Yes - 24 months is what they have allocated, and the trial may well go longer than that, because it will include time to monitor progress of patients after dose escalation to whatever they decide is the highest dose (assuming all goes well of course). If patients do well (ie survive) they will be tracked for years. The good news, however - if patients really do well, then that will become obvious within a year, and if we get progress reports showing Cliniical effectiveness and increased survival then the SP will boom long before the trial officially ends.
The FDA is understandably very careful with virus based therapy and they have required the Check-vacc dose escalation trial to proceed one patient at a time - not dosing several patients in a cohort all at once. Because Check-vacc and Vaxinia are slightly different (even though Check-vacc is just a variant of CF-33) I assume they are requiring the same cautious protocol.
The Trial is not yet available on Clinicaltrials.gov but I am assuming it will look a lot like the Check-vacc trial protocol.
The primary Outcome Measure will be Incidence of Adverse Events - and hopefully there will be none - but they will also be looking for secondary measures, related to effectiveness. Some of those will produce data within 6 months to a year. and some as long as three years.
For Check-vacc those secondary measures include:
Response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 6 months ]Will estimate the response rate by the percent of evaluable patients and its 95% confidence interval (C.I.) by the exact method.
Response rate based on immune related iRECIST [ Time Frame: Up to 6 months ]Will estimate the response rate by the percent of evaluable patients and its 95% C.I. by the exact method.
Progression free survival [ Time Frame: Up to 1 year ]Will be estimated using the Kaplan-Meier product-limit method.
Clinical benefit rate [ Time Frame: Up to 6 months ]
Percentage of patients who achieved Partial Response/ Complete Response/ Stable disease at 6 monthsEvent-free survival [ Time Frame: Up to 3 years ]
Event-free survival (EFS): defined as the duration of time from start of protocol treatment to time of disease relapse/progression or death due to any cause, whichever occurs earlier.Duration of response [ Time Frame: Up to 3 years ]
Duration of response (DOR): defined as the time from the first achievement of PR and CR to time of PD.Overall survival [ Time Frame: Up to 3 years ]Will be estimated using the Kaplan-Meier product-limit method.
Dr Daneng Li is highly experience - with 15 trials currently listed on Clinicaltrials.gov under Dr Li's name.
Imugene is playing in the Big League here. There are no shortcuts, but the stakes are very very high. If either (or both) of the CF33 trials start to show real clinical effectiveness, that will happen well before the official end point of the trials. It will also trigger massive interest in Imugene and a re-rate of the share price which could be eye waveringly large and fast.
Nothing is certain, but I'm prepared to wait it out.
(20min delay)