NEW YORK, Aug. 10, 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 received a Notice of Allowance from the United States Patent and Trademark Office related to RV01 and RV02, the Company's two lead vaccine candidates. The Notice of Allowance is a written communication stating that the patent application has been allowed and will be granted as a new patent. RV01 and RV02, generated using the Company's RECALL-VAX technology, have the potential to delay the onset of or prevent Alzheimer's disease in individuals susceptible by age, genetic or other risk factor. Patents previously have been issued in Europe, Australia, New Zealand and South Africa, and patents are pending in Canada and Israel.
Dr. Daniel Chain, Chairman and Chief Executive Officer of Intellect, commented, "Many view a vaccine of this nature, which is analogous to a flu shot, as the ultimate quest in Alzheimer's research. This new patent should increase interest from potential strategic partners to collaborate with Intellect on the RECALL-VAX program. Alzheimer's disease remains the largest unmet medical need in neurology, with existing Alzheimer's treatments only easing symptoms of the disease. This patent is indicative of the type of innovative research at Intellect aimed at discovering drugs that can fundamentally transform the way Alzheimer's disease is treated and ultimately prevent the onset of the disease. The Notice of Allowance is another important milestone for Intellect. It heralds a bold new approach that may drastically reduce the incidence of Alzheimer's disease for the 115.4 million people who are expected to suffer from the disease by 2050."
Professor Benjamin Chain, Department of Immunology, UCL School of Life and Medical Sciences, London, UK, is the inventor of the RECALL-VAX technology. Professor Chain, brother of Intellect CEO Dr. Daniel Chain, is a member of the Company's scientific advisory board.
Intellect presented the first animal data regarding RECALL-VAX in August 2007 at the 13th International Congress of Immunology in Rio de Janeiro, Brazil. "We demonstrated in preliminary animal studies that we can use this method of vaccination to generate highly specific antibodies in blood that bind Aβ toxin, which accumulates in the brains of Alzheimer's patients, while avoiding binding to the Amyloid Precursor Protein, which has important physiological functions in the brain and other tissues," added Daniel Chain. "This vaccine could achieve the goal of a safe immunotherapy for Alzheimer's disease, providing prevention in at-risk populations. To the best of our knowledge, no other vaccine in development guarantees specificity for Aβ, which is necessary to avoid possible toxicities that may manifest over time."
Intellect's Immunotherapy Approaches:
The Alzheimer's toxin Aß is generated from a much larger protein known as the Amyloid Precursor Protein ("APP"). APP is widely expressed and especially concentrated in the synapses of CNS neurons and on the surface of blood platelets. Various physiological functions are attributed to APP, including the growth and protection of neurons and wound healing. In 1997, Dr. Daniel Chain invented a method, the ANTISENILIN® platform, using an administered monoclonal antibody for treating Alzheimer's disease. The goal was to remove Aβ protein without affecting the normal physiological role of APP. However, Aβ is almost identical to APP, making it difficult to achieve the required specificity. Dr. Chain overcame this problem by pinpointing the unique molecular signatures at either end of Aβ, which are not present in APP: the presence of a free amino (NH2) and carboxyl (CO2) group. Major pharmaceutical companies have monoclonal antibodies in Phase 2 and Phase 3 clinical trials based on Dr. Chain's invention and have purchased royalty-bearing licenses from the Company. RECALL-VAX is a method to reproduce the same specificity in an active vaccine. The advantage of a vaccine is that it can be administered less frequently and is less expensive than a monoclonal antibody and has the possibility to be used in a larger population than a monoclonal antibody. Moreover, a vaccine is more easily used as a preventative treatment as well as a therapeutic treatment. After specificity, the primary concern related to using an active vaccine based on an endogenous protein such as Aβ is the existence of T-cell epitopes that could give rise to an autoimmune response in certain individuals, as occurred previously with the AN1792 vaccine tested by Elan Pharma and Wyeth. Another challenge is overcoming a weak immune system in elderly people. To overcome these issues, RECALL-VAX generates antibodies that are highly specific for Aβ such that they will not bind to APP, have low potential to stimulate an autoimmune response and stimulate an autoimmune response in elderly patients. The technology utilizes Tetanus Toxoid, previously used in other vaccines in FDA-approved clinical trials, to activate a memory imprint in the immune system, which is expected to overcome the problem of immunizing older people without the need to resort to potentially harmful adjuvants. Preliminary results demonstrate that mice vaccinated with RECALL-VAX generate antibodies that bind to Aβ, but not APP. The result could be a safe, efficacious, and cost-effect preventative treatment and therapeutic agent for Alzheimer'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 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 effects. 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, 2009, and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2010, filed on May 17, 2010.