Best guess estimate would be 2 to 4 weeks (Prep,Test, Report) based on previous study conducted by the company:
Medolife Rx Announces Preclinical Trial Results From Toxicity Study on Lead Drug Candidate
The study, which was completed through a third-party contract research organization (CRO) located in California under strict medical guidelines, was conducted in two phases on BALB/c mice. The first phase was completed on 12 mice where the mice were given the drug candidate at a 26 µg/kg dose volume and monitored for 24 hours. At the conclusion of the first phase, researchers did not observe any significant abnormalities. In the second phase, the same dose of the drug candidate was administered daily over the course of 14 days where researchers also observed no significant abnormalities in clinical observations, body weight, necropsy observation, hematology, and clinical chemistry. These observations rendered a study result that the candidate is well-tolerated in mice and thus is proven safe and non-toxic.
The company has been tasked with measuring toxicology at DNA level:
Subsequent to the acknowledgement of the trial, the FDA has requested that the Company complete two additional toxicology studies in animals. Since adoption of COVID-19 vaccinations, the FDA altered its protocol for measuring toxicology to include studying it at the DNA level. As this is a newer development, the agency has asked Medolife to provide data in this regard. Medolife has the product and protocol necessary to complete these studies in short-order.
I have not found any information on this particular testing protocol (DNA)to suggest a time frame however I did find this on the FDA website:
The US FDA's Coronavirus Treatment Acceleration Program ...
Overview of Non-Clinical Safety Assessment for Antiviral Drugs and Vaccines Development
• To Open an IND for Small Molecule Drugs
A battery of nonclinical studies to support a first-in-human (FIH) trial should include:
- STANDARD SAFETY PHARMACOLOGY STUDIES (e.g., cardiovascular, respiratory, and central nervous system assessments) but can be incorporated into general toxicology studies
- GENERAL TOXICOLOGY STUDIES in two species (at least one nonrodent)
- GENETIC TOXICOLOGY, including an Ames reverse mutation assay and a second in vitro assessment
What is Ames reverse mutation assay?
The Ames Salmonella/microsome mutagenicity assay (Salmonella test; Ames test) is a short-term bacterial reverse mutation assay specifically designed to detect a wide range of chemical substances that can produce genetic damage that leads to gene mutations. The test employs several histidine dependent Salmonella strains each carrying different mutations in various genes in the histidine operon. These mutations act as hot spots for mutagens that cause DNA damage via different mechanisms. When the Salmonella tester strains are grown on a minimal media agar plate containing a trace of histidine, only those bacteria that revert to histidine independence (his(+)) are able to form colonies. The number of spontaneously induced revertant colonies per plate is relatively constant. However, when a mutagen is added to the plate, the number of revertant colonies per plate is increased, usually in a dose-related manner. The Ames test is used world-wide as an initial screen to determine the mutagenic potential of new chemicals and drugs. The test is also used for submission of data to regulatory agencies for registration or acceptance of many chemicals, including drugs and biocides. International guidelines have been developed for use by corporations and testing laboratories to ensure uniformity of testing procedures. This review provides historical aspects of how the Ames was developed and detailed procedures for performing the test, including the design and interpretation of results.
What does the Ames test determine?
The Ames test is a rapid and reliable bacterial assay used to evaluate a chemical's potential genotoxicity by measuring its ability to induce reverse mutations at selected loci of several bacterial strains.
What is the purpose of the Ames assay?
The Ames test is a widely employed method that uses bacteria to test whether a given chemical can cause mutations in the DNA of the test organism. More formally, it is a biological assay to assess the mutagenic potential of chemical compounds.
What is the main advantage of the Ames test for mutation detection?
The Ames test has several key advantages: It is an easy and inexpensive bacterial assay for determining the mutagenicity of any chemical. Results are robust, and the Ames test can detect suitable mutants in large populations of bacteria with high sensitivity. It does not require any special equipment or instrumentation.Mar 22, 2021
How long does the Ames test take?
The plate is incubated for 48 hours. The mutagenicity of a substance is proportional to the number of colonies observed.
That being said, the testing will move the IND application forward and possibly approved if no further information is required.
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