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Regen, Charles River Enter GLP Tox Pact

Will initiate a GLP toxicity study

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By: Kristin Brooks

Managing Editor, Contract Pharma

Regen BioPharma, Inc. has engaged Charles River Laboratories to initiate a Good Laboratory Practices (GLP) toxicity study related to HemaXellerate, Regen’s cellular drug designed to heal damaged bone marrow.
 
Regen BioPharma has developed a protocol, which was reviewed by the FDA, for assessing safety of the HemaXellerate product in mice lacking an immune system. This sophisticated animal model is commonly used in cell therapy research as a last safety assessment before products enter clinical trials. 
 
“We are enthusiastic about initiating what we hope to be the last phase of experimentation before the HemaXellerate aplastic anemia trial can begin,” said David Koos, chairman and chief executive officer of Regen BioPharma. “Working with the team at Charles River in establishing the protocol and timetable has been very productive. We look forward to rapid and efficient completion of the laboratory experimental phase of this program.” 

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