HAIFA, Israel, December 29, 2020 (GLOBE NEWSWIRE) – Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading renewable pharmaceutical company developing a platform of novel biological therapeutic products, announced today that it has entered into a cooperation agreement with Mexican pharmaceutical company Innovare R&D to expand their ongoing clinical program of PLX cells in the treatment of COVID-19-related Hunger Respiratory Motion Syndrome (ARDS) in Mexico. A Phase II study in Mexico is subject to approval by local authorities, with the aim of being carried out under the U.S. Food and Drug Administration (FDA). protocol.
Under the agreement, Innovare will open clinical sites and register patients for the planned clinical trial in Mexico. Innovare will fund the study in Mexico and purchase PLX cells for the study from Pluristem. Subject to the results of a potential advanced clinical trial and a Mexican regulatory license to trade, the agreement grants Innovare exclusive exclusive release rights in Mexico to provide PLX cells for the treatment of COVID cases -19 heavy which is complicated by ARDS. All intellectual property and manufacturing rights remain with Pluristem.
With 1,389,430 cases and 122,855 deaths as of December 29, 2020, COVID-19 disease and mortality rates in Mexico have been on the rise. The highest deaths in Mexico in proportion to COVID-19 cases or population in the world as of December 28, 2020, as reported by Johns Hopkins University of Medicine.
“We are excited to join Innovare, a leading innovation company that aims to be part of the solution for fighting the COVID-19 pandemic in Mexico,” said Pluristem CEO and President , Yaky Yanay. “Thanks to our core competitive advantage of in-house manufacturing facility, advanced logical capabilities, and global reach, we are able to bring PLX cells to clinical centers worldwide as we expand our business. global support for COVID-19 into Latin America. By conducting the study both in the US and in Mexico, in parallel with the EU and Israel, we continue to focus on achieving clinical milestones and goals, and at the one time giving the potential treatment of PLX cells to those in need. ”
Gerardo Cárdenas Vogel, Head of Innovare R&D, said, “As a company seeking worldwide partners demonstrating clinical promise for unmet medical needs, we are excited to be collaborating with Pluristem . We look forward to leveraging our clinical and commercial capabilities with Pluristem’s advanced cell therapy solution to help develop and potentially deliver much-needed treatments to CODS-related ARDS patients to Mexico. ”
Pluristem is currently conducting two Phase II studies in CODS related to COVID-19 in the U.S., Europe and Israel, an Extended Access Program in the U.S. and a compassionate use program for all patients in Israel.
About I.R&D nnovare
Innovare R&D involves a group of pharmaceutical companies that develop and trade drugs in the fields of hematology, immunology, infectious disease, central nervous system, and urology. They established a specific partnership model to collaborate with biopharmaceutical companies in a strategy to determine the appropriateness of their platform in improving patient outcomes. Innovare R&D has a regional (Mexico) commercialization of products already agreed with the FDA / European Pharmaceutical Agency (EMA) / Health Canada / Swissmedic / TGA, while Innovare R&D is leading their developments own product with partners in the US and Europe. .
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in a number of indicators for their patented PLX cell product candidates and is currently conducting late-stage clinical trials in a number of indicators. PLX cell output candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematologic disorders and radiation damage. The cells are grown using the Company’s proprietary three-dimensional extension technology and can be taken to patients off the shelf, without matching cloth. Pluristem has a strong intellectual property position; GMP certified manufacturing and research facility; strategic relationships with key research centers; and a quarterly management team.
Safe Harbor Statement
This press release contains forward-looking or explicit statements contained within the Private Security Literature Reform Act 1995 and other U.S. Federal securities laws. For example, Pluristem uses forward-looking statements when considering the possible Phase II study in Mexico, subject to local authority approval, that it is continuing aims to achieve milestones and clinical goals, while at the same time providing the potential treatment in PLX cells of those in need and potentially treating its there is a great need for COVID-19-related ARDS patients to Mexico. These positive statements and their merits are based solely on what is currently expected from Pluristem’s rule, and are subject to a number of features and uncertainties from which actual results may differ significantly. -full of those described in the forward-looking statements. The following factors, among others, may cause real results to differ significantly from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may experience delays or obstacles to the successful launch and / or completion of its clinical trials; Pluristem’s results may not be approved by regulatory bodies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may not be able to retain or attract key employees with the necessary knowledge to improve its products; unexpected scientific difficulties may develop with the Pluristem process; Pluristem’s results may end up being more expensive than expected; laboratory results may not translate into equally good results in real clinical situations; the results of preclinical studies may not correlate with the results of human clinical trials; Pluristem patents may not be enough; Pluristem results can harm recipients; changes in legislation can adversely affect Pluristem; the inability to develop and introduce new technologies, products and applications; loss of market share and price pressure due to competition, which may cause real results or performance of Pluristem to differ significantly from those considered in forward-looking statements. But as required by law, Pluristem assumes no responsibility for the public release of any revisions to reveal the events or circumstances that lie ahead after the date here or to indicate unexpected events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference will be made to Pluristem reports filed from time to time by the Securities and Exchange Commission.
Contact:
Dana Rubin
Director of Investment Relations
972-74-7107194
[email protected]