Anavex Life Sciences
Encyclopedia
Anavex Life Sciences Corp. is a biopharmaceutical company engaged in the discovery and development of new drugs for the treatment of neurological diseases and cancer, utilizing its proprietary drug discovery SIGMACEPTOR™ platform. The Anavex portfolio comprises novel, wholly owned sigma receptor agonists and antagonists. The company’s lead drug candidate for Alzheimer’s disease (AD), ANAVEX 2-73, is in Phase 1 clinical trials, getting assessed for its safety, maximally tolerated dose, pharmacokinetics and pharmacodynamics. The company has also started scale-up manufacturing for ANAVEX 1-41, its second lead compound, targeting depression and AD. With sufficient quantities of ANAVEX 1-41 in hand, the company will be in a position to advance the program and begin preclinical studies on large animals in the near term.
Neurological diseases (CNS): Anavex SIGMACEPTOR™-N program involves the discovery and development of original drug candidates, targeting neurological diseases such as Alzheimer’s disease, epilepsy, and depression. The company’s lead drug candidates exhibit high affinity and selectivity to sigma receptors and also synergistic action with other receptors, such as Muscarinic and NMDA, with strong evidence of anti-amnesic, neuroprotective, and anxiolytic properties.
Oncology: Anavex SIGMACEPTOR™-C program involves the discovery and development of original drug candidates targeting cancer. The company’s lead drug candidates exhibit high affinity to sigma receptors with strong evidence for selective apoptosis of cancerous cells, without affecting healthy cells, anti-metastatic and low toxicity properties in various types of cancer such as melanoma, prostate and pancreas, and neuropathic pain.
In addition, several series of sigma ligands currently at different stages of development, target stroke, diabetes, multiple sclerosis and Parkinson’s disease.
Anavex boasts a network of strategic collaborations with ABX-CRO, Syntagon, Cerep, Oncodesign, Eurogenet Laboratories, FORENAP Pharma EURL, Amylgen SAS and leading academic institutions, such as Université Montpellier, Université Nice and Sophia Antipolis in France. These collaborations make it possible for Anavex to outsource parts of its R&D process to drive capital efficiency while maintaining control of its research initiatives and intellectual property.
The company’s lead drug candidate for Alzheimer’s disease (AD), ANAVEX 2-73, has successfully completed a Phase 1 single ascending dose (SAD) clinical trial. Results regarding the compound’s safety profile are very encouraging, as there is no evidence of any treatment-related adverse effects. In this Phase 1 SAD study, the maximum tolerated single dose was defined per protocol as 55-60 mg. This dose is above the equivalent dose shown to have positive effects in mouse models of AD. There were no significant changes in laboratory or electrocardiogram (ECG) parameters. ANAVEX 2-73 was well tolerated below the 55-60 mg dose with only mild adverse events in some volunteers. Observed adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs that target central nervous system (CNS) conditions, including AD.
ANAVEX 2-73 has been shown to provide protection from oxidative stress
, which damages and destroys neurons and is believed to be a primary cause of Alzheimer’s disease. Research in recent years indicates that oxidative stress
is a precursor to amyloid-beta plaques and tau
(see also Neuro-Fibrillary Tangles), and could be a novel and appropriate therapeutic target.
In epilepsy, ANAVEX 19-144 has shown to control seizures and the epileptogenesis
process. The neuroprotective properties prevent the process that causes long-term damage to tissue and cells as well as biochemical and physiological alterations to the brain from epileptic seizures.
The company's ANAVEX 1-41 drug candidate is a compound in pre-clinical development for Alzheimer’s disease and depression. Animal studies indicate that ANAVEX 1-41 prevents the expression of caspase-3, an enzyme
that plays a key role in programmed cell death and in the loss of cells in the hippocampus
, the part of the brain that regulates learning, emotion and memory.
. These compounds induced apoptosis
during in-vitro and in-vivo studies in three types of cancers which are prostate
, melanoma
, and pancreas
, demonstrating evidence of pro-apoptotic and anti-metastatic action with low toxicity
.
In advanced pre-clinical studies, ANAVEX 1007, the company’s lead drug candidate for the treatment of prostate cancer, revealed anti-tumor potential without major toxic side effects. The compound has also been shown to selectively kill human cancer cells without affecting normal/healthy cells and also to suppress tumor growth in immune-deficient mouse models.
Neurological diseases (CNS): Anavex SIGMACEPTOR™-N program involves the discovery and development of original drug candidates, targeting neurological diseases such as Alzheimer’s disease, epilepsy, and depression. The company’s lead drug candidates exhibit high affinity and selectivity to sigma receptors and also synergistic action with other receptors, such as Muscarinic and NMDA, with strong evidence of anti-amnesic, neuroprotective, and anxiolytic properties.
Oncology: Anavex SIGMACEPTOR™-C program involves the discovery and development of original drug candidates targeting cancer. The company’s lead drug candidates exhibit high affinity to sigma receptors with strong evidence for selective apoptosis of cancerous cells, without affecting healthy cells, anti-metastatic and low toxicity properties in various types of cancer such as melanoma, prostate and pancreas, and neuropathic pain.
In addition, several series of sigma ligands currently at different stages of development, target stroke, diabetes, multiple sclerosis and Parkinson’s disease.
Anavex boasts a network of strategic collaborations with ABX-CRO, Syntagon, Cerep, Oncodesign, Eurogenet Laboratories, FORENAP Pharma EURL, Amylgen SAS and leading academic institutions, such as Université Montpellier, Université Nice and Sophia Antipolis in France. These collaborations make it possible for Anavex to outsource parts of its R&D process to drive capital efficiency while maintaining control of its research initiatives and intellectual property.
Program pipeline
The company’s drug development program is based around its proprietary SIGMACEPTOR Discovery Platform, which generates small-molecule candidates. The company currently has seven product candidates in development for seven disease indications.Sigmaceptor-N
Anavex’s SIGMACEPTOR-N program involves the development of disease-modifying treatments that target neurological and neurodegenerative diseases.The company’s lead drug candidate for Alzheimer’s disease (AD), ANAVEX 2-73, has successfully completed a Phase 1 single ascending dose (SAD) clinical trial. Results regarding the compound’s safety profile are very encouraging, as there is no evidence of any treatment-related adverse effects. In this Phase 1 SAD study, the maximum tolerated single dose was defined per protocol as 55-60 mg. This dose is above the equivalent dose shown to have positive effects in mouse models of AD. There were no significant changes in laboratory or electrocardiogram (ECG) parameters. ANAVEX 2-73 was well tolerated below the 55-60 mg dose with only mild adverse events in some volunteers. Observed adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs that target central nervous system (CNS) conditions, including AD.
ANAVEX 2-73 has been shown to provide protection from oxidative stress
Oxidative stress
Oxidative stress represents an imbalance between the production and manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage...
, which damages and destroys neurons and is believed to be a primary cause of Alzheimer’s disease. Research in recent years indicates that oxidative stress
Oxidative stress
Oxidative stress represents an imbalance between the production and manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage...
is a precursor to amyloid-beta plaques and tau
Tau
Tau is the 19th letter of the Greek alphabet. In the system of Greek numerals it has a value of 300.The name in English is pronounced , but in modern Greek it is...
(see also Neuro-Fibrillary Tangles), and could be a novel and appropriate therapeutic target.
In epilepsy, ANAVEX 19-144 has shown to control seizures and the epileptogenesis
Epileptogenesis
Epileptogenesis is a process by which a normal brain develops epilepsy, a chronic condition in which seizures occur. The process, which is gradual, occurs in symptomatic epilepsy, in which seizures are caused by an identifiable lesion in the brain. It results from acute brain insults such as...
process. The neuroprotective properties prevent the process that causes long-term damage to tissue and cells as well as biochemical and physiological alterations to the brain from epileptic seizures.
The company's ANAVEX 1-41 drug candidate is a compound in pre-clinical development for Alzheimer’s disease and depression. Animal studies indicate that ANAVEX 1-41 prevents the expression of caspase-3, an enzyme
Enzyme
Enzymes are proteins that catalyze chemical reactions. In enzymatic reactions, the molecules at the beginning of the process, called substrates, are converted into different molecules, called products. Almost all chemical reactions in a biological cell need enzymes in order to occur at rates...
that plays a key role in programmed cell death and in the loss of cells in the hippocampus
Hippocampus
The hippocampus is a major component of the brains of humans and other vertebrates. It belongs to the limbic system and plays important roles in the consolidation of information from short-term memory to long-term memory and spatial navigation. Humans and other mammals have two hippocampi, one in...
, the part of the brain that regulates learning, emotion and memory.
Sigmaceptor-C
Anavex’s SIGMACEPTOR-C program involves the development of novel drug candidates targeting cancerCancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
. These compounds induced apoptosis
Apoptosis
Apoptosis is the process of programmed cell death that may occur in multicellular organisms. Biochemical events lead to characteristic cell changes and death. These changes include blebbing, cell shrinkage, nuclear fragmentation, chromatin condensation, and chromosomal DNA fragmentation...
during in-vitro and in-vivo studies in three types of cancers which are prostate
Prostate
The prostate is a compound tubuloalveolar exocrine gland of the male reproductive system in most mammals....
, melanoma
Melanoma
Melanoma is a malignant tumor of melanocytes. Melanocytes are cells that produce the dark pigment, melanin, which is responsible for the color of skin. They predominantly occur in skin, but are also found in other parts of the body, including the bowel and the eye...
, and pancreas
Pancreas
The pancreas is a gland organ in the digestive and endocrine system of vertebrates. It is both an endocrine gland producing several important hormones, including insulin, glucagon, and somatostatin, as well as a digestive organ, secreting pancreatic juice containing digestive enzymes that assist...
, demonstrating evidence of pro-apoptotic and anti-metastatic action with low toxicity
Toxicity
Toxicity is the degree to which a substance can damage a living or non-living organisms. Toxicity can refer to the effect on a whole organism, such as an animal, bacterium, or plant, as well as the effect on a substructure of the organism, such as a cell or an organ , such as the liver...
.
In advanced pre-clinical studies, ANAVEX 1007, the company’s lead drug candidate for the treatment of prostate cancer, revealed anti-tumor potential without major toxic side effects. The compound has also been shown to selectively kill human cancer cells without affecting normal/healthy cells and also to suppress tumor growth in immune-deficient mouse models.
See also
- Clinical trialClinical trialClinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
- Drug developmentDrug developmentDrug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
- Pharmaceutical companyPharmaceutical companyThe pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...
- Pre-clinical developmentPre-clinical developmentIn drug development, pre-clinical development is a stage of research that begins before clinical trials can begin, and during which important feasibility, iterative testing and drug safety data is collected....