Regen BioPharma engages Charles River to initiate FDA-requested study with regard to HemaXellerate
Wednesday, April 22, 2015
Regen BioPharma, Inc. (OTCBB: RGBP) (OTC PINK: RGBP) announced today that it has engaged Charles River Laboratories to initiate a Good Laboratory Practices (GLP) mouse toxicity study with regards to HemaXellerate. HemaXellerate, a therapy under development by Regen, is a cellular drug designed to heal damaged bone marrow.
After consultations with the FDA as well as its Scientific Advisory Board members, Regen BioPharma has developed a protocol for assessing safety of the HemaXellerate product in mice lacking an immune system. The protocol was reviewed by the FDA before finalization. This sophisticated animal model is commonly used in cell therapy research as a last safety assessment before products are allowed to 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 & CEO 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."
Charles River Laboratories is a NYSE-traded company with 8,500 employees, established in 1947 specializing in a variety of pre-clinical and clinical laboratory services for the pharmaceutical, medical device and biotechnology industries. The company has facilities in Canada, Belgium, Finland, France, Germany, Hungary, Italy, Ireland, China, Japan, the Netherlands, Spain, and the United Kingdom.
"As with any cellular therapy, safety is our top-most priority. The decision to engage Charles River, a premier contract research organization, to perform these fundamental experiments was based on extensive discussions and deliberations between our Scientific Advisory Board members as well as external industry experts," said Thomas Ichim, PhD, Chief Scientific Officer of Regen BioPharma. "We are confident that working with an industry leader like Charles River will allow for seamless execution of the experimental protocol and a clear path to initiation of the clinical trials."
money.cnn.com
