Knopp Initiates Phase II Amyotrophic Lateral Sclerosis Study
Posted on: Tuesday, 8 April 2008, 09:04 CDT
US based Knopp Neurosciences has started the first Phase II study of KNS-760704 in patients with amyotrophic lateral sclerosis.
The study is designed as a two-part, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of KNS-760704 oral tablets. It will be conducted at approximately 20 centers in the US.
In the first past of the study, approximately 80 amyotrophic lateral sclerosis (ALS) patients from ages 21 to 80 whose symptoms started within the past two years will receive 12 weeks of treatment with low-dose, mid-dose, or high-dose KNS-760704 or matching placebo. Participants who complete part one will be eligible for a part two extension in which they will be re-randomized and will receive up to 28 weeks of treatment with either low-dose or high-dose KNS-760704. The company plans to initiate a larger proof-of-concept study in 2009, if KNS-760704 is shown to be safe and well-tolerated in this Phase IIa study.
Michael Bozik, president and CEO of Knopp, said: "Following the successful completion of our Phase I healthy volunteer studies in late 2007; we're pleased to be advancing KNS-760704 into clinical trials for ALS patients. This step represents another important milestone for Knopp in our efforts to develop an effective treatment for this relentless disease."
Source: Datamonitor
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