Aldagen Announces Initiation of ALD-101 Phase III Trial for Improving Cord Blood Transplants in Pediatric Patients With Inherited Metabolic Diseases
Trial to Be Conducted at Multiple Clinical Sites
DURHAM, NC--(Marketwire - April 16, 2008) - Aldagen, Inc. today announced that the first patient has been treated in a Phase III clinical trial for ALD-101. Aldagen is developing ALD-101 to improve cord blood transplants used to treat inherited metabolic diseases in pediatric patients. ALD-101 is a population of adult stem cells isolated from cord blood using Aldagen's proprietary technology. The company commenced the Phase III clinical trial of ALD-101 to evaluate its ability to accelerate neutrophil and platelet engraftment following cord blood transplantation in these patients.
40 pediatric patients with inherited metabolic diseases undergoing a cord blood transplant will be treated in the multi-site Phase III clinical study. The primary goal of the study is to determine if ALD-101 can accelerate the restoration of circulating platelets. A 24-patient Phase I/II study of ALD-101 was previously conducted and a statistically significant reduction in the time to platelet engraftment was observed in patients receiving ALD-101 as part of a cord blood transplant compared to patients who had received a cord blood transplant without ALD-101 in an earlier independent clinical trial.
Cord blood transplantation has been shown to successfully treat children with inherited metabolic diseases, such as Krabbe Syndrome, Metachromatic Leukodystrophy, Hurler Syndrome, and Adrenoleukodystrophy. These diseases are often fatal with few treatment options other than a stem cell transplant. Cord blood transplants do carry numerous risks. The time for cord blood transplant patients to regain adequate levels of neutrophils and platelets, referred to as engraftment, can be lengthy. During the period of time between transplant and engraftment, patients are at high risk for life-threatening infections, bleeding, and transfusion-related reactions. About Cord Blood Transplants
Umbilical cord (UBC) stem cells are located in the umbilical cord of a newborn at birth. After the baby has been delivered and the umbilical cord has been cut, blood is drawn from the umbilical cord. It is a completely non-invasive procedure with absolutely no risk to either mother or child. Umbilical cord stem cells are not embryonic stem cells. 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 III clinical trial to evaluate its effectiveness in improving cord blood transplants used to treat inherited metabolic diseases in pediatric patients. The Company is also conducting Phase I/II clinical trials on three product candidates: ALD 151 to improve cord blood transplants in the treatment of leukemias, ALD-301 to treat critical limb ischemia, and ALD-201 to treat ischemic heart failure. Aldagen's product candidates consist of specific populations of active adult stem cells that the Company isolates using its proprietary technology. To learn more about ALDAGEN, please visit www.aldagen.com.
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