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Avalon Pharmaceuticals Announces Positive Interim Results For,AVN944 Phase I Trial

e dose escalation trial in patients with advanced hematologic malignancies. Patients are dosed for 21 days on a 28-day cycle. A minimum of three patients are treated at each dose level. The study is divided into two arms, one for treatment of leukemia patients and the other for treatment of patients with lymphoma and myeloma. For the leukemia arm of the study, patients are currently being treated at the tenth dose level, 250 mg twice daily. For the lymphoma and myeloma arm, patients are currently being treated at the sixth dose level, 150 mg twice daily.

Positive Safety and Tolerability Data: The goal of the Phase I study is to establish the safety, tolerability and pharmacokinetics of the drug. Thus far, 104 one-month cycles of AVN944 have been initiated in 46 patients and the compound is well tolerated. Pharmacokinetics measurements indicate dose proportional plasma levels of AVN944 during treatment and sustained plasma concentrations at the dose levels tested thus far.

Early Activity Indicators: This Phase I study is designed to evaluate several pharmacodynamic and efficacy-related endpoints. Upon entering the trial, all patients have refractory, progressive disease and have failed all prior therapies. Thus far, 18 of 39 evaluable patients (46%) showed stabilized disease after one cycle of treatment with AVN944. These include patients with both leukemia and multiple myeloma. Patients who have achieved stable disease following completion of a one-month treatment cycle with AVN944, as determined by the clinical investigator, may be advanced to a subsequent cycle.

In the multiple myeloma cohort 60% of the patients have achieved stabilized disease after one month. Two of these patients completed five months of treatment and two others completed one full year of treatment. One AML patient has completed 8 monthly cycles of treatment.

Positive Dose Dependent Biomarker Data: The AvalonRx(R) platform has identified selected biomarkers from pati
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