VANCOUVER, BRITISH COLUMBIA--(Marketwire - Oct. 20, 2011) -[ Allon Therapeutics Inc. ] (TSX:NPC) announced today that it has successfully achieved the enrollment objective of 300 patients in the phase 2/3 pivotal clinical trial evaluating the Company's lead neuroprotective drug candidate [ davunetide ] as a potential treatment for progressive supranuclear palsy (PSP), a rapidly progressing and fatal degenerative brain disease.

[ Gordon McCauley ], Allon's President and CEO, said the Company expects to complete the treatment phase of the study and release data near the end of 2012. "We expect that this pivotal study will provide the data sufficient for a regulatory submission for marketing approval," said McCauley.

"The completion of enrollment nearly three months ahead of schedule reflects the commitment of PSP patients, caregivers, and clinicians," McCauley said. "PSP is a terrible and debilitating disease for which davunetide has the potential to be the first effective drug. Achieving this enrollment milestone reflects the commitment and selflessness of all of the patients, caregivers, and medical professionals involved in the study and Allon is deeply grateful for this help."

Enrollment began in the fourth quarter of 2010. The trial is being conducted under a Special Protocol Assessment (SPA) with the FDA, which ensures that the agreed clinical trial design meets the FDA's expectations for a pivotal study. Allon has obtained Orphan Drug and Fast Track Status in the U.S. and Orphan Status in the EU. This pivotal trial is based upon statistically significant efficacy demonstrated in patients with amnestic mild cognitive impairment (a precursor to Alzheimer's) and cognitive impairment associated with schizophrenia. The trial 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 trials.gov ].

The market opportunity for PSP treatments in the U.S. and EU is conservatively estimated at $700 million. McCauley also said that success in treating PSP with davunetide would define the opportunity to use davunetide in other tau-related diseases, such as Alzheimer's and several subtypes of frontotemporal dementias as well as other neurodegenerative diseases like schizophrenia and Parkinson's.

About PSP

PSP is one of a group of progressive neurodegenerative disorders called frontotemporal dementias (FTD) in which movement, speech, and behaviour are affected, and for which there are no approved treatments. Approximately 25,000 and 50,000 persons, in the U.S. and EU respectively, have PSP. Approximately half of FTDs, including PSP, are tauopathies, or involve impairment of the tau protein in brain cells.

PSP is often initially characterized by progressive difficulty with balance and walking leading to falls, eye movement abnormalities, and cognitive and personality changes. Patients are typically diagnosed when they are between 45 and 75 years of age. PSP is associated with progressive disability and death, often three years following diagnosis. The disease is slightly more common in men than women, but there are no known geographical, occupational, or racial patterns.

Davunetide for PSP

The pathology of PSP and Alzheimer's disease is similar in that both diseases involve impairment of the brain protein tau — and davunetide is the most advanced tau therapy in the world. Allon has demonstrated a strong scientific and clinical rationale for the potential efficacy of davunetide in PSP, driven by the demonstration of activity in preclinical models of tauopathies and clinical efficacy in amnestic mild cognitive impairment, an early form of Alzheimer's disease known to be associated with the build-up of tau tangles.

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. For additional information, please visit our website: [ http://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. Similarly, nothing in this press release is meant to promote a pharmaceutical product or make a regulated claim of efficacy.

Contributing Sources

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