TKT REPORTS POSITIVE RESULTS OF HUNTER SYNDROME PIVOTAL TRIAL

Transkaryotic Therapies has announced positive top-line results from the company's pivotal Phase III clinical trial evaluating its investigational human enzyme replacement therapy, iduronate-2-sulfatase (I2S), for the treatment of patients with Hunter syndrome.

Hunter syndrome, also known as MPS II, is a rare, life-threatening genetic disorder with no available treatment.

In the trial, patients who received 0.5 mg/kg of I2S on a weekly basis showed a statistically significant improvement in the primary efficacy endpoint compared to patients receiving placebo. Based on these results, TKT expects to file for regulatory approval of I2S in both the U.S. and Europe in the fourth quarter of 2005.