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IND Filed for AL-208 for Treatment of Mild Cognitive Impairment Associated with Cardiac Artery Bypass Surgery
Jun 21, 2005, 11:04, Reviewed by: Dr.
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FDA approval will enable us to begin clinical trials for our second product and second
indication barely six months after commencing clinical trials on our first product, AL-108, as a treatment for Alzheimer's disease."
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By Allon Therapeutics Inc.,
Allon Therapeutics Inc. (TSX-V: "NPC"), The Neuro Protection Company, announced today it has filed an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking approval to begin human clinical trials evaluating the company's
second product AL-208 as a treatment for for the mild cognitive impairment (MCI) associated with cardiac artery bypass surgery.
Gordon McCauley, President and CEO of Allon, said that subject to FDA approval, the company will commence a Phase I clinical trial during Q3 2005 evaluating the safety, tolerability, and pharmacokinetics of AL-208 in healthy
adults. The company expects the Phase I trials to be complete in Q4 2005 with data available in Q1 2006.
"This is another significant milestone for Allon and underlines the momentum of our clinical development program," McCauley said. "FDA approval will enable us to begin clinical trials for our second product and second
indication barely six months after commencing clinical trials on our first product, AL-108, as a treatment for Alzheimer's disease."
"It is important that we be very strategic about these trials", McCauley said. "Because we have seen such broad pre-clinical efficacy for these compounds we want to be able to proceed expeditiously into other indications
where we have seen efficacy."
When the AL-108 and AL-208 Phase I trials are complete at the end of the year, Allon expects to have a broad clinical
foundation from which multiple Phase II trials can be conducted. This foundation includes a high safety ceiling for the products and a very broad therapeutic window.
About MCI from artery bypass surgery
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Mild cognitive impairment is a common result of damage to brain tissue that often occurs after cardiac artery bypass graft surgery (CABG - commonly known as "bypass surgery").
Some studies estimate that post-surgical cognitive impairment can occur in up to 90% of the 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 (Newman et al, New England Journal of Medicine 2001). The studies also showed that after five years, 42% of patients were significantly cognitively impaired compared to their
pre-surgery performance.
Approximately 500,000 patients in the United States and 800,000 patients worldwide undergo cardiac artery bypass graft surgery every year. The post-CABG MCI market is estimated to be approximately $3 billion annually.
Currently there is no therapy available that ameliorates or treats the cognitive damage caused by neurons damaged or dying under the temporary anoxic conditions caused by artery bypass surgery.
About Allon technology
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Neurons, or brain cells, are the essential functional units of the central nervous system. Natural aging, neurodegenerative diseases, and trauma all lead to the damage or death of neurons. Keeping neurons healthy and alive under the many circumstances that could lead to their demise is the objective of neuroprotection.
Neuroprotection can be administered therapeutically following a central nervous system trauma to prevent secondary neuronal loss, or prophylactically prior to surgical procedures known to cause cognitive impairment.
Allon's portfolio of neuroprotective compounds, including first product AL-108, currently in Phase I human clinical trials for Alzheimer's, and this second product AL-208, are derived from neuroprotective proteins that occur naturally in the brain.
Allon's extensive pre-clinical research suggests that its compounds protect against the injury and death of neurons from disease or injury to the central nervous system. Pre-clinical models have demonstrated that Allon's compounds have potential in at least eight diseases and injuries of the central nervous system. This research has been published in more than 60 articles in leading peer-reviewed scientific journals. 
- U.S. Food and Drug Administration (FDA)
www.allontherapeutics.com
About Allon
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Allon Therapeutics Inc. is a clinical-stage Canadian biotechnology company developing drugs that protect against neurodegenerative conditions such as stroke, traumatic brain injury, Alzheimer's, multiple sclerosis and neuropathy. The company is listed on the Canadian TSX Venture Exchange under the trading symbol "NPC" (Neuro Protection Company) and based in Vancouver.
The TSX Venture Exchange has neither approved nor reviewed the contents of this press release.
For further information:
Investor Contact:
Gordon C. McCauley,
President & CEO,
Allon Therapeutics Inc.,
P: (604) 736-0634,
C: (604) 218-4742,
E: [email protected]
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