SOURCE: Medistem Inc.

Medistem Inc.

August 26, 2011 03:52 ET

Medistem Submits Response to FDA Clinical Hold

SAN DIEGO, CA--(Marketwire - Aug 26, 2011) - Medistem Inc. (PINKSHEETS: MEDS) announced today filing with the FDA a response to clinical hold regarding the company's FDA Phase I clinical trial application, BB-IND 13898, entitled "Allogeneic-Unrelated, Menstrual Derived, Mesenchymal Stem Cell-Like Endometrial Cells Administered Intramuscular."

The proposed clinical trial, for which Dr. Michael P Murphy from Indiana University is Principle Investigator, seeks to treat 10 patients with critical limb ischemia who have no options but amputation with the company's universal donor Endometrial Regenerative Cells (ERC).

"Thanks to funding from a federal SBIR grant, the support of our investors, and numerous industry and academic collaborators, we have been able to perform the experiments requested by the FDA regarding our cellular product," said Thomas Ichim, CEO of Medistem. "While there are no guarantees that the clinical hold will be removed, filing of the current response represents a major milestone for our company."

Since receiving the clinical hold in 2009, Medistem has published 4 peer reviewed publications on new data regarding the endometrial-derived adult stem cells (1-4). Additionally, several groups independent of Medistem have reported in the scientific literature that cells similar to the ERC and which are covered in Medistem's filed intellectual property induce benefit in animal models of heart failure (5), Parkinson's Disease (6), diabetes (7), and stroke (8).

"A major priority of Medistem's new ownership and management has been obtaining an initial IND approval by the FDA, which will then allow us to begin developing our pipeline of other clinical indications," said Vladimir Bogin, MD, President and Chairman of the Board. "The ERC is one cell that can become 9 different tissues: heart, bone, muscle, brain, pancreas, liver, fat, blood vessel, and lung. While critical limb ischemia is our initial indication, we plan to aggressively pursue other conditions, a business model that has recently been validated by transactions such as Mesoblast-Cephalon, Pluristem-United Therapeutics, and Athersys-Pfizer."

Medistem is currently working with strategic partners in the areas of veterinary medicine, laboratory reagents, and clinical utilization for an indication that has not been disclosed. The company's business model revolves around generation of inexpensive, easy-to-use, universal donor stem cells that can be administered in a global manner without need for complex interventions or equipment.

References:

1. Han et al. Inhibition of intracranial glioma growth by endometrial regenerative cells. Cell Cycle. 2009 Feb 15;8(4):606-10. http://www.landesbioscience.com/journals/cc/HanCC8-4.pdf

2. Zhong et al. Feasibility investigation of allogeneic endometrial regenerative cells. J Transl Med. 2009 Feb 20;7:15. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2649897/pdf/1479-5876-7-15.pdf

3. Ichim et al. Combination stem cell therapy for heart failure. Int Arch Med. 2010 Apr 14;3(1):5. http://www.intarchmed.com/content/pdf/1755-7682-3-5.pdf

4. Ichim et al. Mesenchymal stem cells as anti-inflammatories: implications for treatment of Duchenne muscular dystrophy. Cell Immunol. 2010;260(2):75-82.

5. Hida et al. Novel cardiac precursor-like cells from human menstrual blood-derived mesenchymal cells. Stem Cells. 2008 Jul;26(7):1695-704. Epub 2008 Apr 17. http://onlinelibrary.wiley.com/doi/10.1634/stemcells.2007-0826/pdf

6. Wolff et al. Endometrial stem cell transplantation restores dopamine production in a Parkinson's disease model. J Cell Mol Med. 2011 Apr;15(4):747-55.

7. Li et al. Induction of insulin-producing cells derived from endometrial mesenchymal stem-like cells. J Pharmacol Exp Ther. 2010 Dec;335(3):817-29.

8. Borlongan et al. Menstrual blood cells display stem cell-like phenotypic markers and exert neuroprotection following transplantation in experimental stroke. Stem Cells Dev. 2010 Apr;19(4):439-52.

About Medistem Inc.
Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf. ERC can be purchased for scientific use through Medistem's collaborator, General Biotechnology http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells.

Cautionary Statement
This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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 information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

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