NEW YORK, Dec. 27, 2010 (GLOBE NEWSWIRE) -- 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."
About OX1 (OXIGON™)
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.
About Alzheimer's Disease
Alzheimer's disease, the most common form of dementia, is characterized by progressive loss of memory and cognition, ultimately leading to complete debilitation and death. A hallmark feature of Alzheimer's pathology is the presence of insoluble protein deposits, known as amyloid beta, on the surface of nerve cells, which results from the accumulation of soluble neurotoxic amyloid beta in the brain. The effects of the disease are devastating to patients as well as their caregivers, with significant associated health care costs. It is estimated that there are more than five million Americans and about 30 million people worldwide suffering from Alzheimer's disease, with the number expected to increase dramatically as the global population ages. Currently marketed drugs transiently affect some symptoms of the disease, but there are no drugs on the market today that slow or arrest the progression of the disease. These symptomatic drugs are projected to generate more than US $6 billion in sales this year, indicating both the size of the market and the demand for effective treatment beyond symptomatic improvements.
About Intellect Neurosciences, Inc.
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. The Company's drug product pipeline includes OX1, which has been tested in Phase 1 clinical trials; IN-N01, a humanized monoclonal antibody designed to promote the clearance of soluble amyloid beta; and RECALL-VAX, a vaccine technology that has the potential to delay or prevent Alzheimer's disease in people who are at risk.
The Company has significant intellectual property assets, which include several patent families underlying the Company's internal programs, and a pivotal patent estate regarding passive AD immunotherapy.
The Company's ANTISENILIN® patent estate claims monoclonal antibodies that bind either end of amyloid beta but do not interact with the amyloid precursor protein from which amyloid beta is produced in the body. This high degree of specificity is an important safety feature reducing the potential for adverse affects. Examples of monoclonal antibodies exhibiting this property are Bapineuzumab and Ponezumab in Alzheimer's Phase 3 and Phase 2 clinical trials, respectively (http://clinicaltrials.gov/ct2/show/NCT00574132?term=bapineuzumab&rank=1; http://clinicaltrials.gov/ct2/results?term=PF-04360365).
Patents have been granted in Europe, Japan, China and elsewhere, and are pending in the United States. Intellect has granted royalty-bearing licenses to its ANTISENILIN® patent estate to several top tier global pharmaceutical companies developing monoclonal antibodies for Alzheimer's disease. For further information, see the Company's filings with the Securities and Exchange Commission, including Forms 8-K filed on:
May 1, 2009
http://www.sec.gov/Archives/edgar/data/1337905/000114420409023426/v147731_8k.htm
January 8, 2009
http://www.sec.gov/Archives/edgar/data/1337905/000114420409000980/0001144204-09-000980-index.htm
October 14, 2008
http://www.sec.gov/Archives/edgar/data/1337905/000114420408057464/0001144204-08-057464-index.htm
May 19, 2008
http://www.sec.gov/Archives/edgar/data/1337905/000114420408030722/v115138_8k.htm
Safe Harbor Statement Regarding Forward-Looking Statements:
The statements in this release and oral statements made by representatives of Intellect relating to matters that are not historical facts (including without limitation those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Intellect's product candidates and the sufficiency of Intellect's cash and other capital resources) are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Intellect's ability to fund such efforts with or without partners. Intellect undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Intellect's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in Intellect's Annual Report on Form 10-K, (file no. 333-128226) filed on October 13, 2010.