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Pluristem Enters Collaboration With Pharmaceutical Company Innovare R&D to Expand Pluristem’s ARDS Associated With COVID-19 Program to Mexico

Wednesday, December 30, 2020

Pluristem Therapeutics Inc., a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today it has entered into a collaboration agreement with Mexican pharmaceutical company Innovare R&D to expand its ongoing clinical program of PLX cells in the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 in Mexico. The Phase II study in Mexico is subject to the approval of local authorities, with the goal of being conducted under the U.S. Food and Drug Administration (FDA) cleared protocol.

In accordance with the agreement, Innovare will open clinical sites and enroll patients for the proposed clinical study in Mexico. Innovare will fund the study in Mexico and will purchase PLX cells for the study from Pluristem. Subject to potential positive clinical study results and Mexican regulatory approval for commercialization, the agreement grants Innovare exclusive distribution rights in Mexico to supply PLX cells for treating severe COVID-19 cases 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, Mexico’s COVID-19 infection and mortality rates have been increasing. Mexico has the highest deaths proportionally to COVID-19 cases or population in the world as of December 28, 2020, as reported by Johns Hopkins University of Medicine.

“We are pleased to join forces with Innovare, a leading innovative company aiming to be part of the solution for combating the COVID-19 pandemic in Mexico,” stated Pluristem CEO and President, Yaky Yanay. “Thanks to our key competitive advantage of having in-house manufacturing facility, advanced logistical capabilities, and a global reach, we are able to supply PLX cells to clinical centers around the world while extending our global support for COVID-19 into Latin America. By conducting the study in both the U.S. and Mexico, in parallel to the E.U. and Israel, we are continuing our focus on achieving clinical milestones and objectives, while bringing the potential treatment of PLX cells to those in need.”

Gerardo Cárdenas Vogel, CEO of Innovare R&D commented, “As a company that is seeking worldwide partners showing clinical promise for unmet medical needs, we are excited to collaborate with Pluristem. We look forward to leveraging our clinical and commercial capabilities with Pluristem’s advanced cell therapy solution to help develop and potentially bring a much needed treatment for ARDS patients associated with COVID-19 to Mexico.”

Pluristem is currently conducting two Phase II studies in ARDS associated with COVID-19 in the U.S., Europe and Israel, an Expanded Access Program in the U.S. and a per patient compassionate use program in Israel.

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