Theralase Technologies Inc. V.TLT

Theralase = TLD-1433

[fredgoodwinson]

TLD-1433 is the super compound. As Quattro mentioned it has built-in safety with its` steep green light gradient and high selectivity for surface cancers and when pre-incubated to create Rutherrin can treat deeper and larger tumours whether through multi-wavelength PDT or X-Ray.

 

Phase II NMIBC is doubly disappointing as if correctly dosed these first 12 could have showcased TLD-1433 to the wider world. It is galling to think that cruder photosensitisers have been activated with less attempted precision at doses sufficient to kill NMIBC while the much safer and more cytotoxic TLD-1433 has not.

 

The long-term intellectual property ownership of this and the suite of potential metal-based photosensitisers that the Company took under license from Sherri IS Theralase but TLD-1433 in particular as it has IND status and a growing Clinical database.

 

The great advances made and being made by Dr.Lilge in developing safe and effective treatment strategies should not restrict the Company from looking to commercialise TLD-1433 on as wide a basis as possible. Full Monte is open source and as Lumeda show the DFOC not the only device. It is time for deals to be done.

 

[Oilminerdeluxe]

Any thoughts on when we might hear something about the patients that are supposed to get re-examined and perhaps put in the CR category? (Unless I misunderstood the info?). Could make a world of difference.

[fredgoodwinson]

Agreed Oilminer - in the medium term there are only 3 positive possibilties from Phase II: That the 5 patients to receive a second treatment at the revised and now allegedly correct doses of light and drug achieve or retain a resultant Complete Response. That enrolees presently without a confirmed Complete Response are re-categorised as such (these first two categories may overlap). That the

[Oilminerdeluxe]

Fred, your first two poaints feels quite likely to happen if things do go our way.

[enriquesuave]

Nice one Fred.  Can they use multi wavelength PDT to address CIS within possible folds in the bladder and thus reduce possible under treatment further?  I think that simply correcting the error of using maximum bladder volume both when instilling the drug and when irradiating with green light should solve the problems encountered.  I thought they had already cleared that up in PH1

[fredgoodwinson]

Oilminer/Enrique - yes they must be trying to get those 5 re-treated as soon as feasible as until at least 90 days` after the last of these second treatments and despite no deficiency in the compound itself TLD-1433 will be unfairly blighted by the deficiencies of the initial dosing and activation. Would hope that they really have got a handle on the dosing but as you say we thought that at the

[Quattro74]

I think they made assumptions, based on two patients, that perhaps had more uniform bladders in shape and size? They applied these ideas to a larger group and oops!

[fredgoodwinson]

Not looking to be too critical or negative -  new territory after all. Long here and like many longs this means 6 years and counting but in fact quite upbeat. Way nearer the end than the beginning but with a market cap less than that for the rat results 4 years`ago. Buying opportunity?

[StevenBirch]

I agree Fred, the timeline has been pushed out a bit unfortunately but only because the execution was off and not because of the effectiveness of TLD 1433 or the delivery system. So there have been some good comments here, Hempdoc has added some colour to the bland set of numbers released yesterday and I think the next step is to hear that type of explanation from the company. I think we went

[Quattro74]

Good points Steven, This PDC and DFOC are brand spankin' new tech. Only 18 treated so far. The DFOC for this Ind is very complex. Rather steep learning curve. I hope the docs can perfect it. That is the risk here.

[StevenBirch]

I agree Quattro and for me the only 'risk' is the timing. I think some some sold yesterday to deploy cash elsewhere, covid is the new pot mania, and not because there is anything wrong here. But I really don't think we are set back that much further and maybe thanks to covid! Anxious to hear something from the company and at worst that is Sept so we've seen the weakness now it'

[Quattro74]

I wonder if we will have some 1yr numbers to look at in Sept? Maybe the 3 that were CR will still be? Will they release 6 month data?

[Quattro74]

Fred and others, We certainly lucked out that TLT desided to design study 2 with two treatments. This way they will get a second chance with many of this first batch. And, if it still needs some fine tuning, with future batches.

[Pandora]

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[thadeush]

I know they're probably monitoring the testing meticulously and I hate to bring this up, but the conspiracy part of my personality thinks that the success of TLT's Phase 2 might bring quite a bit of pain to the stock price of other treatments. Is it possible that any of the doctors doing the test could have been 'incentivised' by some large pharma groups to alter the doses and

[skier59]

I have to say, this has also crossed my mind. 

[Macer]

Well this post takes the cake. i can't read this $hit anymore. See you all in 2021  Macer

[thadeush]

I'm a big fan of TLT and would buy more at these levels if I could. I'd rather have management act like anything could happen and prepare for it than not. These last test results were unusual compared to all other results and they need to figure out why - I'm just trying to make sure ppl are alert to any wrenches that might have been thrown into the process. Yes, I've probably

[CAinPlap]

Yes the subterfuge suggestion is hard to shake off.  Before these results were released, many were confident the science was a slam dunk. Now some doubts have inevitably crept into the science side.

[Quattro74]

Well, I just read through this ann again. Yes, it has allowed some doubt to surface. I am still reasonably sure that they have/ or will fix this, possibly even greatly improve the %s with the first twelve. I can't believe they made the mistakes they did, regardless of whose is to blame. They just need to move forward with the fixes, and respond quickly to any other 'oversights'. I

[skys1]

The science is just as valid as it was a year & 1/2 ago. It's just that since Shawn has shown up most has gone wrong.If it was up to me, I'd send him back from whence he came - Big Pharma. An accomplished CEO would straighten out this company in a few months. Still, I believe the net result of the Ph 2 trial will be a CR % substantially above 60. That would put our ACT in the drivers

[Quattro74]

Yep, go Roswell Park go!

[Hempdoc]

Take us out at what price?....better be good : ).  Don't think RW would accept a low-ball offer, though Shawn maybe.    

[Hempdoc]

I think/hope licensing is in our future...way too early for any buyout/jv considerations.

[Pandora]

And meanwhile, back at the ranch, closed Friday at $4.64, opened today at $20 hit a high of $33 and closed at $22: Shares of Seres Therapeutics Inc.(MCRB) rocketed nearly fourfold (up 270%) on heavy volume in premarket trading Monday, after the microbiome therapeutics company reported upbeat results of a Phase 3 trial of its SER-109 for recurrent C. difficile infections (CDI), or an infection of

[Yajne]

thadeush, that's a big word to drop on us suddenly!! Interesting choice of your words. Subterfuge...several possible meanings, but I think one of these might apply: "a trick or dishonest way of achieving something" "an action taken to hide something from someone"

[Eoganacht]

So thadeush - you think Dr. Kulkarni and/or Dr. Kassouf were bribed by "big pharma" to sabotage the treatment of the critically ill cancer patients in their care. And then the ever-obliging Theralase covered for them by publicly stating that the problem was not with those running the trial but with the clinical protocol that was submitted to them by the company. I guess big pharma also

[LaserStock29]

Consider all the dosimitry work done by Dr.Lilge et al... eliminating meticiously one objection at a time... the ability to measure light.. incidence and refractory.... 'bouncing off the luminal layer'  automatically calculated by a computer...  Monte Carlo then the upgraded Full Monte. etc Then consider 2016 AGM   9:40 2016 Agm Then consider 2016 AGM mark 2016

[Pandora]

Yes, it's tough to accept that these "top academic medical experts" could screw up 12 patients so badly in a Phase 2 trial --- but then I have also known some doctors that could fit this mode - but they were just GP's not research type's, if there is a difference.

[Eoganacht]

Theralase has admitted the errors were on their side. How this could have happened I don't have the slightest clue. But I don't buy that the doctors sold out their patients for cash payments and then, for some reason, Theralase took the blame.

[LaserStock29]

Water or 'Urine' under the bridge :-) time to get the corrections made.. open the trial if Toronto gets clinial trials Phase 3 open.. and get this done right.

[enriquesuave]

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

[LaserStock29]

Enriquesuave.. those questions might have been relevant in 2014...  These issues were discussed now for 10 years... and we have the doctors since running the photofrin trial from 1993... so whatever happend it happened.. and 2m volume was gifted to particular parties who didn't want them at $1 or higher IMO. Heck maybe if we got a 'complete' report with 58% CR  and find out

[Hempdoc]

I feel your pain LS...This company is essentially worthless without Sherri M/TLD-1433 & Roswell. Fortunately, her compound will likely generate multiple collaborations.  I think Roger has been too fixated on lasers (especially LLLT) for too long.  I'd like to see TLT expand their research horizons & partially/fully replace their LLLT interests with expertise in interventional

[Hempdoc]

Enrique 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

[Hempdoc]

  Clarification:  During treatment, they fill the bladder with a "water-based" solution of compound (not saline-based).  Sterile water (not saline) is also used for the laser light treatment.  Guess I have to cut the company some slack now for their human error ; )

[fredgoodwinson]

Yes Quattro - thank goodness for the 2nd treatment the Covid delay and the process of the FDA.

[Quattro74]

Nice points Enrique, I agree about TLT with 100 patients getting approval, since this is a pivotal study. I also agree about the ~40% being a good number to shoot for. I do think though that TLT might be able to better this and as you say get to Accelerated Approval. I'm betting a max of 60 patients treated between US/Canada is when we will get that BTD or AA. IF the % is somewhat better than

[Quattro74]

Yeah Fred, I'm still super excited about the super compounds and their potential, too early to know if any will be as practicable as 1433.  TLT stubbed their toe here with these first 12. Let's not forget though how complicated NMIBC DFOC is compared to other indications. Everyones bladders are different and the interior being so shiny and reflective has to be accounted for