Regen BioPharma Inc (OTCMKTS:RGBP) On The Verge Of A Breakout

Regen BioPharma Inc (OTCMKTS:RGBP) has exploded off 52 weeks lows and captured a lot of investor interest. While Regen has been around since 2012, the company made some real progress last year. Now investors are waking up to the company's potential as big things are expected to happen in 2016, including orphan drug designation.Regen BioPharma seeks to identify undervalued regenerative medicine applications in the immunotherapy and stem cell space. The company is focused on rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials. Currently the company is centering on gene silencing therapy for treating cancer, telomeres and small molecule therapies, along with developing stem cell treatments for aplastic anemia.In December, Regen received word from the FDA allowing for initiation of clinical trials under its Investigational New Drug (IND) #15376. The clearance of the IND allows the company to initiate clinical trials of HemaXellerate, a personalized immune-modulatory cell therapy that has demonstrated benefit in animal models of aplastic anemia. The initial Phase I clinical trial will treat patients having refractory aplastic anemia - aplastic anemia patients who haven't responded to first-line immunosuppressive therapy - with HemaXellerate and follow them for safety parameters and signals of efficacy. Therapeutic effects will be quantified based on immunological and hematological measurements. Because the trial will be unblinded, data will be available as the study progresses.Then in January, Regen submitted to the FDA an application requesting Orphan Drug status for the use of HemaXellerate for the treatment of aplastic anemia. Having an Orphan Drug designation for HemaXellerate is important as it will allow for annual grant funding to defray the cost of clinical testing, tax credits for the costs of clinical research, assistance in clinical research study design, seven-year period of exclusive marketing after an orphan drug is approved, and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.The key here is that because aplastic anemia is a rare disease, we expect that the FDA will grant it Orphan Drug Status and thus accelerate any approvals as the product is developed. We expect Regen BioPharma to begin the clinical trial by Q3 2016.In addition, we expect Regen to receive word from the FDA any day now regarding dCellVax. Regen has already submitted an IND to, and received comments from, the FDA regarding this product. With dCellVax, Regen takes cells from a patient with breast cancer, expands a select portion of their immune cells (called dendritic cells), inhibits the expression of a specific protein in these cells (called IDO) and then reinjects back these modified dendritic cells into the patient. The FDA has already asked the company to perform additional experiments before clearing this IND application. Regen has been working on these additional experiments with the John Wayne Cancer Center to satisfy the FDA.Last week, Regen BioPharma announced that it had completed its experiments demonstrating immunological mechanisms of its novel NR2F6 gene silencing approach. Subsequent to these experiments, the company has begun the process of compiling an Investigational New Drug Application (IND) with the FDA for testing of this approach in cancer patients. The experiments revealed that administration of Regen's proprietary gene silencing compounds triggered cells of the immune system to profoundly produce growth factors such as interleukin-17 and interleukin-18. These factors are critical to inducing an anticancer immune response.The company is currently developing a cellular product that involves extraction of a small amount of patient blood, isolating specific immune cells from the blood, gene-silencing the NR2F6 target in the extracted immune cells, and subsequently re-administering the immune cells. The goal is to "reprogram" the immune cells to attack tumors. Regen has also recently filed two patent applications covering the molecular pathways activated by NR2F6 silencing. These applications cover mechanisms by which interleukin-17 and interleukin-18, which are produced as a result of NR2F6 gene silencing, mediate various anticancer effects.Regen BioPharma is one name on the OTC markets that has the potential to be a multi-bagger for investors. We expect to be hearing from the FDA shortly and that could lead to a deal with big pharma. RGBP is one name that's on our radar screen and one which we think will be on some very big players radar screens shortly. We will be updating Insider Financial as soon as we know more. For continuing coverage on RGBP and our other hot stock picks, sign up for our free newsletter today and get our next hot stock pick!Disclosure: We have no position in RGBP and have not been compensated for this article.