Allon files IND for approval of Schizophrenia Phase II clinical trials
- Category: Proteins and Peptides
- Published on Friday, 23 February 2007 02:00
- Hits: 2055
VANCOUVER, Canada | Feb 21, 2007 | Allon Therapeutics Inc. (TSX:NPC), The Neuro Protection CompanyTM, announced today that it has filed an Investigational New Drug application (IND) with the United State Food and Drug Administration (FDA) seeking approval to begin human clinical trials evaluating the Company’s product AL-108 as a treatment for Schizophrenia related cognitive impairment. The Company announced on January 8th that the United States National Institute of Mental Health-funded project, Treatment Units for Research of Neurocognition in Schizophrenia (TURNS) has selected Allon’s drug for Phase II clinical trials.
Gordon McCauley, President and CEO of Allon, said the TURNS group plans to commence a Phase II clinical trial evaluating the effectiveness of the AL-108 as treatment for Schizophrenia related cognitive impairment. The trial is scheduled to be conducted at the 7 TURNS participating sites: Harvard Medical School, The University of California at Los Angeles, Maryland Psychiatric Research Center, Washington University Medical Center, Nathan Kline Institute, Columbia University Medical Center and Duke University.
“Our team continues to meet our milestones and this is the next step in determining the potential for AL-108 as a treatment for Schizophrenia patients,” said McCauley. “We now have three Phase II efficacy trials that seek to use the unique underlying mechanism of our drugs.”
There are estimated to be over 2 million people in North America who suffer cognitive impairment related to schizophrenia according to Datamonitor. TURNS was created by the U.S. National Institute of Mental Health, one of the U.S. National Institutes of Health, to identify drugs that improve cognition and that can be combined as co-treatments with anti-psychotic drugs that control the psychotic episodes that characterize schizophrenia. To date, first and second generation anti-psychotic drugs have shown little impact on cognition impairment suffered by schizophrenia patients.
The Company has two products in human clinical trials. AL-108 is being evaluated in a Phase II trial as a treatment for Alzheimer’s and AL-208 is being evaluated in a Phase II trial as a prevention and treatment for the mild cognitive impairment (MCI) that commonly occurs following coronary artery bypass graft (CABG) surgery.
Allon Therapeutics Inc. is a clinical-stage Canadian biotechnology company developing drugs that protect against neurodegenerative conditions such as Alzheimer's, cognitive impairment, stroke, traumatic brain injury, multiple sclerosis and neuropathy. 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
The Treatment Units for Research of Neurocognition in Schizophrenia (TURNS) program is a National Institute of Mental Health (NIMH) supported network that provides an infrastructure for clinical studies of pharmacological agents for enhancing neurocognition in patients with schizophrenia. For additional information visit www.turns.ucla.edu.
Forward Looking Statements
There are forward-looking statements contained herein that are not based on historical fact, including without limitation statements containing the words “believes,” “may,” “plans,” “will,” “estimate,” “continue,” “anticipates,” “intends,” “expects,” and similar expressions. Such forward-looking statements involve 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 such forward-looking statements. Such factors include, among others, Allon’s stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market Allon’s products, the ability to protect its intellectual property and dependence on collaborative partners. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.
SOURCE: Allon Therapeutics Inc