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Sunday, October 10, 2021 4:43:43 PM
Understandably, a frequent topic has been ‘biomarkers,’ as they might indicate therapeutic efficacies of certain drugs, or the presence of actual disease conditions, etc.
What, actually, constitutes a ‘biomarker?’ What is a biomarker? Here’s where the FDA defines it: https://www.fda.gov/drugs/biomarker-qualification-program/about-biomarkers-and-qualification
Specifically:
“The Biomarkers, EndpointS and other Tools (BEST) glossary defines a biomarker as a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers. A biomarker is not an assessment of how an individual feels, functions, or survives.
I find interesting the last sentence in the FDA’s definition—which I believe should be kept in mind regarding blarcamesine:
A biomarker is not an assessment of how an individual feels, functions, or survives.
Clearly, the the FDA separates how a biomarker is used in a clinical trial, compared to how patients in that trial actually responded to the drug being tested. No connection to how the patients felt, functioned, or survived after being on the drug.
What, then, is the function of either clinical drug tests, or the therapeutic administration of any drug? Aren’t drugs supposed to share two traits, a) to work safely, and b) to provide favorable therapeutic outcomes (making patients “feel better, function better, or survive better”)? Focusing solely on biomarkers simply avoids determining if patients got better. They are, as the FDA defined, only “Molecular, histologic, radiographic, or physiologic characteristics....”
Isn’t the presence of beta-amyloids in neurons or nerves a biomarker for Alzheimer’s? Except—lots of people have lots of amyloids in their brains, equivalent to others with profound Alzheimer’s; but have no Alzheimer’s symptoms. Simply, beta-amyloids are not a reliable or accurate predictor or trait of Alzheimer’s. In many with the disease, yes. But beta-amyloids don’t necessarily, in every case produce Alzheimer’s symptoms. Lots of people have lots of amyloids, but no Alzheimer’s (as posthumous histological examinations of brain tissues have revealed).
Personally, I’m not much interested in the clinical ‘biomarkers’ arbitrarily connected to blarcamesine therapy. I’m not much interested at all if the Anavex drug increases the synthesis of sigma-1 receptor proteins. If it does (as current research indicates), well and good. But the only things that really matter are safety and efficacy. Does blarcamesine administered to patients with accurately diagnosed CNS diseases work safely and reduce symptoms, or not? ‘Biomarkers’ are effectively irrelevant. Is the drug safe and effective, or not? Let actual therapeutic outcomes of the three on-going clinical trials of blarcamesine answer those two seminal questions.
Recent AVXL News
- Anavex Life Sciences to Present at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference • GlobeNewswire Inc. • 06/20/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/17/2024 11:30:10 AM
- Anavex Life Sciences Announces Expansion of Leadership Team • GlobeNewswire Inc. • 05/22/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 10:01:00 AM
- Anavex Life Sciences to Present at the H.C. Wainwright 2nd BioConnect Investor Conference at NASDAQ • GlobeNewswire Inc. • 05/14/2024 11:30:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More • PR Newswire (US) • 05/10/2024 09:45:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:35:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 12:00:30 PM
- Anavex Life Sciences Reports Fiscal 2024 Second Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 05/09/2024 11:30:00 AM
- The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders • PR Newswire (US) • 05/07/2024 09:45:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/06/2024 10:03:33 AM
- Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights - AVXL • PR Newswire (US) • 05/03/2024 09:45:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Second Quarter Financial Results on Thursday, May 9th, 2024 • GlobeNewswire Inc. • 05/02/2024 11:30:00 AM
- May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL • PR Newswire (US) • 04/26/2024 09:45:00 AM
- Contact The Gross Law Firm by May 13, 2024 Deadline to Join Class Action Against Anavex Life Sciences Corporation(AVXL) • PR Newswire (US) • 04/19/2024 09:45:00 AM
- The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of May 13, 2024 in Anavex Life Sciences Lawsuit - AVXL • PR Newswire (US) • 04/16/2024 09:45:00 AM
- Class Action Filed Against Anavex Life Sciences Corporation (AVXL) - May 13, 2024 Deadline to Join - Contact The Gross Law Firm • PR Newswire (US) • 04/12/2024 09:45:00 AM
- Anavex Life Sciences to Present at the Noble Capital Markets Virtual Healthcare Equity Conference • GlobeNewswire Inc. • 04/11/2024 11:30:00 AM
- Class Action Filed Against Anavex Life Sciences Corporation (AVXL) - May 13, 2024 Deadline to Join - Contact The Gross Law Firm • PR Newswire (US) • 04/09/2024 09:45:00 AM
- Anavex Life Sciences Corporation Class Action: The Gross Law Firm Reminds Anavex Life Sciences Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of May 13, 2024 - AVXL • PR Newswire (US) • 04/05/2024 09:45:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 04/02/2024 09:45:00 AM
- Lost Money on Anavex Life Sciences Corporation(AVXL)? Join Class Action Suit Seeking Recovery - Contact The Gross Law Firm • PR Newswire (US) • 03/29/2024 09:45:00 AM
- Investors who lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 03/26/2024 09:45:00 AM
- Anavex Life Sciences to Present at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 03/25/2024 11:30:00 AM
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