The second program is based on a patent portfolio, including patent # 8,389,708 for which Regen has signed a Letter of Intent for licensing from Professor Wei-Ping Min from the University of Western Ontario. To date approximately 1.5 million dollars has been spent on development of the technology. Published research by Professor Min demonstrates effective killing of tumor cells without side effects in mice models of melanoma (Zheng et al. J Immunol. 2006 Oct 15;177(8):5639-46) and breast cancer (Zheng et al. Int J Cancer. 2013 Feb 15;132(4):967-77).
We plan to in-license the patent portfolio in Q2 of 2013 and establish collaborations with academic and industry groups to file an IND by Q4 of 2013. The first indication we will be pursuing will be therapy-resistant metastatic breast cancer. There are 209,995 new cases of breast cancer per year, of which 30% are treatment resistant(1). Herceptin, which induces therapeutic effects in only 25% of patients with metastatic breast cancer, had sales of $1.1 billion in 2011(2). The clinical trial is anticipated to be a Phase I/II proof of concept trial which will take 12-18 months to complete. As with the HemaXellarate Program, we anticipate licensing/co-development once clinical proof of concept is achieved.
Below is a summary of our milestones achieved and upcoming projections:
•HemaXellarate product developed •Preclinical data published •Principle Investigator recruited •FDA # granted •Second program conceptualized, discussions ongoing for licensing
•Response to FDA questions: Q3 2013 •Initiate HemaXellerate trial: Q4 2013 •Complete HemaXellerate trial: Q4 2014-Q2 2015 •In license Min technology: Q2 2013 •File IND on Min technology: Q4 2013 •Initiate clinical trial on Min technology: Q4 2013 •Complete clinical trial on Min technology: Q4 2014-Q2 2015
About Bio-Matrix Scientific Group, Inc. and Regen BioPharma, Inc.:
Bio-Matrix Scientific Group, Inc. (OTCQB: BMSN) through its wholly owned subsidiary, Regen BioPharma, Inc., is a biotechnology company focused on identifying undervalued regenerative medicine patents in the stem cell space and rapidly advancing these technologies through pre-clinical and Phase I/II clinical trials. To follow our development, visit us at www.regenbiopharma.com.
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.
(1) Gonzalez-Angulo et al. Overview of Resistance to Systemic Therapy in Patients with Breast Cancer (2000) http://www.ncbi.nlm.nih.gov/books/NBK6306/
Bio-Matrix Scientific Group, Inc. and
Regen BioPharma Inc.
David R. Koos, PhD
Chairman & Chief Executive Officer
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