News
Allon presents at BIO Europe Partnering Meeting
VANCOUVER, April 8, 2008 — Allon Therapeutics Inc. (TSX: NPC), presented today at the BIO-Europe Spring 2008 partnership conference in Madrid, Spain sharing with prospective pharmaceutical partners the human efficacy data from the Company’s Phase IIa clinical trial in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer’s disease (AD).
Allon announced February 26, 2008 initial top-line data showing that the Company’s drug AL-108 had a positive impact on memory function in patients with aMCI. Statistically significant, dose dependent and durable improvement was measured in two key cognitive tests, delayed-match-to-sample (DMTS) and digit span, which are widely recognized and validated as effective measures of memory function relevant to Alzheimer’s disease.
Gordon McCauley, Allon’s President and Chief Executive Officer, today presented additional top-line data providing new comparisons with the high dose (15 mg twice daily), the low dose (5 mg once daily) and placebo groups for both DMTS and digit span. In addition, McCauley presented data from the three other DMTS tests performed in the study.
“The additional data adds weight to the internal consistency of the results,” McCauley said. “Even where results were not statistically significant, the high dose group generally performs better than the low dose group and the low dose performs better than placebo.”
“These additional top-line data complement our earlier high dose data on key endpoints that measured short-term, working and recognition memory — three types of memory that are clinically relevant in AD,” McCauley said.
McCauley told the BIO-Europe Spring 2008 conference that the Company will release a full analysis of the Phase IIa aMCI trial data at midyear and remains on track to initiate a Phase IIb study in Alzheimer’s disease by year end.
BIO-Europe Spring 2008, being held at Madrid’s Palacio Municipal de Congresos, is being attended by 1,200 delegates from 700 companies from 35 countries. The conference brings together biotech companies and large international pharmaceutical companies to explore partnering opportunities. A copy of the presentation is available on the Company’s website at http://www.allontherapeutics.com/ir_calendar.htm.
Allon has previously announced that one of its 2008 milestones is to complete a development and commercialization partnership with a major pharmaceutical company.
Initial top-line data
As released February 26, 2008, the high dose group showed a 62.4% improvement from baseline (p=0.038, versus placebo) in the DMTS, 12 second delay, by the end of the trial. Similarly, the high dose group showed a 17.2% increase from baseline (p=0.028, versus placebo) in the digit span combined test.
High dose AL-108 resulted in a statistically significant improvement in DMTS, 12-second delay. Improvement increased with the duration of treatment: at Week 4, 34.2% change from baseline (p=0.067 , versus placebo); at Week 8, 46.8% (p=0.039, versus placebo); at Week 16, 62.4% (p=0.038, versus placebo). As expected, AL-108 did not affect performance under the simultaneous, zero or four second delay, in which attention and focus are measured. This internal consistency, showing an effect when expected at the 12 second delay and not at the shorter delays, demonstrates the strength of this data set.
An improvement on digit span forward of the high dose group was observed as early as Week 4 with performance trending toward significance compared to placebo (p=0.059, versus placebo) with a 10.3% change from baseline. The degree of improvement was relatively stable throughout the course of the study and by Week 8, an 11.2% change from baseline was statistically significant (p=0.032, versus placebo), and remained significant at Week 16 with an 11.7% change from baseline (p=0.052, versus placebo). The low dose AL-108 was no different from placebo.
For the age-adjusted digit span combined test, the high dose group performed consistently better than both placebo and the low dose group throughout the study. At Weeks 4 and 16, the high dose resulted in 11.7% (p=0.037, versus placebo) and 17.2% (p=0.028, versus placebo) statistically significant changes from baseline.
Additional top-line data
As released today at BIO-Europe Spring 2008, as expected in the DMTS test neither the high or low dose AL-108 had any impact on performance under the simultaneous, zero or four second delays. The simultaneous, zero and four second delays measure attention and focus which were not expected to be impacted by AL-108 and are not relevant to the memory loss associated with clinical AD. In the 12-second delay, Week 4, the low-dose AL-108 and placebo performance scores compared with baseline were 6.8% and -6.0% respectively; Week 8, 7.8% and 1.8%; Week 12, 12% and 19%; and Week 16, 17% and 17.6%.
In the digit span forward test, the low dose group was generally better than placebo throughout the study. At week 4, the low-dose AL-108 and placebo performance scores compared with baseline were 3.7% and 1.6% respectively; Week 8, 3% and 2.2%; Week 12, 3.5% and 6.2%: and Week 16, 5.1% and 1.5%.
In the digit span test combined, the low dose group performed consistently better than placebo throughout the study. At Week 4, the low-dose AL-108 and placebo performance scores compared with baseline were 8.7% and –0.4% respectively; Week 8, 7.8% and 5.2%; Week 12, 9.0% and 7.7%; and Week 16, 11.2% and 4.5%.
About Allon
Allon Therapeutics Inc. is a clinical-stage biotechnology company developing treatments for major neurodegenerative conditions. In Q1 ’08 Allon’s drug AL-108 demonstrated robust human efficacy in amnestic mild cognitive impairment, a precursor to Alzheimer’s disease. Allon has two other Phase II human efficacy trials under way pursuing three large underserved markets: Alzheimer's disease, stroke and cognitive impairment associated with schizophrenia. The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC" (Neuroprotection 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
Manager, Investor Relations
(604) 742-2540 or Cell: (604) 323-6911
Email: akeay@allontherapeutics.com
Website: www.allontherapeutics.com
