VANCOUVER, Feb. 29, 2012 /CNW/ - 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
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.
For further information:
Allon Therapeutics Inc.
Director, Investor Relations