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Allon Granted U.S. Patent for Lead Product in New Technology Platform
Wednesday, July 09, 2008
Vancouver, British Columbia -- Allon Therapeutics Inc. (TSX: NPC) announced today that it has been granted a United States patent covering composition, delivery and method of use for AL-309, the lead product candidate in the Company's second neuroprotection technology platform, called Activity Dependent Neurotrophic Factor (ADNF).
Gordon McCauley, President and CEO of Allon, said the Company plans to begin human clinical trials in 2009 to evaluate AL-309 as a treatment for peripheral neuropathy, a condition suffered by millions of people resulting from nerve damage that leads to pain, discomfort, numbness and muscle weakness. Among the major causes of neuropathy are diabetes and cancer chemotherapy.
"Drug sales in the U.S. and Europe amount to approximately $4 billion a year to treat neuropathy, yet these approved drugs are only moderately effective in treating neuropathy pain and have virtually no impact on the nerve damage that causes the pain," said McCauley. "Our preclinical studies have shown that AL-309 has neuroprotective activity relevant to neuropathy and potentially to other neurodegenerative conditions."
McCauley said development of its ADNF platform will bring Allon significant new commercial opportunities that are distinct from, and in addition, to the development of its first neuroprotection technology platform, Activity Development Neuroprotective Protein (ADNP) platform.
Allon's ADNP compounds AL-108 and AL-208 are now in Phase II clinical trials as treatments for Alzheimer's disease, cognitive impairment associated with schizophrenia and mild cognitive impairment after coronary artery bypass graft surgery (MCI-CABG).
During Q1 2008, Allon announced Phase IIa clinical trial results showing that AL-108 improves the memory of patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer's. The trial demonstrated statistically significant improvements on key endpoints that measure short-term recall and working memory - two types of memory that are clinically relevant in Alzheimer's disease. The trial also demonstrated that AL-108 was safe and well tolerated by patients.
This Phase IIa efficacy data will be featured at a news conference July 28 at the International Conference on Alzheimer's Disease and Related Disorders (ICAD 2008) in Chicago, the world's leading Alzheimer's disease conference. Allon data will also be presented at four scientific sessions at the five-day conference organized by the Alzheimer's Association, the leading U.S. voluntary health organization in Alzheimer's care, support and research.
Allon director Dr. Anthony Phillips elected Councillor of Society for Neuroscience
Allon also announced today that Dr. Anthony Phillips, a Director of the Company since it was founded, has been elected a Councillor of the Society for Neuroscience. The Society for Neuroscience is the world's largest and most prestigious professional organization dedicated to understanding the brain, spinal cord and peripheral nervous system. Currently, the Society more than 38,000 physician and scientist members worldwide.
Dr. James J. Miller, Chairman of Allon, said, "This honour is a reflection of contributions Tony has made to the field of neuroscience throughout his career as a scientist, teacher and corporate leader. Tony is a founder of Allon and his counsel has been essential to the success of the Company."
A psychopharmacologist by training, Dr. Phillips holds an appointment in the Department of Psychiatry, Faculty of Medicine at the University of British Columbia. He is Chairman of the Board of the CIHR Institute of Neuroscience, Mental Health and Addictions. He is also senior investigator with the UBC/Vancouver Coastal Health Brain Research Centre.
About Allon's neuroprotective platforms
Allon's two neuroprotective platforms originated from studies on vasoactive intestinal peptide (VIP), a major central nervous system peptide that early Allon studies showed to be a broadly-acting neuroprotectant. VIP was shown to exert its effects by causing neuroprotective proteins to be secreted from glial cells, also known as astrocytes (brain support cells).
Allon identified activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF) as the proteins secreted by glial cells that provide neuroprotection in response to VIP. Allon drugs under development from the ADNP and ADNF proteins are different molecules with different therapeutic mechanisms and with different commercial opportunities. Among the distinctions are mode of delivery: ADNP drugs AL-108 and AL-208 are administered intranasally and intravenously respectively, while ADNF drug AL-309 is administered orally.
Allon Therapeutics Inc. is a clinical-stage biotechnology company developing treatments for major neurodegenerative conditions. In Q1 2008 Allon's drug AL-108 demonstrated human efficacy in amnestic mild cognitive impairment, a precursor to Alzheimer's disease. Allon has two other Phase II human efficacy trials under way pursuing three large underserved markets: Alzheimer's disease, stroke and cognitive impairment associated with schizophrenia.
The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC" (Neuroprotection Company) and based in Vancouver. For additional information please visit the Company's website: www.allontherapeutics.com.
Forward Looking Statements
Statements contained herein, other than those which are strictly statements of historical fact may include forward-looking information. Such statements will typically contain words such as "believes", "may", "plans", "will", "estimate", "continue", "anticipates", "intends", "expects", and similar expressions. While forward-looking statements represent management's outlook based on assumptions that management believes are reasonable, forward-looking statements by their nature are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by them. Such factors include, among others, the inherent uncertainty involved in scientific research and drug development, Allon's early stage of development, lack of product revenues, its additional capital requirements, the risks associated with successful completion of clinical trials and the long lead-times and high costs associated with obtaining regulatory approval to market any product which Allon may eventually develop. Other risk factors include the limited protections afforded by intellectual property rights, rapid technology and product obsolescence in a highly competitive environment and Allon's dependence on collaborative partners and contract research organizations. These factors can be reviewed in Allon's public filings at www.SEDAR.com and should be considered carefully. Readers are cautioned not to place undue reliance on such forward-looking statements and Allon disclaims any obligation to update or announce changes in any such factors except in its periodic filings.
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