29.12.2020 13:22:27

Pluristem Collaborates With Innovare R&D To Expand ARDS Associated With COVID-19 Program To Mexico

(RTTNews) - Pluristem Therapeutics Inc. (PSTI) said Tuesday that it has reached 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 or 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 cleared protocol.

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.

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.

Pluristem said it 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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