NEW YORK, May 15, 2012 /PRNewswire/ -- Intellect Neurosciences, Inc. (OTCBB: ILNS), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment of Alzheimer's and other neurological diseases, today issued the following Letter to Shareholders from Dr. Daniel Chain, Chairman and CEO.
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Every day we draw closer to the announcement of data results from the bapineuzumab and solanezumab Phase 3 studies. There is a great deal of speculation and anticipation regarding the results, which we expect will be reflected soon in the mainstream media. In the meantime, we are reintroducing Intellect to professional investors and the media, as we are part of this historic moment. While today we may be relatively unknown, our pioneering ANTISENILIN technology is at the heart of several of the Alzheimer's compounds in development. Accordingly, positive data will provide validation of our technology and raise our corporate profile.
It is possible that data from the Phase 3 studies will fail to demonstrate a statistically significant benefit over placebo. Enormous challenges come with conducting a complex trial across hundreds of clinical centers around the globe and in a population as heterogeneous as Alzheimer's patients. Yet, a less than clear-cut result should not end the development of these drug candidates. Moreover, the read-outs from these trials will provide vital information that will be used by the industry when designing future clinical trial protocols for next-generation therapeutics like Intellect's dual target vaccine RV03 and other drug candidates in our preclinical pipeline.
The ongoing Phase 3 studies were designed several years ago. The Alzheimer's field has developed tremendously since that time. Scientists have increased their understanding of the underlying pathophysiology involved at all stages of the disease, and there are better tools available to help select pre-symptomatic patients or those at the earliest stages of the disease and to monitor them for drug effectiveness. These developments, in part driven by previous bapineuzumab and solanezumab trials, should reduce the complexity of future trials and increase the speed at which new Alzheimer's disease drugs come to market.
Approximately eighteen months ago, Intellect renewed its focus on developing innovative new platforms, which have led us to file a plethora of patent applications in the U.S. and abroad. The size and scope of our patent estate has generated significant interest from the pharmaceutical industry in our technology platforms for Alzheimer's disease and other serious unmet medical needs. This interest demonstrates our unique ability to identify new therapeutic directions based on cutting-edge technology platforms, which keeps us ahead of the curve in discovery and development of therapeutics for a broad range of diseases.
Tau Immunotherapy: Last week we announced the addition of two new tau programs to our Alzheimer's pipeline (TOC-1 and TAUC3), which we obtained through an exclusive license from Northwestern University. Obtaining this license was a remarkable achievement given the enormous interest that has developed in tau as a therapeutic target. We believe we prevailed over the competition for this license because of our strong expertise and deep leadership position in Alzheimer's disease research and our demonstrated success in licensing key technologies to the pharmaceutical industry. Importantly, we added 100 new claims to the TOC-1 patent application, thus expanding the original patent application filed by the Northwestern. As a result, we were named as an additional inventor of the University-owned patent application.
The monoclonal antibodies were developed by Professor Lester Binder, Ph.D., the Abbott Laboratories, Duane and Susan Burnham Research Professor of Genetic and Molecular Medicine, at Northwestern University. Our analysis of Professor Binder's work led us to novel and independent inventions, including a new platform technology for generating antibodies and vaccines against a range of targets important for Huntington's, Parkinson's and other diseases. As a result, we filed three new patent applications in April.
We plan to develop the Tau antibodies licensed from Northwestern as passive immunotherapy for Alzheimer's disease and other tauopathies, including frontotemporal dementia, a devastating and presently incurable, orphan disease. Also, we plan to exploit the diagnostic utility of these antibodies, which detect neurotoxic intermediates found at the earliest stages of these diseases prior to the development of tangles.
The new passive immunotherapy program we licensed from Northwestern complements our active immunotherapy program, particularly RV03, which targets both beta amyloid and delta tau. Recently we commenced preclinical testing of RV03 under a collaboration agreement between Intellect and Dr. Frank LaFerla, Chancellor's Professor and Chair, Neurobiology and Behavior School of Biological Sciences, Director, Institute for Memory Impairments and Neurological Disorders at the University of California, Irvine, and his team, and in collaboration with Dr. Kim Green. Previously, Dr. LaFerla's group proposed a novel mechanism establishing a causative link between the accumulation of beta amyloid in the brain of Alzheimer's patients and the formation of neurofibrillary tangles comprised of tau protein. This link is an important step towards explaining how these two different proteins act synergistically to cause irreversible damage and death of nerve cells. Dr. LaFerla, a world leader in Alzheimer's disease research, expressed his excitement about the seminal work being done at Intellect and offered to test the therapeutic and prophylactic potential of RV03. He stated, "Our combined research may develop the first dual vaccine against these two important therapeutic targets and prevent the irreversible damage and death of nerve cells caused by these two proteins."
IN-N01-OX2: We continue to advance our CONJUMAB-A platform technology, which we introduced last October, culminating in a detailed road-map for the development of our lead candidate IN-N01-OX2. This compound, based upon our expertise in Alzheimer's, has significant potential utility to treat wet age related macular degeneration (AMD).
The global market for wet AMD therapies currently is valued at US$ 4 billion annually, according to data from IMS Health. This market is relatively new and was introduced in the past decade with pegaptanib (Macugen, OSI Pharmaceuticals), followed by the current market leader ranibizumab (Lucentis; Genentech/Roche), an antibody fragment specific for vascular endothelial growth factor (VEGF) that accounts for approximately 98 percent of sales. A third therapy, Aflibercept (Eylea; Regeneron Pharmaceuticals/sanofi-aventis), was launched in November 2011 and is generating significant attention.
Although the sales numbers lead one to believe these drugs are curing the disease, a closer look reveals a different story. Only an estimated 30 percent of patients with wet AMD experience a significant improvement in vision with anti-VEGF therapy. With 70 percent of wet AMD patients finding little benefit in visual improvement, alternative strategies are being investigated.
Our candidate, IN-N01-OX2, applies antibody drug conjugate technology as a novel approach to the treatment of AMD and other forms of retinal degeneration, including diabetic retinopathy and glaucoma. IN-N01-OX2 is comprised of a humanized monoclonal antibody against beta amyloid that is chemically conjugated to melatonin, which is known to have potent neuroprotective properties. We expect the compound will increase clearance of the beta amyloid that accumulates in the retina and, concomitantly, deliver neuroprotection to the site of damage. Already, a well-known pharmaceutical company has approached us with interested in obtaining this technology. Ultimately, we expect several companies will compete for an exclusive license to develop and commercialize IN-N01-OX2 as the program matures.
On May 8, 2012, the U.S. Patent and Trademark Office (USPTO) granted our patent covering Intellect's ANTISENILIN monoclonal antibody platform technology for the treatment and prevention of Alzheimer's disease. This patent is at the heart of one of our license agreements and triggers a significant milestone payment from one of our licensees, a global pharmaceutical company. Meanwhile, we have filed a continuation patent application in April seeking additional claims similar to those that have been allowed in Japan, Europe, China and several other countries.
We overcame an exceptionally high threshold for allowance set by the USPTO. Our success demonstrates the strength of our patent and the significance of the underlying invention and rewards our relentless efforts to obtain a patent of meaningful commercial value on behalf of the company and our shareholders. We remain confident we will obtain allowance in the future of the additional claims for the other components of the ANTISENILIN platform.
Professor Kelvin Davies, Chairman of the Company's Scientific Advisory Board, and the James E. Birren, Chair in Gerontology at the University of Southern California, emphasized the significance of this achievement stating, "It is important that the USPTO finally has acknowledged Dr. Chain's seminal discovery in 1997, which laid the foundations for Alzheimer's passive immunotherapy treatments targeting the soluble beta amyloid that accumulates in the brain of Alzheimer's patients leading to neurodegeneration. Dr. Chain's approach has been adopted by several major pharmaceutical companies, which has resulted in promising clinical data."
Increased Public Awareness:
We continue our efforts to increase public and investor awareness of Intellect through media outreach and other activities, including participation as presenter at several international industry and investor conferences. Our activities and developments are reported in the media, including financial and industry publications. Recently, articles featuring Intellect Neurosciences appeared in Xconomy, Fierce Vaccines, CEO/CFO, Scrip and BioCentury. These activities have contributed to the increased attention we have received from potential strategic partners and form an important element of our business development efforts.
It is with a heavy heart that I address our inclusion in a negative story. On May 9, 2012, David Blech pleaded guilty to securities fraud charges, including certain prohibited activities with respect our stock. David has been supportive of Intellect's mission and a personal friend. I had absolutely no knowledge of his activities. I have had multiple discussions with the authorities involved who acknowledge that company officers were blind to the actions taking place around us. Now I look forward to devoting all of my energies to continuing to build Intellect Neurosciences into the pre-eminent developer of new drugs to treat Alzheimer's and neurodegenerative diseases.
Our reputation and relationships with the key thought leaders in academia and senior industry executives have significant importance to Intellect Neurosciences. We call upon these leaders when selecting the next generation of cutting-edge technologies that likely are to be of interest to the pharmaceutical industry. I have endeavored to build Intellect into a company with a set of distinctive platform technologies that generate drug candidates for a wide variety of neurodegenerative diseases, which are protected by an extensive patent portfolio that safeguards the company's inventions. Beginning in 2014, the earliest of our license agreements to Intellect's patents may begin to deliver significant returns to the company, and as a result, our shareholders. By the end of this year, the world will know the results of the Phase 3 studies being conducted in Alzheimer's patients, one of which holds particular importance to Intellect, and both of which hold particular importance to the people living with Alzheimer's and to their loved ones.
Thank you for your continued support of Intellect Neurosciences and our important mission to create a world without Alzheimer's disease and other debilitating neurodegenerative diseases.
Daniel Chain, PhD
Chairman and Chief Executive Officer
Safe Harbor Statement Regarding Forward-Looking Statements:
The statements in this release and oral statements made by representatives of Intellect Neurosciences 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, 2011, and in our Quarterly Report on Form for the quarterly period ended March 31, 2012, which was filed on May 14, 2012.
JQA Partners, LLC
SOURCE Intellect Neurosciences, Inc.