Regen BioPharma Inc (RGBP)

[1~Eye~Jack!!]

~ RGBP = FDA Issues IND Number for~Regen..BioPharma's.=.dCellVax Therapeutic Application, a Proposed Treatment for Breast Cancer!! ( o )( o )
---
BMSN owns 58% of RGBP!!
...Time to Buy!
***Also More Important Info posted by NEW4THIS below this PR!
---
11/4/14 | Marketwired

Regen BioPharma, Inc. (OTCBB: RGBP) (PINKSHEETS: BMSN) announced today issuance of IND (Investigational New Drug Application) number 16200 from the FDA for a proposed Phase I/II clinical trial assessing safety with signals of efficacy of the dCellVax gene silenced dendritic cell immunotherapy for treating breast cancer.

The proposed trial will recruit 10 patients with metastatic breast cancer and will involve 4 monthly injections of the dCellVax gene-silenced dendritic cell therapy. The trial will last one year, with tumor assessment before therapy and at 6 and 12 months.

Regen's dCellVax therapy is based on US Patent # 8,389,708, acquired from Professor Wei-Ping Min at the University of Western Ontario, Canada, as well as a collaboration between Dr. Min and the Company's Chief Science Officer Dr. Thomas Ichim. Preclinical studies have demonstrated efficacy in mouse models of breast cancer and melanoma.

"We see the granting of an IND number as an important first step in the clinical development of this new personalized therapy that will hopefully add a new treatment option to patients without the horrific side effects of chemotherapies," said Dr. Ichim.

Dr. Ichim further noted, "As part of the clinical trial approval process, we do anticipate comments from the FDA on our application, which will follow a similar pattern to our previous IND application for which a number was issued for our first immunotherapeutic product, HemaXellerate. Once all of the FDA comments are addressed, the Company aims to initiate gene silencing immunotherapy for Metastatic Breast Cancer Patients."

dCellVax is manufactured by generating a potent type of immune system cell, the dendritic cell, from patient's own blood. The dendritic cells are subsequently made resistant to the immune suppressive effects of the tumor by silencing the gene indolamine 2,3 deoxyagenase, technology that was licensed from Benitec BioPharma. Advantages of cancer immune therapies include: a) lack of toxicity; b) ability to attack tumor metastasis; and c) generation of immunological memory, which protects the body from recurrence of the tumor.

"I'm extremely excited about the foundation that was laid by Dr. Wei-Ping Min and his academic research leading to our dCellVax therapeutic, along with the accomplishments of Dr. Ichim and his research team in taking the first step in moving dCellVax from an academic concept to a potential drug in development," said David Koos, Chairman & CEO of Regen BioPharma. "While we are beginning with breast cancer, this first trial will serve as validation of our platform, which can be expanded into other tumor types."

About Regen BioPharma Inc.: Regen BioPharma Inc. (OTCBB: RGBP) is a majority owned subsidiary of Bio-Matrix Scientific Group, Inc. (PINKSHEETS: BMSN). Regen is a biotechnology company focused on identifying undervalued regenerative medicine applications in the stem cell space and rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials.

Currently the Company is focused on developing treatments for Aplastic Anemia and a gene silencing therapy for treating cancer. For more information refer to the company's website http://www.regenbiopharma.com/

Disclaimer: This news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

Contact:
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
Phone: [phone]
---

*** The following was posted by NEW4THIS:

The Phases in the FDA Approval Process

Pre-Clinical Phase

In the pre-clinical or drug discovery phase of the approval process, researchers look for potential new compounds to treat targeted diseases. Once a compound has been identified and refined to a formula that can be tolerated by humans, its toxicology is tested in animals and living tissue. The process takes roughly three and a half years. During this phase researchers look for:
•correct dosage level
•how frequently it should be administered
•the best delivery system (oral, topical, intravenous, etc.)
•short- and long-term survival of the animals

After pre-clinical testing is completed, the company then files an Investigational New Drug Application (IND) with the FDA. Fast Track Designation is an expedited review of a drug that is given to a company whose drug or biologic makes both a product and a marketing claim that addresses an unmet medical need. It can be granted at any point after the FDA approves an IND.


Phase I

If the FDA approves the IND, the experimental drug then moves into Phase I human testing. In this phase, the drug is tested in a small number (under 100) of healthy participants. Researchers look to see how well the drug is tolerated, how it is processed by the human body, and the correct dosing. This process takes a year.


Phase II

Once a compound is found to be well tolerated in healthy individuals, it is then tested for effectiveness for a targeted disease in a small number of patients. In this phase 100-300 people are administered the investigational drug to see if it actually works, and to determine its short-term effects. This process takes about two years.


Phase III

Phase III is a large-scale study of the effectiveness and side effects of the drug in a larger population, usually ranging from 1000-3000 patients. If the drug is submitted to the FDA for approval, the FDA will look at the Phase III data to determine if the drug is safe and effective. Aside from testing the drug’s viability, the company producing the drug also determines the logistics involved in creating a large supply of the treatment. Phase III of the FDA approval process takes about three years.


New Drug Application (NDA)/ Biologics License Application (BLA)

If the drug proves to be safe and effective, the company then files an NDA or BLA with the FDA. NDAs and BLAs are typically 100,000 pages long and include results of human and animal trials as well as information on how the drug is manufactured. It usually takes the FDA 1-2 years to complete the review process and approve a drug. However, there are cases when approval can be accelerated.
•At the time of application Priority Review can be granted to drugs that treat an unmet medical need.
•Orphan Drug Status is granted to drugs that treat rare diseases, or diseases that have no other available treatments.

Phase IV

Once a drug has received FDA approval it is then marketed to the general population. Short- and long-term side effects continue to be monitored and results are submitted to the FDA. Companies will also look for additional indication for the drug. In order for the drug to be approved for a new indication, it must receive approval from the FDA.

FierceBiotech is a free daily email newsletter that keeps you up to speed on important clinical trial developments, New Drug Applications, and FDA approvals. We pay special attention to the business side of clinical trials. The newsletter tracks advances in pharmacogenomics and screening techniques, venture capital investments in drug development companies, key initiatives from the NIH (National Institutes of Health) and other organizations, and companies' efforts to advance their clinical trials pipelines and bring new drugs and treatments to market.

Sign up for FierceBiotech today -- get clinical trial updates and FDA approval information that help you save time and get ahead!









































___________
As always,, the above Post is "Just My Opinion!"