Bio-Matrix Scientific Group's Regen BioPharma Provides Update on Preclinical and Clinical Development
April 04 2013 - 4:05PM
Marketwired
Regen BioPharma, Inc. (Regen), a wholly-owned subsidiary of
Bio-Matrix Scientific Group, Inc. (OTCQB: BMSN), provided an update
on the Company's progress with HemaXellerate and other new
developments.
Currently, Regen is focused on two core areas: a)The
HemaXellerate Program, which is based on treating disorders of
blood production; and b) Our cancer immunotherapy Program which
leverages specific cells called "dendritic cells" to specifically
kill cancer but not healthy tissue.
In June 2012 the Company acquired an option to license US patent
# 6,821,513 covering use of endothelial cells to stimulate blood
cell production. Subsequently Regen has filed patent applications #
61/648898 and # 61/670791 covering stimulation of blood cell
production using placental and fat derived cells, respectively.
Utilizing these technologies, as well as, results obtained from
studies performed at the Torrey Pines Institute for Molecular
Medicine by Sophia Khaldoyanidi, M.D., Ph.D., Regen has developed
the HemaXellerate product, which is a patient-specific composition
of cells that has previously been demonstrated to repair damaged
bone marrow and stimulate production of blood cells.
Together with opinion leaders from University of Utah, Indiana
University, and Cook General Biotechnology, Regen has published a
peer-reviewed paper describing preclinical data supporting the use
of HemaXellerate
http://www.translational-medicine.com/content/pdf/1479-5876-10-231.pdf.
This paper was widely received by the scientific community and was
granted "Highly Accessed" status by the Journal of Translational
Medicine.
On February 5th, 2013 Regen filed an Investigational New Drug
(IND) application with the FDA to initiate clinical trials using
HemaXellerate for treatment of patients with aplastic anemia that
are resistant to current therapies. The FDA issued IND # 15376 to
Regen in response to the Company's IND application. The Company has
been in communication with the FDA, which informed us that, as per
FDA procedure, a letter outlining items which must be addressed
prior to initiating clinical trials will be sent to us shortly.
Regen is confident the Company will be able to address these items
to the FDA's satisfaction. It is the goal of the Company to
initiate clinical trials by Q4 of 2013. Additionally, aplastic
anemia is considered an Orphan Disease and we plan to apply for
Orphan Drug Status during clinical development.
Proof of concept in the proposed 10 patient aplastic anemia
trial will allow us to expand into the larger market of blood
production disorders which exceeds $4.84 billion per year and
currently addressed by growth factors such as Neupogen®, Neulasta®,
Leukine® and Revolade®. (www.wikinvest.com/stock/Amgen). The
clinical trial is anticipated to take 12-18 months until completion
and the Principle Investigator is Dr. Michael Murphy from Indiana
University who previously published with us. Regen plans to execute
a licensing/co-development agreement once proof of concept in
patients has been obtained.
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:
Milestones Achieved
- HemaXellarate product developed
- Preclinical data published
- Principle Investigator recruited
- FDA # granted
- Second program conceptualized, discussions ongoing for
licensing
Upcoming Milestones
- 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.
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.
(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/
(2)
http://www.fiercepharma.com/special-reports/top-10-best-selling-cancer-drugs/herceptin-166-billion
Contact: Bio-Matrix Scientific Group, Inc. and Regen BioPharma
Inc. David R. Koos, PhD Chairman & Chief Executive Officer
619-702-1404 www.regenbiopharma.com