NEW YORK, Feb. 22, 2011 (GLOBE NEWSWIRE) -- Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease with an internal diversified pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, today issued the following Letter to Shareholders from Dr. Daniel Chain, Chairman and CEO.
Dear Shareholder,
I would like to take this opportunity to update you of pertinent corporate and industry developments contemporaneous with the current filing of our quarterly financial statements with the SEC.
Of particular note, is the progress that we are making in regards to obtaining a US patent for our ANTISENILIN® technology platform, which is the subject of our royalty-bearing license agreements with major pharmaceutical companies. Under the terms of our license agreements, we are entitled to significant milestone payments upon issuance of a US patent on our application by the United States Patent and Trademark Office ("USPTO"). Corresponding patents have issued in Europe, Japan, China and several other countries. Recently, an independent, world renowned, New York-based academician who is a recognized expert in Alzheimer's disease immunotherapy provided a written declaration in support of our response to an Official Action by the USPTO. This latest development bolsters our confidence that we will be granted a US patent, which will trigger the milestone payments and greatly increase the royalties payable to Intellect when drugs based on its technology reach the market. We expect a decision from the USPTO on our ANTISENILIN® patent application within the next several months.
Also, we are encouraged by a positive report in January from Jefferies & Co in which analyst Corey Davis wrote that Bapineuzumab, in Phase 3 clinical trials, "… has the potential to transform the treatment of one of the most elusive pharmaceutical targets…" Bapineuzumab, a highly specific monoclonal antibody targeting amyloid beta protein that accumulates in the brain of Alzheimer's patients, is based on our ANTISENILIN® technology.
Pipeline Developments:
We reached an important development milestone in December with the receipt of a full report from Kendle, a global clinical research organization, regarding safety and pharmacokinetic data for OX1. These data confirmed that OX1 is safe and well tolerated in elderly healthy volunteers and that it is rapidly absorbed and distributed in the body after oral administration. The Phase 1b trial was conducted 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.
In January 2011, we signed a continuation service agreement with i3, a global research organization. The agreement concerns data analysis from the OX1 Phase1b trial, obtained by using a computerized neuropsychological test battery (CNTB) system. CNTB is an assessment tool for neuro-psycho-pharmacologic research that is based on assessments previously shown to be sensitive to subtle changes in neuropsychological functioning. Its use of a computer as an expert system maximizes standardization and ease of administration, data collection and analysis. The test was performed twice on Day -1 of the trial (practice and pre-dose assessment) and once on Days 3, 9 and 15, and during the follow-up visit. The test was used to establish a baseline in normal healthy individuals and possible drug effects for consideration in designing a Phase 2 clinical trial in Alzheimer's patients. We expect to receive data and a report from i3 during the next quarter.
OX1 has exceptional neuroprotective properties to Aβ neurotoxicity, which makes it a particularly promising drug candidate for Alzheimer's disease. In addition, we intend to establish proof of concept studies for OX1 in other diseases, such as Friedriech's Ataxia, a rare inherited disease that causes progressive damage to the nervous system. The non-clinical development of OX1 has received financial support from the Institute for the Study of Aging, the BIRD Foundation and the National Institute of Aging (part of the National Institutes of Health), which recently indicated it will fund further safety studies for OX1 as part of a federal effort to work with the private sector to encourage the discovery and development of drugs for Alzheimer's disease. The next anticipated milestones for OX1 are the filing of an Orphan Drug Application for Friedriech's Ataxia and submission of two INDs (Investigational New Drug applications) with the U.S. Food and Drug Administration's (FDA) to support initiation of Phase 2 clinical trials in Friedriech's Ataxia and Alzheimer's disease. We are working with key experts, including independent Alzheimer's clinical development consultants and the Friedreich's Ataxia Research Alliance ("FARA").
Strategic Collaborations:
We are engaged in both new and ongoing discussions with mid and large-size pharmaceutical companies concerning potential collaborations or licensing deals. We believe that the pipeline developments described above will facilitate these discussions and broaden our appeal as a strategic partner.
New Patent Filing:
In February, we filed a new Provisional Patent application with the USPTO. The patent application is based on a novel immunotherapy-based approach that I have developed in relation to Alzheimer's and other diseases. My approach targets certain abnormal forms of tau protein while leaving the normal protein untouched. In addition to Alzheimer's disease, abnormal neurotoxic tau is implicated in other neurological diseases, such as progressive supranuclear palsy (PSP), corticobasal degeneration, (CBD), Pick's disease (PiD) and a group of related disorders collectively termed frontotemporal dementia with Parkinsonism linked to chromosome 17 (FTDP-17), amyotropic lateral sclerosis (ALS) and others. Both amyloid beta and tau have been extensively studied with regard to their separate modes of action and recent findings suggest that tau is a crucial partner of amyloid beta in the pathogenesis of Alzheimer's disease (as noted, e.g., by Lars Itnner and Jürgen Götz, two leading experts, in the most recent issue of Nature Reviews, volume 12, pages 67-72, February 2011). My aim is to engage potential collaborators and partners to accelerate proof of concept and development of new vaccines and antibody-based therapies for these diseases with an approach that is potentially synergistic with current drugs in development by Intellect. We expect significant interest from pharmaceutical companies regarding the new technology, especially in view of the recent attention given to the importance of tau working in concert with amyloid beta to drive the neuropathological process.
Yahoo trading symbol
Recently, our stock symbol as shown on Yahoo Finance and certain other financial web sites changed from ILNS.OB to ILNS.PK. The .PK and .OB are not officially part of our stock symbol. These are added by Yahoo because they deal with so many international markets. Those suffixes are not always assigned appropriately.
Yahoo designates the .PK or .OB suffix based on where the stock is quoted. Many market makers increasingly choose to quote SEC reporting OTC securities on the Pink OTC Markets' electronic quotation and trading system rather than on the OTCBB because of ease of electronic trading and cost savings. As a result, many securities that may have formerly been identified as OTCBB are now labeled Pink Sheets and are being moved to the Pink OTC Market system without "doing anything wrong". ILNS falls into that category.
Financial results:
Net loss from operations for the three months ended December 31, 2010 was $751,003, reflecting increased R&D expenses related to our OX1 product candidate and G&A professional fees related to consultants engaged in investor and public relations and attorney fees. Currently we have 1,309,685,570 common shares issued and outstanding out of a total authorized number of 2 billion. We had 1,062,597,208 shares issued and outstanding on December 31, 2010.
Industry Developments:
An important recent industry development was a landmark decision by the FDA in January 2011, to conditionally approve a novel tool for imaging of amyloid plaques in the brain as a method of diagnosing or ruling out Alzheimer's disease in dementia patients. The FDA Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously to recommend approval of Amyvid conditional on a reader training program that demonstrates reader accuracy and consistency through a re-read of previously acquired scans. The Committee stated that a negative scan would be clinically useful in indicating that Alzheimer's pathology is unlikely to be the cause of a patient's cognitive decline. The decision was a landmark in the diagnosis of Alzheimer's disease and also underscores the importance of therapeutic approaches such as those being developed by Intellect, aiming to prevent the accumulation of amyloid beta and reduce its toxicity in the brain of Alzheimer's patients.
Another significant development occurred this month when The Committee for Medicinal Products for Human Use (CHMP), which is part of the European Medicines Agency (EMA) said that it backs use of amyloid biomarkers for Alzheimer's. In a draft qualification opinion, CHMP concluded that low levels of beta amyloid (1-42) and high tau in cerebrospinal fluid (CSF) together is predictive of Alzheimer's disease-type dementia in patients with minimal cognitive impairment. The Committee based its opinion on a review of published literature that found the sensitivity of the biomarker signature to predict Alzheimer's-type dementia was 87%, with a specificity of 70% and positive predictive value of 65%. CHMP said ELISA methods to measure the CSF biomarkers signature are commercially available, but noted that existing guidelines for collection and analysis should be enforced to obtain reliable results. The Committee said this was the first biomarker qualification opinion for use in humans. Comments on the opinion are due by March 23. In contrast to plaques which occur relatively late in Alzheimer's, the changes in amyloid beta tau ratios will make it easier to test new potential disease-modifying or prevention drugs in presymptomatic patients before irreversible steps in the disease take place.
Eli Lilly announced the first case of asymptomatic vasogenic edema in relation to its Phase 3 trials for Solanezumab, a competing antibody to Bapineuzumab. Although the reasons and clinical implications remain to be determined, several commentators have expressed concern, especially in view of the unprecedented, accelerated clinical trial process for this drug, which has been much faster than for other Alzheimer's drugs. Of special concern is the lack of long-term safety and efficacy Phase 2 trials for solanezumab prior to commencement of Phase 3 trials. Moreover, in contrast to Bapineuzumab and Ponezumab (both based on Intellect's technology), which bind only amyloid beta, Solanezumab binds a mid-portion of the neurotoxin and therefore lacks sufficient specificity to avoid also binding to the ubiquitous, multifunctional amyloid precursor protein (APP), which is highly enriched at the connection between nerve cells and on the surface of blood platelets involved in clotting. Binding of antibody to soluble or membrane bound APP can affect both its normal functions and metabolism. The scarcity of human safety data and lack of specificity are two of the principle concerns regarding the safety of Solaneuzumab. These safety issues underscore the competitive advantages of Bapineuzumab, which is further in development, supported by long-term human safety studies prior to the commencement of Phase 3 trials, is being tested at doses that do not cause vasogenic edema, and is highly specific for amyloid beta.
Increased public awareness:
We have continued our efforts to increase public and investor awareness of Intellect Neurosciences through media outreach and other activities.
I was recently interviewed by a journalist writing for the New York Post and was extensively quoted in an article written by Anusha Kambhapaty, Healthcare Reporter for BioPharm Insight (owned by the Financial Times Group), covering the recent Solaneuzumab development.
I participated as a Distinguished Speaker at the 4th Annual Alzheimer's Drug Development Summit sponsored by The Center for Business Intelligence (CBI) December 14-15, 2010 in Washington D.C. www.cbinet.com/alzheimers). The meeting was attended by senior drug development executives representing several major pharmaceutical companies. My talk was followed by an encouraging presentation from Pfizer discussing the clinical development of Ponezumab that is based on Intellect's ANTISENILIN® platform as is the case with Bapineuzumab. The Pfizer presentation showed that Ponezumab has an excellent safety profile.
Conclusion:
Admittedly, the devaluation of our stock over the last several months has been disappointing. It is surprising in view of the positive developments that occurred during the same period. In light of these developments and the fundamental strength of our technology, pipeline and license agreements, I continue to be excited and optimistic regarding Intellect's near and longer term prospects.
It has been gratifying to receive the declaration of a world-renowned expert in Alzheimer's disease immunotherapy who provided strong support for our position in response to an Official Action by the USPTO with respect to our ANTISENILIN® patent application. Issuance of a patent by the USPTO would be an extremely important event for Intellect Neurosciences especially given that the main Bapineuzumab Phase 3 are trials fully enrolled and expected to complete next year. The successful completion of those trials would signify a medical breakthrough of major public benefit and at the same time reward our shareholders for their long term support.
Our strategy in the meantime is to continue supporting operations through a combination of financings, license fees and milestone payments that would enable us to progress the development of our internal pipeline in a meaningful way to deliver additional shareholder value and new drug products for patients affected by neurological diseases.
Despite the challenges we face in the capital markets, Intellect continues to make significant progress, keeping its eye firmly focused on the target for the long-term benefit of its shareholders.
We thank you for your continued support of our mission and vision to create a world without Alzheimer's disease.
Sincerely,
Daniel Chain, PhD, Chairman and Chief Executive Officer
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 Alzheimer's 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, which are 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:
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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 and information contained in our Quarterly Report on Form 10-Q for the three month period ended on September 30, 2010 filed on November 18, 2010.