Intellect obtains pharmacokinetic data from OX1 Phase 1b trial for Alzheimer's disease

Dec 28 2010

Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and multiple licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has obtained a draft pharmacokinetic report from its completed Phase 1b trial for its lead Alzheimer's candidate, OX1. The Company previously reported on the safety aspects of the trial, which demonstrated that OX1 is safe and well tolerated at all dose levels tested. 

The pharmacokinetic data indicates that the drug is rapidly absorbed and distributed in the body after oral administration. Moreover, the terminal elimination half-life increased from approximately 6-8 hours on the first day of the trial to 8-9 hours on the fourteenth day. 

The draft report was provided by Kendle, a global clinical research organization, which conducted the Phase 1b trial through the Kendle Clinical Pharmacology Unit located in Utrecht, The Netherlands.  Intellect is the sponsor of the trial, which consisted of 14 days of repeated dosing in a double blind, randomized, placebo-controlled, multiple escalating dose study with 3 groups of 12 healthy elderly volunteers aged 60 or more. Subjects in each group, consisting of 4 subjects receiving placebo and 8 subjects receiving OX1, were administered daily doses of 200, 400 or 800 mg at quarterly (6 hour) intervals.  

Dr. Daniel Chain, Chairman and Chief Executive Officer of Intellect, commented: "The increase in terminal elimination half-life suggests that the drug could be administered less frequently than in our completed Phase 1 trials. We are pleased to receive this data, which we will use in designing our planned Phase 2 trial, where we aim to demonstrate the drug's effect in Alzheimer's patients on a relevant biomarker in the cerebrospinal fluid." 

In a separate development, the Company announced that the National Institute of Aging (NIA), part of the National Institutes of Health, will support toxicology studies for OX1 as part of a federal effort to work with academia and the private sector to encourage the discovery and development of drugs for Alzheimer's disease. The NIA previously supported key safety and toxicology studies for OX1, which were conducted by the Biosciences Division of SRI International, Menlo Park, California. Dr. Chain commented: "We are delighted that the NIA will support additional development work needed for future clinical studies of OX1, which we expect to undertake early in the New Year."

Dr. Chain continued: "OX1 is a small molecule that works through a completely different mechanism of action than our products that are focused on immunotherapy-based approaches. OX1 not only promotes clearance of soluble beta amyloid but also directly blocks neurotoxicity caused by free radical generating reactions that damage synaptic function in the brain and ultimately give rise to irreversible changes inside nerve cells. We have received interest from several large pharmaceutical companies regarding OX1 and anticipate partnering this drug in the future.  We look forward to moving forward with our clinical and regulatory development plan that includes the filing of an Investigational New Drug application (IND) with the FDA to support initiation of Phase 2 trials. Typically, licenses and or collaborations with large pharmaceutical companies yield substantial revenues from license fees, development milestone payments and royalties from sales."