Saturday, February 10, 2018 6:59:10 AM
Just to preface my comments below, I have no experience in the medical field and still don't even understand the Western Blots graph, but I am frustrated with K like others.
The first sentence describing the study on clinicaltrials.gov:
"This is an open label, dose-escalation trial to study the safety, biomarker changes (including modulation of p53), objective tumor response changes, and pharmacokinetics following administration of two different treatment regimens of Kevetrin over a 3-week period to subjects with platinum-resistant/refractory ovarian cancer."
I would consider it successful if IPIX provided data that supports everything above. Even if some secondary endpoints weren't met, it could still be successful if they provided evidence as to why they weren't met (i.e. short half life).
How many patients completed the trial? Was there any tumor response? Any safety issues? Any differences in biomarker changes between patients? Did the higher and more frequent dosing provide any patient benefit over the Ph1 dosing?
Why was the trial discontinued? Was it because modulation of p53 was met in the first patients (if so, why wasn't the trial discontinued on 12/27)? Was it because there was no tumor response? If so, why did we see some tumor response at less frequent dosing in Ph1?
What is the status on the oral formulation? How long until it's ready?
Maybe they will be providing additional info in the coming weeks, but they don't state that in the PR.
The first sentence describing the study on clinicaltrials.gov:
"This is an open label, dose-escalation trial to study the safety, biomarker changes (including modulation of p53), objective tumor response changes, and pharmacokinetics following administration of two different treatment regimens of Kevetrin over a 3-week period to subjects with platinum-resistant/refractory ovarian cancer."
I would consider it successful if IPIX provided data that supports everything above. Even if some secondary endpoints weren't met, it could still be successful if they provided evidence as to why they weren't met (i.e. short half life).
How many patients completed the trial? Was there any tumor response? Any safety issues? Any differences in biomarker changes between patients? Did the higher and more frequent dosing provide any patient benefit over the Ph1 dosing?
Why was the trial discontinued? Was it because modulation of p53 was met in the first patients (if so, why wasn't the trial discontinued on 12/27)? Was it because there was no tumor response? If so, why did we see some tumor response at less frequent dosing in Ph1?
What is the status on the oral formulation? How long until it's ready?
Maybe they will be providing additional info in the coming weeks, but they don't state that in the PR.
