Aldagen, Inc. Reaches Agreement With FDA on a Special Protocol Assessment (SPA) for Phase 3 Trial of ALD-301 for Critical Limb Ischemia

DURHAM, NC--(Marketwire - August 05, 2009) - Aldagen, Inc. today announced that it has received a Special Protocol Assessment (SPA) concurrence letter from the U.S. Food and Drug Administration (FDA) for the design of a Phase 3 study of ALD-301 for Critical Limb Ischemia (CLI). An SPA is a written agreement between the Company, as the trial's sponsor, and the FDA regarding the design, endpoints, and planned statistical analysis of the Phase 3 trial to be used in support of a Biological License Application (BLA). The SPA letter received by Aldagen from the FDA states that the Phase 3 study is adequately designed to provide necessary data that, depending on outcome, could support a BLA submission.

The Phase 3 trial will be a double blind, placebo-controlled study designed to assess the ability of ALD-301 to improve clinical outcomes in patients with CLI, including amputation rates, ulcer healing and pain reduction. The study will involve patients with advanced critical limb ischemia who no longer have revascularization options. The patients will be evaluated over a six month timeframe.

"We are excited to have reached agreement with the FDA on a clinical path that could ultimately lead to approval of ALD-301, which may provide an important new treatment option for advanced CLI patients with very few alternatives," said Tom Amick, Chairman and Chief Executive Officer of Aldagen. "This SPA is also the first one for a stem cell therapy in the cardiovascular area -- a significant milestone for Aldagen and the regenerative medicine field."

ALD-301 Overview

ALD-301 is the population of stem and progenitor cells that are produced using Aldagen's proprietary technology to sort a specified quantity of bone marrow collected from the patient receiving the therapy. Aldagen's technology isolates specific populations of adult stem cells that express high levels of aldehyde dehydrogenase (ALDH-bright cells). ALDH(br) cell populations isolated from bone marrow contain potent stem and progenitor cells representing all cell types thought to be needed for ischemic repair and include hematopoietic, endothelial, mesenchymal, and neural progenitor cells. A preclinical study involving hindlimb ischemia demonstrated that the ALDH(br) population was highly effective in restoring blood flow to ischemic limbs. CLI patients treated in a Phase 1/2 clinical study of ALD-301 experienced improvements in both blood flow and overall clinical status.

About Critical Limb Ischemia

Critical limb ischemia is a condition characterized by significant impairment of blood flow to the legs and feet caused by a blockage of the arteries. Patients with severe cases of critical limb ischemia may experience persistent pain in their lower extremities and may also suffer from severe tissue damage in the affected area. There are no drugs currently approved by the FDA for the treatment of this condition. For advanced critical limb ischemia patients with no other therapeutic options for improving blood flow, amputation of the affected limb is often the only available clinical option. The Sage Group estimates that approximately 2.0 million people in the United States have been diagnosed with critical limb ischemia and projects that this patient population will grow to nearly 2.8 million by 2020. The Sage Group also estimates that there are approximately 160,000 leg amputations performed on critical limb ischemia patients annually in the United States.

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 has three other products that are currently in, or have recently completed Phase 1 or Phase 1/2 clinical trials: 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.