Pluristem CEO issues shareholder update
HAIFA, Israel, September 22, 2021 (GLOBE NEWSWIRE) – Pluristem Therapeutics inc. (Nasdaq: PSTI) (TASE: PSTI), a leading biotechnology company, today released an update to its shareholders from its CEO and Chairman Yaky Yanay.
Less than three months after the start of a new fiscal year, several important developments are on the horizon for Pluristem, including four studies in the process of clinical publication in the coming quarters. These studies align with our mission to develop new cell therapy product candidates, built using Pluristem’s cutting-edge technology.
Clinical pipeline: milestones
In the coming year, we plan to take several clinical milestones, which represents significant potential for our cellular platform.
First, our Phase I study evaluating PLX-R18 cells in subjects with incomplete hematopoietic recovery after hematopoietic cell transplant (HCT) demonstrated positive results as reported in April 2021, and we plan to present a full reading. data for the fourth quarter of this calendar year. . We also plan to continue the development of the program and to initiate a phase II study in the hematological indication. Second, we await first results in the fourth quarter of this calendar year for our two Phase II studies of PLX-PAD cells to treat acute respiratory distress syndrome (ARDS) associated with COVID-19 in the United States, Europe. and in Israel. Third, our Phase III study evaluating PLX-PAD cells to support muscle regeneration after hip fracture surgery has enrolled over 95% of its patients and is expected to complete enrollment in October 2021.
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Strategic plan: platform expansion
Over the past decade, we have developed a robust automated Good Manufacturing Practices (cGMP) manufacturing platform for allogeneic cells from fetal and maternal cells of the placenta. Using this platform, we can produce large quantities of high quality cells suitable for a variety of applications and uses. The manufacturing platform allows us to develop targeted pipelines of cellular product candidates, including induced or modified PLX cells:
Induced PLX cells: These placental cells are induced by different cytokines to transiently modify their secretion profile. Our first product candidate under this technology is the PLX-R18. The positive data presented in the hematology study in April 2021 supports our approach to targeting cells with superior activity per indication. We plan to continue to develop this platform for cell induction and are under advanced development to complement other targeted product candidates of this nature.
PLX cells modified using CRISPR technology: We are also working on the integration of the revolutionary genetic engineering technology of CRISPR to potentially design PLX cells with new and targeted functionalities. Combined with our placenta-derived cell manufacturing platform, Pluristem would use CRISPR technology to potentially develop a new class of PLX allogeneic cell therapy product candidates modified ex vivo to address new indications.
In short, we have developed a reliable, stable and cost effective cell extension platform. We believe that the use of the placenta as a single cellular source, combined with our innovative, high-quality research, development and manufacturing capabilities, will be the engine that propels this platform technology towards the successful development of product candidates and products. ‘additional indications for PLX cell therapy.
We are excited to continue to develop the potent therapeutic capabilities of placental cells while using our advanced technology to push the boundaries.
Summary: Key competitive advantage
What is the biggest advantage of Pluristem? Our talented management team and I have posed this question in recent months as part of our five-year strategic discussions. The result is clear: to develop effective and innovative cellular product candidates while ensuring downstream manufacturing capability when the product candidate is ready to be marketed. We believe this is our defining competitive advantage. Over the years, we have generated interest from potential partners to use our platform for pharmaceuticals and other industries. Pluristem intends to use its unparalleled technological advantage to establish mutually beneficial partnerships towards the best use and optimization of our assets for the benefit of our shareholders.
CEO and chairman
About Pluristem Therapeutics
Pluristem pushes the boundaries of science and engineering to reinvent pharmacological treatments and improve the quality of care. The Company’s cell therapies advance the field of regenerative medicine, with potentially revolutionary applications for the treatment of damaged muscle, hematologic impairment and inflammation. Pluristem derives its therapeutic cells from the placenta, a potent and ethically accepted source. The cells are easy to collect and do not require blood or tissue pairing. The cells of a placenta can treat 20,000 patients. The company’s manufacturing platform, the Bioreactor, is a patented and validated advanced 3D cell expansion system designed to mimic the human body. The Pluristem method is particularly precise, cost effective and consistent from batch to batch.
Safe Harbor Declaration
This press release contains express or implied forward-looking statements under the Private Securities Litigation Reform Act of 1995 and other US federal securities laws. For example, Pluristem uses forward-looking statements when discussing the expected timing of the first results of its phase II studies of PLX-PAD cells in ARDS associated with COVID-19 and the presentation of the full readout of the phase I data. of HCT. study evaluating PLX-R18 cells, completed enrollments expected in its Phase III study evaluating PLX-PAD cells to support muscle regeneration after hip fracture surgery, its expectation that it continues to develop its platform. form to induce cells and is in advanced development to complement additional targeted product candidates of this nature, its intention to use CRISPR technology to potentially develop a new class of allogeneic PLX cell therapy product candidates modified ex vivo to treat new indications and that it intends to use its technological advantage to establish mutually beneficial partnerships towards the best use and optimization of its assets. These forward-looking statements and their implications are based on the current expectations of Pluristem’s management only and are subject to several 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 forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in the launch and / or success of its clinical trials; Pluristem’s products may not be approved by regulatory bodies, Pluristem’s technology may not be validated as it progresses, and its methods may not be accepted.
by the scientific community; Pluristem may not be able to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with the Pluristem process; Pluristem’s products may end up being more expensive than expected; laboratory results may not translate to such good results in actual clinical settings; the results of preclinical studies may not correlate with the results of clinical trials in humans; Pluristem’s patents may not be enough; Pluristem’s products may harm recipients; changes in legislation may have a negative impact on Pluristem; the inability to develop and introduce new technologies, products and applications in a timely manner; loss of market share and price pressure resulting from competition, which could cause Pluristem’s actual results or performance to differ materially from those contemplated in these forward-looking statements. Unless otherwise required by law, Pluristem does not undertake to publish revisions of these forward-looking statements to reflect events or circumstances subsequent to the date hereof or to reflect the occurrence of unforeseen 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.
Director of Investor Relations