Proactiveinvestors USA & Canada Anavex Life Sciences https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Anavex Life Sciences RSS feed en Sun, 16 Jun 2019 11:45:43 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[Media files - Anavex Life Sciences advancing its Parkinson's disease therapy through the pipeline ]]> https://www.proactiveinvestors.com/companies/stocktube/12195/anavex-life-sciences-advancing-its-parkinson-s-disease-therapy-through-the-pipeline-12195.html Tue, 12 Feb 2019 19:13:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/12195/anavex-life-sciences-advancing-its-parkinson-s-disease-therapy-through-the-pipeline-12195.html <![CDATA[News - Anavex Life Sciences doses patients in Phase 2 ANAVEX2-73 Parkinson disease dementia study ]]> https://www.proactiveinvestors.com/companies/news/211180/anavex-life-sciences-doses-patients-in-phase-2-anavex2-73-parkinson-disease-dementia-study-211180.html Anavex Life Sciences Corp (NASDAQ:AVXL) told analysts Wednesday that it has started enrolling and dosing patients for its phase two ANAVEX2-73 Parkinson’s disease dementia (PDD) study.

The New York-based biotech’s lead drug candidate ANAVEX 2-73 has already completed Phase 2a clinical trials for the treatment of Alzheimer's disease.

The drug is also in preclinical clinical trials to treat Rett Syndrome, a rare neurological disorder that occurs mainly in girls, epilepsy and Parkinson's disease dementia, a decline in reasoning that develops in many people living with Parkinson’s a year after diagnosis.

READ: Anavex Life Sciences shares rise after FDA gives green light on Phase 2 trial

“We were pleased to report that we have successfully activated 100% of all planned clinical study sites representing 20 clinical trial sites for the Phase 2 ANAVEX2-73 Parkinson disease dementia study,” Anavex Life Sciences CEO Christopher Missling told analysts on a call Wednesday.

“Enrollment and dosing of patients is currently proceeding as planned,” he added.

The biopharma is proceeding with a phase two double-blind, randomized, placebo-controlled, 14-week safety and efficacy trial of ANAVEX2-73 for the treatment of Parkinson’s disease dementia.

Missling said the company had also successfully initiated a novel genomic marker driven later-stage CNS precision medicine trial for Alzheimer’s disease for ANAVEX2-73 entering fiscal 2019.

“The company has successfully activated 75% of all planned clinical study sites representing 9 clinical trial sites for the Phase 2b/3 ANAVEX2-73 Alzheimer disease study,” said Missling indicating that enrollment and dosing of patients was currently proceeding as planned.

Earnings in focus

The biotech logged a net loss for the year of $17.5 million, or $0.39 per share, compared to a net loss of $13.5 million, or $0.33 per share for the comparative year.

The biotech said that it had cash and equivalents of $22.9 million on its books as of September 30, 2018.

Shares of the biotech fell nearly 3.3% to $2.05 Thursday in midday trade on a broad market pullback.

 

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Thu, 13 Dec 2018 13:37:00 -0500 https://www.proactiveinvestors.com/companies/news/211180/anavex-life-sciences-doses-patients-in-phase-2-anavex2-73-parkinson-disease-dementia-study-211180.html
<![CDATA[News - Anavex Life Sciences shares rise after FDA gives green light on Phase 2 trial ]]> https://www.proactiveinvestors.com/companies/news/207497/anavex-life-sciences-shares-rise-after-fda-gives-green-light-on-phase-2-trial-207497.html Anavex Life Sciences Corp (NASDAQ: AVXL) shares are on the rise following the US Food and Drug Administration’s approval of its Investigational New Drug application for its Phase 2 trial of its drug Anavex2-73 for the treatment of Rett Syndrome.

Rett Syndrome is a rare, non-inherited neurological disorder that occurs mainly in girls and can lead to severe impairments, including losing the ability to speak, walk, eat and breathe.

READ: Why Viking Therapeutics isn’t waiting for a white knight

“The acceptance of this IND by the FDA is a significant milestone for Anavex2-73,” stated CEO Christopher U. Missling in the company’s press release.

“This is an important step toward achieving clinical data for the third indication for Anavex2-73 also incorporating genomic precision medicine biomarkers.”

Shares of the New York-based biopharmaceutical company jumped nearly 14% to $2.81 in Friday morning trading.

Anavex will proceed with a double-blind, randomized Phase 2 study using Anavex2-73 for the treatment of patients with Rett syndrome.

The company also has clinical development programs for the drug for the treatment of Alzheimer’s disease and Parkinson’s disease dementia.

 

Contact Lenore Fedow at lenore@proactiveinvestors.com

Follow her on Twitter: @LenoreMariee

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Fri, 19 Oct 2018 10:54:00 -0400 https://www.proactiveinvestors.com/companies/news/207497/anavex-life-sciences-shares-rise-after-fda-gives-green-light-on-phase-2-trial-207497.html
<![CDATA[News - Anavex Life Sciences gets go-ahead from Spain to begin trial for its Parkinson's disease treatment ]]> https://www.proactiveinvestors.com/companies/news/200412/anavex-life-sciences-gets-go-ahead-from-spain-to-begin-trial-for-its-parkinson-s-disease-treatment-200412.html Anavex Life Sciences (NASDAQ:AVXL) today revealed that it has gotten the green light from the Spanish Agency for Medicinal Products and Medical Devices to introduce its Phase 2 trial of Anavex 2-73 for the treatment of Parkinson’s disease dementia.

The Phase 2 trial will be a double-blind, placebo-controlled 14-week study that will analyze 120 patients who will take either one of two different doses of Anavex2-73 or a placebo.

The primary goal of the study is to measure cognition and the secondary goals are to measure Parkinsonian motor symptoms and sleep function.

READ: Anavex Life's Alzheimer's drug awarded orphan status for child seizures

“We are excited about the approval to initiate the Phase 2 study of Anavex 2-73 for the treatment of Parkinson’s disease dementia, which will focus on the effect of Anavex 2-73 on both the cognitive and motor impairment of Parkinson’s disease,” said Christopher Missling, Anavex’s chief executive.

The trial, which kicks off in the coming months, will be held in Europe to start, but may expand to the US and Australia.

Parkinson’s is a neurological disorder, which can trigger dementia in its later stages.

Maxim cites cash on hand

The New York-based biopharma has sufficient cash on hand to fund its clinical trials, according to analyst Jason McCarthy of Maxim Group.

This month, Anavex entered into a so-called "at the market" sales agreement of its common stock for up to US$50mln.

“This, along with its current US$28mln in cash on the balance sheet, should be sufficient runway through the next series of catalysts including the completion of phase 2 studies in Parkinson’s disease with dementia, and Rett syndrome (both to initiate in 2H18) and potentially the P2b/3 in Alzheimer’s disease (AD, initiating 2H18),” wrote McCarthy in a note to investors.

He has a Buy rating and US$7 price target on the shares.

Anavex shares were 2% lower at US$3.37 in afternoon trade.

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Mon, 09 Jul 2018 14:53:00 -0400 https://www.proactiveinvestors.com/companies/news/200412/anavex-life-sciences-gets-go-ahead-from-spain-to-begin-trial-for-its-parkinson-s-disease-treatment-200412.html
<![CDATA[News - Anavex Life's Alzheimer's drug awarded orphan status for child seizures ]]> https://www.proactiveinvestors.com/companies/news/127399/anavex-life-s-alzheimer-s-drug-awarded-orphan-status-for-child-seizures-127399.html Anavex Life Sciences Corp (Nasdaq:AVXL) has received US orphan drug status in infantile spasms for  a drug it is currently trialing to ease Alzheimer’s.

Anavex 2-73 is the second of the company’s projects to get ODD status, a designation the US Food and Drug Administration awards to fast track treatments for diseases that affect fewer than 200,000 people.

It gives Anavex a seven year window of commercial exclusivity in the US in the area of infantile spasms, prioritized consultation by the FDA on clinical studies and exemptions on some regulatory fees.

An infantile spasm is a specific type of seizure usually in the first year of life and typically between the ages of 4-8 months. Roughly 2-3 babies per 10,000 get them, with peak incidence at 6 months of age and less than 10% of cases presenting after 12 months of age.

Children with symptomatic spasms more frequently exhibit neurological deficits and cognitive and developmental delays, the company said.

Anavex 2-73 is the company’s lead candidate and currently in a Phase 2a clinical trial for Alzheimer’s disease. 

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Wed, 22 Jun 2016 08:39:00 -0400 https://www.proactiveinvestors.com/companies/news/127399/anavex-life-s-alzheimer-s-drug-awarded-orphan-status-for-child-seizures-127399.html
<![CDATA[News - Anavex Life Sciences Corp unveils positive pre-clinical data on Alzheimer’s candidate ]]> https://www.proactiveinvestors.com/companies/news/123649/anavex-life-sciences-corp-unveils-positive-pre-clinical-data-on-alzheimers-candidate-123649.html Anavex Life Sciences Corp (NASDAQ:AVXL) said pre-clinical data from its candidate ANAVEX 3-71 reinforced its belief it could be a treatment for the cognitive disease Alzheimer's.

The findings, which were from studies on rats, were presented at the 14th international symposium of advances in Alzheimer's Therapy (AAT) from March 9-12.

The firm said there was a statistically significant reduction in the rate of cognitive deficit, amyloid beta pathology and inflammation when ANAVEX 3-71 had been administered.

Professor Claudio Cuello of McGill University, Montreal, Canada, the main author of the study, said: "The data from this study further validates the belief that ANAVEX 3-71 may have significant utility in the treatment of Alzheimer’s disease. 

"This study examined potential long-term effect of the compound following a five-week hiatus from dosing, which suggests the potential for disease modification – something we have not often seen."

Chief executive of Anavex Christopher U. Missling added: "This body of data of ANAVEX 3-71, in addition to our clinical candidate, ANAVEX 2-73 suggests that our approach of targeting the complex pathology of Alzheimer’s disease further upstream may have the potential to address the areas of unmet need for individuals living with this disease."

The firm is developing therapeutics for the treatment of neurodegenerative 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.

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Mon, 14 Mar 2016 11:07:00 -0400 https://www.proactiveinvestors.com/companies/news/123649/anavex-life-sciences-corp-unveils-positive-pre-clinical-data-on-alzheimers-candidate-123649.html
<![CDATA[News - Anavex Life shares advance on positive data for ANAVEX 2-73 ]]> https://www.proactiveinvestors.com/companies/news/123009/anavex-life-shares-advance-on-positive-data-for-anavex-2-73-123009.html Shares of Anavex Life Science (NASDAQ:AVXL) rose more than 5% on Thursday after the clinical-stage biopharmaceutical company reported positive data of ANAVEX 2-73 in an exploratory study in a Rett syndrome model.

Revealed at the 2016 Epilepsy Pipeline Conference being held February 25-26 in San Francisco, the company said chronic oral daily dosing of ANAVEX 2-73 starting at 5.5 weeks of age was conducted in the MECP2 Rett syndrome disease mouse model and continued through a 12-week behavioral testing time point 60 minutes pre‐treatment during the behavioral testing.

Rett syndrome is rare 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.

"The data demonstrates dose related and significant improvements in an array of behavioral and gait paradigms in a mouse model with a MECP2-null mutation that causes neurological symptoms that mimic Rett syndrome," said Steven Kaminsky, PhD, Chief Science Officer of Rettsyndrome.org.

"There is a tremendous need for therapeutic solutions for the individuals living with Rett syndrome and their families, and we are very encouraged by the data we have seen with ANAVEX 2-73," he added.

Anavex Life specialises in therapeutics for the treatment of neurodegenerative diseases including Alzheimer’s Disease, other central nervous system CNS diseases, pain and various types of cancer.

Anavex shares were up 5.7% at $4.48.

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Thu, 25 Feb 2016 14:26:00 -0500 https://www.proactiveinvestors.com/companies/news/123009/anavex-life-shares-advance-on-positive-data-for-anavex-2-73-123009.html
<![CDATA[News - Anavex to advance Alzheimer’s drug with larger Phase 2/3 trial ]]> https://www.proactiveinvestors.com/companies/news/119366/anavex-to-advance-alzheimers-drug-with-larger-phase-23-trial-119366.html Anavex Life Sciences (NASDAQ:AVXL, OTCMKTS:AVXL) has told investors it will advance regulatory filings for the development of its Alzheimer’s drug.

It comes as the US Foods and Drugs Administration (FDA) provided the company with guidance on its proposed strategy for the drug candidate.

The company said it will advance a larger and more innovative Phase 2/3 trial for the drug, ANAVEX 2-73.

Christopher Missling, Anavex chief executive, said: “By implementing a different, innovative trial design for ANAVEX 2-73 in Alzheimer’s treatment, it is believed that this is more efficient than a conventional Phase 2 study since it is designed to reduce the risk of a Phase 3 trial failure, as well as receiving the best quality information we can about ANAVEX 2-73.”

Missling highlights that the prior Phase 2a trial used Adaptive Design and Population Pharmacokinetics/Pharmacodynamics (PK/PD) modelling, which he says was a “major strength” which benefits the drugs development for Alzheimer’s disease as well as other central nervous system (CNS) diseases.

The proposed Phase 2/3 trial will be double-blinded, randomized and placebo-controlled.

In pre-market trading the Nasdaq quoted shares were up 87 cents, about 27%, changing hands at US$4.11. It comes after a sharp drop in the price, down to a US$3.24 close, on Tuesday.

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Wed, 18 Nov 2015 07:53:00 -0500 https://www.proactiveinvestors.com/companies/news/119366/anavex-to-advance-alzheimers-drug-with-larger-phase-23-trial-119366.html