The U.S. Food and Drug Administration has accepted an investigational new drug application from Aldagen Inc., clearing the way for the Durham-based drug developer to start phase II clinical trials on its regenerative cell therapy for stroke patients.
Aldagen, which has had an $81 million initial public offering pending since fall 2009, says that the clinical trial will test the use of the company’s ALD-401 collection of stem cells as a treatment for stroke victims.
The 100 or so participants in the clinical trial will receive an injection of ALD-401 stem cells 13 to 19 days after suffering a stroke. The trial will test the ability of the stem cell therapy to alleviate stroke damage.
“Stroke represents the leading cause of disability in the U.S. and the third leading cause of morbidity,” said Aldagen CEO Lyle Hohnke in a news release. “The only product currently available for stroke treatment is an anti-clotting agent that must be administered within three hours of onset of the stroke. Because of this timing requirement, less than 5 percent of stroke patients receive the treatment. ALD-401 will be delivered about two weeks after a stroke and therefore has the potential to treat a large group of patients who have no therapeutic options.”
Aldagen filed plans in October 2009 for an $81 million initial public offering of stock but has yet to move forward with the IPO. The company in October 2010 announced the departure of Tom Amick as CEO and the hiring of Hohnke as Amick’s replacement. The company gave no reason for the departure of Amick.