NEW YORK, Oct. 27, 2010 (GLOBE NEWSWIRE) -- 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 obtained an initial draft report 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 3 groups of 12 healthy elderly volunteers aged 60 or more during 14 days of repeated dosing in a double blind, randomized, placebo-controlled, multiple escalating dose study. Each group consisted of 4 subjects receiving placebo and eight subjects receiving OX1 at doses of 200, 400 or 800 mg daily. The main conclusions of the draft report are that OX1 was safe and well tolerated at all dose levels, that there was no relationship between the frequency, incidence, severity, onset or duration of any the Adverse Events (AEs) and that these were not different from those in subjects receiving placebo. 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.
Dr. Daniel Chain, Chairman and Chief Executive Officer of Intellect, commented: "OX1 is the most advanced candidate in our internal pipeline and we are pleased to obtain this encouraging data concerning the safety of OX1 in humans. Much of the neurotoxicity in the Alzheimer's brain is believed to be related to the toxicity from super reactive oxygen species ("ROS") produced in the brain by beta amyloid bound to copper. Our excitement about the potential of OX1 as a disease-modifying treatment is based on this drug's unusual dual mechanism of action both as an extremely potent antioxidant and direct inhibitor of amyloid aggregation, apparently by interacting with the high affinity copper binding site. These properties make OX1 a promising form of treatment for Alzheimer's and numerous other indications involving copper mediated redox reactions. Moreover, the drug was previously shown to have strong neuroprotective effects in the brain especially against damage to cell membranes and DNA caused by ROS from different sources. For example, among independent research spanning more than a decade, a report last year in the Journal of Neuroscience (Volume 87, Issue 9, pages, 2126-2137, 2009) showed that in rodents, OX1 attenuates neuronal damage and oxidative stress in the ischemic hippocampus, the memory center of the brain."
Dr. Chain continued: "We anticipate obtaining a final audited report in December containing pharmacokinetic and other data concerning secondary objectives of the trial. We believe, based on discussions with potential pharma partners and other third parties, that positive data from planned proof of concept trials in patients 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."
About OXIGON™ (OX1)
The development of the OXIGON™ 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 OXIGON™ 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. OXIGON™ 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, motor neuron disease and Wilson's 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 U.S. $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.