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Last updated on April 19, 2014 at 1:20 EDT

Allon Presents Baseline Data from PSP Clinical Trial to Alzheimer’s Conference

July 16, 2012

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.


Source: PR Newswire