Theralase Technologies Inc. V.TLT

Great News

[Eoganacht]

8 of the 12 will receive a second treatment. If all of them turned out to be CR at one year we would have our 67%. We should do even better than that as the dosing problem has been rectified for the second treatments and for all new patients. Accelerated approval is looking ever more likely.

[Quattro74]

Yep, and we'll do way better IMO % wise on that second cohort of 12-13 patients. Getting TLT to that magik number of 25 for FDA   AA. :-)

[Oilminerdeluxe]

Hm, did the first 3 already treated for the 2nd time get the new optimized treatment? Perhaps not important in the long run if we can start a new batch of patients with the right dosage and light.  i wish Lilge would zapp everyone participating.

[tomchoco]

So it would appear that either FTA or the AGM are next on the agenda. Other than that, what else should we be looking for. Curious to see how many options are doled out this year.

[Pandora]

Just an attempt to put the info from the newsletter in a little different format: Of the 8 patients eligible to receive the second treatment in Study II, three patients have received their second treatment. These patients had "CR" results i.e. no evidence of cancer in their bladders -and- no evidence of carcinoma cells in their urine. Note: I had a little problem with clearly

[Pandora]

Oops, probably should have edited the bottom end of that after doing the copy and paste. Oh well!

[Yajne]

Excellent post Pandora, lots of detail I didn't know before and I'm headed in for a long-awaited physical in two days, with a few nagging symptoms. Therefore I am a sponge for education on such things right now and truly appreciate the details in your post.

[enriquesuave]

I don't think we were told which category of patients were the 3 who were already retreated (2nd treatment). with the non-optimized procedure.  We specifically told that from now on the 5 patients awaiting 2nd treatment and all new patients will be treated with optimized procedure.  Will take time, but we should see major improvement I sure hope.  IMO 

[Pandora]

From the newsletter: Of the 7 patients, who demonstrated a Response to the Study Treatment defined as negative cystoscopy i.e.(no evidence of cancer in their bladders) or negative urine cytology i.e.(no evidence of urothelial carcinoma cells in their urine) at 90 days post initial treatment: 43% (3 patients) achieved a 'Complete Response' (“CR”) -- (negative cystoscopy and negative

[enriquesuave]

Not really, as all 8 regardless of category will get retreated with 2nd treatment.  Only patients who show cancer progression from now on will be removed from trial and not retreated.  All others will get 2nd treatment so could be any of the 3 categories of patients who showed a response or who show CIS with no progression.  From my understanding.

[Hempdoc]

Enrique wrote: "Not really, as all 8 regardless of category will get retreated with 2nd treatment.  Only patients who show cancer progression from now on will be removed from trial and not retreated.  All others will get 2nd treatment so could be any of the 3 categories of patients who showed a response or who show CIS with no progression.  From my understanding." That

[Pandora]

I give up! I'm sure they would first go to patients 4, 5. and 6 with complications rather than just do the 3 that came out clear. Glad you guys cleared that up :-))

[Quattro74]

Ok, wow. So very few patients then will be excluded going forward. Assuming TLT got dosing correct at the end of Phase 1, and now have a working model for how to measure the bladder volume. Bodes well for this Phase 2 once completed.

[Oilminerdeluxe]

Thanks, Pandora

[2b7f6fab]

It is good news.  Things are looking up again.  Hopefully we can all be proud of mgmt again before year end.

[Quattro74]

:-O Lol, good one 2b7f. 'proud' isn't the word I would use. I guess if they manage to turn this around, pronto, I wont be too mad.

[langosta1]

It might be 'Great News' if, if, if, we could remove all the if, if, ifs'.