VANCOUVER, B.C. — Allon Therapeutics Inc. (TSX: NPC) today announced it will receive the Gold Leaf Award as the Early Stage Company of the Year (Health) from BIOTECanada, Canada’s national biotechnology industry organization. The award will be presented on June 28 at 4PM at the BIO 2011 International Convention in Washington, D.C. BIOTECanada said Allon was chosen as the top pre-commercialization company in the Canadian biotechnology healthcare sector “by distinguishing themselves from their peers with demonstrated technology innovation and achieved milestones.”
Gordon McCauley, Allon’s President and CEO, said the prestigious Gold Leaf Award recognizes the Company’s clinical trial successes and progress toward commercializing products in devastating degenerative brain diseases, such as Alzheimer’s, Parkinson’s and several types of frontotemporal dementia.
“Being chosen as Canada’s leading pre-commercial healthcare biotech company is a great honour and an enormous compliment to the dedication, innovation, and excellence demonstrated by our team every day,” said McCauley. “It is also important recognition of the investigators, patients, and caregivers we partner with to find solutions to these awful diseases.”
Allon announced last month it had successfully enrolled 50% of its 300-patient objective in a pivotal clinical trial evaluating lead drug candidate davunetide as a treatment for progressive supranuclear palsy (PSP), a rapidly progressing and fatal degenerative brain disease. The company is on track to complete enrolment by the end of 2011 and to report data approximately one year later.
The pivotal trial is being conducted under a Special Protocol Assessment granted by the United States Food and Drug Administration (FDA), which means that the agreed clinical trial design meets the FDA’s expectations for a pivotal study. Designation of davunetide for PSP as an Orphan Drug in the United States and the European Union brings significant commercial incentives for the company.
McCauley said the pivotal trial is based upon statistically significant human efficacy demonstrated in amnestic mild cognitive impairment (a precursor to Alzheimer’s disease), cognitive impairment associated with schizophrenia, and positive biomarker data.
About BIOTECanada
BIOTECanada is dedicated to the sustainable commercial development of biotechnology innovation in Canada. It is the national industry-funded association with over 250 member companies representing the broad spectrum of biotech constituents including emerging and established firms in the health, industrial, and agricultural sectors, as well as academic and research institutions and other related organizations.
About BIO
The Biotechnology Industry Organization (BIO) represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.
About Allon
Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on bringing to market innovative central nervous system therapies. Allon’s lead drug davunetide is proceeding in a pivotal Phase 2/3 clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under an SPA with the FDA. This pivotal trial is based upon statistically significant human efficacy demonstrated in amnestic mild cognitive impairment (a precursor to Alzheimer’s disease), cognitive impairment associated with schizophrenia, and positive biomarker data.
The Company is listed on the Toronto Stock Exchange under the trading symbol “NPC”.
About Davunetide
Allon is currently enrolling patients in a pivotal Phase 2/3 clinical trial evaluating davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly-progressing and fatal movement disorder with dementia which is often misdiagnosed as Parkinson’s or Alzheimer’s disease. Allon reached agreement on a Special Protocol Assessment with the U.S. Food and Drug Administration, as well as Orphan Drug and Fast Track Status in the U.S. Similarly, Allon has Orphan Status for davunetide in the EU.
Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP). Allon’s human clinical and pre-clinical data suggest that davunetide works on microtubules, structures in the brain critical to communication between cells, and central to the tau pathway. Davunetide has shown statistically significant impacts on memory, activities of daily living, and a biomarker of brain cell function and integrity. Allon has extensive intellectual property protecting davunetide.
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. Similarly, nothing in this press release is meant to promote a pharmaceutical product or make a regulated claim of efficacy.
FOR FURTHER INFORMATION PLEASE CONTACT:
Rick Smith
Allon Therapeutics Inc. - Investor Contact
Director, Investor Relations
(604) 742-2543
info@allontherapeutics.com
www.allontherapeutics.com
