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Allon Therapeutics Announces Publication of davunetide Data Demonstrating Cognition Improvement in Schizophrenia Model


Published on 2010-05-11 05:41:47 - Market Wire
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VANCOUVER, BRITISH COLUMBIA--(Marketwire - May 11, 2010) - [ Allon Therapeutics Inc. ] (TSX:NPC) today announced publication of data from preclinical studies that demonstrate the Company's lead neuroprotective candidate [ davunetide ] improved cognitive performance in a model of schizophrenia. The article entitled "NAP (davunetide) enhances cognitive behavior in the STOP heterozygous mouse - a microtubule-deficient model of schizophrenia" was published in PEPTIDES, an international peer-reviewed journal presenting original contributions on the science of peptides, as well as their neurological, psychological and behavioral effects.

The research found that treatment with davunetide improved schizophrenia-like symptoms, such as hyperactivity and memory deficits, in a model where the condition is dependent on reduced expression of the microtubule-associated protein, stable tubule-only polypeptide or STOP. These results suggest that davunetide may alter the course of neurological disease through effects on microtubules, critical structures for neurotransmission.

Authors include Prof. Illana Gozes, professor of clinical biochemistry at the Tel Aviv University's Sackler Faculty of Medicine, where the studies were conducted. Prof. Gozes is the founder of Allon.

The animal study results correspond to data from human trials in schizophrenia patients, which demonstrated that both the daily functioning of these patients and the chemistry of their brain cells were positively impacted by davunetide.

  • In 2009, Allon released Phase 2a clinical trial data showing that 12 weeks of treatment with davunetide achieved statistically significant measurable positive treatment effects in schizophrenia patients with cognitive impairment. These patients showed improvements in their functional capacity to carry out important activities in their daily lives. The trial was managed by TURNS (Treatment Units for Research on Neurocognition and Schizophrenia) with substantial financial support from the National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health.
  • In early 2010, Allon released top-line results from an imaging study of the brains of schizophrenia patients in the Phase 2a trial showing that 12 weeks of treatment with davunetide resulted in statistically significant increased levels of a biomarker (N-acetyl aspartate, or NAA) that is an important indicator of brain cell health. The imaging results are consistent with the hypothesis that davunetide improves brain cell function by repairing and stabilizing microtubules, the protein strands that comprise brain cell structure.

About Allon's neuroprotective platforms
Allon's two neuroprotective technology platforms are based on two naturally occurring proteins produced by the brain in response to a range of insults. The platforms are activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF).

Because the two platforms are based on different proteins, the drugs from each are different molecules with different therapeutic mechanisms and distinct commercial opportunities. Clinical-stage drugs based on davunetide are derived from ADNP, while preclinical stage drug AL-309 is derived from ADNF. Davunetide is focused on Alzheimer's disease, cognitive impairment in schizophrenia, progressive supranuclear palsy (PSP). ADNF drug candidate AL-309 is being developed for the treatment of peripheral neuropathies and is administered orally or subcutaneously.

About Allon
Allon Therapeutics Inc. is a clinical-stage biotechnology company developing treatments for major neurodegenerative conditions. Allon's drug davunetide has demonstrated human efficacy in amnestic mild cognitive impairment, a precursor to Alzheimer's disease, and cognitive impairment associated with schizophrenia. Allon has Phase 2 human efficacy programs pursuing large underserved markets, such as Alzheimer's disease and cognitive impairment associated with schizophrenia, and in orphan markets, such as frontotemporal dementias. The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC" (Neuro Protection 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.