Marshall
Edwards, Inc., an oncology firm focused on the clinical progress of novel
therapeutics targeting cancer metabolic rate, introduced the fact that first
cohort of affected individuals continues to be dosed in a Phase I clinical
trial of ME-344, the Company's manage mitochondrial inhibitor drug candidate,
in affected individuals with refractory solid tumors. The treatment increases
trial is predicted to register up to 24 affected individuals in as much as five
cohorts with final security and pharmacokinetic data anticipated to begin with
half of 2013.
"We
are very happy to see the exhilaration adjacent our preliminary clinical trial
of ME-344, together with the first cohort of patients now well underway only a
month after our Investigational New Drug utility was accepted by the FDA,"
said Robert D. Mass, MD, Chief Medical Officer of Marshall Edwards.
"ME-344 is definitely a novel compound that in fact showed compelling
anti-tumor exercise in pre-clinical research. Now we examine forward to
gathering important clinical data within the months ahead, all of these will
help enhance the design of our Phase II performance studies."
The
Phase I clinical trial is assessing the security and tolerability of intravenous
ME-344 in escalating treatment cohorts of 1.2 mg/kg, 2.5 mg/kg, 5 mg/kg, 10
mg/kg and 20 mg/kg. Moreover, the trial requires embrace the pharmacokinetic
profile of ME-344 and explain any preliminary clinical anti-tumor exercise
observed. Affected individuals in the trial are applied intravenous infusions
of ME-344 once weekly for 3 weeks and, after safety evaluation, may keep weekly
dosing if a medical benefit is decided.
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