Allon advances into second phase of work in preclinical PD model

Mar 12 2012

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.