Allon Therapeutics Inc.
TSX : NPC

Allon Therapeutics Inc.

January 26, 2010 09:00 ET

Allon Therapeutics Inc.: Pilot Clinical Trial Initiated to Evaluate Davunetide in Tau-Pathology Dementias

VANCOUVER, BRITISH COLUMBIA--(Marketwire – Jan. 26, 2010) - Allon Therapeutics Inc. (TSX:NPC) announced today commencement of a pilot clinical trial in the Company's program to develop its lead neuroprotective drug candidate davunetide as the first approved treatment for frontotemporal dementia (FTD), a group of rapidly progressive and fatal degenerative brain diseases, often mis-diagnosed as Parkinson's or Alzheimer's disease.

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 in which the pathology is known to involve impairment of the brain protein tau.

Gordon McCauley, president and CEO of Allon, said the study initiated today is sponsored by the Memory and Aging Center of the University of California, San Francisco (UCSF). This pilot clinical study, enrolling approximately 12 patients, will help Allon and its clinical collaborators validate the trial design and prepare for a larger Phase 2 PSP clinical trial scheduled to begin this year. Trial investigators are among the leading experts in the field, including Drs. Bruce Miller and Adam Boxer of the Memory and Aging Center.

McCauley said Allon has demonstrated a strong scientific and clinical rationale for the potential efficacy of davunetide in FTD and PSP. "The pathology of PSP and Alzheimer's is similar in that both diseases involve the tau protein — and we have shown that davunetide is the most advanced tau therapy in the world."

McCauley said davunetide's potential as a treatment for PSP was confirmed in both animal studies and in a Phase 2 human clinical trial with patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer's in which the neuropathology also involves tau. 

The primary objective of the clinical study is to obtain safety and tolerability data with 15 mg of davunetide given twice daily relative to placebo when administered intranasally over 12 weeks. The clinical study's second objective is to determine patients' and caregivers' perspectives on the battery of tests proposed for use in the Phase 2 study in the PSP patient population. 

About PSP

PSP is one of a group of progressive disorders called frontotemporal dementia (FTD), that affect the frontal and temporal lobes of the brain, and for which there are no approved treatments. Approximately 200,000 persons in the United States and Canada have been diagnosed with a form of FTD, including 20,000 diagnosed with PSP.

Approximately half of FTDs, including PSP, are tauopathies, which are pathologies that involve the tau protein in brain cells.

PSP is often characterized by progressive difficulty with balance and walking, eye movement abnormalities, and cognitive and personality changes. Patients are typically diagnosed when they are between 45 and 65 years of age. PSP is associated with progressive disability and death with a median survival of five to 8 years following onset. The disease is slightly more common in men than women, but there are no known geographical, occupational, or racial patterns.

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(TM)) 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 and Allon disclaims any obligation to update or announce changes in any such factors except in its periodic filings.

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