Avalon initiates Phase II cancer drug trial

The trial will be conducted in two parts, both using an open-label, non-controlled design. Eligible patients will include adult patients with advanced newly diagnosed pancreatic cancer. Part A is a dose-escalation study with a primary objective to determine the maximum tolerated dose or effective biologic dose of AVN944 in combination with gemcitabine. Approximately 15-20 patients will be enrolled in Part A.

Part B is to establish the efficacy and safety of the AVN944/gemcitabine combination and approximately 110-120 patients will be enrolled. Patients will receive an initial treatment cycle of AVN944 and gemcitabine and may receive additional cycles of treatment every 28 days at the discretion of the investigator and with the agreement of the patient.

Results from preclinical studies of AVN944 indicate that the drug candidate inhibited the proliferation of lymphoid and myeloid cells, the principal cells involved in the most common types of human leukemias. In a single-dose, dose- escalation Phase I clinical trial of AVN944 conducted in the UK in healthy volunteers, AVN944: was well tolerated at all tested doses with no notable side effects; demonstrated good pharmacokinetic properties; and had a significant inhibitory effect on inosine monosphospate dehydrogenase enzyme activity.

Avalon filed an IND with the FDA in August 2005 and initiated US Phase I clinical trials in January 2006 for the treatment of hematological cancers.