Aldagen discontinues ALD-101, amends IPO

Aldagen Inc. (Durham, N.C.) disclosed in an SEC filing that in January it discontinued development of lead clinical candidate ALD-101 to improve cord blood transplantation in pediatric patients with inherited metabolic disorders. The company said the agency was unlikely to accept the use of historical controls from a Phase I trial of ALD-101 as a comparator in a Phase III trial, which the company has terminated. The company concluded that further development was not a "prudent use of resources." ALD-101 is a mix of stem and progenitor cells isolated from the 20% fraction of a banked cord blood unit. Aldagen also said it split the roles of CEO and Chairman W. Thomas Amick. Amick is remaining CEO and became president in March, while Richard Kent, a venture partner at Intersouth Partners, became chairman.

The company's next most advanced clinical candidate is ALD-301, a mix of stem and progenitor cells isolated from the patient's bone marrow. It has completed Phase I/II testing to treat critical limb ischemia, with a Phase II trial planned for this year. Aldagen also has two marketed products: Aldefluor, a kit to identify stem and progenitor cells for research; and Aldecount, an in vitro diagnostic to identify and count stem and progenitor cells that express high levels of aldehyde dehydrogenase (ALDH). ...