Intellect Neurosciences locks database of OXIGON Phase 1b clinical trial for Alzheimer's disease

Aug 18 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 locked the database 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 36 healthy elderly volunteers aged 60 or more during 14 days of repeated dosing in a double blind, randomized, placebo-controlled, multiple escalating dose study. Locking of a database is done after review, query resolution, and a determination that the database is ready for analysis. 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.  As the sponsor, Intellect takes responsibility for the initiation and management of the clinical trial.

Dr. Daniel Chain, Chairman and Chief Executive Officer of Intellect, commented: "OX1 is the most advanced candidate in our internal pipeline.  The drug works directly on amyloid beta to which it binds, stabilizing the non-toxic form of the protein and, through an antioxidant mechanism, prevents oxidative damage, which would otherwise lead to inflammation and cell death. This dual activity gives OX1 the potential to slow down or arrest Alzheimer's disease in the early stages. Moreover, we believe that OX1's mechanism of action has applications for other disease indications, such as Wilson's disease, a rare but potentially fatal hereditary disorder for which no effective treatment exists."  

Dr. Chain continued: "We are pleased to reach this important milestone. We anticipate  obtaining a draft report in October, followed soon thereafter by a final report containing the audited data from the trial. The next step is to file an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to permit the initiation of Phase 2 trials in patients, which we intend to conduct at a single clinical trial center in the United States, assuming sufficient financial resources. Our Phase 2 plan is to test OX1 in Alzheimer's patients and examine its effects on various relevant biological markers in the brain and blood. We believe, based on discussions with potential pharma partners and other third parties that positive data from this short and cost efficient trial 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."