VANCOUVER, Feb. 29, 2012 /PRNewswire/ - Allon Therapeutics Inc. (TSX: NPC) announced today that a review of davunetide as a potential treatment for progressive supranuclear palsy (PSP) was published in the February edition of Neuropsychiatric Disease and Treatment. The article describes davunetide as the most advanced drug candidate in the world for PSP patients. Allon is conducting a pivotal trial testing the efficacy of davunetide in PSP. The trial is fully enrolled and is expected to complete patient dosing and release top-line data by late 2012.
In the article, some of the leading experts in PSP outline the characteristics of the disease, the rationale for treating PSP with davunetide and identify some of the challenges of conducting clinical trials in this patient population. PSP is a progressive neurodegenerative disease 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. This disease is considered a tauopathy, involving impairment of the tau protein in brain cells. The article reviews the 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 (aMCI), an early form of Alzheimer’s disease known to be associated with the build-up of tau tangles. Previous clinical studies in PSP have laid a foundation for better trial methodology and measurement of disease progression.
Dr. Michael Gold, Allon’s Chief Medical Officer, said “Allon has shown in many different animal studies, including models of tauopathies, as well as its human studies, that davunetide appears to impact microtubule function and tau aggregation.” Dr. Gold adds, “These data suggest that davunetide is generally well tolerated and has the clear potential to show efficacy in a tauopathy like PSP.”
Neuropsychiatric Disease and Treatment is an international, peer-reviewed journal of clinical therapeutics and pharmacology focusing on concise rapid reporting of clinical or pre-clinical studies on a range of neuropsychiatric and neurological disorders. The abstract of the article, as well as a downloadable version of the full article can be found here:
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’s current trial in PSP 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.
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.
The market opportunity for PSP treatments in the U.S. and EU is conservatively estimated at $700 million. Allon believes 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.
The Company is listed on the Toronto Stock Exchange under the trading symbol “NPC”.
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.
Rick Smith
Allon Therapeutics Inc.
Director, Investor Relations
(604) 742-2543
info@allontherapeutics.com
www.allontherapeutics.com
SOURCE Allon Therapeutics Inc.