Replies to post #97090 on NanoViricides Inc. (NNVC)

[drkazmd65]

A little something to think about as regards drug safety and toxicology testing.

From:
http://ocw.jhsph.edu/courses/drugdevelopment/PDFs/FDA_Guidance_on_NonClinical_Safety_Studeis.pdf

Guidance for Industry
M3 Nonclinical Safety Studies for
the Conduct of Human Clinical
Trials for Pharmaceuticals

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
July 1997
ICH

Some Excerpts:

From Page 4 of that document - as regards repeated dose Toxicity studies of a new prospective drug/treatment:

A. Phase I and II Studies (5.1)
A repeated dose toxicity study in two species (one nonrodent) for a minimum duration of
2-4 weeks (Table 1) would support Phase I (Human Pharmacology) and Phase II
(Therapeutic Exploratory) studies up to 2 weeks in duration. Beyond this, 1-, 3-, or 6-
month toxicity studies would support these types of human clinical trials for up to 1, 3, or
6 months, respectively. Six-month rodent and chronic nonrodent studies (Ref. 11) would
support clinical trials of longer duration than 6 months.

So a large part of how long toxicity studies need to be conducted will depend on the type of clinical trial (especially regarding length or duration of the individual trials) being conducted.

Shorter trials (for example treatment of a single, acute disease with a short period like influenza) would likely be expected to be quite short as even a bad flu infection is measured in terms of days, rather than weeks or months.

IF the Flucide IV treatment is to be regarded as a single dose treatment (this may be debatable depending on persistence half-life of the drug in a living system) then Repeated dose toxicity studies usually would be expected to be also quite short (measured in terms of weeks, not months). There is some variation in the length of time required by different countries.

These are the duration of studies required by most organizations in order to allow the beginning of testing on Humans (Phase I/II). Longer studies may be required in order to allow a drug/treatment to pass into Phase III testing.



Similarly - base acute safety Toxicokinetic and pharmacokinetic studies are measured (typically) in terms of days or weeks - in order to get Phase I/II testing data in hand.

Longer following of tested cohorts of animals may be required (in addition to following the medical histories of human patients in Phase I and II trials) in order to allow a drug or treatment to move forward into Phase III studies.

So - UNLESS there is significant data noted early on indicating that there is a potential problem meriting greater scrutiny - once the TOX work is begun at BASi - we are talking q1uite a bit less than several months (perhaps on the order of weeks) to get the testing done sufficiently to permit filing for IND and moving into Phase I testing.

Additional testing will need to be done to allow the candidate treatment to move forward into Phase III - BUT can be done in parallel with Phase I and Phase II studies.

This talk of >9 months to get the ball rolling here on TOX and into Phase I testing is complete hogwash.