Allon advances Parkinson's disease program
VANCOUVER, March 12, 2012 /PRNewswire/ - Allon Therapeutics Inc. (TSX: NPC) announced today the completion of its first phase of work in a preclinical Parkinson's disease (PD) model and advancement into the second phase of work. Both phases are funded by The Michael J. Fox Foundation (MJFF) for Parkinson's Research and carried out by Prof. Marie-Francoise Chesselet's lab at the University of California Los Angeles (UCLA).
The first phase of the project conducted experiments on young alpha-synuclein transgenic animals, a model for PD. Feedback from a recent review by MJFF scientists and an expert panel of scientific reviewers helped strengthen the study design of the second phase of the project, studying the effect of davunetide on aged transgenic animals with pronounced motor impairment and dopaminergic deterioration, similar to what is seen in mild-to-moderate PD patients. Allon expects the results of these studies to be released in conjunction with publications or presentation at an international meeting at a later date.
The objective of this work is centred on using relevant preclinical models to determine if there is a strong scientific rationale for moving davunetide into clinical trials in PD. In assessing the clinical potential of davunetide in PD, there are a number of studies that should be completed to understand how new products might be used. Dr. Bruce Morimoto, Allon's Vice President of Drug Development, describes the path forward: "Allon is committed to methodically evaluating a series of detailed preclinical studies in the models that will provide an assessment of davunetide's potential to treat Parkinson's disease. We are encouraged with the results of this MJFF-sponsored research, which helps define the scientific rationale and justification in Parkinson's, and complements our existing data on davunetide's mechanism of action."
Allon previously announced November 30, 2010 that MJFF, encouraged by earlier preclinical results, provided $625,000 of research funding to the Company's davunetide research in PD. The decision to provide additional funding is also driven by the advanced clinical status of davunetide that could allow rapid development in PD.
On February 2, 2011, Allon announced that intranasal davunetide treatment significantly improved motor function and brain pathology in a mouse model which replicates certain characteristics of PD. Treatment with davunetide caused a 38% improvement in motor performance and coordination relative to controls. The study results were published in the international peer-reviewed journal Molecular and Cellular Neuroscience under the title: "A pilot trial of the microtubule-interacting peptide (NAP) in mice overexpressing alpha-synuclein shows improvement in motor function and reduction of alpha-synuclein inclusions."
Allon is currently conducting a fully enrolled pivotal trial testing davunetide in Progressive Supranuclear Palsy (PSP) and expects to complete patient dosing and release data by late 2012. PSP is a rapidly progressing and fatal neurodegenerative movement disorder often misdiagnosed as PD. Allon believes that success in treating PSP with davunetide would define the opportunity to use davunetide in other neurodegenerative diseases, such as Parkinson's and Alzheimer's disease.
About The Michael J. Fox Foundation
As the world's largest private funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $285 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson's research, the Foundation forges ground-breaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson's disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. For more information, visit: www.michaeljfox.org
Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on bringing to market innovative central nervous system therapies. Allon's lead drug davunetide is proceeding in a fully enrolled pivotal clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). This pivotal trial is based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment (a precursor to Alzheimer's disease), cognitive impairment associated with schizophrenia, and in positive biomarker data. For more information, please visit: www.allontherapeutics.com
The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC".
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. Similarly, nothing in this press release is meant to promote a pharmaceutical product or make a regulated claim of efficacy.
SOURCE Allon Therapeutics Inc.
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