Bio-Matrix Scientific subsidiary RegenBioPharma, Inc. today said it has submitted to the U.S. Food and Drug Administration its response to the agency’s comments regarding the company’s IND#15376, which covers the use of HemaXellerate for treatment of immune suppressant resistant aplastic anemia.
In its response, RegenBioPharma provided new data demonstrating HemaXellerate’s ability to accelerate stem cell recovery after chemotherapeutic injury. While the possibility exists that the FDA may request additional comments, RegenBioPharma said it is confidant in its response as it looks forward to advancing HemaXellerate to clinical trials.
“We are pleased with the responses that we have provided to the FDA and look forward to initiating our clinical trials,” David Koos, chairman and CEO of RegenBioPharma stated in the press release. “Although it is possible that a second round of comments may be issued, we feel this process is extremely useful to creating a clinical trial that is optimized for safety and detection of efficacy.”
HemaXellerate uses cells from the patient’s own fat stem cells to repair and stimulate the hematopoietic stem cells of the bone marrow. Clinical trials of the candidate aim to recruit 10 patients with aplastic anemia that have not shown material signs of improvement under the current the standard of care. If the first round of clinical trials is a success, RegenBioPharma said it will advance to larger efficacy-finding trials and expand applications of the drug to other diseases that would benefit from enhancement of bone marrow stem cells.
For more information visit www.regenbiopharma.com
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