Great News out on $RGBP$ Today !!
Regen BioPharma, Inc. Submits IND Application to FDA on tCellVax, a Checkpoint Inhibitor for Cancer Therapy
New approach uses siRNA to silence NR2F6 activity in human immune cells
SAN DIEGO, March 23, 2016 /PRNewswire/ --
Regen BioPharma, Inc., (RGBP) and (RGBP) announced today submission to the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (NYSE:IND) application focused on using a novel method to unleash the body's innate ability to kill cancer (immunotherapy).
The application submitted contained preclinical experiments as well as details of the proposed clinical trial. Results of the studies clearly demonstrated that the approach outlined, using siRNA to silence NR2F6 activity in human immune cells, is dramatically effective at stimulating the type of immune response associated with known checkpoint inhibitors.
"Because tCellVax is a personalized cell therapy product aimed at activating the immune system of patients with cancer, we are excited to potentially have a product to deliver to patients who at the moment have no other options," said David Koos, PhD, Chairman & CEO of Regen BioPharma.
"The NR2F6 gene is clearly playing a role as a very potent immune checkpoint. tCellVax is one of the programs we are developing to inhibit this protein. Immune modulation, both inhibitory and stimulatory, is unlocking many novel ways to have the human body heal itself. tCellVax is only one of our immune modulatory products that we expect to bring to market in the future. The data package we sent to the FDA is an important step in this process," said Harry Lander, Ph.D., MBA, President and Chief Scientific Officer of Regen BioPharma.
** dCellVax has already been approved by the FDA for its IND # and Regen believes that upon their completion of Pre-Clinicals, and having completed the Q&A-Comments on their behalf, they merely await FDA Clearance for usage in Human Trials for Breast Cancer. (Pre Clinicals w/Lab Animals are ongoing for Kidney/Prostate/ Liver cancers & Leukemia-other Rare Blood diseases/disorders)
HemaXellerate FDA Cleared for Human Trials-They will be done in conjunction with The NIH-Orphan Status has been filed, if that is approved, Govt Funding to continue will be granted.
We believe $RGBP$ is a Diamond in the Rough-A LONG PLAY with Proven Short Term Gain Potential (25-100%+ past)
Regen will become the Player in Stem Cell Tech and Treatment or become an attractive Buy Out Target for Larger Pharma.
Robert E. Kreh
Small Cap Solutions, LLC
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