Proteonomix Receives FDA Permission to Initiate Company-Sponsored Phase 1 Clinical Trial with UMK-121 in Patients with …

MOUNTAINSIDE, N.J.--(BUSINESS WIRE)--

Proteonomix, Inc. (OTC/BB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, today announced that the U.S. Food and Drug Administration (FDA) has granted permission to the Company to initiate a Phase 1 clinical trial with its mobilization technology UMK-121. The Proteonomix-sponsored trial will evaluate UMK-121 in patients with end-stage liver disease (ESLD).

Permission by the FDA marks an important milestone in our plans to initiate a Company-sponsored clinical trial with UMK-121, following years of research and investment to advance development of this drug candidate, said Proteonomix Chief Technology Officer Steven Byle. We hope and anticipate that this trial will demonstrate the potential of UMK-121 to mobilize stem cells in order to improve liver function in patients with ESLD. We consider ourselves fortunate to be involved with a development-stage therapy that could improve the life expectancy for this class of terminally ill patients awaiting liver transplants.

Proteonomix CEO Michael Cohen added, This is a significant step for our Company as this is the first FDA IND to be held by Proteonomix and demonstrates the ability of the Company to move basic research projects into clinical trials.

UMK-121 is a patent-pending combination of two FDA-approved drugs designed to mobilize mesenchymal stem cells from the bone marrow to the peripheral circulation. The combination drug is designed to reduce inflammation and increase angiogenesis to restore liver function. UMK-121 was developed by Proteonomix Chief Scientific Officer Ian McNiece and President and CEO Michael Cohen, and subsequently licensed to Proteonomix through its wholly owned subsidiary Thor Biopharma, Inc.

About Proteonomix, Inc.

Proteonomix is a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives. The Proteonomix family of companies includes Proteoderm, StromaCel, PRTMI and THOR Biopharma. Proteoderm is a wholly owned subsidiary that has developed an anti-aging line of skin care products. StromaCel develops therapeutic modalities for the treatment of cardiovascular disease and plans to file an IND application for treatment of patients who have suffered post-myocardial infarction. Proteonomix Regenerative Translational Medicine Institute, Inc. (PRTMI) intends to focus on the translation of promising research in stem cell biology and cellular therapy to clinical applications of regenerative medicine. Additional information is available at http://www.proteonomix.com and http://www.proteoderm.com.

Certain statements contained herein are "forward-looking statements" (as defined in the Private Securities Litigation Reform Act of 1995). Proteonomix, Inc. cautions that statements made in this press release constitute forward-looking statements and makes no guarantee of future performance. Actual results or developments may differ materially from projections. Forward-looking statements are based on estimates and opinions of management at the time statements are made.

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Proteonomix Receives FDA Permission to Initiate Company-Sponsored Phase 1 Clinical Trial with UMK-121 in Patients with ...