Intellect obtains initial draft report of OXIGON Phase 1b clinical trial for Alzheimer’s disease

Oct 27 2010

Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has obtained an initial draft report of the Company's Phase 1b clinical trial for its lead Alzheimer's candidate, OXIGON™ (OX1). The Company tested OX1 for safety and tolerability in 3 groups of 12 healthy elderly volunteers aged 60 or more during 14 days of repeated dosing in a double blind, randomized, placebo-controlled, multiple escalating dose study. Each group consisted of 4 subjects receiving placebo and eight subjects receiving OX1 at doses of 200, 400 or 800 mg daily. The main conclusions of the draft report are that OX1 was safe and well tolerated at all dose levels, that there was no relationship between the frequency, incidence, severity, onset or duration of any the Adverse Events (AEs) and that these were not different from those in subjects receiving placebo. Intellect is the sponsor of this trial, which was conducted by Kendle, a global clinical research organization, through the Kendle Clinical Pharmacology Unit located in Utrecht, The Netherlands. 

Dr. Daniel Chain, Chairman and Chief Executive Officer of Intellect, commented: "OX1 is the most advanced candidate in our internal pipeline and we are pleased to obtain this encouraging data concerning the safety of OX1 in humans. Much of the neurotoxicity in the Alzheimer's brain is believed to be related to the toxicity from super reactive oxygen species ("ROS") produced in the brain by beta amyloid bound to copper. Our excitement about the potential of OX1 as a disease-modifying treatment is based on this drug's unusual dual mechanism of action both as an extremely potent antioxidant and direct inhibitor of amyloid aggregation, apparently by interacting with the high affinity copper binding site. These properties make OX1 a promising form of treatment for Alzheimer's and numerous other indications involving copper mediated redox reactions. Moreover, the drug was previously shown to have strong neuroprotective effects in the brain especially against damage to cell membranes and DNA caused by ROS from different sources. For example, among independent research spanning more than a decade, a report last year in the Journal of Neuroscience (Volume 87, Issue 9, pages, 2126-2137, 2009) showed that in rodents, OX1 attenuates neuronal damage and oxidative stress in the ischemic hippocampus, the memory center of the brain."

Dr. Chain continued: "We anticipate obtaining a final audited report in December containing pharmacokinetic and other data concerning secondary objectives of the trial. We believe, based on discussions with potential pharma partners and other third parties, that positive data from planned proof of concept trials in patients would help secure a strategic partnership to accelerate OX1's development and commercialization. Typically, license and or collaborations with large pharmaceutical companies yield substantial revenues from license fees, development milestone payments and royalties from sales."