Allon Therapeutics Inc.

Allon Therapeutics Inc.

June 25, 2009 09:15 ET

Allon Therapeutics Forms Steering Committee for Phase II Human Trial

VANCOUVER, BRITISH COLUMBIA--(Marketwire - June 25, 2009) - Allon Therapeutics Inc. (TSX:NPC) reported today that leading neurologists and psychiatrists have joined a special Steering Committee to help the Company design and conduct a Phase II human clinical trial that will evaluate whether Allon's lead neuroprotective drug candidate, davunetide intranasal (AL-108), has the potential to become the first effective treatment for a number of brain disorders broadly categorized as frontotemporal dementia (FTD). The study will evaluate the effect of davunetide for the treatment of Progressive Supranuclear Palsy (PSP), one type of FTD. A smaller study in other related forms of FTD will be carried out in parallel.

PSP is a degenerative brain disease that is often characterized by progressive difficulty with balance and walking, eye movement abnormalities, and cognitive and personality changes. PSP affects approximately 20,000 people in the United States, a patient population size consistent with an orphan drug designation. The company expects that efficacy in PSP would define the opportunity to use davunetide (AL-108) in other FTD subtypes that are tauopathies.

Gordon McCauley, President and CEO of Allon, said the Company plans to begin the Phase II trial in FTD during the second half of 2009.

"Physicians and researchers who specialize in FTD are enthusiastic about evaluating davunetide intranasal (AL-108) in FTD patients, primarily because about 50% of FTD and related disorders are tauopathies, or tau-related diseases - and Allon's technology is recognized as the most clinically advanced tau-related therapy," McCauley said.

The Company identified some of the members of its FTD Steering Committee as:

- Adam L. Boxer, M.D., Ph.D., Director of the University of California, San Francisco (UCSF) Alzheimer's Disease and Frontotemporal Dementia Clinical Trials Program and Assistant Professor of Neurology at the UCSF Memory and Aging Center, who specializes in Alzheimer's Disease, Frontotemporal Dementia and related disorders such as Corticobasal Degeneration and Progressive Supranuclear Palsy.

- Rachelle S. Doody, M.D., Ph.D., Professor of Neurology and Effie Marie Cain Chair in Alzheimer's Disease Research at Baylor College of Medicine, Houston, who specializes in Alzheimer's disease and memory disorders.

- Murray Grossman, M.D., Professor of Neurology and Psychiatry at the University of Pennsylvania School of Medicine, who specializes in the diagnosis and treatment of non-Alzheimer's forms of dementia such as frontotemporal dementia, corticobasal degeneration, amyotrophic lateral sclerosis, and Lewy body disease.

- Anthony E. Lang, M.D., Director of the Division of Neurology and Jack Clark Chair for Parkinson's Disease Research at the University of Toronto, and Director of the Morton and Gloria Shulman Movement Disorders Centre, Toronto Western Hospital.

- Bruce L. Miller, M.D., Professor of Neurology at the University of California, San Francisco, A.W. & Mary Margaret Clausen Distinguished Chair, and Clinical Director of the UCSF Memory and Aging Center, which treats patients with diseases that cause dementia, including Alzheimer's disease, corticobasal degeneration, Creutzfeldt-Jakob disease and frontotemporal dementia.

- Lon S. Schneider, M.D., Professor of Psychiatry, Neurology and Gerontology at the Keck School of Medicine of the University of Southern California, whose specialization includes Alzheimer's disease and dementia.

FTD encompasses several cognitive disorders, including Behavioral Variant-Frontotemporal Dementia, Semantic Dementia and Progressive Nonfluent Aphasia, and the movement disorders, Corticobasal Degeneration and Progressive Supranuclear Palsy. No effective treatment is currently available for FTD, and several FTD syndromes are fatal within three to five years. FTD is often incorrectly diagnosed as Alzheimer's disease.

In 2008, Allon reported efficacy results from a Phase IIa clinical trial that demonstrated that davunetide intranasal (AL-108) improved short-term and working memory performance in patients with amnestic mild cognitive impairment, a precursor to Alzheimer's disease.

The pathology of Alzheimer's disease and many forms of FTD has some similarities, including the presence of altered forms of the brain protein tau. In Alzheimer's, altered tau forms tangles, part of the well-established plaques and tangles hallmarks of Alzheimer's pathology. PSP is associated with "pure" tau pathology, unlike Alzheimer's disease in which both amyloid and tau pathology is identified. This provides additional rationale for the use of AL-108 which targets tau in PSP.

Allon has shown that decreasing the levels of altered forms of tau with davunetide intranasal (AL-108) preserved the memory of mice bred to replicate Alzheimer's or FTD pathology. Allon's preclinical studies have also shown that davunetide intranasal (AL-108) preserved the memory and learning function of mice bred to replicate the altered tau pathology associated with FTD.

About Allon's neuroprotective platforms

Allon's two neuroprotective technology platforms are based on 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 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) are focused on Alzheimer's disease, frontotemporal dementias, and cognitive impairment. 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 intranasal (AL-108) has 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:

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. 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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