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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
Agreement comes as United Arab Emirates (UAE) and Israel Reach Historic Agreement to Fully Normalize Diplomatic Relations
HAIFA, Israel, August 17, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today its subsidiary, Pluristem Ltd., has signed a non-binding Memorandum of Understanding (MOU) with the United Arab Emirates-based Abu Dhabi Stem Cells Center (ADSCC), a specialist healthcare center focused on cell therapy and regenerative medicine. Executives from both companies took part in a signing ceremony held via video conference between Israel and the UAE. The aim of the collaboration is to capitalize on each company’s respective areas of expertise in cell therapies to deliver regenerative medicine for the benefit not only of the citizens of the UAE and Israel, but for humanity as a whole. The collaboration between the parties was initiated by the Better Alternatives advisory firm.
The parties have agreed to exchange research results, share samples, join usage of equipment and testing, and other essential activities related to advancing the treatment and research of cell therapies for a broad range of medical conditions, including COVID-19.
ADSCC has been treating COVID-19 patients with stem cells sourced from the patient’s blood, by returning the cells back into the patient’s lungs as a fine mist through a nebulizer, a machine that helps a patient breathe in medicine through a mask or mouthpiece. Pluristem has treated patients with its placental PLX-PAD allogenic product via compassionate use programs in Israel and the U.S. and is currently conducting phase II studies in the U.S. and EU.
“We are extremely proud to partner with our colleagues at the ADSCC by sharing knowledge and expertise that we believe will advance healthcare within and across our borders. We see l ife science and regenerative medicine as a bridge for building peace, prosperity, and well-being in our region and for the entire world. I believe it is our obligation and privilege as business and scientific leaders to lead the way forward to strengthen collaborations, and promote innovation and education. We are honored to be on the front line of this historical moment,” stated Pluristem CEO and President Yaky Yanay.
Dr Yendry Ventura, General Manager of the ADSCC commented, “Pluristem is a major player in the cell therapy field with years of experience, a unique platform and a robust clinical pipeline. We are excited to join forces and to promote the research and development of cell therapies for the best of the patients and the human society as a whole.”
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.
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 aim of the collaboration with the ADSCC is to capitalize on each company’s respective areas of expertise in cell therapies to deliver regenerative medicine for the benefit not only of the citizens of the UAE and Israel , but for humanity as a whole and the belief that it is its obligation and privilege as business and scientific leaders to lead the way forward to strengthen collaborations, and promote innovation and education.
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
Pluristem étend la portée de son programme sur la COVID-19 à l’Europe et reçoit une autorisation du PEI pour commencer une étude de phase II en Allemagne
HAÏFA, Israël, 12 août 2020 /PRNewswire/ — Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), une société de premier plan dans le domaine de la médecine régénérative développant une plateforme de produits thérapeutiques biologiques novateurs, a annoncé aujourd’hui que l’agence allemande de réglementation de la santé, le Paul Ehrlich Institute (PEI), a approuvé le protocole clinique de phase II de la société pour son étude intitulée « 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 » (Une étude de phase II randomisée, contrôlée, multicentrique, en groupes parallèles pour évaluer l’efficacité et l’innocuité d’injections intramusculaires de PLX PAD pour le traitement des cas graves de COVID-19). Quarante
(40) patients hospitalisés présentant une forme grave de la COVID-19 accompagné de complications du syndrome de détresse respiratoire aiguë (SDRA) seront recrutés dans l’étude.
Le critère principal qui permettra de mesurer l’efficacité de l’étude est le nombre de jours passés sans respirateur pendant la totalité des 28 jours de l’étude. Le suivi du taux de survie et du niveau d’innocuité sera effectué au 60 ème jour , ainsi qu’aux semaines 26 et 52.
« Nous sommes ravis d’étendre notre programme sur la COVID-19 à un territoire supplémentaire et nous sommes impatients de commencer l’essai clinique de nos cellules PLX pour le traitement des cas graves de COVID-19 et ayant développé des complications du SDRA en Europe. Sur la base de nos discussions avec le PEI, il s’agira d’une étude indépendante, où le groupe expérimental sera comparé au groupe dit de contrôle suivant les recommandations thérapeutiques standards. Pluristem mène plusieurs programmes de développement clinique avancé en Europe qui sont soutenus par Horizon 2020 et, dès réception des fonds, par la Banque européenne d’investissement (BEI). Nous sommes reconnaissants de leur soutien important à notre plateforme thérapeutique. Pluristem est déterminée à utiliser ce qui, selon nous, constitue les principaux avantages concurrentiels de notre plateforme technologique et à apporter des médicaments régénératifs aux patients en Europe et dans le monde entier », a déclaré Yaky Yanay, CEO et President de Pluristem.
Outre cette étude en Allemagne, Pluristem mène actuellement un essai de phase II sur la COVID-19 aux États-Unis, qui recrutera 140 patients.
Les cellules PLX peuvent être administrées sans ordonnance et, une fois commercialisées, elles peuvent être fabriquées en grandes quantités. Pluristem estime que ses cellules PLX offriront un avantage clé dans la lutte contre la pandémie mondiale
de COVID-19. Les cellules PLX sont semblables aux cellules allogéniques mésenchymateuses; les propriétés immunomodulatrices de ces cellules provoquent les régulateurs naturels du système immunitaire – les macrophages M2 et les lymphocytes T, et peuvent ainsi prévenir ou inverser la suractivation dangereuse du système immunitaire.
Par conséquent, les cellules PLX peuvent potentiellement réduire l’incidence et/ou la gravité de la pneumonie provoquée par la COVID-19, menant, nous l’espérons, à un meilleur pronostic pour les patients. Les résultats de précédent es études précliniques sur les cellules PLX ont révélé des bienfaits thérapeutiques dans des études sur les animaux concernant l’hypertension pulmonaire, la fibrose pulmonaire, les lésions rénales aiguës et les lésions gastro-intestinales, qui sont des complications potentielles des graves infections à la COVID-19. Les données cliniques sur l’utilisation de cellules PLX ont démontré la grande puissance immunomodulatrice de celles -ci chez des patients ayant subi une intervention chirurgicale majeure. Les données cliniques préliminaires, obtenues au terme d’un suivi de 28 jours chez les patients atteints de la COVID-19 en unité de soins intensifs et traités dans le cadre d’un programme d’usage compassionnel, ont été précédemment publiées.
Les capacités potentielles des cellules PLX, combinées avec le profil d’innocuité observé lors d’essais cliniques impliquant des centaines de patients dans le monde entier, placent les cellules PLX comme traitement potentiel pour atténuer les effets néfastes de la COVID-19 sur les tissus.
Pluristem Therapeutics Inc. est une société de premier plan dans le domaine de la médecine régénérative qui développe des produits candidats novateurs de thérapie cellulaire à base de placenta. La société a rendu compte de solides données d’essais cliniques dans plusieurs indications pour ses produits candidats brevetés à cellules PLX et mène actuellement des essais cliniques en phase avancée dans plusieurs indications. On estime que les produits candidats à cellules PLX libèrent une variété de protéines thérapeutiques en réponse à l’inflammation, à l’ischémie, aux traumatismes musculaires, aux troubles hématologiques et aux dommages par radiations. Les cellules sont développées à l’aide de la technologie d’expansion tridimensionnelle exclusive de la société et peuvent être administrées aux patients sans requérir une compatibilité tissulaire. Pluristem possède une solide position en matière de propriété intellectuelle : une usine de fabrication et de recherche certifiée GMP détenue et exploitée par la société, des relations stratégiques avec de grandes institutions de recherche et une équipe de direction chevronnée.
Contact :
Dana Rubin
Director of Investor Relations
+972-74-7107194
Pluristem étend la portée de son programme sur la COVID-19 à l’Europe et reçoit une autorisation du PEI pour commencer une étude de phase II en Allemagne
HAÏFA, Israël, 12 août 2020 /PRNewswire/ — Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), une société de premier plan dans le domaine de la médecine régénérative développant une plateforme de produits thérapeutiques biologiques novateurs, a annoncé aujourd’hui que l’agence allemande de réglementation de la santé, le Paul Ehrlich Institute (PEI), a approuvé le protocole clinique de phase II de la société pour son étude intitulée « 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 » (Une étude de phase II randomisée, contrôlée, multicentrique, en groupes parallèles pour évaluer l’efficacité et l’innocuité d’injections intramusculaires de PLX PAD pour le traitement des cas graves de COVID-19). Quarante
(40) patients hospitalisés présentant une forme grave de la COVID-19 accompagné de complications du syndrome de détresse respiratoire aiguë (SDRA) seront recrutés dans l’étude.
Le critère principal qui permettra de mesurer l’efficacité de l’étude est le nombre de jours passés sans respirateur pendant la totalité des 28 jours de l’étude. Le suivi du taux de survie et du niveau d’innocuité sera effectué au 60 ème jour , ainsi qu’aux semaines 26 et 52.
« Nous sommes ravis d’étendre notre programme sur la COVID-19 à un territoire supplémentaire et nous sommes impatients de commencer l’essai clinique de nos cellules PLX pour le traitement des cas graves de COVID-19 et ayant développé des complications du SDRA en Europe. Sur la base de nos discussions avec le PEI, il s’agira d’une étude indépendante, où le groupe expérimental sera comparé au groupe dit de contrôle suivant les recommandations thérapeutiques standards.
Pluristem mène plusieurs programmes de développement clinique avancé en Europe qui sont soutenus par Horizon 2020 et, dès réception des fonds, par la Banque européenne d’investissement (BEI). Nous sommes reconnaissants de leur soutien important à notre plateforme thérapeutique. Pluristem est déterminée à utiliser ce qui, selon nous, constitue les principaux avantages concurrentiels de notre plateforme technologique et à apporter des médicaments régénératifs aux patients en Europe et dans le monde entier », a déclaré Yaky Yanay, CEO et President de Pluristem.
Outre cette étude en Allemagne, Pluristem mène actuellement un essai de phase II sur la COVID-19 aux États-Unis, qui recrutera 140 patients.
Les cellules PLX peuvent être administrées sans ordonnance et, une fois commercialisées, elles peuvent être fabriquées en grandes quantités. Pluristem estime que ses cellules PLX offriront un avantage clé dans la lutte contre la pandémie mondiale
de COVID-19. Les cellules PLX sont semblables aux cellules allogéniques mésenchymateuses; les propriétés immunomodulatrices de ces cellules provoquent les régulateurs naturels du système immunitaire – les macrophages M2 et les lymphocytes T, et peuvent ainsi prévenir ou inverser la suractivation dangereuse du système immunitaire. Par conséquent, les cellules PLX peuvent potentiellement réduire l’incidence et/ou la gravité de la pneumonie provoquée par la COVID-19, menant, nous l’espérons, à un meilleur pronostic pour les patients. Les résultats de précédent es études précliniques sur les cellules PLX ont révélé des bienfaits thérapeutiques dans des études sur les animaux concernant l’hypertension pulmonaire, la fibrose pulmonaire, les lésions rénales aiguës et les lésions gastro-intestinales, qui sont des complications potentielles des graves infections à la COVID-19. Les données cliniques sur l’utilisation de cellules PLX ont démontré la grande puissance immunomodulatrice de celles -ci chez des patients ayant subi une intervention chirurgicale majeure. Les données cliniques préliminaires, obtenues au terme d’un suivi de 28 jours chez les patients atteints de la COVID-19 en unité de soins intensifs et traités dans le cadre d’un programme d’usage compassionnel, ont été précédemment publiées. Les capacités potentielles des cellules PLX, combinées avec le profil d’innocuité observé lors d’essais cliniques impliquant des centaines de patients dans le monde entier, placent les cellules PLX comme traitement potentiel pour atténuer les effets néfastes de la COVID-19 sur les tissus.
Pluristem Therapeutics Inc. est une société de premier plan dans le domaine de la médecine régénérative qui développe des produits candidats novateurs de thérapie cellulaire à base de placenta. La société a rendu compte de solides données d’essais cliniques dans plusieurs indications pour ses produits candidats brevetés à cellules PLX et mène actuellement des essais cliniques en phase avancée dans plusieurs indications. On estime que les produits candidats à cellules PLX libèrent une variété de protéines thérapeutiques en réponse à l’inflammation, à l’ischémie, aux traumatismes musculaires, aux troubles hématologiques et aux dommages par radiations. Les cellules sont développées à l’aide de la technologie d’expansion tridimensionnelle exclusive de la société et peuvent être administrées aux patients sans requérir une compatibilité tissulaire. Pluristem possède une solide position en matière de propriété intellectuelle : une usine de fabrication et de recherche certifiée GMP détenue et exploitée par la société, des relations stratégiques avec de grandes institutions de recherche et une équipe de direction chevronnée.
Contact :
Dana Rubin
Director of Investor Relations
+972-74-7107194
Pluristem weitet COVID-19-Programm auf Europa aus und erhält PEI-Zulassung für Phase-II-Studie in Deutschland
HAIFA, Israel, 12. August 2020 /PRNewswire/ — Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), ein führendes Unternehmen für regenerative Medizin, gab heute bekannt, dass die deutsche Gesundheitsaufsichtsbehörde, das Paul-Ehrlich-Institut (PEI), das klinische Protokoll der Phase II des Unternehmens für seine Studie mit dem Titel „Eine randomisierte, gesteuerte, multizentrische Phase-II-Studie mit Parallelgruppen zur Bewertung der Wirksamkeit und Sicherheit von intramuskulären Injektionen von PLX PAD zur Behandlung schwerer COVID-19-Erkrankungen” freigegeben hat. Vierzig (40) Patienten, die mit schweren Fällen von COVID-19 und einem akuten Lugenversagen (ARDS) im Krankenhaus liegen, werden in die Studie aufgenommen.
Der primäre Wirksamkeitsendpunkt der Studie ist die Anzahl der beatmungsfreien Tage während der 28 Tage vom ersten Tag bis zum 28. Tag der Studie. Nachkontrollen zur Sicherheit und Überlebensrate werden am 60. Tag, in der 26. Woche und in der
„Wir freuen uns, unser COVID-19-Programm auf ein zusätzliches geographisches Gebiet auszuweiten und in Europa mit einer klinischen Studie unserer PLX-Zellen zur Behandlung schwerer COVID-19-Fälle mit einer ARDS-Komplikation zu beginnen. Basierend auf unseren Gesprächen mit dem PEI wird dies eine eigenständige Studie sein, bei der die Therapie mit PLX-Zellen mit dem aktuellen Pflegestandard verglichen wird. Pluristem führt in Europa mehrere fortgeschrittene klinische Entwicklungsprogramme durch, die durch Horizont 2020 und nach Erhalt der entsprechenden Mittel von der Europäischen Investitionsbank (EIB) unterstützt werden. Wir sind für diese wichtige Unterstützung unserer therapeutischen Plattform dankbar. Pluristem setzt sich dafür ein, die unserer Meinung nach großen Wettbewerbsvorteile unserer technologischen Plattform zu nutzen und Patienten in Europa und auf der ganzen Welt regenerative Medizin anbieten zu können”, sagte Yaky Yanay, CEO und Präsident von Pluristem.
Zusätzlich zu dieser Studie in Deutschland führt Pluristem derzeit auch in den USA eine Phase-II-COVID-19-Studie durch, in die 140 Patienten aufgenommen werden.
PLX-Zellen sind gebrauchsfertig erhältlich und können nach der Kommerzialisierung in großen Mengen hergestellt werden. Pluristem glaubt, dass PLX-Zellen einen wichtigen Vorteil bei der Bekämpfung der globalen COVID-19-Pandemie bieten werden. PLX-Zellen sind allogene mesenchymalartige Zellen, deren immunmodulatorische Eigenschaften die natürlichen regulativen T-Zellen des Immunsystems und M2-Makrophagen induzieren und
somit eine gefährliche Überaktivierung des Immunsystems verhindern oder umkehren können. Dementsprechend können PLX-Zellen die Inzidenz bzw. Schwere einer COVID- 19- Lungenentzündung potenziell reduzieren, was hoffentlich zu einer besseren Prognose für Patienten führen wird. Frühere präklinische Befunde von PLX-Zellen zeigten einen therapeutischen Nutzen in Tierstudien bei Lungenhypertonie, Lungenfibrose, akuter Nierenverletzung und Magen-Darm-Verletzungen, die potenzielle Komplikationen einer schweren COVID-19-Infektion darstellen. Klinische Daten von PLX-Zellen belegten die starke immunmodulatorische Potenz von PLX-Zellen bei Patienten nach einer größeren Operation. Erste klinische Daten zum Abschluss einer nach 28 Tagen durchgeführten Kontrolle von COVID-19-Patienten, die auf der Intensivstation mit einem Compassionate- Use-Programm behandelt wurden, sind bereits veröffentlicht worden. Auf Basis des Sicherheitsprofils, das in klinischen Studien mit Hunderten von Patienten auf der ganzen Welt beobachtet wurde, lässt sich erkennen, dass die potenziellen Fähigkeiten von PLX- Zellen als eine Therapie zur Linderung der gewebeschädigenden Auswirkungen von COVID-19 genutzt werden könnten.
Pluristem Therapeutics Inc. ist ein führendes Unternehmen für regenerative Medizin, das neuartige plazentabasierte Produktkandidaten für Zelltherapien entwickelt. Das Unternehmen konnte robuste klinische Studiendaten mit mehreren Indikationen für seine patentierten PLX-Zell-Produktkandidaten zeigen und führt zurzeit klinische Studien mit mehreren Indikationen im Spätstadium durch. Es wird angenommen, dass PLX- Zellproduktkandidaten eine Reihe therapeutischer Proteine als Reaktion auf Entzündungen, Ischämie, Muskeltrauma, hämatologische Störungen und Strahlenschäden freisetzen. Die Zellen werden mithilfe der proprietären dreidimensionalen Expansionstechnologie des Unternehmens kultiviert und können in ihrer handelsüblichen Form ohne Gewebeanpassung an Patienten verabreicht werden. Pluristem verfügt über eine starke IP-Position, eine unternehmenseigene und vom Unternehmen selbst betriebene GMP-zertifizierte Produktions- und Forschungseinrichtung, strategische Beziehungen zu großen Forschungsinstituten und ein erfahrenes Managementteam.
Kontakt:
Dana Rubin
Director of Investor Relations
+972-74-7107194
HAIFA, Israel, August 10, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that Germany’s health regulatory agency, the Paul Ehrlich Institute (PEI), has cleared the Company’s Phase II clinical protocol for its 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.” Forty (40) patients hospitalized with severe cases of COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled in the study.
The primary efficacy endpoint of the study is the number of ventilator free days during the 28 days from day 1 through day 28 of the study. Safety and survival follow-up will be conducted at day 60, week 26 and week 52.
“We are pleased to expand our COVID-19 program to an additional territory and look forward to commencing a clinical trial of our PLX cells for the treatment of severe COVID-19 cases complicated by ARDS in Europe. Based on our discussions with the PEI, this will be a standalone study, with the active arm compared to the current standard of care. Pluristem is conducting several advanced clinical development programs in Europe which are supported by the Horizon 2020 and, upon receipt of funds, by the European Investment Bank (EIB). We are grateful for their important support of our therapeutic platform. Pluristem is committed to utilizing what we believe is the major competitive advantages of our technological platform and to bringing regenerative medicine to patients in Europe and around the world,” stated Pluristem CEO and President Yaky Yanay.
In addition to this study in Germany, Pluristem is currently conducting a Phase II COVID-19 trial in the U.S. which will enroll 140 patients.
PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities.
Pluristem believes its PLX cells will offer a key advantage in addressing the COVID-19 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 prevent or reverse the dangerous overactivation of the immune system. Accordingly, PLX cells may potentially reduce the incidence and/or 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 at the conclusion of a 28 day follow up from COVID-19 ICU patients that were treated under a Compassionate Use Program, 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 Europe, its belief that its study will be a standalone study, with the active arm compared to the current standard of care, the potential receipt of funds from the EIB, that it is committed to utilizing what it believes is the major competitive advantages of its technological platform and to bringing regenerative medicine to patients in Europe and around the world, when it discusses 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
HAIFA, Israel, July 21, 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,
During this challenging period marked by the ongoing global COVID-19 pandemic, we are continuing to advance our regenerative medicine product candidates with the aim of improving the lives and health of people around the world. In addition to our clinical programs, we are also taking an active role in finding an effective treatment solution to COVID-19 complications. We hope and believe that PLX-PAD may play an instrumental role in overcoming the devastating impact of the coronavirus.
Today I would like to provide an update on the key clinical milestones and corporate developments for the year to come. We are heading towards a pivotal year with four clinical readouts, on multiple opportunities for success in advancing PLX product candidates towards registration with applicable regulatory agencies. The entire Pluristem team is dedicated to success, and I would like to make sure all of you are aware of important milestones ahead of us.
Over the last few months, we held discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to reaffirm understandings related to the interim readout of our global pivotal Phase III study of PLX-PAD in CLI. We expect to announce top line interim data analysis results during the fourth quarter of calendar 2020.
An analysis of the interim data will have three possible outcomes: a) an earlier than planned end- of-study may be achieved if the top line interim data analysis achieves overwhelming efficacy (p
≤0.01), b) the study may be declared futile if there is no probability of successfully achieving the primary endpoint on the full data set after enrolling all patients, or c) the study is in line with the protocol assumptions and considered to be in a promising zone for success. If the third possible outcome results, Pluristem will continue to enroll patients, and will analyze the data again on the full data set.
Following the FDA’s and EMA’s advice and recommendations, the following are the main items implemented in the study design and the interim readout:
After a slowdown in enrollment due to COVID-19, we currently expect the pace of enrollment to accelerate and forecast to complete enrollment of the study population in the U.S., Europe and Israel by the fourth quarter of calendar 2020. This expectation takes into consideration the impact of COVID-19 on the access to treatment and follow up sites while maintaining the safety of the patients, as we continue to follow FDA and EMA guidelines for conducting clinical studies during COVID-19.
For our Phase III trial of PLX-PAD in muscle regeneration following hip fracture in the U.S., Europe and Israel, we have enrolled more than 60% of the 240 patients planned for the study and we expect to complete enrollment by the end of calendar 2020.
Top line results are expected in the third quarter of calendar 2021.
The Phase II U.S. study evaluating PLX-PAD in patients suffering from severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) is planned to enroll 140 subjects.
We continue to open sites in accordance with the changing dynamics of the spread of COVID-19 in the U.S. In addition, we are finalizing our discussions with Germany’s health regulatory agency, the Paul Ehrlich Institute, in order to launch a study in Europe.
Our target is to complete enrollment and to provide top line 28-days follow-up data on our U.S. study during the fourth quarter of calendar 2020.
Our Phase I study of PLX-R18 in hematology, specifically for incomplete hematopoietic recovery following HCT, is enrolling patients in the U.S. and in Israel.
Following discussions with our advisory board, we intend to complete enrollment with 20 patients.
We expect to meet this milestone by the end of the third quarter of calendar 2020, and subsequently provide top line results in the first quarter of calendar 2021.
Pluristem had approximately $59 million in cash and cash equivalents as of June 30, 2020.
We expect that our current resources, together with the funds expected from the European Investment Bank (EIB), assuming all agreed milestones are achieved, will support our operations for over three years.
We believe this will enable us to complete the development of our current pipeline, with the goal to bring multiple product registrations both in the U.S. and Europe.
In these times of global challenges, we continue advancing our ongoing clinical trials, while keeping our commitment to the health and wellbeing of all of our stakeholders.
We wish all our shareholders, clinical and business partners, employees and patients good health and resilience at this time.
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 hope and belief that PLX-PAD will play an instrumental role in overcoming the impact of the coronavirus, the expected timing of the completion of enrollment and release of top line readouts from its various clinical studies, the potential outcomes from the top line interim data analysis results relating to its Phase III CLI study, the belief that the changes in the primary endpoint for the interim analysis from the Phase III CLI study will enable its study to meet the required endpoints for both the FDA and EMA and to start discussions regarding filing of a BLA, that it expects to receive the funds from the EIB and, such funds together with its existing cash and equivalents, will fund and support its operations for over three years and will enable it to execute its goals.
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, June 11, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today the activation of clinical sites and initiation of enrollment in its Phase II U.S. Food and Drug Administration (FDA) study of PLX cells for the treatment of severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS). The Company is focused on expanding to clinical sites throughout the U.S. in accordance with the changing dynamic spread of the COVID-19 pandemic, using its advanced operational capabilities and cold chain agility. The trial is expected to include up to 25 sites.
The randomized, double-blind, placebo-controlled, multicenter, parallel-group 140 patient study is evaluating the efficacy and safety of intramuscular (IM) injections of PLX-PAD for the treatment of severe COVID-19 cases complicated by ARDS. The primary endpoint is the number of ventilator free days during the main 28-day study period. Safety and survival follow-up will be conducted at week 8, 26 and 52. Secondary efficacy endpoints include all-cause mortality, duration of mechanical ventilation, ICU free-days, and hospitalization free-days.
“Pluristem is closely following the spread of the COVID-19 pandemic globally as well as the ‘hot spots’ in the U.S. We are targeting locations that show the highest rate of new cases and incorporating the ready-to-use advantages of our PLX-PAD product candidate. Pluristem’s confirmed operational and unique cold chain logistical capabilities enable us to treat patients within hours of notice. We also believe this will enable us to deliver COVID-19 treatments in a timely manner and in the right place, while assisting the healthcare systems in the fight against COVID-19, its complications, and its burden on the medical infrastructure.”
PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, offering 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 prevent or reverse the dangerous overactivation of the immune system.
Accordingly, PLX cells may potentially reduce the incidence and\or severity of COVID-19 pneumonia and pneumonitis 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.
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 focus on expanding clinical sites throughout the U.S., the expected number of clinical sites it expects will be included in the trial, the belief that its confirmed operational and unique ‘cold chain’ logistical capabilities enable it to treat patients within hours of notice, its belief that it will be able to deliver potential COVID- 19 treatments in a timely manner, and in the right place, while assisting the healthcare systems in the fight against COVID-19, its complications, and its burden on the medical infrastructure and when it discusses 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 pneumonitis, 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
HAIFA, Israel, June 3 , 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that it was selected as a member of the CRISPR-IL consortium, a group funded by the Israeli Innovation Authority. CRISPR-IL brings together the leading experts in life science and computer science from academia, medicine, and industry, to develop artificial intelligence (AI) based end-to-end genome-editing solutions. These next-generation, multi-species genome editing products for human, plant, and animal DNA, have applications in the pharma, agriculture, and aquaculture industries. Pluristem’s Vice President Research & Intellectual Property, Racheli Ofir, will lead CRISPR-IL’s pharma working group.
CRISPR-IL is funded by the Israeli Innovation Authority with a total budget of NIS36 million, or approximately US$10 million, for a period of 18 months, with a potential for extension of an additional 18 months and additional budget from the Israeli Innovation Authority. CRISPR-IL participants include leading companies, and medical and academic institutions.
In addition to Pluristem, key participants from industry include BTG – Bio-technology General Israel, Colors Farm, Hazera Seeds, NRgene, Evogene, TargetGene Biotechnologies and Rahan Meristem Ltd.; medical institutions include Sheba Medical Center and Schneider Children’s Medical Center; and members from academia include Bar-Ilan University, Ben Gurion University of the Negev, Hebrew University of Jerusalem, the Weizmann Institute of Science, IDC Herzliya, and Tel-Aviv University.
CRISPR is a genome-editing technology for detecting and modifying DNA sequences. It is used as a tool to enable genetic changes.
The technology enables the development of unique bio-based products and novel therapeutics while reducing the time and cost of development.
Current CRISPR-based workflows target precise areas within the DNA; however, these workflows still face several challenges, which prevent more extensive use of this tool, including: (i) accidental off- target modification, (ii) inefficient modifications and (iii) inaccurate measuring tools to ascertain if the modification was effective as intended.
The CRISPR-IL consortium intends to develop an AI- based system to provide users improved genome-editing workflows.
The system aims to provide end-to-end solutions, from the user interface to an accurate measurement tool.
The system is expected to include the computational design of on-target DNA modification, with minimal accidental, off-target modifications, improve modification efficiency and provide an accurate measuring tool to ensure the desired modification was made.
“CRISPR gene editing technology creates new technological options in healthcare that are both personalized and regenerative. We see cell therapy and gene editing as highly synergistic methods to treat and cure diseases using advanced technologies. Pluristem is honored to bring its allogeneic cell therapy and manufacturing expertise to the CRISPR-IL consortium and to lead the development of next generation of allogeneic cell therapies for treating the diseases of today and the future,” stated Pluristem CEO and President, Yaky Yanay. “Our future product development strategy leverages our well established PLX platform to integrate CRISPR technology, opening new opportunities for Pluristem to provide an expanded pipeline of products.”
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 potential of CRISPR gene editing technology and its potential integration with Pluristem’s PLX platform leading to new opportunities and an expanded pipeline of products.
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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