New drug AVN944

Avalon Pharmaceuticals, Inc. (Nasdaq: AVRX), a biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced the completion of a three week dosing regimen on the first patient in Cohort II and the initiation of Cohort I of its Phase I clinical trial of AVN944 in patients with advanced hematological malignancies. The first patient in Cohort II, which is focused on multiple myeloma and lymphoma patients, completed the three week scheduled dosing at the University of Arkansas for Medical Sciences with no adverse side effects.

The Phase I clinical trial is designed as an open-label, repeat dose-escalation study for the evaluation of the safety and tolerability of AVN944 in adult patients with advanced hematological malignancies including those with leukemia, lymphoma or myeloma. The study is designed to determine the optimal dose with which to advance Phase II efficacy trials. In the current study, as many as 36 patients could receive AVN944 at or near this optimal dose. Currently, this trial is being conducted at four leading cancer centers in the United States, including the University of Arkansas for Medical Sciences, The University of Texas MD Anderson Cancer Center, Stanford University, and The Ohio State University Comprehensive Cancer Center -- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. Information on the trial, including other site locations when they initiate treatment, will be available at the National Institutes of Health clinical trial database at http://www.ClinicalTrials.gov.

AVN944 is an oral, small molecule inhibitor of the enzyme inosine monophosphate dehydrogenase (IMPDH), an enzyme that is essential for the de novo synthesis of the nucleotide guanosine triphosphate (GTP). AVN944 appears to inhibit cell proliferation by denying dividing cells of the GTP necessary for synthesis of DNA and RNA. IMPDH is highly upregulated in hematologic cancers and many other types of cancer cells are also sensitive to IMPDH inhibition.

AVN944 was in-licensed by Avalon from Vertex Pharmaceuticals Incorporated in February of 2005. Vertex conducted a Phase I trial in the U.K. in normal human volunteers where AVN944 was shown to be orally bioavailable and well-tolerated.

This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to future clinical progress in the development of AVN944. Such statements reflect the current views of Avalon management and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, risks and uncertainties including the risk that AVN944 will not progress successfully in its clinical trials, and other risks described in our SEC filings. There can be no assurance that such development efforts will succeed, that AVN944 will receive required regulatory clearance or, even if such regulatory clearance is received, that any subsequent products will ultimately achieve commercial success.

Source: http://www.avalonrx.com/