Allon Therapeutics Inc.

Allon Therapeutics Inc.

September 28, 2011 08:30 ET

Allon Granted Important U.S. Patent for Preclinical Compound AL-408

VANCOUVER, BRITISH COLUMBIA--(Marketwire - Sept. 28, 2011) - Allon Therapeutics Inc. (TSX:NPC) announced today that it has been granted an important United States patent covering the composition of matter for the D-isomer of NAP (davunetide). The D-isomer of davunetide is known as AL-408 in the company's pipeline. This new patent strengthens Allon's intellectual property estate which includes 15 patent families, 58 issued patents and over 30 pending applications worldwide.

Previous pre-clinical studies have demonstrated that AL-408 shows potent neuroprotective effects in a number of in vitro and in vivo models of neurotoxicity. In an animal model of fetal alcohol syndrome, AL-408 increased survival and improved cognitive performance1. AL-408 has also shown potential neuroprotective activity in a preclinical model of amyotrophic lateral sclerosis (ALS)2.

Dr. Alistair Stewart, Allon's Vice President of Commercial Research, said this new U.S. patent provides protection for an important early-stage compound within the Company's product pipeline. "Allon's technology platform of neuroprotective peptides derived from naturally occurring brain proteins shows broad neuroprotective effects in a variety of diseases and conditions," explains Stewart. "AL-408 has shown some interesting early-stage research results in areas outside of neurodegenerative diseases, further diversifying and adding value to our product pipeline."

Allon's patent portfolio also includes issued patents and pending patent applications that provide protection around davunetide and its technology platform for treatment of neurodegenerative diseases, including progressive supranuclear palsy (PSP), Alzheimer's disease, and Parkinson's disease.

On August 12, 2011, the Company announced it had enrolled approximately 75% of the 300 patients specified in the protocol designed to assess efficacy and safety of davunetide (AL-108) in PSP patients. Enrollment began in the fourth quarter of 2010. The trial is being conducted under a Special Protocol Assessment (SPA) granted by the United States Food and Drug Administration (FDA), which ensures that the agreed clinical trial design meets the FDA's expectations for a pivotal study. This multi-national study is being conducted at leading medical institutions in the United States, Canada, the United Kingdom, France, Germany, and Australia. Details can be found at clinical

The patent granted by the United States Patent and Trademark Office covers the composition of matter for AL-408 that has the same amino acid sequence as davunetide but contains all D-amino acid isomers. Davunetide contains all L-isomers.

1 "Protective Peptides That Are Orally Active and Mechanistically Nonchiral", JPET 309: 1190–1197, 2004, Brenneman, D.E., et al.
2 "D-NAP provides neuroprotection in an ALS mouse model: evaluation of different administration schedules", J Mol Neurosci (2009) 39 (Suppl 1): S57 (abstract only), Jouroukhin Y. and Gozes I.

About Allon

Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on bringing to market innovative central nervous system therapies. Allon's lead drug davunetide is proceeding in a pivotal Phase 2/3 clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). This pivotal trial is based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment (a precursor to Alzheimer's disease) and cognitive impairment associated with schizophrenia, and in positive biomarker data.

The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC".

About Davunetide

Allon is currently enrolling patients in a pivotal Phase 2/3 clinical trial evaluating davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly-progressing and fatal movement disorder with dementia which is often misdiagnosed as Parkinson's or Alzheimer's disease. Allon reached agreement on a SPA with the FDA, as well as Orphan Drug and Fast Track Status in the U.S. Similarly, Allon has Orphan Status for davunetide in the EU.

Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP). Allon's human clinical and pre-clinical data suggest that davunetide works on microtubules, structures in the brain critical to communication between cells, and central to the tau pathway. Davunetide has shown statistically significant impacts on memory, activities of daily living, and a biomarker of brain cell function and integrity. Allon has extensive intellectual property protecting davunetide.

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 and should be considered carefully. Readers are cautioned not to place undue reliance on such forward-looking statements. Similarly, nothing in this press release is meant to promote a pharmaceutical product or make a regulated claim of efficacy.

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