Allon Therapeutics Inc.
TSX : NPC

Allon Therapeutics Inc.

February 23, 2011 08:31 ET

Allon Appoints Dr. Michael Gold Chief Medical Officer

VANCOUVER, BRITISH COLUMBIA--(Marketwire - Feb. 23, 2011) - Allon Therapeutics Inc. (TSX:NPC) announced today the appointment of Dr. Michael Gold, M.Sc., M.D. as Vice President, Clinical Development and Chief Medical Officer. Gold joins Allon directly from GlaxoSmithKline Inc. (GSK) where he most recently served as Vice-President, Neuroscience Medicines. At GSK, Gold was responsible for late-stage neurology compounds for the global pharmaceutical company.

Gordon McCauley, Allon's President and CEO, said the addition of Dr. Gold is critical now that Allon's lead product davunetide is in a global pivotal clinical trial. "Dr. Gold is an outstanding neurologist and a successful clinical development leader, who has precisely the experience and track record we need now to guide our late-stage clinical trial and to help build and diversify our product pipeline," McCauley said. 

Gold will be responsible for all clinical development programs and medical affairs at Allon. His primary focus will be the global pivotal trial underway with Allon's davunetide program. This trial is evaluating davunetide as a therapy for progressive supranuclear palsy (PSP), a rapidly progressing and fatal degenerative brain disease. Allon is currently enrolling patients in this trial in North America, Europe, and Australia, following the protocol approved under the Special Protocol Assessment (SPA) issued by the United States Food and Drug Administration (FDA).

Gold said joining Allon gives him the opportunity to make a major contribution to an important program at a critical time. "I have had the chance to interact with the Allon team over the last few years and develop a strong understanding of the potential for davunetide and the pipeline," Gold said. "I am eager to join Allon and assist the team in progressing through this pivotal trial and help bring to patients this urgently needed product."

Gold received his M.D. from the University of Miami Medical School and is board certified in neurology and psychiatry. He has been an Assistant Professor of Neurology at the University of South Florida (USF) Medical School and Director of the USF Memory Disorders Clinic. In 1998, Gold joined Bristol-Myers Squibb in pharmacology and experimental medicine. He subsequently moved to Johnson & Johnson (J&J) in 2001 where he made significant contributions to the FDA approval of several compounds as well as being responsible for strategic development within the company's analgesia and neurodegeneration franchises. 

From J&J, Gold moved to GSK in 2005 where he held various leadership responsibilities in neurological clinical development from Phase 2 clinical trials through regulatory approval, including supporting global registration and commercialization of new products.

Gold will take up his new responsibilities at Allon effective March 7, 2011.

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 and dementia which is often misdiagnosed as Parkinson's or Alzheimer's disease. Allon has agreed on a Special Protocol Assessment with the FDA, 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.

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 based on davunetide are derived from ADNP, while preclinical stage drug AL-309 is derived from ADNF. Davunetide is focused on Alzheimer's disease, cognitive impairment associated with schizophrenia, and progressive supranuclear palsy (PSP). 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 focused on developing the first drugs that impact the progression of neurodegenerative diseases. Allon's lead drug davunetide, is proceeding in a 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, cognitive impairment associated with schizophrenia, and positive biomarker data.

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.

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.

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