NEW YORK, Feb. 9, 2015 — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (AVXL) today confirmed positive preclinical data for its lead drug candidate ANAVEX 2-73 for the potential treatment of epilepsy, validating it also as a prospective platform drug for the treatment of other neurodegenerative diseases beyond Alzheimer’s. The data demonstrates significant improvement in the reduction of seizures relative to three generations of epilepsy drugs currently on the market, as well as significant synergy with each of these drugs. ANAVEX 2-73 has successfully completed a Phase 1 human clinical trial, in which it was shown to be safe, and is currently in a Phase 2a clinical trial for Alzheimer’s disease.
“Efficacy is important in an anticonvulsant drug candidate. The key, however, to the next generation of epilepsy therapies is safety since most currently used epilepsy drugs require therapeutic drug monitoring given their significant differences in individuals’ therapeutic dosages. Adding ANAVEX 2-73 to a current epilepsy drug regimen has the potential to increase safety by means of a dose reduction, while at the same time significantly improving anti-seizure efficacy. This data also suggests that ANAVEX 2-73 has the potential to become a platform drug for additional indications beyond Alzheimer’s disease,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Another important implication is a recent finding that Alzheimer’s disease and seizures together seem to accelerate the worsening of symptoms, suggesting that the seizure disorder adds to the degenerative Alzheimer’s disease pathology to exacerbate the cognitive decline. We are encouraged to explore this additional indication in parallel with our ongoing Phase 2a Alzheimer’s study.”
ANAVEX 2-73 for Epilepsy
To study the anticonvulsant effect of ANAVEX 2-73, three generations of epilepsy drug candidates were tested in multiple standard seizure-inducing animal models. The results noted below were following administration of ANAVEX 2-73, both alone and in combination with three drugs currently on the market.
• On its own, ANAVEX 2-73 exhibited significant anticonvulsive dose-dependent action by providing almost complete protection from tonic seizures. In maximum electroshock (MES)-induced convulsions, it was observed that 30 mg/kg ANAVEX 2-73 alone was able to provide 90% protection.
• ANAVEX 2-73 in combination with Ethosuximide (ETS) (Zarontin(R)), a first-generation antiepileptic drug, showed a strong synergistic effect in the MES test. In MES-induced convulsions, the combination of 10 mg/kg of ANAVEX 2-73 and 200 mg/kg of ETS provided 80% protection, while no protection at all was observed at the same dose ETS alone.
• ANAVEX 2-73 in combination with the first line anti-epileptic drug Valproic acid (VPA) (Depakene(R)) displayed a strong synergistic effect. In the pentylenetetrazole (PTZ)-induced convulsion model, the combination of 10 mg/kg of ANAVEX 2-73 metabolite and 200 mg/kg of VPA showed 92% protection from tonic seizures, compared with modest 12.5% protection when 200 mg/kg of VPA was administered on its own. The combination with ANAVEX 2-73 also prolonged life during a seizure, compared to when VPA was used alone.
• ANAVEX 2-73 in combination with the newer generation anti-epileptic drug gabapentin (Neurontin(R)) also showed a statistically strong effect in the reduction of seizures, compared to gabapentin alone. The combination of 5 mg/kg of ANAVEX 2-73 metabolite with 100 mg/kg of gabapentin resulted in 90% protection from tonic seizures as compared to 40% protection with 100 mg/kg of gabapentin alone in the MEZ test.
Anavex plans to release the full preclinical anti-seizure data for ANAVEX 2-73 at an upcoming scientific conference.
About ANAVEX 2-73
ANAVEX 2-73 is an orally available small molecule that targets sigma-1 and muscarinic receptors, which have shown in preclinical studies to reduce stress levels in the brain. ANAVEX 2-73 is currently undergoing a Phase 2a clinical trial for Alzheimer’s disease. A Phase 1 trial was successfully completed and showed no safety issues or toxicity signals. A total of 22 healthy male volunteers received single ascending oral doses of ANAVEX 2-73 to determine the maximum tolerated dose and investigate what, if any, side effects may result. ANAVEX 2-73 was well tolerated even at the highest tested dose of 55 mg. Study participants did not exhibit any serious side effects, nor was there any study discontinuation due to adverse events. In addition, ANAVEX 2-73 demonstrated a pharmacokinetics (PK) profile to potentially support once-daily oral dosing. PK data revealed biotransformation of ANAVEX 2-73 to its main metabolite, which also actively targets sigma-1 and muscarinic receptors like its parent drug ANAVEX 2-73.
Epilepsy is the most common serious neurological disorder, affecting people of all ages. It is a term used for recurring seizure disorder, a condition that is characterized by the tendency for an individual to have repeated nervous seizures (interruption of normal brain activity). Epilepsy is considered to be a spectrum disorder that can cause other health problems, with a wide range of seizure types and control varying from person to person. The greatest unmet need in epilepsy remains the inadequate control of seizures that occur in 20 to 30% of drug-treated epilepsy patients, translating into a significant market opportunity. The global epilepsy market was estimated at $4.2 billion in 2012 and is expected to grow to $5.35 billion by 2022, with more than 50% of sales coming from the United States.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept(R)), are currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually.
Further information is available at www.anavex.com
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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