News
Allon Therapeutics announces milestones for 2009
VANCOUVER — January 12, 2009 - Allon Therapeutics Inc. (TSX: NPC) announced today its 2009 milestones and confirmed that the Company’s existing cash resources are sufficient to fund its business into 2011.
Gordon McCauley, President and CEO of Allon, said, “The Company takes the establishment and achievement of milestones very seriously with the same focus it places on prudent management of cash resources. We are proud of the fact that we have substantively achieved our past milestones and are in a strong cash position today.”
McCauley said the most significant milestone not yet achieved is the establishment of a pharmaceutical partnership for the Company’s Alzheimer’s disease (AD) program. “We are continuing commercial partnership discussions with several pharmaceutical companies and expect to successfully conclude a partnership in 2009.”
“A number of pharmaceutical companies have confirmed they are keenly interested in our neuroprotection drugs and technology but 2008’s international financial crisis pushed these partnership decisions into 2009,” McCauley said. Given the state of these negotiations, the Company will initiate a Phase IIb study in AD after a partnership is signed.
While Allon continues partnership negotiations in AD, it will move forward with a Phase II clinical trial in frontotemporal dementia (FTD). FTD describes several cognitive disorders, such as Pick’s disease, for which no treatment is currently available, including several that are fatal within three to five years of diagnosis. In addition, about 50% of the FTD disorders are tauopathies, or tau-related diseases. Allon’s technology is recognized as the most clinically advanced tau-related therapy.
The Company believes that there are regulatory routes to achieve an approval with FTD in a much shorter timeframe than AD, while moving forward concurrently with a partner in AD.
Dr. Bruce Miller, Professor of Neurology and Director of the University of California San Francisco Memory and Aging Center, said that over the past 10 years FTD has emerged as the most common cause of early-onset dementia under the age of 60 years, outstripping even AD in prevalence.
“Our review of AL-108 data related to impact on tauopathies has convinced us that this drug’s potential in FTD warrants investigation at the earliest opportunity,” Dr. Miller said.
In addition, the Company will initiate a Phase II study to examine the effect of AL-108 on human brain metabolism, which declines with progression of AD. Positron emission tomography (PET scans) will be used to image glucose metabolism in the brains of patients with AD, providing a method for evaluating the short-term treatment effects of AL-108. Examination of AL-108’s effects on human brain metabolism will add significantly to the understanding of dosing, pharmacokinetics and pharmacodynamics of AL-108.
The Company expects to announce top-line results in the first half of 2009 from a Phase II clinical trial evaluating the efficacy and safety of AL-108 in patients with schizophrenia-related cognitive impairment. Patient enrolment was completed in November 2008. This 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.
Beyond these specific clinical milestones, the Company will not advance further programs until the financial climate has improved.
“Our team has done an excellent job of pursuing our key milestones, while managing our cash prudently, which is why we will have cash into 2011,” McCauley said. “In this climate, the only added value recognized by the marketplace is human clinical progress. Therefore, we will continue to advance our clinical-stage assets, reduce non-essential costs, and examine ways to broaden our pipeline without impacting our clinical milestones or cash.”
Milestone Summary
• Execute a partnership agreement with a major pharmaceutical company.
• Commence a Phase IIb study in AD with a partner.
• Initiate a Phase II study in frontotemporal dementia.
• Initiate a Phase II PET study in AD patients.
• Announce top-line results from the Phase II study in schizophrenia-related cognitive impairment.
About FTD
Frontotemporal dementia (FTD) is a collection of neurodegenerative syndromes characterized clinically by behavioural disturbance, impaired fluency of speech, difficulty in finding words and involuntary movements in some cases. In contrast to AD, FTD generally affects younger patients aged 45-65 years.
FTD is a devastating disease with a median survival of approximately six years from symptom onset and three years after diagnosis in some types. The median time from symptom onset to institutionalization is approximately five years but only one year from formal diagnosis. According to Orphanet, the European portal for rare diseases and orphan drugs, the prevalence for FTD is approximately 3.6-15 per 100,000. Age at onset for FTD is generally earlier than AD and it is referred to as a pre-senile disorder.
FTD is most closely associated with atrophy of the brain involving the frontal lobes, temporal lobes or both, often asymmetrically. Neurochemical evaluations have demonstrated that the cholinergic system is largely intact while dopaminergic and serotoninergic systems are compromised. A variety of neuropathologic changes can be seen including neuronal loss, astrogliosis and loss of synapses but there is no single signature of changes.
Tau abnormalities are seen in several variants of FTD and make up approximately 50% of the FTD population. Neurofibrillary tangles that stain positive for tau are particularly associated with coritcobasal degeneration and progressive supranuclear palsy.
2008 achievements
Allon’s 2008 achievements included:
February 26: Allon released top-line results of a Phase IIa clinical trial showing that AL-108 improved specific memory functions in patients with amnestic mild cognitive impairment (aMCI), a precursor to AD. Allon said statistically significant efficacy was achieved on key endpoints that measured short-term recall and working memory, two types of memory that are clinically relevant in AD. The trial also demonstrated that AL-108 was safe and well tolerated by patients.
June 10: Allon was granted a United States patent that covers the composition of AL-309, a novel neuroprotective compound that is derived from Allon’s proprietary technology platform, activity-dependent neurotrophic factor (ADNF).
July 15: Allon announced it has successfully raised $20 million of equity through a bought deal public offering of common shares.
July 28-30: At the International Conference on Alzheimer’s Disease and Related Disorders (ICAD 2008), Allon made several scientific presentations of its Phase IIa aMCI trial human efficacy data as well as animal data showing that AL-108 reduced the classic AD “tangles” pathology and also increased memory function. The presentations validated the therapeutic potential of addressing the “tangles” component of the classic AD “plaques and tangles” pathology.
August 12: Allon announced that a pharmacokinetics study confirmed that the Company’s clinical stage drugs AL-108 and AL-208 penetrate the blood brain barrier of healthy adults and AD patients in sufficient quantities to enable a therapeutic effect on AD and other neurodegenerative diseases.
October 7: Allon announced that it has been granted a U.S. patent covering composition, delivery and method of use for new neuroprotective drugs comprised of combinations of peptides from the Company’s two proprietary technology platforms, activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF). The Company said the combinations have improved cognitive performance and provide neuroprotection in animals.
November 18: Allon announced it has been issued a U.S. patent covering the use of its neuroprotective drugs as potential treatments for peripheral neuropathy, a group of debilitating and painful conditions suffered by millions of people and resulting from nerve damage for which there is currently no effective treatment available. Allon animal studies have shown that Company product candidate AL-309 not only reduced the pain symptoms associated with neuropathy but also decreased nerve damage.
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. The ADNF drug candidate, AL-309 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 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 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.
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FOR FURTHER INFORMATION PLEASE 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
