Allon Therapeutics Inc.

Allon Therapeutics Inc.

March 12, 2009 09:15 ET

Allon Presents Data at Alzheimer's/Parkinson's Conference in Prague Confirming the Potential of Davunetide Intranasal (AL-108) to Treat Frontotemporal Dementia

VANCOUVER, BRITISH COLUMBIA--(Marketwire - March 12, 2009) - Allon Therapeutics Inc. (TSX:NPC) announced today that a new series of preclinical studies has confirmed the potential of the Company's lead neuroprotective drug candidate davunetide intranasal (AL-108) as a treatment for frontotemporal dementia (FTD). FTD covers several cognitive disorders for which no effective treatment is currently available.

The new preclinical data demonstrates that davunetide intranasal (AL-108) reduces the "tangle" pathology in brain cells and improves cognitive performance in mice bred to replicate two human mutations of the tau gene, both of which are found in the genetic forms of FTD. Approximately 50 per cent of all FTD cases show tau-related pathology, regardless of the presence of mutations. Mutations in tau are known to occur in approximately 10-30 per cent of patients with a family history of FTD, leading to the formation of tangle-like structures in the brains of these FTD patients.

The new data is being presented on March 15th, 2009 by Professor Illana Gozes of Tel Aviv University, discoverer of davunetide intranasal (AL-108) and Chief Scientific Officer of Allon, in Prague, Czech Republic, to the 9th International Conference for Alzheimer's Disease and Parkinson's Disease. The data has also been published in Neurobiology of Disease.

Allon announced January 12, 2009 that it will commence a Phase II clinical trial in 2009 to evaluate davunetide intranasal (AL-108) in patients with FTD.

The new data are from a study in which two-month-old mice bred to replicate two mutations of the tau gene were treated daily for five months with davunetide intranasal (AL-108). After five months, the treated mice demonstrated increased learning and memory performance compared with untreated tau-mutated mice.

Treatment continued for a second five-month period after which the brains of the animals were analyzed and found to have reduced levels of phosphorylated tau, a form of tau that leads to formation of tangle-like structures.

By reducing the level of phosphorylated tau, davunetide intranasal (108) maintains the levels of normal tau functioning in microtubules. Microtubules are key components of the communication and transport pathways inside brain cells.

Davunetide intranasal (AL-108) is an intranasal formulation of Allon's compound davunetide (NAP), an eight amino acid peptide (NAPVSIPQ: "NAP") derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP).

The new data extend the human and animal data presented by Allon last summer to the International Conference on Alzheimer's Disease and Related Disorders (ICAD 2008). The ICAD 2008 data validated the therapeutic potential of addressing the "tangles" component of the classic Alzheimer's "plaques and tangles" pathology.

The human data presented at ICAD 2008 demonstrated that specific memory function improved in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer's disease, after 12 weeks of treatment with davunetide intranasal (AL-108). The animal data showed that davunetide intranasal (AL-108) reduced the classic Alzheimer's "tangles" pathology and also increased memory function.

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).

Since the two platforms are based on different proteins, the drug candidates from each represent different classes of molecules with different therapeutic mechanisms and distinct commercial opportunities. Clinical-stage drugs davunetide intranasal (AL-108) and davunetide intravenous (AL-208) are derived from ADNP, while preclinical stage drug AL-309 is derived from ADNF. ADNP drugs davunetide intranasal (AL-108) and davunetide intravenous (AL-208), focused on Alzheimer's disease and cognitive impairment, are administered intranasally and intravenously respectively. 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. In Q1 2008, Allon's drug davunetide intranasal (AL-108) demonstrated human efficacy in amnestic mild cognitive impairment, a precursor to Alzheimer's disease. Allon has Phase II human efficacy programs pursuing large underserved markets: Alzheimer's disease, frontotemporal dementia and schizophrenia-related cognitive impairment. 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:

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