboration will allow ADSCC to expand its stem cell therapy options using Pluristem’s novel PLX cells, while enabling Pluristem to leverage ADSCC’s nebulizer administration experience to develop a new treatment delivery model for PLX cells. ADSCC has reported effectively using nebulizers to treat patients suffering from COVID-19 infection with stem cells sourced from the patient’s own blood.
Further discussions for additional projects are underway, including for the potential collaboration in chronic Graft Versus Host Disease (cGvHD), a life-threatening immune response of the donor’s stem cells against the host (patient).
The parties presented the joint projects to a distinguished audience at the Malta Conferences Foundation, including Nobel Laureates, scientists, and diplomats.
The foundation’s mission is to address the shared desire to improve the quality of life and political stability in the Middle East by identifying unique opportunities for collaboration to meet the scientific and technological challenges of the region.
“I am delighted by the opportunity to convene this important meeting.
The Malta Conferences are the only platform in the world where scientists from 15 Middle East countries, Morocco and Pakistan can get together under the same roof with several Nobel Laureates. They develop collaborations and friendship which overcome the chasms of distrust and intolerance.” said Prof. Zafra Lerman, President of Malta Conferences Foundation.
“Embarking on this journey with Pluristem, to overcome one of this generation’s most complex medical challenges, marks an exciting new chapter full of possibilities when it comes to knowledge sharing and medical innovation. Our partnership speaks volumes about the power of collaboration between partners across previously divided borders.
While we simply do not yet know the long-term impact, the novel coronavirus will have on recovered patients, by working together we believe that we are able to leverage the best medical technologies and minds in the region to develop solutions to prevent and treat the lingering symptoms and long-term complications that are emerging,” said Dr. Yendry Ventura, General Manager of ADSCC.
“We were very honored to unveil our first joint projects with the ADSCC at the Malta Conferences Foundation. We see our partnership as a movement between Israel and the UAE, which we hope will lay the foundation for future collaborations that will help potentially bring change to our region and the entire world. As we work together to develop regenerative medicine for key unmet medical needs of benefit to patients around the world, we are excited for the future and its possibilities,” stated Pluristem CEO and President Yaky Yanay.
‘Two world-class players in the field of cell therapy join forces and cooperate on the fight of COVID-19. May this courageous cooperation serve as an example to the world,” says kENUP Foundation’s Executive Chairman, Holm Keller.
The foundation’s mission is to address the shared desire to improve quality of life and political stability in the Middle East by identifying unique opportunities for collaboration to meet the scientific and technological challenges of the region.
The Malta Conferences deal with issues of science education, air and water quality, and alternative energy sources, among other topics of mutual interest.
Global leaders have recognized that science diplomacy is an extremely important mechanism for working toward stability in the Middle East, and this is what the Malta Conferences have done for the past 17 years.
Abu Dhabi Stem Cells Center (ADSCC) is an Abu Dhabi-based specialist healthcare center focused on cell therapy and regenerative medicine, as well as delivering cutting-edge research on stem cells in the region.
The Center was founded in March 2019 to meet growing domestic and regional demand for highly specialized medical services and treatments.
Equipped with the latest technologies, medical devices which are unique to the region, and a team of internationally recognized doctors working hand in hand with researchers, ADSCC is the first of its kind in the UAE. ADSCC specialties include immunology, hematology, clinical stem cell therapy, molecular biology, immunotherapy, orthopedics, and urology – amongst others.
kENUP is a global partnership in innovation, promoting research-based innovation for Europe with public and societal benefit.
It is a not-for-profit organization established as a foundation in the Republic of Malta by Public Deed on November 6, 2014. kENUP’s activities are published in the European Transparency Register.
The Foundation supports European corporations active in industries with substantive underlying market failures by preparing corporate innovation programs for an investment by the European Investment Bank (EIB), or by other public investment banks in the EU, often in close collaboration with private or venture investors.
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 currently conducting late stage clinical trials 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 its first project with ADSCC and that such collaboration will allow ADSCC to expand its stem cell therapy options using its novel PLX cells, while enabling it to leverage ADSCC’s nebulizer administration experience to develop a new treatment delivery model for PLX cells, potential future projects with ADSCC, including the potential collaboration in chronic GvHD, the belief that it and ADSCC are able to leverage the best medical technologies and minds in the region to develop solutions to prevent and treat the lingering symptoms and long-term complications that are emerging and that it sees its partnership with ADSCC as a movement between Israel and the UAE, which it hopes will lay the foundation for future collaborations that will help potentially bring change to its region and the entire 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.
Dana Rubin
Director of Investor Relations 972-74-7107194
HAIFA, Israel, September 15, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today issued an update to its shareholders from its Chief Executive Officer and President Yaky Yanay.
Dear Fellow Shareholders,
This year, we saw the unprecedented need for the collaboration between industry and government in order to meet the challenge of the COVID-19 pandemic.
Pluristem is fully engaged in this effort and is harnessing all of its knowledge, experience, and dedication to improve the wellbeing of patients.
We believe our regenerative medicine product candidates are ideally suited to today’s healthcare challenges.
Through our late stage pipeline of product candidates and indications, we are paving the way towards marketing and commercialization, and strengthening our global presence through strategic collaborations including our most recent one with the Abu Dhabi Stem Cells Center.
As reported on July 21, 2020, we are heading into a pivotal year with four clinical readouts expected including: interim analysis of the Phase III study in Critical Limb Ischemia (CLI), top line efficacy results of the Phase III study in muscle regeneration following hip fracture, top line efficacy results of the Phase II study in COVID-19 and data analysis of the Phase I study in incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).
In the fourth quarter of calendar 2020, we expect to announce the interim analysis results for our global pivotal Phase III study of PLX-PAD in CLI.
We continue to enroll patients in the full clinical study in the U.S., Europe, and Israel and we recently added clinical sites as part of our efforts to introduce our PLX cells at additional key medical centers. The interim and/or final data set results are expected to enable discussions with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the filing of a Biologics License Application (BLA).
Over the past few weeks, we have shifted our clinical site openings from the New York area to other regions in the U.S., as we follow the spread of the COVID-19 pandemic, and we are also considering adding clinical partners to accelerate site openings. In line with these steps, we are updating our expectation of completing enrollment in the first quarter of calendar year 2021. In the U.S., under the Expanded Access Program, up to 100 patients suffering from severe COVID- 19 complicated by Acute Respiratory Distress Syndrome (ARDS), who are not eligible for inclusion to the Phase II study, may be treated with PLX-PAD and the gathered data will be evaluated alongside the Phase II study data. In Europe, we continue to advance the Phase II clinical study which has been cleared in Germany to commence patient enrollment, and in Israel we continue to treat patients under the per-patient Compassionate Use program.
Pluristem had $59 million in cash, cash equivalents and bank deposits as of June 30, 2020.
Moving forward into our 2021 fiscal year, which coincides with our Jewish New Year, we reiterate Pluristem’s commitment to all of our stakeholders including shareholders, patients, employees and our partners. While this year brought unprecedented challenges, we witnessed, more than ever, Pluristem’s resilience and ability to face those challenges. This is a credit to our dedicated and passionate employees who have a profound commitment to excellence.
We are proud of our tenured team of 160 employees, over 45% of which have been with the Company for 5-10 years. I truly believe that our very strong culture is the one reason that Pluristem has won recognition for being one of the best places to work in Israel, for four years in a row.
More importantly, we see the commitment of our employees as one of the main factors driving our success and we are all committed to continuing to drive for such success in the coming year.
Sincerely, Yaky Yanay
Chief Executive Officer
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 currently conducting late stage clinical trials 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 its belief that its regenerative medicine product candidates are ideally suited to today’s healthcare challenges, its belief that it is heading into a pivotal year with four clinical readouts expected including interim analysis of the Phase III study in CLI, top line efficacy results of the Phase III study in muscle regeneration following hip fracture, top line efficacy results of the Phase II study in COVID-19 and data analysis of the Phase I study in incomplete hematopoietic recovery following HCT, that it expects the interim and/or final data set results from the Phase III CLI study to enable discussions with both the FDA and the EMA regarding the filing of a BLA, that it expects to complete enrollment of its Phase II COVID-19 study in the first quarter of calendar year 2021 and its belief that its strong culture is the one reason that it has won recognition for being one of the best places to work in Israel, for four years in a row.
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.
Dana Rubin
Director of Investor Relations 972-74-7107194
HAIFA, Israel, August 19, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today it has completed patient enrollment in its Phase I study evaluating PLX-R18 as a treatment for incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT), in the U.S. and in Israel.
Incomplete hematopoietic recovery poses a significant risk to HCT recipients who fail to respond to standard of care treatments, making them vulnerable to infections and bleeding. PLX-R18 may address the unmet need in this patient population by stimulating the regenerative potential of bone marrow where other treatments have proven ineffective. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PLX-R18 in this indication.
The Phase I multi-center, open-label, 3 cohort dose-escalating study is evaluating the safety of intramuscular (IM) injections of PLX-R18 cells in 20 subjects, with incomplete hematopoietic recovery persisting for at least 3 months after HCT. The follow up period is 12 months. Safety is the primary endpoint, with efficacy endpoints including changes in white blood cells, platelets counts, hemoglobin levels, changes in blood products requirements, and changes in quality of life. As previously reported, Pluristem expects to announce top line efficacy results during the first quarter of calendar year 2021.
“We are glad to meet an additional important clinical milestone that keeps us on track for our expected time to readout, and is one of four data readouts we expect to announce in the coming twelve months. We look forward to seeing data that may position PLX-R18 as an important drug candidate for hematological disorders. We would like to thank the medical teams across the clinical sites supporting our program in the most professional and caring way,” stated Pluristem CEO and President, Yaky Yanay.
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 currently conducting late stage clinical trials 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 expected timing of the top line results for its Phase I study and other readouts and the ability of PLX-R18 to address unmet needs in patients by stimulating the regenerative potential of the bone marrow.
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.
Dana Rubin
Director of Investor Relations 972-74-7107194
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