NEW YORK, April 12, 2011 (GLOBE NEWSWIRE) -- Intellect Neurosciences, Inc. (OTCBB:ILNS), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for Alzheimer's disease and other serious neurodegenerative conditions, with an internal diversified pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced today that it has filed an orphan drug application with the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) to have Orphan Drug Designation granted to its clinical stage drug candidate, OX1 (OXIGON™) for the treatment of Friedreich's Ataxia ("FA"). The United States Orphan Drug Act of 1983 is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders.
FA is a rare, hereditary, progressive, neurodegenerative disease caused by a defective gene affecting energy production. About six thousand people in the United States are estimated to suffer from the disease. Orphan Drug designation would provide a seven-year term of market exclusivity for OX1 if ultimately approved by the FDA pending successful outcome of planned clinical trials and would enable the Company to take advantage of various financial and regulatory benefits, including government grants for conducting clinical trials, waiver of FDA user fees and certain tax credits. The Company anticipates filing for Orphan Drug designation in Europe as well. The Company recently reported obtaining a positive clinical data report from human Phase 1 trials indicating that OX1 appears to be safe and well tolerated.
Dr. Daniel Chain, Chairman & CEO of Intellect commented: "The filing of an orphan drug application is an important step in our drug development strategy. Our decision pending grant of an Orphan Drug Designation, to develop OX1 as a potential ground-breaking treatment for FA, results from the convergence of two independent lines of inquiry over several years: one relates to the general properties and mechanisms of action of the drug and the other relates to a greater understanding of the pathogenic mechanisms underlying FA, especially the important role of oxidative stress. These parallel developments spanning more than a decade of research by numerous investigators, helped bring to light the strong potential of OX1 as a disease-modifying treatment for FA based on its unique multimodal antioxidant properties preventing damage to cell membranes as well as the oxidation of proteins and DNA. We believe that OX1 will ultimately prove disease modifying for FA and other neurodegenerative diseases. We are pleased by the interest shown in the program from numerous experts in FA research and grateful for the amount of assistance we received from FARA bringing us up to date on developments and clinical trial experience in this important field of biomedical research."
Jennifer Farmer, MS, CGC, Executive Director, FARA () commented: "FARA is excited that Intellect Neurosciences has decided to advance clinical research of OX1 in Friedreich's Ataxia. There is no treatment for this devastating disease. Research into the underlying mechanism of FA and damage that occurs in the cells strongly supports such a therapeutic candidate. FARA has supported the necessary clinical research infrastructure, such as a worldwide patient registry and clinical research network, to expedite planning and execution of clinical trials. We look forward to partnering with Intellect Neurosciences as their research efforts move forward."
About Friedreich's Ataxia
Friedreich's Ataxia is rare hereditary disease caused by a mutation in a gene which encodes frataxin, a protein essential for proper functioning of mitochondria, the energy pumps of the cell. In the absence of frataxin, iron in the cytoplasm builds up and causes free radical damage. The disease causes progressive damage to the nervous system, resulting in symptoms ranging from gait disturbance to speech problems; it can also lead to heart disease and diabetes. The ataxia of Friedreich's ataxia results from the degeneration of nerve tissue in the spinal cord, in particular sensory neurons essential for directing muscle movement of the arms and legs. The spinal cord becomes thinner and nerve cells lose some of their myelin sheath. The primary site of pathology is spinal cord and peripheral nerves. Symptoms typically begin sometime between the ages of 5 and 15 years, but may occur in the 20s or 30s. The disease usually presents with progressive staggering or stumbling and frequent falling. The symptoms are slow and progressive. The median age of death is 35 years. Currently there are no FDA approved drugs for FA.
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 serious neurodegenerative disorders. The Company's most advanced internally developed product is OX1, which has been tested in Phase 1 clinical trials and has broad potential to treat diseases in which tissues especially nervous tissue, is damaged by oxidative stress. The Company plans to conduct clinical proof of concept patient trials for OX1 in Friedreich's Ataxia, a rare inherited disease that brings about free-radical mediated progressive damage to the nervous system.
The Company's ANTISENILIN® monoclonal antibody technology platform for treatment of Alzheimer's disease, invented fourteen years ago by Dr. Chain, was the first to specifically target the soluble "floating" beta amyloid that is now generally believed to be responsible for most of the damage in the brain of Alzheimer's patients. Importantly, ANTISENILIN® antibodies bind the major classes of beta amyloid including soluble and plaque-bound forms, but avoid binding to the amyloid precursor protein from which beta amyloid is produced in the body. This high degree of specificity is an important safety feature, significantly reducing the potential for adverse affects for Alzheimer's immunotherapy. Patents have been granted in Europe, Japan and several other countries with corresponding patent applications pending in the United States. The Company is developing IN-N01, a next generation humanized monoclonal, and Recall-Vax, a vaccine technology, which has the potential to delay or prevent Alzheimer's disease in people who are at risk.
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 September 30, 2010, filed on November 18, 2010.
CONTACT: Intellect Neurosciences, Inc. Elliot Maza, JD, CPA, President and Chief Financial Officer Tel. 212-448-9300 45 West 36th St. 3rd Floor New York, NY 10018, USA. http://www.intellectns.com