BMSN – BioMatrix Scientific Group, Inc. Company Profile By Admin on May 13, 2013 There has been a lot of press recently from BMSN including the announcement about issuance of IND number 15376 to its wholly-owned subsidiary Regen BioPharma, Inc. This is good news because they can begin the proposed Phase I/II clinical trial evaluating use of its stem cell product, HemaXellerate, for treatment of aplastic anemia. As part of the clinical trial approval process, the FDA will issue comments on the proposed trial which must be addressed to the FDA’s satisfaction before patient dosing is initiated. The clinical trial will treat ten patients with aplastic anemia that have not responded to conventional therapy and lack a bone marrow donor. ”We are pleased that the company has been issued an IND number and has taken the first step towards regulatory approval in the USA,” said David Koos, Chairman & CEO of Bio-Matrix. “We have compiled an internationally-renowned team, consisting of corporate and academic partners, which cover the manufacturing, regulatory, and medical aspects of the project. Members of the team have previously published with Regen the scientific rational for the trial in a peer-reviewed publication in January of last year which may be found at translational-medicine/content/pdf/1479-5876-10-231.pdf.” BMSN Wholly Owned Subsidiary Regen BioPharma Announces the Start of FDA Trials for the Treatment of Aplastic Anemia. Also in the news, Regen BioPharma (Regen) has assessed over 20,000 stem cell related issued patents, narrowed down to 2000 patents with commercial applicability, and further identified 30 patents available for licensing. The company seeks to in-license, take the product to, and through clinical safety and efficacy “signal” and spin out technologies. More, BMSN majority owned subsidiary Entest BioMedical Inc. (ENTB) is involved with the development of stem cell therapy treatments for Chronic Obstructive Pulmonary Disease (COPD), cancer immuno-therapies, testing procedures for diabetes and stem cell research applications for diabetes and other illnesses. entb.net/ And then, from a May 6th Marketwire news release we learn that Regen acquired a cancer vaccine technology with an initial focus on breast cancer: SAN DIEGO, CA, May 06, 2013 (Marketwired via COMTEX) — Regen BioPharma, wholly owned subsidiary of Bio-Matrix Scientific Group, Inc. (otcqb:BMSN), announced today it has purchased patent #8,389,708 from Professor Wei-Ping Min of the University of Western Ontario, London, Canada. This patent covers a novel means of stimulating the immune system against cancer through blockade of a cancer specific molecular pathway (gene silencing). Preclinical studies demonstrating effective stimulation of anticancer immunity and molecular mechanisms mediating therapeutic effects of the technology have been reported in the Journal of Immunology(1). “The blockbuster potential of cancer immune therapies is illustrated by the $1.66 Billion sales of Herceptin(2), a monoclonal antibody used to treat breast cancer, in 2011,” said David Koos, Chairman and CEO of Bio-Matrix Scientific Group Inc. and its subsidiary, Regen BioPharma Inc. “This newly acquired technology has passed the preclinical stages of testing and we are eager to continue development through the FDA IND process.” The acquired technology covers the use of RNA Interference to specifically inhibit the enzyme indolamine 2,3 deoxygenase (IDO). Tumors are known to escape the immune system by specifically activating this enzyme. In the patent and previous publication, Dr. Min and his team demonstrated that by blocking function of IDO, tumors would enter remission. “My laboratory is looking forward to working with Bio-Matrix Scientific’s Regen BioPharma towards advancing our new method of treating cancer from mice to people,” stated Dr. Wei-Ping Min, Professor at the University of Western Ontario. “Having previously published(3) with Dr. Koos on our RNA interference technique, I am eager to now expand our collaboration into the area of oncology.” The cancer vaccine market is expected to grow from a 2010 value of US$12.8 billion, to US$17.4 billion by 2018. Approximately 1.5 million Americans are being diagnosed with cancer annually, and the annual overall cost of the disease is estimated to be $230 billion(4). All these developments may prove to be the jolt this stock needs for a breakout. According to James Brumley, reporting from Smallcap Network, it is a penny stock to watch: As for Bio Matrix Scientific Group, it would be a very bullish play, if the stock could just get past the resistance at its 200-day moving average line (green). It came close to clearing that ceiling a week ago, but it was a start that couldn’t be sustained. After a pullback this week (which didn’t cut as deep), the bulls have regrouped and are looking to take BMSN higher again after a sharp pullback in March and April. Indeed, it’s the size of that pullback that makes the rebound potential so big. BMSN Provides Update on Preclinical and Clinical Development Regen BioPharma, Inc. (Regen), a wholly-owned subsidiary of Bio-Matrix Scientific Group, Inc. (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. b) The 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 here: translational-medicine/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. From Regen: 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®. (wikinvest/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 MM 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 BMSN and Regen BioPharma, Inc: 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 developments, visit regenbiopharma. Here’s a few more links for your research: From the NYTimes: topics.nytimes/topics/news/business/companies/bio-matrix-scientific-group-inc/index.html And Yahoo Finance: finance.yahoo/q?s=BMSN Disclaimer This company profile report 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.
Posted on: Thu, 11 Jul 2013 20:31:25 +0000
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