MYRIAD GENETICS LAUNCHES BRAIN TUMOR STUDY

Myriad Genetics has initiated the first Phase II clinical trial of its therapeutic candidate, Azixa (MPC-6827), in patients with brain cancer.

The trial is designed to determine the safety profile of Azixa and the extent of its ability to improve the survival of patients with glioblastoma multiforme, the most common form of primary brain cancer. The trial will compare the survival of patients treated with Azixa with the survival of those treated with oxaliplatin alone and Azixa plus oxaliplatin.

The trial is designed as an adaptive, open-label, multiple-dose study in patients with recurring or relapsed glioblastoma multiforme. The first stage of the trial is designed to determine the safety and the maximum tolerated dose of Azixa in combination with oxaliplatin in approximately 16 patients. The maximum tolerated dose of Azixa alone was determined during the earlier Phase I trials.

The second stage of the trial will then assess the survival of patients treated with the Azixa-oxaliplatin combination therapy compared with Azixa or oxaliplatin alone. Patients will be randomized into one of the three treatment arms.

Azixa has a dual mode of action: It acts as a cytotoxin and a vascular disrupting agent (VDA). VDAs kill tumor cells by reducing the blood supply to a tumor. The disruption of the tumor vasculature results in acute ischemia followed by massive tumor cell death. Azixa is believed to selectively disrupt tumor vasculature and not healthy tissue by inhibiting the formation of microtubules. Tumors rely on microtubules to maintain the cytoskeletal structure of their new vasculature, whereas mature vascular endothelium of healthy tissue uses actin filaments to provide the needed structure, according to Myriad.