Friday, June 17, 2022 5:37:22 PM
Tests for carcinogenicity (cancer-causing) and genomic disruptions are standard preclinical tests for proposed new drugs, conducted in a host of organisms. If they haven't been conducted and their results are not available to the FDA, chances of a New Drug Approval are essentially nil.
The Ames Test is the first one, followed by lower animal exposures of the proposed drug, such as tests on Caenorhabditis elegans, a common lab nematode. Then, long-term tests in animals (lab mice, rats). Finally, there is the monitoring of any genomic disruptions (mutations, changes in DNA) in the Phase 1 human trials.
Search all of the literature on blarcamesine in organisms, whether bacteria or animals. I've never seen a single discovery or incident of blarcamesine-induced or -associated carcinogenicity or induction of mutations of any sort. If any are published, please post them.
To the contrary, blarcamesine's favorable modulation of gene expression by its enhancement of chromatin functions tends to obviate against the aberrant mechanisms involved in the genetics of neoplasms (cancers). The FDA review board will be impressed with the absence of evidence or incidents of any carcinogenicity related to blarcamesine.
Actually, many approved drugs are known to be associated with or to induce cancers. Nonetheless, their therapeutic benefits outweigh the infrequent hazards of the drug's cancers.
Recent AVXL News
- Anavex’s Blarcamesine Achieves Pre-specified Efficacy in Phase IIb/III Alzheimer’s Trial: Data Presented at CTAD Conference 2024 • GlobeNewswire Inc. • 10/31/2024 08:00:00 AM
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- Anavex Life Sciences Announces Encouraging Preliminary Biomarker Results from Ongoing Phase 2 Study of ANAVEX®3-71 for the Treatment of Schizophrenia • GlobeNewswire Inc. • 10/17/2024 11:30:00 AM
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- Anavex Life Sciences to Present at the H.C. Wainwright 26th Annual Global Investment Conference 2024 • GlobeNewswire Inc. • 09/03/2024 11:30:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 09:21:05 PM
- Anavex Life Sciences Reports Fiscal 2024 Third Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 08/06/2024 11:30:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Third Quarter Financial Results on Tuesday, August 6, 2024 • GlobeNewswire Inc. • 08/01/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 09:20:53 PM
- Anavex Life Sciences Announces Translational Biomarker Data for ANAVEX®2-73 (blarcamesine) in Fragile X Syndrome (Major Cause of Autism) at the 19th NFXF International Fragile X Conference • GlobeNewswire Inc. • 07/30/2024 11:30:00 AM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 07/29/2024 09:21:49 PM
- Results from Anavex Life Sciences Landmark Phase IIb/III Trial of Blarcamesine Presented at Alzheimer's Association Conference • GlobeNewswire Inc. • 07/28/2024 09:00:00 PM
- 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
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 10:01:00 AM
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- 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
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- 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
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