RE:RE:About Day 7 ...EnriqueSuave ...
Until now, the only set of officially published data was at 6-month (90 days), in the Ph. 1b interim report of Nov. 2017 below: The urology community would now officially know, backed by
officially published data
@day-7, about how instant is that technology. That would blow their mind, leave no dout to even the skeptics and leave no justification to urologists to keep promoting BCG and immuno-therapies! Which could instantly prompt displacement of BCG as SOC treatment. Maybe that's their strategy.
For sure, if day-7 data shows no sign of disease (apart from adverse events), that would be unheard of, to the oncology community. Remember that after instillment of BCG, urologists don't even bother doing a cystoscopy before the next 3 months to let inflamation go away. Gathering of blow minding data @day 7 (or @30-day) could force them to re-write the NMIBC book of urology!
Showing more official data on how quick this technology destroys (wipes out) the tumours is the best way to create early adoption, fasten mass adoption, and so, create market valuation by accelerated sales.
Theralase Provides Interim Data Analysis on Anti-Cancer Treatment for First Four Patients Treated
First Four Patients Treated with Company’s Anti-Cancer Treatment Achieve Pre-Defined Primary, Secondary and Exploratory Outcome Measures November 8, 2017 The Study data results will be evaluated by the Data Safety Monitoring Board (“DSMB”) and Health Canada, upon completion, based upon achievement of the primary and secondary objectives.
Interim Data Results:
1) As previously reported, the first three patients treated at the MRSD successfully achieved the primary, secondary and exploratory outcome measures at 90 days post treatment.
2) Patient four treated at the Therapeutic Dose successfully achieved the primary, secondary and exploratory outcome measures at 90 days post treatment. During the 90 day cystoscopy analysis, patient number four’s bladder surface wall was observed to be red and inflamed. The patient will continue to be monitored to see if this condition resolves.
3) Although not a pre-defined outcome measure of the Study, patient one, two and three have successfully achieved the primary and secondary outcome measures at 180 days post treatment.
4) Although not a pre-defined outcome measure of the Study, patient one, two and three have not achieved the exploratory outcome measure at 180 days post treatment.
Conclusions:
Light activated TLD-1433 PDC, based on initial data, has demonstrated:
1) A high level of safety, tolerability and PK, in patients with high risk, Ta, T1 or CIS NMIBC, for 180 days post PDT treatment, when treated at the MRSD;
2) A high level of safety, tolerability and PK, in patients with high risk, Ta, T1 or CIS NMIBC, for 90 days post PDT treatment, when treated at the Therapeutic Dose;
3) An ability to delay recurrence and progression of NMIBC at the MRSD for between 90 to 180 days post treatment for patients, who have a clinical history or are at high risk of UUTUC and potentially longer for those that do not;
4) An ability to delay recurrence and progression of NMIBC at the Therapeutic Dose for 90 days post treatment.
Roger Dumoulin-White, President and CEO of Theralase stated that, “I am pleased in the performance of both the TLD-1433 PDC and the laser light system used to activate it, in the first four patients treated clinically. TLD-1433 demonstrated an ability to localize specifically to the bladder cancer lesions preferentially over healthy urothelium. The volume of the patient’s bladders and hence their surface areas, treated to date has varied significantly; however, the DFOC adequately compensated for these variations and was able to deliver a fairly uniform distribution of laser light across the bladder wall surface area and hence a fairly uniform activation of the absorbed TLD-1433. Optimization of the dose of TLD-1433 to use in a Phase II clinical study, coupled with optimization of both the TLC-3200 and TLC-3400 DFOC technology, currently underway by the Company, to increase ease of manufacture and optimize uniformity of light distribution, will be important to successfully achieve a primary efficacy outcome measure.” _________________
enriquesuave - (9/10/2019 3:38:56 PM) RE:About Day 7 ... The one shot Optimized treatment we saw in patients 5 & 6 of PH1 which have so far yielded 18 months CR for patient 5 and at least 12 months for #6 , seem to confirm this Claridge. We know that there is instant tumour destruction during the treatment. No recurrence or evidence of disease at any point beyond 12 months indicates that our treatment completely destroys every cancer cell present within the bladder lining and/or also produces a potent enough immune response to achieve a durable response. The second treatment they will do in PH2 is to maximize the CR rate by once again eliminating any possible reccurence detected or undetected at 6 months. In cases where a detected or undetected recurrence occurs at 6 months, the second treatment will give a second chance at complete tumour destruction of all cancer cells as well as re- prime the immune system to further prevent recurrence in more cases than with acheieved with only one single treatment. All imo. Let’s go. Maximum safety and Maximum Efficacy headed our way. IMHO
Claridge wrote: Could wisely be for them to collect data to later on show how instant is this new technology when compared to immuno-therapies that take weeks and many treatments to take off.
We know this, but the market doesn't that, for the moment.
Such observation could then be published in, lets say, the 3-month interim report and the 12-month data to come support that it is instant and durable. It could also be used when they sit down with the regulatory bodies.
Day 7: How instant is the treatment (when compared to immuno-therapies)
Day 30: Is there a complete response (Primary endpoint requested by the FDA)
Day 360: Is there a durable response (Secondary endpoint requested by the FDA)
Imagine a statement like this:
Interim report on the first 15 patients has shown that x% had a complete response @3-month and y% already shown no sign of disease as soon as 7 days after the first treatment!
That would mark the end of immuno-therapies for our market indications. And instantly put PDT/PDC on the map.