November 04, 2014: 08:30 AM ET
Regen BioPharma, Inc. (OTCBB: RGBP) 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.
Regen BioPharma, Inc. (OTCBB: RGBP) 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.
