🕐19.08.11 - 00:27 Uhr

ALLON THERAPEUTICS GAINING GROUND ON BREAKTHROUGH NEUROLOGICAL DRUG






Allon Therapeutics Gaining Ground On
Breakthrough Neurological Drug

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By James West
VantageWire.com
August 18, 2011

Allon Therapeutics Inc. (TSX: NPC) is developing drugs that target neurodegenerative diseases like dementia, schizophrenia and Parkinsons disease. Allon is currently enrolling patients in a pivotal Stage 2/3 clinical trial to evaluate davunetide, Allons lead drug, as a potential treatment for Progressive Supranuclear Palsy (PSP), a form of dementia that affects about 75,000 people worldwide. Over half of the 300 total patients have been enrolled in the pivotal trial with results expected at the end of 2012.

Allons Technology
Davunetide is a peptide (a protein fragment) derived from a naturally occurring neuroprotective brain protein. Allons human clinical and pre-clinical data suggest that davunetide works on microtubules, structures in the brain critical to communication within 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.

Neurons are the brain cells responsible for transmission of signals along their axon

Microtubules are structures within the axon that are essential for the movement of nutrients and neuro-transmitters within the neurons

Breakdown of microtubule structure due to loss of tau function is a central event in the cell death and brain atrophy in tauopathies

Initial Target Disease
PSP, a type of frontotemporal dementia (FTD), is a terminal neurodegenerative brain disease that has no known cause, treatment or cure. It affects brain cells (neurons) that control walking, balance, mobility, vision, speech, and swallowing. There are 25,000 people with this disease in North America and about 40,000 in Europe. Symptoms typically begin when an individual is in their early 60s, but may start as early as their 40s. PSP is slightly more common in men than women, but getting PSP is not tied to geography, occupation or race.

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 European Union (EU). These regulatory advances mean that the FDA has accepted the clinical trial design as appropriate for a drug approval; there is longer and greater market exclusivity associated with orphan drug status; and the approval process is faster and more efficient with the orphan and fast track designations.

Commercial Opportunity
Allon consulted clinicians in the United States and the EU, who agreed in stating that if davunetide were approved it would be clinically appropriate for 84% of their patients suffering from PSP. Using very conservative pricing assumptions, Allon estimates the market for PSP treatments to be greater than $700 million.

The companys strategy is to first obtain FDA and EU approval for davunetide as a treatment for PSP, and will then seek approval in other tau-related FTDs which is roughly 4 times the size of the PSP market. Because orphan drug designation does not restrict a drug from larger diseases, it will have no impact on the Companys strategy to seek approval in these larger markets, such as Alzheimers, schizophrenia and Parkinsons in collaboration with a major pharma partner.

Recent News & Highlights:

On August 4, 2011, Allon announced a new U.S. patent was granted covering davunetide as a treatment for schizophrenia. Two weeks earlier, Allon announced new human imaging data supports the neuroprotective effects of davunetide as it appears to prevent cortical thinning of important parts of the brains of schizophrenia patients. In June, 2011, Allon won the Gold Leaf Award as the Early Stage Company of the Year from BIOTECanada, Canadas national biotechnology industry organization. The Vancouver Sun wrote an article covering this prestigious award. In June 2011episode of Market Call on BNN, Jeff Parent from Quadrexx Asset Management in Toronto gave Allon a "top pick" rating. Mr. Parent says theres a lot of opportunity and promise in the stock, and recommended accumulating small positions. Practical Neurologys April 2011 edition of "In the Pipeline" featured a research project funded by the Michael J. Fox Foundation (MJFF) for Parkinsons Research found that intranasal davunetide treatment significantly improved motor function and brain pathology in a mouse model which replicates certain characteristics of Parkinsons disease (PD). Canaccord Genuity analysts recently issued a statement in their Daily Letter that states, "We value Allon using an explicit NPV model of the global opportunity for davunetide in FTD. Based on this analysis, we arrive at a target price of CA$1.20, which supports our BUY recommendation."

Financial Information
As of March 31, 2011, Allon has $15 million available for continued clinical development. Traded on the Toronto Stock Exchange under the symbol "NPC", there are 78.5 million shares issued and outstanding. Institutions own 60% of the companys stock.

For more information, visit Allons website:

Click here for contact information

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