Icagen Initiates Enrollment in Trial of ICA-17043 to Treat Sickle Cell Disease

Icagen has initiated enrollment in its pivotal Phase III trial of ICA-17043 for the treatment of sickle cell disease.

The ASSERT study, or "A Stratified Sickle Event Randomized Trial," is a randomized, double-blind, placebo-controlled study in 300 patients. The study will be conducted at approximately 60 sites across the U.S. and in selected other countries.

Patients will be eligible for the ASSERT study if they have a diagnosis of sickle cell disease, are between the ages of 16 and 65 and have a history of at least two vaso-occlusive crises requiring a visit to a medical facility in the year prior to enrollment. The protocol provides for patients to be randomized into either a treatment arm or a placebo arm, each consisting of approximately 150 patients. Under the study protocol, patients are to be treated for a period of one year.

The primary endpoint for this study is vaso-occlusive crisis rate. In addition, a number of secondary endpoints will be evaluated, including many of those, such as hemoglobin level, analyzed in the Phase II trial of ICA-17043.