Aldagen Announces Review Article On Potential of Its Adult Stem Cell Therapies for Cardiovascular Diseases

Aldagen Announces Review Article On Potential of Its Adult Stem Cell Therapies for Cardiovascular Diseases

Durham, NC - July 29, 2009 - Aldagen, Inc. today announced that it authored a review article describing the potential of ALDH-bright (ALDHbr) adult stem cells to treat cardiovascular diseases. Aldagen's clinical pipeline includes two therapies composed of ALDHbr cells for the treatment of ischemic heart failure and critical limb ischemia (CLI). The article provides an overview of preclinical research and clinical development progress and plans for these two indications. The paper appears in the July/August 2009 issue of Congestive Heart Failure and was authored by Laurence H. Keller, MD, Chief Medical Officer of Aldagen.

There has been a growing body of research regarding the use of adult stem cells to treat cardiovascular diseases such as ischemic heart failure and CLI. The article describes the selection and clinical application of a mix of potent stem and progenitor cells, referred to as ALDHbr stem cells, which include all the cell types thought to be needed for repair of tissue damaged by insufficient blood supply. Aldagen identifies and isolates these cells based upon the presence of an intracellular enzyme that is highly expressed in multiple adult stem and progenitor cell lineages. ALDHbr cells can be quickly selected from the patient's own bone marrow, and they do not need to be expanded or manipulated in any way, enabling a streamlined manufacturing process and rapid turnaround to the patient.

"Preclinical and clinical research has suggested that ALDHbr cells may facilitate the repair of ischemic tissue damage by promoting the creation of new blood vessels in the injured tissue," said Dr. Keller. "The advantages of using these selected cells are several-fold: they appear to contain all the cell types needed for tissue repair; they appear to be more potent than the broader population of bone marrow cells; we don't have to place a bet on which cell type or types are the right ones for ischemic repair; and the cells don't need to be expanded or otherwise manipulated. The critical limb ischemia and ischemic heart failure populations that we are studying represent growing patient populations without good treatment alternatives."

The key findings surrounding ALDHbr adult stem cells discussed in the article include:

* A preclinical study involving hindlimb ischemia demonstrated that the ALDHbr population was highly effective in restoring blood flow to ischemic limbs.

* Approximately two-thirds or more of bone marrow cells expressing surface markers that researchers commonly use to identify various types of stem cells for use in ischemic repair (e.g., CD34, CD133, CD105) are not ALDHbr. In the hindlimb ischemia preclinical study the bone marrow cells that were not ALDHbr had the same effect as a salt water solution control, indicating that all of the ischemic repair activity is found in the ALDHbr cells.

* Clinical studies were initiated utilizing this approach for two indications: CLI and ischemic heart failure.

* Clinical results for the Phase 1/2 CLI study were very encouraging, with improvements seen in blood flow and clinical status.

* Data analysis is under way for 6-month follow-up results for the Phase 1 ischemic heart failure study.

"This article provides a great overview of the promise of Aldagen's adult stem cell therapies to treat cardiovascular diseases," said Tom Amick, Chairman and Chief Executive Officer of Aldagen. "We believe we have the most advanced adult stem cell products in clinical trials for critical limb ischemia and ischemic heart failure, and look forward to publishing or presenting clinical data for each if these indications in the second half of 2009."

About Aldagen, Inc.

Aldagen is a biopharmaceutical company developing proprietary regenerative cell therapies that target significant unmet medical needs. The company has four product candidates in clinical trials. Aldagen's most advanced product candidate, ALD-101, is currently in a pivotal Phase 3 clinical trial to evaluate its efficacy in improving umbilical cord blood transplants used to treat inherited metabolic diseases in pediatric patients. The company also is conducting or supporting Phase 1 or Phase 1/2 clinical trials of three other product candidates: ALD 151 to improve umbilical cord blood transplants used in the treatment of leukemia, ALD-301 to treat critical limb ischemia, and ALD-201 to treat ischemic heart failure. Aldagen's product candidates consist of specific populations of adult stem cells that the company isolates using its proprietary technology.