Patient Treatment Completed in Pivotal Trial Evaluating Allon Therapeutics, Inc.'s Davunetide
Published: Nov 13, 2012
VANCOUVER, Nov. 13, 2012 /PRNewswire/ - Allon Therapeutics Inc. (TSX: NPC) announced today that patient treatment has been completed in the multinational pivotal phase 2/3 clinical trial that is evaluating the Company's lead product davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly progressing and fatal degenerative brain disease.
Allon President and CEO Gordon McCauley made the announcement today during his business update presentation to the 18th annual BIO-Europe conference in Hamburg, Germany, the largest conference in Europe focusing on partnering activities for the global biotechnology industry.
McCauley said achieving this milestone means the Company is on track to release top-line data from the clinical trial in the second half of December.
Allon is conducting the study under a Special Protocol Assessment with the U.S. Food and Drug Administration meaning the data from this study can be used as part of a marketing approval for davunetide.
Allon estimates the market potential for the first approved treatment for PSP could exceed $700 million in the U.S. and Europe. PSP is suffered by approximately 25,000 people in the United States and 40,000 people in the European Union.
McCauley told the BIO-Europe partnering conference that positive data from the clinical trial would present Allon with several options, including pursuing regulatory approval in the U.S. and other markets for PSP as well as define the opportunity to evaluate davunetide in other tau-related diseases, such as Alzheimer's, subtypes of frontotemporal dementia, as well as other neurodegenerative diseases such as schizophrenia and Parkinson's.
The trial treated more than 300 patients at leading medical institutions in the United States, Canada, the United Kingdom, France, Germany, and Australia. Details can be found at clinical trials.gov. It is based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and positive biomarker data.
This year´s BIO-Europe partnering event has drawn approximately 3,000 industry attendees from more than 40 countries representing 1,800 companies for three days of high level networking. BIO-Europe is organized by EBD Group, the leading partnering firm for the global biotechnology industry, in alliance with the Biotechnology Industry Organization (BIO).
Although McCauley's presentation at BIO-Europe will not be webcast, it is available at the company's website at the following link: http://www.allontherapeutics.com/corporate/news/events-and-webcasts/.
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.
SOURCE Allon Therapeutics Inc.