Biotech Values

[DewDiligence]

Second addendum on CA4P’s QTc-prolongation:

On the OXGN board on Yahoo (#30626) “jeffreyvs/ azpharmacygirl” has cited a reference from Bayer on QTc-prolongation:

http://tinyurl.com/3dlul

According to the guildines in the above reference:

“Any prolongation of less than 30 milliseconds seems to be of no concern about a potential risk. Prolongation of more than 60 milliseconds raises a clear concern.”

By implication, QTc-prolongation between 30ms and 60ms inclusive is a cause for some concern.

In trying to make a case that CA4P’s QTc-prolongation is not worrisome, “jeffryvs” from the Yahoo board ends up making a strong argument for the opposite conclusion.

At 4 hours after treatment, the mean QTc-prolongation of patients in the CA4P trial was 30.8ms (see bottom of iHub message #908: #msg-2178433), which is within the middle range (30-60ms) that indicates possible trouble. Moreover, this 30.8ms figure was an average figure for the patients in the CA4P trial and hence the QTC-prolongation values of some patients in the trial must have been greater than this average.

One must conclude that a significant proportion of CA4P patients in the trial in question had QTc-prolongation values that would at least warrant extra caution and a high level of continuing scrutiny.