Avacta Dose Escalation RNS3 Feb 2022 09:41
The Avacta RNS today was sufficient to indicate that AVA6000 is safe in humans at the dose of 80mg/m2. None of the patients would have experienced a dose-limiting toxicity (DLT). Amongst other markers, they will have tested Cmax (maximum plasma concentration) along with exposure and half-life with renal clearance. DLTs are important for the chemotherapy related cardiotoxicity for which assessments would have been made (incl. LV EF, LV Vol, Dyst F. etc.). All of which would have been well within acceptable levels. Also, for escalation to occur, all the combined data would have to be as a whole positive. Along with DLTs, the Cmax and t1/2 are key in to understanding systemic issues. This is resounding news that AVA6000 works at 80mg/m2 with NO and without doubt an MTD will be found for progressing to phase 1b. Remember that doxorubicin is well characterised in humans and the presence of pro-Dox is being escalated and as such the safety profile of the cleaved preCISION chemistry is also a resounding yes. Meaning that if dose escalation has worked for AVA6000, then the underlying mechanism will be the same for AVA3996. Once this news sinks in for Institutional Investors and large holders, the market will react accordingly. Very positive news.
GLA