Today's news is is very good, even if it was anticipated, but it is interesting for what it does not say as much as what it does say. Only safety was commented on, which was all that was required to go forward. No comments were made about efficacy.
In the Cal-1 trial all the cohorts receive the same dose of Cal-1. This is not a dose escalation trial, unlike our TT-034 trial. The difference in the cohorts is the amount of preconditioning received.
What this means is that Calimmune must know what level of transduction was achieved and what the initial reduction in viral load was but they are not saying, yet. They are still keeping their cards close to their chest. They must know how these results stack up against their mathematical modelling which they have just published.
This is neither good nor bad but it does demonstrate that Calimmune are still likely to be very cautious about releasing news.
The other thing about this announcement is the timeframe. It has taken twelve months to be in a position to dose the second cohort which makes it seem difficult, but not impossible, to complete the trial by June next year, which was the original end point for data collection. Hopefully, now that the FDA has allowed as faster recruitment process and safety has been accepted, more volunteers will be lining up.
BLT Price at posting:
$1.20 Sentiment: None Disclosure: Held
