The trial is being managed and funded largely by TURNS (Treatment Units for Research on Neurocognition and Schizophrenia), with support from the U.S. National Institute of Mental Health. Top-line results are expected to be released in 2009.
Gordon McCauley, President and CEO of Allon, said a signal of efficacy from this Phase II trial would extend the potential of AL-108 beyond Alzheimer’s disease.
“The efficacy we reported earlier this year defined the potential of this compound in Alzheimer’s disease” said McCauley. “The schizophrenia-related cognitive impairment Phase II trial is exploratory and in a patient population that has been tough for many drugs. Nonetheless, a positive result would provide evidence of cognitive benefit in a disease and pathophysiology very different to Alzheimer’s or other dementias,” said McCauley.
Dr. Daniel Javitt, Principal Investigator of the Phase II trial, said positive data would support AL-108’s potential to be a breakthrough compound in the treatment of schizophrenia.
“Cognitive deficits are a major cause of chronic disability for individuals suffering from schizophrenia with no current approved treatments,” said Javitt. “AL-108 has a novel and unique mechanism of action. I look forward to the data from this study to see if AL-108 has the potential to improve cognitive function and lessen the burden for millions of schizophrenia patients,” said Javitt. Javitt is Director of the Schizophrenia Research Center at the Nathan S. Kline Institute in Orangeburg, New York and Professor of Psychiatry/Child Psychiatry at New York University School of Medicine, one of seven clinical sites that participated in the trial.
The Phase II trial is a double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability and effect on cognitive function of AL-108 after 12 weeks of intranasal administration in schizophrenia patients with cognitive impairment. The trial was conducted at seven sites in the United States with target enrolment of 60 patients aged 18 to 60 years including both genders. Three groups of patients received either placebo, low dose of AL-108 (5 mg once a day) or high dose (15 mg twice a day) intranasally for 12 weeks. Schizophrenic patients in the trial were maintained on a stable dose of any second generation antipsychotic drug.
The primary endpoint is the MATRICS neuropsychological battery designed specifically by TURNS to measure cognitive impairment in this patient population. Secondary endpoints include scores on symptom rating scales, functional capacity, and safety assessments.
The Phase II trial also includes an imaging-biomarker component. Three different imaging techniques are being used to investigate the scope of AL-108 effects in the treatment of schizophrenia and to better understand the impact of AL-108 treatment on brain structure and neural connectivity.
About schizophrenia-related cognitive impairment
In North America, Datamonitor estimates more than two million people have schizophrenia. In Europe, the European Federation of Associations of Families of People with Mental Illness estimates that 6.6 million people suffer from schizophrenia. While there are sales of $18-billion to treat the psychosis associated with schizophrenia, there are no approved drugs treating schizophrenia-related cognitive impairment.
Most people with schizophrenia also suffer from cognitive impairment independent of the psychotic symptoms of the illness. Cognitive impairments are common at the onset of schizophrenia and can frequently be identified before psychotic symptoms emerge. In contrast to psychotic symptoms which are typically episodic, impairments in cognition appear to be a chronic feature of the illness.
Cognitive impairments are important as a treatment target because they have a substantial impact on the outcome of schizophrenia. Apart from psychotic symptoms, cognitive deficits in schizophrenia patients impact how they function, including social outcome, vocational outcome, and success in rehabilitation programs.
About Allon’s neuroprotective platforms
Allon’s two neuroprotective technology platforms are based on two naturally occurring proteins produced 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. ADNP drugs AL-108 and AL-208, focused on Alzheimer’s disease and cognitive impairment, are administered intranasally and intravenously respectively. ADNF drug candidate AL-309 is being developed for the treatment of peripheral neuropathies and is administered orally or subcutaneously.
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 two large underserved markets: Alzheimer's disease 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.
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.
