Allon Therapeutics Inc.

Allon Therapeutics Inc.

January 28, 2010 09:00 ET

Allon Initiates Trial to Expand Safety Profile for Dementia Drug Davunetide

VANCOUVER, BRITISH COLUMBIA--(Marketwire - Jan. 28, 2010) - Allon Therapeutics Inc. (TSX:NPC) announced today that patient enrolment has begun for a human clinical trial to broaden the demonstrated safety range and pharmacokinetic profile of its lead neuroprotective drug davunetide.

Davunetide has previously demonstrated human efficacy -- as well as an excellent safety profile -- in Phase 2 clinical trials in patients with amnestic mild cognitive impairment, a precursor to Alzheimer's disease, and in patients with cognitive impairment associated with schizophrenia.

Gordon McCauley, president and CEO of Allon, said the trial announced today will provide the Company with more dosing flexibility in a Phase 2 clinical trial scheduled to begin in 2010 that will evaluate davunetide in patients with frontotemporal dementias (FTD), a group of rapidly progressive and fatal degenerative brain diseases, often mis-diagnosed as Parkinson's or Alzheimer's disease.

"Davunetide has already shown efficacy and safety in daily doses of 15 mg and 30 mg and our plan is to demonstrate the drug's safety and to evaluate its pharmacokinetic profile at doses up to 60 mg per day," said McCauley.

The trial is a randomized, double-blind, placebo-controlled study to compare multi-dose safety, tolerability and pharmacokinetic profile of davunetide in a minimum of 10 healthy adult subjects aged 45 to 65 years.

Allon announced January 12, 2010 that the United States Food and Drug Administration (FDA) granted Orphan Drug Designation to davunetide for the treatment of progressive supranuclear palsy (PSP), one type of several types of FTD.

About Allon's neuroprotective platforms

Allon's two neuroprotetive 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 targeted at Alzheimer's disease, cognitive impairment in schizophrenia and frontotemporal dementia and is administered intranasally. 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:

Forward Looking Statements

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