Allon Therapeutics Inc.
TSX : NPC

Allon Therapeutics Inc.

July 09, 2009 16:23 ET

Allon Releases Results of Phase II Schizophrenia Cognitive Impairment Clinical Trial

VANCOUVER, BRITISH COLUMBIA--(Marketwire - July 9, 2009) - Allon Therapeutics Inc. (TSX:NPC) today released top-line results from a Phase IIa clinical trial showing that the Company's lead neuroprotective drug candidate, davunetide intranasal (AL-108), has a positive impact on the ability of schizophrenia patients to carry out important activities in their daily lives.

Allon said statistically significant efficacy (p equals 0.015) was achieved on the UCSD (University of California at San Diego) Performance-based Skills Assessment (UPSA). The UPSA scale assesses the functional capacity of skills for daily living. In total, six domains were tested in staged tasks: medication management, comprehension/planning, financial, communication, transportation, and household skills.

The UPSA scale has been recognized by drug regulators as an important co-primary endpoint in patients suffering from schizophrenia-related cognitive impairment. While there are drug sales of $4-billion to treat the psychosis associated with schizophrenia, there are no approved drugs treating schizophrenia-related cognitive impairment.

In addition to evaluating davunetide intranasal (AL-108) with the UPSA scale, the drug was also evaluated with the MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) composite battery of tests, the primary outcome. Davunetide intranasal (AL-108) did not show significance on this measure.

The trial was managed by TURNS (Treatment Units for Research on Neurocognition and Schizophrenia), with substantial financial support from the National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health.

Gordon McCauley, Allon's President and CEO, said the trial results demonstrate the potential of davunetide intranasal (AL-108) to be developed and approved as the first drug to improve the cognition of schizophrenia patients.

"We believe these results are an important step forward in the development of the first drug to treat the cognitive impairment of millions of people suffering from schizophrenia," McCauley said.

"In this small exploratory study and in a disease state where few drugs have shown positive clinical trial outcomes, we believe it is compelling to see an effect on a clinically relevant outcome measure - and one that the United States Food and Drug Administration considers a validated co-primary outcome."

McCauley also said the Phase IIa clinical trial results reconfirm the potential of davunetide intranasal (AL-108) to treat other patient groups suffering from cognitive impairment. In 2008, Allon reported Phase IIa results showing that davunetide intranasal (AL-108) had a positive impact on memory function in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer's disease (AD).

"This is an excellent example of public research collaboration," McCauley added. "We have a strong focus on our Alzheimer's and dementia program; this support from TURNS and NIMH expands potential treatment options for patients."

Dr. Steven Whitaker, Vice President, Clinical Development and Chief Medical Officer, said the results justify larger clinical trials to evaluate davunetide intranasal (AL-108) in schizophrenia patients.

"Cognitive impairment is a major cause of chronic disability for individuals suffering from schizophrenia, but there are no approved treatments," Dr. Whitaker said. "I think it is quite interesting that davunetide demonstrated an effect on a measure that is related to an individual's ability to function in his or her everyday life. I believe larger and longer trials should be undertaken."

In this study, davunetide was safe and well tolerated by patients, with adverse events typical of this patient population.

The Phase IIa clinical trial was a randomized, double-blind, placebo-controlled, parallel group study, to assess the effect of davunetide intranasal (AL-108) in patients with schizophrenia-related cognitive impairment. Two doses of davunetide intranasal (AL-108), 5 mg once daily, and 15 mg twice daily, were compared to placebo. Patients were treated for 12 weeks. All patients were on a stable dose of an approved anti-psychotic therapy.

A total of 54 patients completed the trial at seven leading medical institutions in the United States: Nathan S. Kline Institute (Daniel Javitt, MD, PhD and Principal Investigator for the study); University of California at Los Angeles (Stephen R. Marder, MD and the Principal Investigator for the TURNS Network); Maryland Psychiatric Research Institute (Robert Buchanan, MD); Washington University (John Csernansky, MD); Massachusetts General Hospital (Donald Goff, MD); Columbia University (Jeffrey Lieberman, MD); Duke University (Joseph McEvoy, MD); and Beth Israel Deaconess Hospital (Larry Seidman, PhD). Data was managed at the Nathan S. Kline Institute (James Robinson, PhD.), and analyzed at the Maryland Psychiatric Research Institute (Robert McMahon, PhD.).

In this trial the impact of davunetide on the positive symptoms of schizophrenia, such as psychosis was examined and, as expected, no treatment effect was observed.

The TURNS group intends to present and publish the full results for this study. These top line results are being disclosed to meet Allon's disclosure obligations as a publicly traded company. In addition, TURNS and Allon collaborated on a companion study looking at changes in brain imaging in a small subset of the patients in the main study. Analysis of the images from this study has neither been completed nor shared with the company. Allon anticipates public disclosure of these findings in due course.

Conference Call

Allon Therapeutics will hold a conference call and webcast to discuss the Phase IIa trial results today, July 9, 2009, at 4:30 p.m. Eastern Daylight Time. The call will be hosted by Matthew Carlyle, CFO of Allon, and include Gordon McCauley, President and CEO of Allon, Dr. Steve Whitaker, Vice-President Clinical Development and Chief Medical Officer, and Dr. Bruce Morimoto, Vice-President, Drug Development of Allon. The conference call will be followed by a question and answer session.

To access the conference call by telephone, dial 1-416-644-3426 or 1-800-594-3615. Please connect approximately 15 minutes prior to the beginning of the call to ensure participation. The conference call will be archived for replay until Sunday, August 9, 2009 at midnight. To access the archived conference call, dial 1-416-640-1917 or 1-877-289-8525 and enter the reservation number 21310358 followed by the number (#) sign.

A live audio webcast of the conference call will be available at http://www.allontherapeutics.com/events_webcasts.html. Please connect at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to join the webcast. The webcast will be archived on the Company's website for 90 days.

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 $4-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 this 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 davunetide intranasal (AL-108)

Davunetide intranasal (AL-108) is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP). Allon's laboratory and animal studies have shown that AL-108 restores the function of structures in the brain - known as microtubules - which are critical to communication between brain cells and the structure of individual cells.

In 2008, Allon reported Phase IIa clinical trial results showing that davunetide intranasal (AL-108) had a statistically significant positive impact on memory function in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer's disease (AD). The data was presented July 28 and July 30, 2008 to the International Conference on Alzheimer's Disease and Related Disorders (ICAD 2008).

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 davunetide intranasal (AL-108) and davunetide intravenous (AL-208) are derived from ADNP, while preclinical stage drug AL-309 is derived from ADNF. ADNP drugs davunetide intranasal (AL-108) and davunetide intravenous (AL-208) are focused on Alzheimer's disease and cognitive impairment. 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. Allon's drug davunetide intranasal (AL-108) has demonstrated human efficacy in amnestic mild cognitive impairment, a precursor to Alzheimer's disease. Allon has Phase II human efficacy programs pursuing large underserved markets: Alzheimer's disease, frontotemporal dementia, and schizophrenia-related cognitive impairment. The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC" (Neuro Protection Company™) and based in Vancouver. For additional information please visit the Company's website: www.allontherapeutics.com.

About TURNS

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

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.

Contact Information