Incara Pharmaceuticals Corporation announced that it has submitted an Investigational New Drug application (IND) with the US Food and Drug Administration (FDA) to begin Phase 1 clinical trials of AEOL 10150 for the possible treatment of patients with amyotrophic lateral sclerosis (also known as "ALS" or "Lou Gehrig's disease").
ALS, the most common motor neuron disease, results from progressive degeneration of both upper and lower motor neurons and is usually fatal within 5 years of symptom onset. Unless there are unexpected questions from the FDA on the IND, Incara expects to begin dosing of the first volunteers for the Phase 1 clinical trials before the end of the second quarter of this year.
The Phase 1 clinical study is designed to test the safety of AEOL 10150 in healthy volunteers and, ultimately, patients diagnosed with ALS. If the Phase 1 clinical trial results are satisfactory in terms of safety, Incara's clinical plan calls for initiating Phase 2/3 clinical trials of AEOL 10150 for the possible treatment of ALS as early as the first half of 2005. Phase 2/3 clinical studies are designed to determine if a new compound is effective in the treatment of a specified disease or disorder. Satisfactory Phase 2/3 clinical trial results could serve as the basis for the filing of a New Drug Application (NDA) for AEOL 10150.
"Submission of the first IND from our catalytic antioxidant programme represents a milestone event for Incara," said Clayton I. Duncan, president and CEO of Incara. "We believe that our patented compounds represent a unique approach for the possible treatment of neurodegenerative diseases, including ALS." Duncan further added that, "Successful development of AEOL 10150 could offer a new treatment option for a group of seriously ill patients who now have few alternatives."
Incara also announced the resignation of Duncan as its president and CEO. Duncan's resignation is immediate, but the company stated that he will remain as a consultant for an indefinite period of time.
"It has been both a pleasure and an honor to work with such a dedicated and talented group of employees, collaborators and scientific founders in completing this important milestone in advancing Incara's catalytic antioxidant programme," said Duncan. "I look forward to following the progress as the company enters clinical trials."