RE:RE:RE:RE:RE:RE:RE:RE:RE:Theralase = TLD-1433Enrique wrote:
"A small yet costly mistake. I'm surprised the PI Urologists didn't realize it. At last AGM Dr. Lilge was presenting on exactly this topic. Perhaps since they had further optimized the hardware to double the power intensity maybe they thought that would compensate for not properly filling the bladder? Had we not undertreated, we would have possibly and most probably gotten much better results. Anything like 8 out of 12 or better CR would have probably sent SP soaring past $1. This would have led to excercise of non trade able warrants and up to $10-12 Million extra in the coffers. IMO Not to mention the confidence it would show to all of the potential trial sites and patients in search of trial participation. We can still catch up but will need to be very careful with next 12-18 patients. Hopefully we can treat as many by December and do it right.
Some questions to possibly ensure success
1) can we use red light as well as green light given high selective drug intake by cancer cells? This would allow for treatment of hard to reach areas within bladder folds, or would properly or slightly overfilling bladder completely be sufficient? Photofrin 60% and Radachlorin 90% 12 months CR
2)Do they also instill bladder to maximum bladder capacity? As this will provide for accurate drug quantity.
3)Can they retreat 4 patients dropped from trial given new protocol?
4)Is it better to slightly over treat given high drug selectivity and hence achieve maximum efficacy while maintaining high safety?
While it is frustrating to see what's happened, it may allow for us to get more shares cheaper and eventually pay off big time? I sure hope so. We will need lots more patience IMO, but should hopefully get there in the end.
All IMO GLTA"
My thoughts...
1 &2). Green light should do the trick if the bladder is "properly" filled. In a "properly" filled bladder, all of the natural crevices between the folds will have been filled equally with saline/drug. "Proper" filling of these crevices with saline should also minimize problems with "diffuse" reflection when the green light is applied. With proper filling, the 3 mm penetration depth of green light should be more than adequate to reach all of the superficial cancer cells, which should all be residing < 3 mm from the inner bladder surface. The biggest problem seems to be "proper filling" imo. Older bladders come with less compliance & likely need higher filling pressures to achieve maximum filling/over-filling. But even if they use 100% maximum bladder volume voided in their calculation, this could still significantly underestimate total bladder volume, especially in an older population where bladder dysfunction & urinary retention (for a variety of reasons) is often the norm...JMO.
Smoother target surfaces (including lumenal) & IV administration should at least be potential pluses for other indications down the road.
3). I believe those 4 patients should & can be treated through expanded access/compassionate use efforts or via the protocol modification...as long as they remain progression-free.
4). I'd like to stick with "proper" treatment for now...neither under or over ; )
Still mind-boggling how this error happened... How does this get missed by our top-notch advisory board & during the pre-IND stages.