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Allon completes dosing in Phase II cognitive impairment trial
VANCOUVER — Allon Therapeutics Inc. (TSX:NPC) today announced it has completed the randomized portion of its Phase II human clinical trial evaluating the Company’s product AL-208 as a treatment for the mild cognitive impairment (MCI) that commonly occurs following coronary artery bypass graft (CABG) surgery. The Company expects to release top-line results from this trial in the third quarter.
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Gordon McCauley, President and CEO of Allon, said the trial will determine whether a single dose of AL-208 administered to patients prior to CABG surgery has an impact on their cognitive performance two to three weeks after their surgery.
“It is well established that a majority of patients who have CABG surgery emerge with mild cognitive impairment (MCI) likely resulting from short-term ischemia, or reduced blood supply, in the brain,” said McCauley.
“A reduction in cognitive impairment in these patients would confirm the efficacy we have already shown in numerous animal studies of acute brain injury. This outcome would establish the potential of AL-208 to reduce or prevent the damage that results from CABG surgery and in other medical conditions, including ischemic stroke and traumatic brain injuries,” said McCauley.
The Phase II clinical trial was conducted at 28 medical centres in the United States and Canada. The study was a randomized, placebo-controlled, double-blind, parallel-group evaluation of the safety, tolerability and effect of a single 300 mg intravenous infusion of AL-208 administered 30 minutes prior to CABG surgery. Approximately half of the 210 patients randomized were treated with AL-208 and half were given a placebo.
The primary objective of the randomized study is to demonstrate an impact on cognitive performance in patients treated with AL-208 compared with patients given placebo when measured 2-3 weeks post surgery. Cognitive performance was assessed by a regimen of neuropsychological tests evaluating memory and executive function. The study will also expand the safety database on this drug.
In several preclinical studies, AL-208 has demonstrated statistically significant protection in animal models of stroke, traumatic brain injury, and in models of acute eye injury.
About MCI-post CABG
Mild cognitive impairment is a common result after CABG surgery. Some studies estimate that cognitive impairment occurs in 90% of cases in the first week post-surgery, that more than 50% of patients show impairment when discharged from the hospital, and that 24% continue to show impairment after six months.
Approximately 500,000 patients in the United States and 800,000 patients worldwide undergo coronary artery bypass graft surgery every year. Currently there is no therapy available that ameliorates or treats the cognitive damage associated with artery bypass surgery. The market for a treatment of MCI-CABG is estimated to be $500-million.
About Allon’s neuroprotective platforms
Allon’s two neuroprotective technology platforms are based on two naturally occurring proteins secreted by the brain in response to a range of insults. The platforms are activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF). Because the two platforms are based on different proteins, the drugs from each are different molecules with different therapeutic mechanisms and distinct commercial opportunities. Clinical-stage drugs AL-108 and AL-208 are derived from ADNP, while preclinical stage drug AL-309 is derived from ADNF.
About Allon
Allon Therapeutics Inc. is a clinical-stage biotechnology company developing treatments for major neurodegenerative conditions. In Q1 2008, Allon’s drug AL-108 demonstrated human efficacy in amnestic mild cognitive impairment, a precursor to Alzheimer’s disease. Allon has Phase II human efficacy programs pursuing three large underserved markets: Alzheimer's disease, stroke and schizophrenia-related cognitive impairment. The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC" (Neuro Protection CompanyTM) and based in Vancouver. For additional information please visit the Company's website: www.allontherapeutics.com .
For further information contact:
Allon Therapeutics Inc. - Investor and Media Contact
Aaron Keay
Director, Investor Relations
(604) 742-2540 or Cell: (604) 323-6911
Email: akeay@allontherapeutics.com
Website: www.allontherapeutics.com
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 and Allon disclaims any obligation to update or announce changes in any such factors except in its periodic filings.
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