Avalon starts second cohort of AVN944 phase 1 clinical trial in cancer

By E. Janene Geiss

Philadelphia, Feb. 7 - Avalon Pharmaceuticals, Inc. announced Tuesday the completion of a three-week dosing regimen on the first patient in cohort II and the initiation of cohort I of its phase 1 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, according to a company news release.

The first patient in cohort I, focused on leukemia patients, began treatment last week at the University of Texas MD Anderson Cancer Center.

"The phase 1 clinical trial for AVN944 has progressed well with the completion of dosing of our first patient and the initiation of the second cohort," Kenneth C. Carter, president and chief executive officer, said in the release.

The phase 1 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 2 efficacy trials, officials said.

In the current study, officials said, as many as 36 patients could receive AVN944 at or near this optimal dose.

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, officials said.

AVN944 was in-licensed by Avalon from Vertex Pharmaceuticals Inc. in February 2005. Vertex conducted a phase 1 trial in the United Kingdom in normal human volunteers where AVN944 was shown to be orally bioavailable and well-tolerated.

Avalon is a Germantown, Md., biopharmaceutical company focused on the discovery and development of small molecule therapeutics through the use of a proprietary suite of technologies based upon large-scale gene expression analysis called AvalonRx.

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