VANCOUVER, July 16, 2012 /PRNewswire/ - Allon Therapeutics Inc. (TSX: NPC) announced that data presented at the Alzheimer’s Association International Conference (AAIC) in Vancouver confirm the integrity of patient enrollment and the importance of cognitive impairment in its pivotal clinical trial evaluating the Company’s lead drug candidate davunetide as a potential treatment of the rapidly progressive neurodegenerative disease progressive supranuclear palsy (PSP).
Dr. Michael Gold, Allon’s Chief Medical Officer and Vice-President of Clinical Development, said the data are an important extension to the scientific literature related to cognition in PSP patients.
“These data confirm that Allon enrolled exactly the kind of patients we set out to enroll in our clinical trial,” said Dr. Gold. “In addition, as most likely the largest data-set of well-characterized PSP patients ever assembled, this information yields novel insights into the extent and nature of cognitive impairment in PSP patients.”
Allon’s clinical trial is fully enrolled and the Company expects to complete the study, analyse the data and release top-line results before the end of 2012.
The poster presentation of the data by Dr. Chris Randolph describes the baseline demographics of subjects enrolled in the pivotal trial (study AL-108-231) as well as baseline cognitive data.
Dr. Randolph is the originator of the Repeatable Battery for the Assessment of Neuropsychological Status, or RBANS, that was used to collect the cognitive data. He is a board-certified clinical neuropsychologist and clinical professor of neurology at Loyola University Medical Center in Chicago and is a consultant to Allon on the application of the RBANS and the analysis of data.
The baseline demographic data include age, sex, race, disease duration and severity and confirm that they are prototypical of PSP patients and within the parameters required by the study.
The RBANS data confirm that cognitive impairment is prevalent in PSP patients and describes qualitatively the nature of that impairment. The RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial skills.
The RBANS was developed for two primary applications: As a stand-alone “core” battery for the detection and neurocognitive characterization of dementia, and as a brief neurocognitive battery for the detection and tracking of neurocognitive deficits in a variety of disorders.
The RBANS is broadly used for clinical diagnostic purposes and is increasingly employed as an endpoint in clinical trials of medications that may impact upon neurocognitive status.
About the AAIC
The Alzheimer’s Association is the leading, global voluntary health organization in Alzheimer’s care and support, and the largest private, nonprofit funder of Alzheimer’s research. The Alzheimer’s Association International Conference (AAIC) is the world’s premiere forum for reporting and discussion of groundbreaking research and information on the cause, diagnosis, treatment and prevention of Alzheimer’s disease and related disorders. As a part of the Association’s research program, AAIC serves as a catalyst for generating new knowledge about Alzheimer’s and fostering a vital, collegial research community.
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 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). The trial is fully enrolled and on track to complete the study, analyse the data and release top-line results before the end of 2012. This pivotal trial is based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and in positive biomarker data.
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.
Carrie Christenson
604-736-0634
info@allontherapeutics.com
www.allontherapeutics.com
SOURCE Allon Therapeutics Inc.
