RCE recce pharmaceuticals ltd

Ann: Phase I Positive Safety Data - 4000mg Complete, page-5

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    Some of you would have seen my comments regarding this cohort previously. The reason it is highly significant is that the company believes that a therapeutic dose for sepsis is some where around 50mg per kilogram of bodyweight. So a 80kg man receiving a 4,000mg infusion is right at that anticipated therapeutic dose rate.

    Is there anything to be gained from the remaing cohorts, 8,000mg and 16,000mg?

    Yes, a few possible benefits.

    Firstly, if the remaining cohort doses prove safe, then the final product becomes more appealing because of a wider therapeutic window (the range of dose rates of therapeutic use which are safe). So if a doctor/nurse accidentally double doses, or adds an extra zero, the patient would be OK.

    It would also open up the possibility to use the product in "pre-sepsis" conditions such as kidney infections. A higher dose would likely be required to achieve therapeutic concentrations in the tissues/organs of interest.

    Also, if a particularly hardy bacterial species/strain is the cause of a sepsis case, a higher dose may prove to be more effective.
 
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