Intellect Neurosciences obtains pharmacokinetic profile report from 14-day safety trial for its Alzheimer's candidate, OX1
Wednesday, December 29, 2010 13:00 IST
New York
Intellect Neurosciences, Inc. 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 I b 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 I trial. We are pleased to receive this data, which we will use in designing our planned phase II 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 II trials. Typically, licenses and or collaborations with large pharmaceutical companies yield substantial revenues from license fees, development milestone payments and royalties from sales."
The development of the OX1 compound has been supported in part by the National Institute of Aging, the BIRD Foundation and The Institute for the Study of Aging. Intellect is developing OX1 as a drug candidate for Alzheimer's disease and is exploring additional indications. The drug has disease-modifying potential because it has potent antioxidant activity and also can prevent aggregation, neurotoxicity and deposition of amyloid beta. The molecule was recently shown to act by a copper-binding mechanism, providing important insight into how the drug neutralizes neurotoxicity in the brain. OX1 has been tested in human Phase 1 trials for safety and tolerability at various doses and durations in a total of 90 elderly, healthy volunteers. The next planned stage of testing will be in patients with Alzheimer's disease. OX1 has broad potential for use in the treatment of other neurodegenerative conditions, such as Parkinson's disease and motor neuron disease.
Intellect Neurosciences, Inc. is a Manhattan-based biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease and other disorders.
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