SOURCE: Medistem Inc.

Medistem Inc.

May 18, 2011 11:14 ET

Medistem Announces Successful Completion of Preclinical Animal Safety Studies Requested by FDA

Stem Cell Company Hits Milestone Toward US Development of Endometrial Regenerative Cells

SAN DIEGO, CA--(Marketwire - May 18, 2011) - Medistem Inc. (PINKSHEETS: MEDS) announced today the completion of additional preclinical studies requested by the FDA as part of the process of IND re-submission. The studies were supported by a federal SBIR grant and involved administration of Medistem's universal donor Endometrial Regenerative Cells (ERC) into mice lacking an immune system. The animals were subjected to a short-term and long-term administration protocol and exhibited no abnormalities, or alteration in behavior. Dr. Brian Johnstone from Indiana University, who is independent of Medistem, conducted the studies.

"The completion of this milestone represents a significant victory for Medistem," stated Vladimir Zaharchook, Vice President and Vice Chairman of Medistem. "Several scientific groups have reported that endometrial stem cells are effective in animal models of Heart Failure (1), Parkinson's Disease (2), Stroke (3), and Diabetes (4). Our ERC product appears to be the only stem cell drug originating from the endometrium that has already been used in humans and now is being developed according to the instructions provided to us by the FDA."

Historically the major source of adult stem cells has been the bone marrow. The endometrium (lining of the uterus) is a unique source because of its high amount of blood vessels created every month, which are subsequently shed during menstruation. Medistem has previously demonstrated that its ERC stem cells are capable of generating 9 different tissues: heart, lung, brain, blood vessel, pancreas, bone, fat, cartilage and muscle (5).

"Since our initial filing of the IND, significant progress has been made by our group in terms of completing these preclinical studies. Additionally, international collaborators have published with us pilot human safety data on the ERC (6-8)," said Dr. Michael Murphy, vascular surgeon from Indiana University and Principle Investigator of the study proposed to the FDA. "Based on our new data, we are optimistic about our resubmission to the Agency."

Medistem's Endometrial Regenerative Cells are available for purchase by qualified researchers from General Biotechnology LLC at: http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells.

References
1. Hida et al. Stem Cells. 2008 Jul;26(7):1695-704. Free link http://onlinelibrary.wiley.com/doi/10.1634/stemcells.2007-0826/pdf
2. Wolff et al. J Cell Mol Med. 2011 Apr;15(4):747-55.
3. Borlongan et al. Stem Cells Dev. 2010 Apr;19(4):439-52.
4. Li et al. J Pharmacol Exp Ther. 2010 Dec;335(3):817-29.
5. Meng et al. J Transl Med. 2007 Nov 15;5:57.
http://www.translational-medicine.com/content/pdf/1479-5876-5-57.pdf
6. Ichim et al. Int Arch Med. 2010 Apr 14;3(1):5
http://www.intarchmed.com/content/pdf/1755-7682-3-5.pdf
7. Ichim et al. Cell Immunol. 2010;260(2):75-82.
8. Zhong et al. J Transl Med. 2009 Feb 20;7:15.
http://www.translational-medicine.com/content/pdf/1479-5876-7-15.pdf

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.

Contact Information

  • Contact:
    Vladimir Bogin, MD
    Chairman of the Board
    Medistem Inc.
    9255 Towne Centre Drive
    Suite 450
    San Diego
    CA 92122
    858 349 3617
    www.medisteminc.com