Regen BioPharma updates on HemaXellerate investigational NDA

Regen BioPharma (OTCBB: RGBP), a US biotechnology company, saw its shares fall 5.36% to $0.13 after it announced that it has responded to question posed by the US Food and Drug Administration with regards to HemaXellerate.

The data package submitted contained the final preclinical toxicology experiments performed by Charles River Laboratories on behalf of Regen as well as details of the proposed clinical trial.  Results of all studies demonstrated lack of toxicity and the company is optimistic that all concerns presented by the FDA have been addressed and that the agency will grant clearance to the company to initiate clinical trials on HemaXellerate.  HemaXellerate is a cellular drug being developed by Regen designed to heal damaged bone marrow

"Because HemaXellerate is a personalized cell therapy product aimed at addressing an unmet medical need, we are in agreement with the FDA in performing the most rigorous safety and efficacy experiments in order to deliver this promising product to patients who at the moment have no other options," said David Koos, chairman and chief of Regen.