Allon Therapeutics Inc.

Allon Therapeutics Inc.

August 04, 2011 08:30 ET

Allon Granted U.S. Patent for Davunetide as a Treatment for Schizophrenia

VANCOUVER, BRITISH COLUMBIA--(Marketwire - Aug. 4, 2011) - Allon Therapeutics Inc. (TSX:NPC) announced today that an important United States patent has been issued covering the method of use for the company's lead product davunetide and its associated neuroprotective technology platform as a treatment for schizophrenia.

Earlier U.S. patents and pending patent applications cover davunetide and its technology platform for neurodegenerative diseases, including progressive supranuclear palsy, Alzheimer's disease, and Parkinson's disease.

Allon is more than halfway enrolled in a pivotal Phase 2/3 clinical trial with davunetide in progressive supranuclear palsy (PSP), under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). PSP is a rapidly progressing and fatal degenerative brain disease which is often misdiagnosed as Parkinson's or Alzheimer's disease.

Alistair Stewart, Allon's Vice President of Commercial Research, said this additional U.S. patent reinforces the commercial market potential of davunetide in disorders outside of dementia which are also associated with neurodegeneration and cognitive decline.

"In a Phase 2a trial testing davunetide as a potential treatment for cognitive-impairment associated with schizophrenia (CIAS), we showed statistical significance on the UPSA test, a measure of functional capacity which is associated with activities of daily living. More recently, positive imaging data from a subset of subjects in the CIAS trial indicates changes consistent with a neuroprotective effect of davunetide. These data give us additional confidence that the broad activity of davunetide should target the core pathology in our on-going PSP trial and also lay the foundation for future work in schizophrenia."

On July 19th, 2011, the Company announced new findings that 12 weeks of treatment with davunetide appears to prevent cortical thinning of important parts of the brains of schizophrenia patients. Allon has previously announced the presentation of imaging data looking at the biochemical changes that are thought to underlie the deficits seen in schizophrenia patients. For example, davunetide treatment produced a statistically significant increase in N-acetylaspartate (NAA), a putative marker of neuronal integrity known to decline in several neurodegenerative disorders including schizophrenia.

"More than two million people in North America have schizophrenia and there are currently no FDA-approved drugs to treat CIAS. The granting of this patent provides important protection as we continue to explore davunetide as a potential treatment for CIAS," Stewart said.

The patent granted by the United States Patent and Trademark Office covers the use and mode of delivery of davunetide, its parent protein ADNP and other derivatives of ADNP in mental diseases and disorders including schizophrenia.

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.

Contact Information