April 3, 2012

Repeatability

I want to approach repeatability and reproducibility in a simple, but not simplified, manner.

Let's revisit PV-10's clinical value proposition:


I think of repeatability as Craig et al., the principal investigators and Moffitt Cancer Center & Research Institute attempting to repeat the features underlying the clinical value proposition.


Do we see a repetition of "much better efficacy" in murine trials? In animal tumors? In human trials? In demonstrating the bystander effect? For example, have you examined the comparable disease stage patients from the Phase 1 and 2 metastatic melanoma trials? In particular, the trial population contemplated for the pivotal MM Phase 3 trial? What does efficacy look like?

Do we see a repetition of "much higher degree of tumor reduction" in murine trials? In animal tumors? In human trials? In demonstrating the bystander effect? What if you were to graph the degree of tumor reduction, would the plot look completely and randomly scattered, or would there be a concentration (a pattern, if you will)? How would that pattern look in murine trials? In animal tumors?

Do we see a repetition of "both local and systemic effects on diseased tissue"in murine trials? In animal tumors? In human trials? In demonstrating the bystander effect?

Do the above -- "much better efficacy," "much higher degree of tumor reduction" and "both local and systemic effects on diseased tissue" -- repeat across different kinds of indications? Do we see the same thing? Do we see "much better efficacy," "much higher degree of tumor reduction" and "both local and systemic effects on diseased tissue" in patients sickened by metastatic melanoma? By hepatocellular carcinoma?

Yes, we do.

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