Anavex Life Sciences Novel Sigma-1 / Sigma-2 Ligand Shows Encouraging Results as an Analgesic in Animal Models of Neuropathic and Visceral Pain
Preclinical Data for ANAVEX 1066 Presented at Society for Neuroscience Annual Meeting
New York, NY – November 14, 2016 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL) today reported encouraging preclinical efficacy for the treatment of neuropathic pain and visceral pain with their novel compound, ANAVEX 1066. The poster titled “Mixed sigma-1 / sigma-2 ligands as analgesics: studies with ANAVEX 1066 in animal models of neuropathic pain and visceral pain” was presented at the annual meeting of the Society for Neuroscience taking place from November 12-16 in San Diego, California.
ANAVEX 1066 was tested in two models of neuropathic and visceral pain that have been extensively validated in rats. In the chronic constriction injury (CCI) model of neuropathic pain, a single oral administration of ANAVEX 1066 dose-dependently restored the nociceptive threshold in the affected paw to normal levels while leaving the contralateral healthy paw unchanged. Efficacy was rapid and remained significant for two hours. In a model of visceral pain, chronic colonic hypersensitivity was induced by injection of an inflammatory agent directly into the colon and a single oral administration of ANAVEX 1066 returned the nociceptive threshold to control levels in a dose-dependent manner. Companion studies in rats demonstrated the lack of any effects on normal gastrointestinal transit with ANAVEX 1066 and a favorable safety profile in a battery of behavioral measures.
Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, stated, “The therapeutic potential of ANAVEX 1066 in two distinct and poorly served populations, patients with neuropathic pain and patients with visceral pain, is encouraging and we look forward to advancing the program for ANAVEX 1066.”
The poster presentation is available on the Publications page of Anavex’s website at http://www.anavex.com/publications/.
ABOUT NEUROPATHIC PAIN AND VISCERAL PAIN
Neuropathic pain is caused by damage to or disease affecting the somatosensory nervous system. Neuropathic pain may be associated with a heightened response to normal pain stimuli (hyperalgesia) or pain from normally non-painful stimuli (allodynia). It may have continuous and/or episodic (paroxysmal) components, the latter resemble stabbing sensations or electric shocks. General population studies, using validated screening instruments, have estimated that 7–8% of adults currently have chronic pain with neuropathic characteristics.
Visceral pain results from the activation of nociceptors of the thoracic, pelvic, or abdominal viscera. Visceral pain is diffuse, difficult to localize and often considered by patients to have a deep, sickening component. It may be accompanied by symptoms such as nausea, vomiting, and changes in vital signs as well as emotional manifestations. Irritable bowel syndrome (IBS), a dysfunctional condition causing recurrent attacks of abdominal pain, has been estimated to affect 25% of the population in many countries and accounts for 40–50% of all gastroenterologic consultations worldwide.
ABOUT ANAVEX 1066
ANAVEX 1066, a mixed Sigma-1/Sigma-2 receptor ligand, has previously demonstrated antitumor activity as well as analgesic effects in an animal model of chemotherapy-induced polyneuropathy. Current therapies for neuropathic and visceral pain are not satisfactory and thus new drugs acting on novel molecular targets are actively being investigated.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is 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 safety 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 animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.
Forward-Looking Statements
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.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Matt Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com
Media:
Dennis Dobson, Jr.
Dobson Media Group
(203) 258-0159
dennisdobsonjr@dobsonmediagroup.com
Preclinical Data for ANAVEX 1066 Presented at Society for Neuroscience Annual Meeting
New York, NY – November 14, 2016 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL) today reported encouraging preclinical efficacy for the treatment of neuropathic pain and visceral pain with their novel compound, ANAVEX 1066. The poster titled “Mixed sigma-1 / sigma-2 ligands as analgesics: studies with ANAVEX 1066 in animal models of neuropathic pain and visceral pain” was presented at the annual meeting of the Society for Neuroscience taking place from November 12-16 in San Diego, California.
ANAVEX 1066 was tested in two models of neuropathic and visceral pain that have been extensively validated in rats. In the chronic constriction injury (CCI) model of neuropathic pain, a single oral administration of ANAVEX 1066 dose-dependently restored the nociceptive threshold in the affected paw to normal levels while leaving the contralateral healthy paw unchanged. Efficacy was rapid and remained significant for two hours. In a model of visceral pain, chronic colonic hypersensitivity was induced by injection of an inflammatory agent directly into the colon and a single oral administration of ANAVEX 1066 returned the nociceptive threshold to control levels in a dose-dependent manner. Companion studies in rats demonstrated the lack of any effects on normal gastrointestinal transit with ANAVEX 1066 and a favorable safety profile in a battery of behavioral measures.
Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, stated, “The therapeutic potential of ANAVEX 1066 in two distinct and poorly served populations, patients with neuropathic pain and patients with visceral pain, is encouraging and we look forward to advancing the program for ANAVEX 1066.”
The poster presentation is available on the Publications page of Anavex’s website at http://www.anavex.com/publications/.
ABOUT NEUROPATHIC PAIN AND VISCERAL PAIN
Neuropathic pain is caused by damage to or disease affecting the somatosensory nervous system. Neuropathic pain may be associated with a heightened response to normal pain stimuli (hyperalgesia) or pain from normally non-painful stimuli (allodynia). It may have continuous and/or episodic (paroxysmal) components, the latter resemble stabbing sensations or electric shocks. General population studies, using validated screening instruments, have estimated that 7–8% of adults currently have chronic pain with neuropathic characteristics.
Visceral pain results from the activation of nociceptors of the thoracic, pelvic, or abdominal viscera. Visceral pain is diffuse, difficult to localize and often considered by patients to have a deep, sickening component. It may be accompanied by symptoms such as nausea, vomiting, and changes in vital signs as well as emotional manifestations. Irritable bowel syndrome (IBS), a dysfunctional condition causing recurrent attacks of abdominal pain, has been estimated to affect 25% of the population in many countries and accounts for 40–50% of all gastroenterologic consultations worldwide.
ABOUT ANAVEX 1066
ANAVEX 1066, a mixed Sigma-1/Sigma-2 receptor ligand, has previously demonstrated antitumor activity as well as analgesic effects in an animal model of chemotherapy-induced polyneuropathy. Current therapies for neuropathic and visceral pain are not satisfactory and thus new drugs acting on novel molecular targets are actively being investigated.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is 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 safety 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 animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.
Forward-Looking Statements
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.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Matt Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com
Media:
Dennis Dobson, Jr.
Dobson Media Group
(203) 258-0159
dennisdobsonjr@dobsonmediagroup.com
