Aldagen Receives Orphan Drug Designation for ALD-101 

Aldagen is currently conducting a Phase 3 trial infusing ALD-101 inpatients with inherited metabolic disorders undergoing umbilical cord bloodtransplantation. Cord blood transplantation is commonly used to treatchildren with inherited metabolic diseases, including Krabbe syndrome,metachromatic leukodystrophy, Hurler syndrome and adrenoleukodystrophy.These diseases are progressive, degenerative and often fatal. In manycases, the only treatment available to these patients is a transplant ofblood-forming stem cells found in cord blood. Umbilical cord stem cells arelocated in the umbilical cord of a newborn at birth. Umbilical cord stemcells are not embryonic stem cells.

The FDA orphan drug designation, administered by the Office of OrphanProducts Development, provides potential incentives such as funding forclinical studies, study design assistance, waiver of FDA user fees, taxcredits and, importantly, up to seven years of market exclusivity uponmarketing approval.

"FDA orphan drug designation for ALD-101 is an important asset in Aldagen'sdevelopment of ALD-101," said Tom Amick, Chairman and Chief ExecutiveOfficer of Aldagen. "We are encouraged by the reductions in engraftmenttimes seen in the Phase 1 ALD-101 trial and look forward to continuing ouron-going Phase 3 trial of ALD-101."

About ALD-101

ALD-101 is the population of stem cells that Aldagen produces from aportion of an umbilical cord blood unit using our proprietary stem cellisolation technology. ALD-101 is infused into the patient shortly after thetransplant of the remaining portion of the cord blood unit. In a 24 patientPhase 1 clinical trial, Aldagen observed a reduction in the time toplatelet and neutrophil engraftment in patients receiving ALD-101 followingtheir cord blood transplant, as compared to similar patients who hadreceived a cord blood transplant without ALD-101 in an earlier independentclinical trial. In each case, these reductions were statisticallysignificant, with p-values of 0.05 or less. The pivotal Phase 3 clinicaltrial of ALD-101 is designed to further evaluate its ability to accelerateengraftment following cord blood transplants in pediatric patients withinherited metabolic diseases.

About Aldagen, Inc.

Aldagen is a biopharmaceutical company developing proprietary regenerativecell therapies that target significant unmet medical needs. The company hasfour product candidates in clinical trials. Aldagen's most advanced productcandidate, ALD-101, is currently in a pivotal Phase 3 clinical trial toevaluate its efficacy in improving umbilical cord blood transplants used totreat inherited metabolic diseases in pediatric patients. The company alsois conducting or supporting Phase 1 or Phase 1/2 clinical trials of threeother product candidates: ALD 151 to improve umbilical cord bloodtransplants used in the treatment of leukemia, ALD-301 to treat criticallimb ischemia, and ALD-201 to treat ischemic heart failure. Aldagen'sproduct candidates consist of specific populations of adult stem cells thatthe company isolates using its proprietary technology.

For more information, contact:Ed FieldPresident and COOAldagen919-484-2571Email ContactMichelle LinnLinnden Communications508-362-3087Email Contact