In reading the short theses Adam Feuerstein provided by a short seller (an MD I believe) for Ziopharm Oncology (ZIOP) (palifosfamide), Clovis Oncology (CLVS) (CO-101) and Celsion (CLSN) (Thermodox), I was struck by what appeared to be the common thread of data mining from results of a previous trial (e.g., Phase 2) leading to trial design of the subsequent one (e.g., Phase 3). While some could be argued all of these drugs provided incremental benefit, many believed prior trial success would lead to successful subsequent trial outcomes, which did not generate near the benefit expected.
PV-10's success utilizing a constrained treatment protocol in its MM Phase 2 trial -- an initial injection into each of up to 20 lesions, followed by up to 3 re-treatments (weeks 8, 12 and 16) -- was fundamentally better on an absolute basis and when compared to other "leading" (at the time) intralesionally injected compounds like T-Vec and Allovectin-7.
The contemplated MM Phase 3 trial for which Provectus is seeking an SPA from the FDA -- an initial injection into any and all lesions, followed by additional re-treatment as necessary -- looks to build upon the success of the compassionate use program ("CUP") where patients were treated with PV-10 more freely and frequently. PV-10 would appear fundamentally better than its intended comparator, DTIC/TMZ.
Lesion > Patient > Cohort > Trial Population.
In the Phase 2 trial, there was an 80% treatment success rate of individual lesions with an associated complete response ("CR") of more than 50%. Think of a set of data comprising all lesions treated, irrespective of patient. Success was achieved in 80% of these datapoints.
80% success was achieved despite limited treatment (i.e., 1 initial injection and up to 3 additional injections), physician error while injecting lesions (i.e., some lesions were improperly injected), patients and their lesions left the trial, and patients with compromised immune systems and ravaged bodies from failed prior treatments had their lesions injected.
Does 20% lack of success of all lesions treated fully or completely comprise limited, improper, incomplete and immuno-challenged treatment? Perhaps not completely, but probably pretty close.
I don't know if Craig's innovated the cure or a cure, but dots connect to a near-100% success rate with freely and frequently treated lesions of, say, Stage III patients.
Now imagine if the lesions of Stage IV or heavily tumor-burdened patients are freely and frequently treated. Oh wait, that's the CUP, where well over a majority of treated patients are now cancer-free.