alzheimer's – Tersan Pharmaceuticals Ltd

Tersan’s AI provides evidence for 3 years clinical efficacy of ANAVEX®2-73 Alzheimer’s targeted therapy @CTAD2018

it — Mon, 29 Oct 2018 07:10:00 +0000

Precision medicine approach using Tersan’s AI KEM® shows that a small data rich open label clinical study of 32 well-characterized patients may be sufficient to identify strong biomarker hypothesis identifying patients with the highest chance of benefiting from the drug.

BARCELONA, October 26^th, 2018. Dr Mohammad Afshar presented 3 years longitudinal data of clinical efficacy of ANAVEX®2-73 (Anavex Life Sciences, Nasdaq: AVXL), and confirmed role of patient selection genomic biomarkers, at the 2018 Clinical Trials on Alzheimer’s Disease Meeting (CTAD).

Using Tersan’s proprietary KEM® (Knowledge Extraction and Management) advanced Artificial Intelligence technology, the analysis of the longitudinal 3-year (148-week) data showed that patient cohort with the higher concentration of ANAVEX®2-73 maintains Activities of Daily Living Score (ADCS-ADL) and display a reduced cognitive decline (MMSE) when compared to the lower concentration cohort.

MMRM adjusted analysis demonstrates that High concentration cohort displays a staggering 88% ADCS-ADL response difference vs low concentration cohort

In contrast to the vast majority of communications at CTAD 2018, the presentation focused on a novel drug target (SIGMAR1), the use of genomic biomarkers, rather than surrogates of response, and demonstrated the ability of the precision medicine approach to confirm significant drug response effects. The observed 3-year effect was large: 88% improvement compared to lower dose for ADCS-ADL (p<0.0001) and 64 % less decline for MMSE (p<0.0008).

“We are excited to see our initial biomarker hypothesis confirmed at 148 weeks. The biomarkers were selected through a data driven unbiased systematic analysis of all available genomic and clinical data, identifying a genomic alteration of SIGMAR1, the putative target of ANAVEX 2-73. The consistency of the DNA and RNA data, as well as multiple end-points and time-points further strengthen this biomarker hypothesis.” Mohammad Afshar, MD, PhD, CEO of Tersan Pharmaceuticals Ltd.“This innovative data analytics approach, using our KEM® Artificial Intelligence platform has the potential to expand the access to precision medicine and precision pharmacology for a wide range of neurodegenerative diseases, thus, identifying the right patients that can benefit from the right therapy, at the right moment.” he added.

Given the current gloom from negative results of late stage clinical trials built on the prevailing amyloid paradigm, which have reported non-conclusive results or worse, have demonstrated negative impact, the novel therapy approach taken by Anavex, using a novel target SIGMAR1 and genomic inclusion biomarkers selected using the KEM Artificial Intelligence platform, brings hope to the field.

“These results further confirm the impact of actionable genetic variants that were previously identified through a full, unbiased genomic analysis of ANAVEX®2-73 in Alzheimer’s disease, raising optimism for the future of biomarker-guided precision medicine to effectively combat this devastating disease,” Professor Harald Hampel, M.D., Ph.D., MA, MSc, AXA Research Fund & Sorbonne University Excellence Chair, Department of Neurology, Sorbonne University, Paris. He is the speaker of the Alzheimer Precision Medicine Initiative (APMI).

M. Afshar, MD, PhD, CEO of Tersan Pharmaceuticals Ltd, presenting presenting Anavex(R) 2-73 results at CTAD 2018

“We are encouraged by these data which now show the clinical impact of ANAVEX®2-73 on patients who have been receiving therapy for almost three years,” Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We continue to build on the body of clinical evidence to support the development of ANAVEX®2-73 as we further our recently initiated Phase 2b/3 study, and we will continue our targeted precision medicine approach to advance ANAVEX®2-73 as a potential therapeutic option for patients with Alzheimer’s disease who will most benefit from treatment.”

Further Readings:

Press Release – Anavex Life Sciences Presents New Three-Year, Longitudinal Clinical Efficacy Data for ANAVEX®2-73 in Alzheimer’s Disease at the 2018 Clinical Trials on Alzheimer’s Disease (CTAD) Meeting. (Anavex press release)

2018 CTAD CORPORATE PRESENTATION – Longitudinal 148-Week Update of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Extension Study. (Presentation PDF)

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Artificial Intelligence enables first biomarker driven precision medicine therapy against Alzheimer

it — Wed, 19 Sep 2018 19:27:00 +0000

Tersan Pharmaceuticals Ltd helps ANAVEX® demonstrate efficacy of its Alzheimer’s therapy in phase 2a clinical trial.

Tersan’s KEM® Artificial Intelligence technology has resulted in the identification of the first actionable genetic variant biomarkers, selecting a specified Alzheimer’s disease population, who demonstrated a confirmed response with ANAVEX®2-73.

Professor Harald Hampel, M.D., Ph.D., presenting results at the AAIC 2018

These results provide support for a faster precision medicine clinical development of ANAVEX®2-73 focusing on the right patients who could benefit from the drug.

“This is the first full genomic analysis of ANAVEX®2-73 in Alzheimer’s disease which resulted in the identification of actionable genetic variants, bringing us one step closer to realizing the full potential of a precision medicine and precision pharmacology approach to treating this devastating disease,” Professor Harald Hampel, M.D., Ph.D., MA, MSc, AXA Research Fund & Sorbonne University Excellence Chair, Department of Neurology, Sorbonne University, Paris.

“The innovative study findings based on ANAVEX®2-73 moves precision medicine and pharmacology a step closer in Alzheimer’s therapy trials,” Christopher U. Missling, Ph.D., President and Chief Executive Officer of Anavex.

“… in CNS-based studies, whether AD or MS, the data are complex across multiple endpoints. As such, having KEM® system with Tersan in place to help analyze complex data is, in our view, a strategic positive for Anavex.” Jason Kolbert, former Executive Managing Director and Head of Healthcare Research at Maxim Group, Managing Director of Research at HC Wainwright & Co.

Identifying the right patient population, the use of Tersan’s proprietary KEM® AI technology has a proven track of increasing the chances of success, accelerating clinical timelines and creating immediate value for the Company.

KEM® is a comprehensive and FDA-tested clinical data analysis system that enables full exploitation of complex datasets. It has uniquely demonstrated its ability to extract biomarkers from small sets of patients.

Beyond CNS, Tersan’s expertise spans multiple medical indications and therapeutic areas, including cancer, metabolic and immunological diseases.

Further reading

Anavex presents results at CTAD, Barcelona (October 2018)

PRESENTATION – Longitudinal 148-Week Extension Study for ANAVEX®2-73 Phase 2a Alzheimer’s Disease Demonstrates Maintained Activities of Daily Living Score (ADCS-ADL) and Reduced Cognitive Decline (MMSE) for Patient Cohort on Higher Drug Concentration and Confirms Role of Patient Selection Biomarkers [Link: Document]

Biomarker data presented at AAIC, Chicago (July 2018)

Anavex Life Sciences Presents New Data Identifying Treatment Response Biomarkers in Alzheimer’s Disease Patients Treated with Investigational ANAVEX®2-73 at 2018 Alzheimer’s Association International Conference (AAIC) Read more

ABSTRACT – Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling Targeted Therapy and a Precision Medicine Approach [Link: Document]

ABSTRACT – Systematic Processing of Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling a Precision Medicine Approach [Link: Document]

POSTER – Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling Targeted Therapy and a Precision Medicine Approach [Link: Document]

PRESENTATION – Systematic Processing of Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling a Precision Medicine Approach [Link: Document]

NASDAQ – Anavex Life Sciences Presents New Data Identifying Treatment Response Biomarkers in Alzheimer’s Disease Patients Treated with Investigational ANAVEX®2-73 at 2018 Alzheimer’s Association International Conference (AAIC) Read more

Mohammad Afshar presents results at CTAD, Boston (November 2017)

Anavex Life Sciences Reports PK and PD Data from Phase 2a Trial of ANAVEX®2-73 in Mild-to-Moderate Alzheimer’s Disease Patients Read more

ABSTRACT – Clinical pharmacokinetics and pharmacodynamics characterization of ANAVEX2-73 for designing a phase 2/3 study in mild-to-moderate Alzheimer’s disease [Link: Document]

PRESENTATION – Clinical Pharmacokine/cs and Pharmacodynamics Characteriza/on of ANAVEX®2-73 for Designing a Phase 2/3 Study in Mild-to-Moderate Alzheimer’s Disease – CTAD November 2017 [Link: Document]

Initiating collaboration (October 2016)

Anavex Life Sciences and Tersan Pharmaceuticals Ltd Collaborate to Accelerate Timelines and Improve Efficiency of Alzheimer’s and Parkinson’s Clinical Development Programs Read more

NASDAQ – Anavex Life Sciences (AVXL) was up 9,3% after teaming up with Tersan Pharmaceuticals Ltd [Link: Document]

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Applying the cancer playbook to find treatment for Alzheimer’s disease

it — Wed, 01 Aug 2018 21:02:00 +0000

Applying the cancer playbook to find treatment for Alzheimer’s disease: see how Tersan’s KEM Artificial Intelligence platform is helping Anavex Life Sciences develop the first targeted therapy against Alzheimer’s disease.

“NEW YORK – July 25, 2018 – 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 diseases including Alzheimer’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported results of the entire genome DNA and RNA evaluation of study participants in a 57-week Phase 2a Alzheimer’s disease study investigating ANAVEX®2-73, a selective sigma-1 receptor agonist, resulting in the analysis of 33,311 genes and 860 pathways. Additionally, direct target occupancy of ANAVEX®2-73 at the sigma-1 receptor using quantitative Positron emission tomography (PET) scanning was presented.“ [Link: Anavex]

Presentations

– Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling Targeted Therapy and a Precision Medicine Approach [Link: Document]

– Systematic Processing of Full Genomic Analysis of ANAVEX®2-73 Phase 2a Alzheimer’s Disease Study Identifies Biomarkers Enabling a Precision Medicine Approach [Link: Document]

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CTAD 2017 (Boston, USA | 1-4 Nov)

it — Sat, 04 Nov 2017 21:31:00 +0000

Dr Mohammad Afshar (Tersan CEO) is presenting on the analysis of Phase 2a trial results using Tersan’s KEM® artificial intelligence platform at CTAD 2017 (10th Clinical Trials on Alzheimer’s Disease) in Boston, USA on 4 November.

LB18 – Clinical Pharmacokinetics and Pharmacodynamics Characterization of ANAVEX2-73 for Designing a Phase 2/3 Study in Mild-to-Moderate Alzheimer’s Disease
Mohammad Afshar, MD, PhD[1], Frédéric Parmentier, PhD[1], Ene I Ette, PhD[2], Emmanuel O Fadiran, PhD[3], Christopher U Missling, PhD[3]
[1]Tersan Pharmaceuticals Ltd, Paris, France, [2]Anoixis Corp., Natick, MA, [3]Anavex Life Sciences Corp., New York, NY

Links: Download Press Release | Download Presentation

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Anavex incorporating Tersan’s KEM® AI platform in Alzheimer’s precision medicine approach

it — Thu, 12 Oct 2017 21:35:00 +0000

Anavex Life Sciences Reports PK and PD Data from Phase 2a Trial of ANAVEX®2-73 in Mild-to-Moderate Alzheimer’s Disease Patients
ANAVEX2-73 demonstrates desirable PK/PD properties, describing the relationship between drug concentration and the effect observed.
Anavex is incorporating advanced Artificial Intelligence platform for the analysis of Phase 2a results with the aim to increase the chances of success in forthcoming Phase 2/3 study.

NEW YORK, October 12, 2017 – Anavex Life Sciences Corp. (Nasdaq: AVXL) today announced pharmacokinetic (PK) and pharmacodynamic (PD) data for ANAVEX2-73 from its positive Phase 2a study in mild-to-moderate Alzheimer’s disease patients. ANAVEX2-73 targets the sigma-1 receptor, which regulates neuroplasticity and cellular homeostasis. Anavex previously reported the Phase 2a trial successfully achieved both primary and secondary endpoints at the pre-specified 57-week analysis.

Data announced today establishes a clear concentration-effect relationship between ANAVEX2-73 and study measurements. These measures obtained from all patients during 57 weeks include cognitive and functional scores as well as a biomarker signal of brain activity. Additionally, ANAVEX2-73 activity appears to be enhanced by its active metabolite (ANAVEX19-144), which also targets the sigma-1 receptor with a half-life approximately twice as long as the parent molecule.

“I welcome such a thorough analysis of data before moving into a Phase 2/3. The intriguing ANAVEX2-73 data shown thus far exemplifies a precision medicine approach, to my knowledge, the first of its kind to broaden the scope of drug development in Alzheimer’s disease and other central nervous system diseases,” said George Perry, PhD, Dean of the College of Sciences at The University of Texas at San Antonio and editor-in-chief of the Journal of Alzheimer’s Disease.

The Company is identifying the best responders to ANAVEX2-73 by using Tersan Pharmaceuticals Ltd’s KEM® advanced Artificial Intelligence technology. This cutting edge trial analysis will be used to more effectively design the upcoming Phase 2/3 clinical study, raising the odds of late stage trial success.

“We continue to be encouraged by the data from our Phase 2a clinical trial for ANAVEX2-73,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We believe that through a systematic analysis of ANAVEX2-73 we might be able to increase the potential impact ANAVEX2-73 may have on this devastating condition.”

On the conference call scheduled for this morning, Christopher U Missling, PhD, President and Chief Executive Officer of Anavex will be joined by Professor George Perry, PhD and Mohammad Afshar, MD, PhD, President and CEO of Tersan Pharmaceuticals Ltd to discuss new findings from the ANAVEX2-73 Phase 2a trial. Further data will be presented at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in November 2017.

Conference call and webcast information
Anavex will host a conference call at 8:30 a.m. ET today, October 12, 2017. The call will be webcast live at http://www.wsw.com/webcast/cc/avxl2 and slides are accessible through the investor relations section of the Company’s website at www.anavex.com. To join the call live via telephone dial 1-866-866-1333 within the United Kingdom or 1-404-260-1421 from outside the United Kingdom. A replay of the call will also be available for a period of three months through the Company’s website shortly after the call.

About ANAVEX®2-73 Phase 2a Clinical Study
The multicenter Phase 2a clinical trial of ANAVEX 2-73 consisted of two parts and a total of 32 mild-to-moderate Alzheimer’s patients. PART A was a simple randomized, open-label, two-period, cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration, adaptive trial lasting up to 5 weeks for each patient. PART B was an open-label extension for an additional 52 weeks. Initially planned for 26 weeks, PART B was extended to 52 weeks as a result of requests from patients and caregivers.
The primary endpoint of the Phase 2a trial was safety, tolerability and maximum tolerated dose (MTD) of ANAVEX2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints included dose response, bioavailability, and exploratory cognitive as well as functional measures using Mini Mental State Examination (MMSE) and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL), as well as Cogstate test battery and biomarker EEG/ERP.

About Tersan Pharmaceuticals Ltd
Tersan® Pharma is a leading digital health Company focused on developing advanced therapeutic decision support systems. Tersan’s innovative clinical data analysis and diagnostic testing solutions help the healthcare sector better adapt patient treatments to individual biological characteristics. Tersan Pharmaceuticals Ltd’s KEM® technology enables personalization of therapies, improves the efficacy and safety of patient treatment, reduces risks and drug development costs, and accelerates time to market. KEM® is the only FDA-tested technology that systematically explores combinations of biomarkers, producing more effective biomarker signatures for precision medicine. Tersan has developed Onco KEM®, the most advanced, clinically tested, oncology treatment selection system. Founded in 2003 as a spin-off of the Institut Pasteur, Paris, France, the company opened a subsidiary in the United Kingdom in 2012. Further information is available at www.tersanpharm.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 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, recently completed successfully a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 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. 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. 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. You can also connect with the company on Twitter, Facebook and LinkedIn.

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[at]anavex.com

Investors & Media:

Clayton Robertson
The Trout Group
(646) 378-2900
crobertson[at]troutgroup.com

Links: Download Press Release | Download Presentation

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Anavex and Tersan Pharmaceuticals Ltd Collaborate to Accelerate Timelines and Improve Efficiency of Alzheimer’s and Parkinson’s Clinical Development Programs

it — Wed, 05 Oct 2016 22:00:00 +0000

NEW YORK, NY – October 5, 2016 – 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 diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced a collaboration with Tersan Pharmaceuticals Ltd (Cambridge, MA and Paris, France) to use Tersan’s proprietary KEM® (Knowledge, Extraction, Management) patient stratification technology to potentially accelerate ANAVEX 2-73’s Phase 2/3 Alzheimer’s clinical development timelines. KEM® is a comprehensive and FDA-tested clinical data analysis system that enables full exploitation of complex datasets including of smaller numbers of patients.

“We are very impressed with the rational and efficient clinical trial path Anavex has embarked upon by adopting population pharmacokinetics (PK) and adaptive trial design in its current ANAVEX 2-73 Phase 2a study in Alzheimer’s disease,” said Mohammad Afshar, CEO of Tersan Pharmaceuticals Ltd. “Tersan has the expertise to fully support Anavex’s precision medicine approach to develop more effective treatments for devastating diseases including Alzheimer’s, Parkinson’s and Rett syndrome.”

Tersan specializes in clinical patient stratification using KEM®, a proprietary decision support technology for rapid and systematic analysis of multi-parametric/multi-objective data. Tersan’s technology uncovers signals and complex relationships overlooked by conventional statistical analysis that minimizes the risk of data over-fitting. This approach increases clinical trial success and reduces drug development risks by systematically identifying patient subgroups most benefiting from a drug and endpoints that best capture its effect. Tersan is one of the first companies to implement the new FDA draft enrichment guidelines for patient stratification and trial enrichment. Tersan’s expertise spans multiple medical indications and therapeutic areas, including immunological and neurological diseases and cancer.

Anavex’s 32-patient Alzheimer’s study utilizing KEM® will enable systematic analysis of more data on each patient in the disease group, on par with similar studies of significantly larger size, while providing greater cost and time efficiency.

“The ongoing Phase 2a Alzheimer’s clinical trial was specifically designed to learn as much as possible about ANAVEX 2-73 in order to optimize trial parameters for future pivotal trials and potentially reduce the risk of failure in a later, larger Phase 2/3 study and in a planned Parkinson’s Phase 2 study. We believe that the collaboration with Tersan Pharmaceuticals Ltd will potentially accelerate the development process,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.

Links: Download Anavex Press Release

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