SGX Pharmaceuticals discontinues clinical trial of Troxatyl in acute myelogenous leukemia

09-28-2006

SGX Pharmaceuticals, Inc. (SGXP) has discontinued the Phase II/III clinical trial of Troxatyl as a third-line treatment for patients suffering from acute myelogenous leukemia (AML), based upon the recommendation of the study's independent data and safety monitoring board (DSMB).

The DSMB found that the study response rates were unlikely to provide evidence of a treatment benefit as a third-line treatment for patients with AML. The recommendation to discontinue the clinical trial was not made due to safety concerns.

The Phase II/III trial was designed to establish the safety and effectiveness of Troxatyl in patients with relapsed or refractory AML. Patients targeted in this study are those who are in a second relapse with duration of second response less than six months, or who were refractory to two previous courses of induction chemotherapy. A DSMB was instituted before the study's commencement to periodically review safety and efficacy data and make recommendations about study conduct.

The study was designed to demonstrate a meaningful improvement over the historical data from the M.D. Anderson Cancer Center database, which documented a complete response rate of 4.7 percent in this patient subgroup. The observed response rates in the Phase II/III trial to date did not show a meaningful improvement over the response rates in the M.D. Anderson Cancer Center historical database. There are no approved therapies for treating third-line adult AML patients and the historical median survival time is approximately two months.

This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2006, Biotech Business Week via NewsRx.com.