Encouraging Ph I data for Avalon's AVN944

The USA's Avalon Pharmaceuticals says that Phase I study data on AVN944, its lead product candidate, for the treatment of hematologic malignancies, shows that it is well-tolerated, has dose-dependent pharmacokinetics, induces biomarkers of programmed cell death in cancer cells from patients and has resulted in stabilized disease after a one-month treatment cycle in half of the patients that have been treated thus far.

Michael Hamilton, chief executive of Avalon, said: "the fact that we have not seen any drug-related serious adverse events, combined with several indications of biological drug effects and disease stabilization in multiple patients indicates that there will likely be a good therapeutic window from which to establish an effective treatment protocol. Based on preclinical data and the positive trends that we have seen thus far in the Phase I, we believe that the immediately upcoming dose levels in the Phase I trial should provide sufficient information to support a goal of initiating multiple Phase II studies during the first half of 2007."

AVN944 is an oral, small-molecule drug that inhibits inosine monosphospate dehydrogenase (IMPDH), a critical enzyme for synthesis of guanosine triphosphate, a molecule required for DNA synthesis and cellular signaling. IMPDH is over expressed in many cancer cells, especially from hematological malignancies. Preclinical studies showed that AVN944 is a highly specific inhibitor of IMPDH, suppresses pools of GTP, and in cultured cells has a selective growth inhibition effect on cancer cells versus normal cells, the firm noted.