SGX ENDS TRIAL OF THIRD-LINE LEUKEMIA TREATMENT
SGX Pharmaceuticals has discontinued the Phase II/III trial of Troxatyl as a third-line treatment for patients with acute myelogenous leukemia (AML) based on the recommendation of the study's independent data and safety monitoring board. The board found that the study response rates were unlikely to provide evidence of a treatment benefit as a third-line treatment. The recommendation to discontinue the clinical trial was not made due to safety concerns.
"The response rates observed to date in our Phase II/III trial of Troxatyl are not at a level that we believe would support a new drug application as a third-line treatment for AML," said Mike Grey, president and chief executive officer of SGX.
The trial was designed to establish the safety and effectiveness of the drug 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. There are currently no approved therapies for treating third-line adult AML patients, and the historical median survival time is approximately two months.