(AP:THE WOODLANDS, Texas) Opexa Therapeutics Inc. said Wednesday it is preparing to start a late-stage clinical trial of Tovaxin, a multiple sclerosis treatment that uses cells from the patient’s body to fight the disease.
The company said it met with the Food and Drug Administration twice after finishing midstage testing of Tovaxin, and now knows what the FDA expects from a late-stage study. That makes it more likely the FDA will approve the drug if the trial is successful. Opexa did not disclose specifics about the trial, but said its plans are partly based on data showing that Tovaxin was effective in reducing MS relapses patients who had not been treated with any other therapies except steroids.
Opexa and the FDA discussed the design of the trial, the types of patients to be selected, and improvements to the manufacturing process for the drug.
Tovaxin is designed to train each patient’s immune system to fight a particular type of white blood cell that is involved in multiple sclerosis. The vaccine is made by drawing blood from a patient and isolating specific types of T-cells. The cells are then expanded and irradiated so they cannot divide and reproduce. Patients take the drug in a series of five injections. The first four are given one month apart, and the fifth is given two months later.
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