Anavex Life Sciences Corp., a clinical stage biopharmaceutical company, engages in the development of drug candidates for the treatment of central nervous system diseases. The company’s lead drug candidate is ANAVEX 2-73, which is in Phase III clinical trial for the treatment of Alzheimer’s disease; Phase II clinical trials to treat Parkinson’s disease; and preclinical clinical trials to treat Rett syndrome, epilepsy, infantile spasms, Fragile X syndrome, Angelman syndrome, multiple sclerosis, and tuberous sclerosis complex. Its preclinical drug candidates include ANAVEX 3-71, a central nervous system (CNS)-penetrable mono-therapy to treat Alzheimer’s and Parkinson’s diseases; ANAVEX 1-41, a sigma-1 agonist for the treatment of depression, stroke, Parkinson’s, and Alzheimer’s diseases; ANAVEX 1066, a mixed sigma-1/sigma-2 ligand for the potential treatment of neuropathic and visceral pain; and ANAVEX 1037 to treat prostate and pancreatic cancer. The company is based in New York, New York.

Anavex utilizes precision genetic medicine to treat severe and devastating neurological disorders and is focusing on rare diseases with no available therapy (Rett syndrome) as well as neurodegenerative diseases that are on the rise due to aging populations (Parkinson’s Disease and Alzheimer’s Disease)

Anavex Life Sciences Announces Publication of Foundational Data for ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

Published in Journal of Neuroimmunology, Results Highlight ANAVEX®2-73 (blarcamesine) Shown to Protect and Repair Myelin Forming Cells

ANAVEX®2-73 (blarcamesine) Provides optimal Protection of Oligodendroglia against Glutamate Toxicity

 

NEW YORK – February 24, 2020 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced the publication in the peer-reviewed Journal of Neuroimmunology, titled “Sigma-1 Receptor Agonists as Potential Protective Therapies in Multiple Sclerosis“ featuring preclinical data of ANAVEX®2-73 (blarcamesine) relevant to multiple sclerosis.

“A unique feature of ANAVEX®2-73 (blarcamesine), compared to another sigma-1 receptor agonist we studied, is that while these molecules increase proliferation of oligodendrocyte precursor cells (OPCs), ANAVEX®2-73 (blarcamesine) does not inhibit the maturation of these OPCs to oligodendrocytes (OLs), also called oligodendroglia”, said Professor Robert P. Lisak, MD the Parker Webber Chair in Neurology, Professor of Neurology and Professor of Biochemistry, Microbiology and Immunology at Wayne State University School of Medicine and lead author of the paper. “This is an important feature since OPCs can replace lost OLs by maturing into new potential myelin-producing cells. In other words, ANAVEX®2-73 (blarcamesine) might promote remyelination by both providing more OPCs and not delaying their maturation into mature OLs. Further data also demonstrates that ANAVEX®2-73 (blarcamesine) provides protection for OLs, OPCs, as well as central nervous system neurons in addition to helping repair by increasing the pool of OPCs that can go on to matter to OLs.“

Multiple sclerosis (MS) is a chronic disease of the central nervous system (CNS) characterized by inflammation, demyelination, loss of oligodendrocytes (OLs) and axonal damage in the white matter accompanied by reactivity of astrocytes and microglia. There are effective disease-modifying therapies (DMTs) approved for treatment of patients with relapsing remitting MS, however, none of these DMTs are cures and many have significant side effects.

The study also described that ANAVEX®2-73 (blarcamesine) provides optimal protection of oligodendroglia against glutamate toxicity in vitro.

“MS is a lifelong disease that has a significant impact on the people affected and their caregivers. We are encouraged by these findings providing additional evidence for the neuroprotective and neurorestorative effects of ANAVEX®2-73 (blarcamesine), as well as further expanding its potential application,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.

The full paper can be accessed online at: (https://www.sciencedirect.com/science/article/abs/pii/S0165572819305831).

 

About Multiple Sclerosis (MS)

Multiple sclerosis (MS) is a chronic autoimmune disease that causes damage to nerve fibers in the central nervous system (CNS), including the brain, spinal cord and optic nerve. This can disrupt communication between the CNS and other parts of the body, resulting in a wide range of physical and cognitive symptoms such as muscle weakness, visual loss, poor balance, chronic pain, tremors, short-term memory loss and other difficulties associated with dementia.

Anavex Life Sciences Reports Fiscal 2020 First Quarter Financial Results And Provides Clinical Study Updates

 

Conference Call and Webcast Today at 4:30 p.m. ET

 

NEW YORK – February 6, 2020 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported financial results for its fiscal 2020 first quarter.

“We are excited about the progress across our pipeline, including the receipt of Fast Track designation for the ANAVEX®2-73 (blarcamesine) clinical development program from the U.S. Food and Drug Administration (FDA) for the treatment of Rett syndrome,” commented Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Our clinical Rett syndrome programs are on track with continued enrollment. While our enrollment and early data have been exciting, we are humbled by the needs of the rare disease and Alzheimer’s and Parkinson’s disease communities with whom we engage. They impress a sense of urgency on our work to deliver a new paradigm that underscores the need for new treatment options for patients and their families.”

Program Updates and Milestones:

  • On February 3, 2020, we announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the ANAVEX®2-73 (blarcamesine) clinical development program for the treatment of Rett syndrome.
  • We announced January 8, 2020 that the United States Patent and Trademark Office (USPTO) granted U.S. Patent No. 10,507,196 to support Anavex’s leading drug candidate, ANAVEX®2-73 (blarcamesine) for the treatment of neurodevelopmental disorders including Rett syndrome, and multiple sclerosis. This patent is expected to remain in force at least until 2037, not including any patent term extensions.
  • On January 27, 2020, we announced that we have met our enrollment target for the ANAVEX®2-73 (blarcamesine) Phase 2 study[1] in Parkinson’s Disease Dementia (PDD). The study enrolled over 120 patients at 20 sites across Spain and 3 sites in Australia. We expect to announce topline results from this study by mid-2020.
  • Enrollment for the Phase 2b/3 ANAVEX®2-73 (blarcamesine) Alzheimer’s disease (AD) study[2] is 50% complete. Recruitment is expected to accelerate given the anticipated international expansion of the study, which will increase the total number of sites from 15 to approximately 45 in 2020.
  • ANAVEX®3-71 successfully completed IND-enabling toxicology studies and drug product manufacturing. ANAVEX®3-71 previously received Orphan Drug Designation from the U.S. FDA for Frontotemporal dementia (FTD). Initiation of the first Phase 1 clinical trial of ANAVEX®3-71 is expected in 2020. ANAVEX®3-71 has demonstrated disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, inflammation, amyloid and tau pathologies.

Financial Highlights:

  • Cash and cash equivalents of $27.5 million at December 31, 2019, compared to $22.2 million at September 30, 2019.
  • Anavex reported a net loss of $6.6 million, or $0.12 per share for the first quarter of 2020, compared to a net loss of $6.9 million, or $0.15 per share in the comparable first quarter 2019. This decrease was due to increased research and development incentive income.
  • Research and development expenses were $6.3 million for the first quarter of 2020 as compared to $5.7 million for the comparable period in 2019. This increase was driven by increased program development activities related to the advancement of the Company’s pipeline.
  • General and administrative expenses were $1.4 million for the first quarter of 2020 as compared to $1.8 million for the comparable period in 2019. This decrease was primarily due to lower non-cash stock-based compensation.

The financial information for the fiscal quarter ended December 31, 2019 should be read in conjunction with the Company’s consolidated interim financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.

Conference Call / Webcast Information

Anavex will host a conference call and webcast today at 4:30 p.m. ET.

The live webcast of the conference call may be accessed online at http://www.wsw.com/webcast/cc/avxl12.

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 49361235, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com.

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 disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), recently completed a successful Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 (blarcamesine) for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and muscarinic receptors, is a promising preclinical drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation.

Anavex Life Sciences Announces Fast Track Designation Granted by U.S. FDA for ANAVEX®2-73 (blarcamesine) Clinical Development Program for the Treatment of Rett Syndrome

NEW YORK – February 3, 2020 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ANAVEX®2-73 (blarcamesine) clinical development program for the treatment of Rett syndrome.

FDA Fast Track is a program designed to facilitate and expedite the development and review of a new drug to address unmet medical need in the treatment of a serious and life-threatening condition for which it demonstrates the potential to address unmet medical needs for such a disease or condition. The purpose of the program is to get important new therapies to the patients earlier in order to address the unmet medical needs in the treatment serious and life-threatening diseases.

In the U.S. Phase 2 Rett syndrome study to date, ANAVEX®2-73 (blarcamesine) demonstrated significant improvements of the two global efficacy endpoints, the Rett Syndrome Behaviour Questionnaire (RSBQ) Total score and the Clinical Global Impression – Improvement (CGI-I).

At the 6th Annual European Rett Syndrome Conference, Anavex presented data demonstrating also that ANAVEX®2-73 (blarcamesine) significantly improved the RSBQ Hand Behaviours and the RSBQ Breathing Abnormalities scores. In addition, efficacy signals on both caregiver- and clinician-based measures of severity correlated with a key biomarker related to disease pathogenesis (Glutamate levels).

This is one of three clinical studies in Anavex’s Rett Syndrome Program: U.S. RTT (ANAVEX®2-73-RS-001), AVATAR (ANAVEX®2-73-RS-002) and EXCELLENCE (ANAVEX®2-73-RS-003).

“With no currently approved agents to treat Rett syndrome, patients and their physicians have an urgent need for new therapeutic options,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We view this FDA Fast Track designation as continued support that ANAVEX®2-73 (blarcamesine) has the potential to address this unmet need. Importantly, Fast Track designation provides a number of important advantages that could expedite the development and review of ANAVEX®2-73 (blarcamesine).”

ANAVEX®2-73 (blarcamesine) is an orally available, small-molecule activator of the sigma-1 receptor which, data suggest, is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.[1]

About FDA Fast Track Designation

Fast Track is a program designed to facilitate the expedited development and review of a new drug alone or in combination with other drugs to treat serious or life-threatening conditions for which there is a demonstration of the potential to address an unmet medical need. The purpose is to advance new drugs earlier for patients who need them. Fast Track addresses a broad range of serious conditions.

A drug that receives Fast Track designation is eligible for some or all of the following:

  • More frequent meetings and interactions with the review team at the FDA to discuss the drug’s development and ensure collection of appropriate data needed to support drug approval as well as to discuss accelerated approval, the structure and content of an NDA, and other critical issues
  • More frequent written communications from FDA about such things as the design of the proposed clinical trials and use of biomarkers
  • Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
  • Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the marketing application is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.[2]

About Rett Syndrome

Rett syndrome is a devastating, non-inherited genetic postnatal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments, affecting nearly every aspect of the child’s life: their ability to speak, walk, eat and even breathe easily. The hallmark of Rett syndrome is near constant repetitive hand movements while awake. It is characterized by normal early growth and development (6 to 18 months) followed by a slowing of development, loss of purposeful use of the hands, distinctive hand movements, autistic features, slowed brain and head growth, ataxia, seizures and intellectual disability. There is currently no cure for Rett syndrome. Rett syndrome is caused by mutations in the MECP2 gene and strikes all racial and ethnic groups and occurs worldwide in approximately one in every 10,000 to 15,000 live female births.

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 disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), recently completed a successful Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 (blarcamesine) for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and muscarinic receptors, is a promising preclinical drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation.

Corporate NEWS
AVXL Website
AVXL SEC Filings
Investor Share Data

PRODUCT PIPELINE

https://www.dailytelegraph.com.au/news/steve-macfarlane-explains-the-alzheimers-worldfirst-drug-trial-at-caulfield-hospital/video/03fe27ae89bdce4912cabf865a99ed80


AVXL DISCLAIMER

This newsletter is a paid advertisement, not a recommendation nor an offer to buy or sell securities. This newsletter is owned, operated and edited by MEC Systems LLC is a wholly owned subsidiary of milestonecgp.com, milestonecapitolgrowthportfolio.com 

Any wording found in this e-mail, disclaimer or company profile referencing to “I” or “we” or “our” or “MEC Systems LLC” refers to MEC Systems LLC.  Our business model is to be financially compensated to market and promote small public companies.  By reading our newsletter and our website you agree to the terms of our disclaimer, which are subject to change at any time. We are not registered or licensed in any jurisdiction whatsoever to provide investing advice or anything of an advisory or consultancy nature, and are therefore are unqualified to give investment recommendations. Always do your own research and consult with a licensed investment professional before investing. This communication is never to be used as the basis of making investment decisions, and is for entertainment purposes only. At most, this communication should serve only as a starting point to do your own research and consult with a licensed professional regarding the companies profiled and discussed. Conduct your own research. Companies with low price per share are speculative and carry a high degree of risk, so only invest what you can afford to lose. By using our service you agree not to hold our site, its editor’s, owners, or staff liable for any damages, financial or otherwise, that may occur due to any action you may take based on the information contained within our newsletters or on our website.

We do not advise any reader take any specific action. Losses can be larger than expected if the company experiences any problems with liquidity or wide spreads. Our website and newsletter are for entertainment purposes only. Never invest purely based on our alerts. Gains mentioned in our newsletter and on our website may be based on end-of-day or intraday data. This publication and their owners and affiliates may hold positions in the securities mentioned in our profiles, which we may sell at any time without notice to our subscribers, which may have a negative impact on share prices. If we own any shares we will list the information relevant to the stock and number of shares here. We have been compensated $10,000k cash via bank wire by AVXL,  to conduct Social Media Program and news distribution for AVXL from 2/04/2020 to 5/04/2020 .  MEC Systems LLC business model is to receive financial compensation to advertise for public companies.  This compensation is a major conflict of interest in our ability to be unbiased regarding. Therefore, this communication should be viewed as a commercial advertisement only.  We have not investigated the background of the hiring third party or parties. The third party, profiled company, or their affiliates may wish to liquidate shares of the profiled company at or near the time you receive this communication, which has the potential to hurt share prices.  Any non-compensated alerts are purely for the purpose of expanding our database for the benefit of our future financially compensated investor relations efforts. Frequently companies profiled in our alerts may experience a large increase in volume and share price during the course of investor relations marketing, which may end as soon as the investor relations marketing ceases. The investor relations marketing may be as brief as one day, after which a large decrease in volume and share price is likely to occur. Our emails may contain forward looking statements, which are not guaranteed to materialize due to a variety of factors.

We do not guarantee the timeliness, accuracy, or completeness of the information on our site or in our newsletters. The information in our email newsletters and on our website is believed to be accurate and correct, but has not been independently verified and is not guaranteed to be correct. The information is collected from public sources, such as the profiled company’s website and press releases, but is not researched or verified in any way whatsoever to ensure the publicly available information is correct. Furthermore, MEC Systems LLC often employs independent contractor writers who may make errors when researching information and preparing these communications regarding profiled companies. Independent writers’ works are double-checked and verified before publication, but it is certainly possible for errors or omissions to take place during editing of independent contractor writer’s communications regarding the profiled company(s). You should assume all information in all of our communications is incorrect until you personally verify the information, and again are encouraged to never invest based on the information contained in our written communications. The information in our disclaimers is subject to change at any time without notice. See full disclaimer at http://milestonecapitalgrowthportfolio.com/terms-conditions-of-use/.