Allon Therapeutics Inc.
TSX : NPC

Allon Therapeutics Inc.

April 06, 2010 08:31 ET

Allon Therapeutics Announces Davunetide Receives FDA Fast Track Status for Treatment of Progressive Supranuclear Palsy

VANCOUVER, BRITISH COLUMBIA--(Marketwire - April 6, 2010) - Allon Therapeutics Inc. (TSX:NPC) announced today that its lead neuroprotective drug candidate, davunetide, has been granted Fast Track status from the United States Food and Drug Administration (FDA) for the treatment of Progressive Supranuclear Palsy (PSP), a rapidly-progressing and fatal degenerative brain disease.

Fast Track status is designed to facilitate development and expedite review of a drug candidate that treats a serious or life-threatening condition and addresses an unmet medical need.

Gordon McCauley, President and CEO of Allon, said the Fast Track status is an important milestone for the Company and validation of the desperate need for therapies in this debilitating disease where davunetide has such potential.

"Fast track status provides for early and frequent communication between the FDA and Allon to resolve questions and issues quickly," said McCauley. "It will ensure that we work with the FDA to gather the critical data needed for approval."

Fast Track also provides for "rolling submissions" in which sections of a new drug application (NDA) can be submitted and reviewed as they are completed rather than the typical process in which review begins only after the submission of the last section. Additionally, Allon may request that davunetide be considered for priority review, and if accepted would result in a six-month review instead of the standard ten-month review.

Allon announced January 12, 2010 that the FDA has granted Orphan Drug status to davunetide for the treatment of PSP treatment in the United States.

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 20,000 and 50,000 persons in the U.S. and EU respectively have PSP.

Approximately half of FTDs, including PSP, are tauopathies, which are pathologies that involve impairment of the tau protein in brain cells. Allon expects that demonstrating efficacy in PSP will define the opportunity to use davunetide in other FTD subtypes that are tauopathies.

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 eight years following onset. The disease is slightly more common in men than women, but there are no known geographical, occupational or racial patterns.

Davunetide for PSP

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

Research has shown that davunetide reduced tau impairment and preserved memory in mice bred to replicate Alzheimer's or PSP tau pathology.

In 2008, Allon reported Phase IIa clinical trial results showing that davunetide had a statistically significant positive impact on memory function in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer's disease (AD). The data was presented July 28 and July 30, 2008 to the International Conference on Alzheimer's Disease and Related Disorders (ICAD 2008).

On December 7, 2009, Allon reported Phase IIa clinical trial results showing that davunetide improved memory function of schizophrenia patients and had a positive impact on the ability of these patients to carry out important activities in their daily lives. The data was presented at the annual meeting of the American College of Neuropsychopharmacology. Further, on March 30, 2010 Allon released top-line results from a schizophrenia imaging sub-study showing that 12 weeks of treatment with davunetide resulted in a statistically significant increase in levels of a biomarker that is an important indicator of brain cell health.

Allon announced commencement of its PSP clinical program January 26, 2010 with a pilot clinical trial 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.

On March 11, 2010 Allon announced completion of a Phase 1 clinical trial that began enrolling patients January 28, 2010. The resulting data expanded the demonstrated safety range and pharmacokinetic profile of davunetide at dosage levels higher than previously used in the
Company's clinical trials. This data will help set the dosing range for the larger Phase 2 PSP clinical trial scheduled to begin this year.

Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP). Allon's laboratory and animal studies have shown that davunetide restores the function of structures in the brain — known as microtubules — which are critical to communication between brain cells and the structure of individual cells.

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 associated with schizophrenia, and frontotemporal dementia. 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 II 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.

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