Vion Pharmaceuticals, Inc. (VION.PK) said Tuesday it entered into an agreement with the Dutch-Belgian Cooperative trial Group for Hematology Oncology or the HOVON to initiate a clinical trial of laromustine in patients with previously untreated acute myelogenous leukemia or AML and high-risk myelodysplasia or MDS.
The trial would be conducted at different sites in Netherlands, Belgium, Switzerland and Norway and is expected to start by September.
The trial that has been designated as Phase III study would be conducted in two parts. The first part or Part A would determine the feasibility of laromustine or Cloretazine VNP40101 administration at three possible dose levels in combination with cytarabine and idarubicin.
In addition, Part A would also study the pharmacokinetics and the clinical efficacy of the laromustine combination.
The second part or Part B would evaluate the clinical efficacy of the laromustine combination versus two cycles of cytarabine and idarubicin without laromustine for clinical outcome, complete reemission rate, disease free survival, risk of relapse and overall survival, as well as the tolerance and toxicity and pharmacokinetics of the combination.
Vion's stock that has been trading in the range of $0.32 to $11.00 in the past 52 weeks closed Monday's session at $0.32.
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