NEW YORK – May 18, 2015 — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, revealed full preclinical anti-seizure data for its lead drug candidate, ANAVEX 2-73, in a presentation on Friday, May 15, 2015 at the Antiepileptic Drug Trials XIII Conference. ANAVEX 2-73 demonstrated convincing data in three well-established and according to experts highly predictive preclinical anti-seizure models with potentially more favorable side effect profile than currently marketed epilepsy drugs. The cognitive-enhancing features of ANAVEX 2-73 might be a differentiating factor since seizures cause neuro-cognitive impairments, which can be worsened by current epilepsy medications.
“With epilepsy, Anavex’s goal is to reduce or eliminate seizures with the fewest potential side effects. We are pleased to take this opportunity to interact with the epilepsy community so that we can effectively translate our preclinical data for potential clinical practices,” said Christopher U. Missling, PhD, President and CEO of Anavex. “There is a significant unmet need in epilepsy treatments. One-third of all pediatric and adult epilepsy patients are resistant to current treatments and many infants with rare, catastrophic forms of epilepsy experience low tolerability as well as co-morbidities. ANAVEX 2-73 is currently in a Phase 2a clinical study for Alzheimer’s, with expected preliminary data expected around the Q3 2015 timeframe. With recent research revealing the link between epilepsy and memory loss, the Company is encouraged to continue exploring this additional indication.”
ANAVEX 2-73 for Epilepsy
ANAVEX 2-73 exhibited dose-dependent significant anti-convulsive action by providing almost complete to complete protection from tonic seizures in three established seizure models:
• In maximum electroshock (MES)-induced convulsions, 30 mg/kg ANAVEX 2-73 provided 90% protection. In pentylenetetrazol (PTZ)-induced convulsions, the same dose provided 85% protection. In a semicarbazide (SCZ) model, the same dose was able to delay the tonic seizures from 56.9 seconds to 99.2 seconds. In (PTZ)-induced convulsions, 60 mg/kg ANAVEX 2-73 had a long-lasting effect with 100% seizure protection after both 4 and 6 hours, respectively.
ANAVEX 2-73 demonstrated robust synergistic effect in combination with three drugs currently on the market:
• With Ethosuximide (ETS) (Zarontin(R)), a first-generation antiepileptic drug, the combination of 10 mg/kg ANAVEX 2-73 and 200 mg/kg ETS provided 80% protection in MES-induced convulsions, while no protection at all was observed at the same dose of ETS alone. In the (PTZ)-induced convulsion model, the combination of 10 mg/kg ANAVEX 2-73 metabolite and 200 mg/kg of first line anti-epileptic drug Valproic acid (VPA) (Depakene(R)) showed 92% protection from tonic seizures, compared with modest 12.5% protection when 200 mg/kg VPA was administered on its own. In combination with the newer-generation anti-epileptic drug gabapentin (Neurontin(R)), ANAVEX 2-73 metabolite also showed a statistically strong effect in the reduction of seizures, compared to gabapentin alone. In the MES test, the combination of 5 mg/kg ANAVEX 2-73 metabolite with 100 mg/kg gabapentin resulted in 90% protection from tonic seizures as compared to 40% protection with 100 mg/kg gabapentin alone.
In order to test for potential side effects often seen with epilepsy drugs currently on the market, ANAVEX 2-73 was assessed in preclinical depression as well as mobility models. In both the forced (Porsolt) swim test and the open-field test, ANAVEX 2-73 showed clear anti-depressant effects and no signs of sedation. In the chimney test, ANAVEX 2-73 yielded no statistically significant motor impairment within the effective dose range.
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 of ANAVEX 2-73 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.
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, including cognitive impairments, with a wide range of seizure types and control varying from person to person. The greatest unmet needs in epilepsy remain the inadequate control of seizures that occur in 20% to 30% of drug-treated epilepsy patients, effective treatments for related orphan indications like Dravet or Lennox-Gastaut Syndrome, rare forms of epilepsy, and therapies with reduced co-morbidity, 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, indicating its potential to treat additional CNS disorders, including epilepsy and others. 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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