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
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
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
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
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.