Intellect Neurosciences, Inc., a biotechnology company with several drugs in various stages of development, released more data today regarding it lead Alzheimer’s candidate, OX1 (Oxigon™), which has recently completed a Phase 1b clinical trial. After releasing data in late October showing that the drug was well tolerated and safe at all dosing levels, the Company announced that it has received a pharmacokinetic profile report from a fourteen-day safety trial.
OX1 is a unique molecule that is being proven effective at promoting clearance of soluble beta amyloid and also blocks neurotoxicity that is created by free radicals. This neurotoxicity damages synaptic function in the brain which results in irreversible changes in the nerve cells.
The study, sponsored by Intellect and conducted by Kendle through the Kendle Clinical Pharmacology Unit in Utrecht, The Netherlands, was a double-blind, randomized, placebo-controlled, multiple escalating doses between three groups of twelve healthy, elderly volunteers over 60 years in age. The patients in the dosing group consisted of eight subjects which were given doses of 200, 400 or 800 mgs of OX1 at six hour intervals.
The new 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. This new data suggests that the drug could be administered less frequently than realized from the Phase I trials. In planning for the Phase II clinical trials, this data will now be factored as the Company plans to demonstrate the effects of OX1 in Alzheimer’s patients on a relevant biomarker in the cerebrospinal fluid.
Additional good news accompanied this pharmacokinetic data as well today as Intellect announced that they have been informed that the National Institute of Aging, a part of the National Institute of Health, will support the toxicology studies for OX1, which are slated to begin in the first part of 2011. This is part of a federal initiative to work at many levels and with many different companies and academics in a quest to find a therapy for Alzheimer’s disease. The National Institute of Aging has already worked with Intellect by giving support in the key safety and toxicology studies for OX1.
Due to the urgency to find a treatment for Alzheimer’s, Intellect is moving itself into a solid position within the industry and has become a subject of interest of larger biotechnology companies. According to Dr. Daniel Chain, Chairman and Chief Executive Officer of Intellect, “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.”
More information on Intellect Neurosciences, Inc. and its pipeline of compounds can be found on the Company’s website at www.intellectns.com.