Theralase Technologies Inc. V.TLT

Collecting data @30 and 60 days ... ;-)

[Claridge]

One important difference between Ph. 1b and Ph. 2b ...

They seem to have designed the Ph. 2b to allow them to collect/show data @30 days and 60 days, instead of just at 90 days, date of the primary endpoint (Is there a complete response?). 

Showing data @30 and 60 days would be the wise way to force the hand of regulatory bodies (... and so urologists) to displace BCG much faster if there's no sign of inflammation at these dates.  On that sole basis, which urologist would then be able to justify BCG if TLD-1433 provides no inflammation @30-day?

That would be the way to put PDT/PDC on the map by showing one huge benefit; rapid clearance of inflamation.


Note this passage from that recent AUA article:

"Cytology and cystoscopy were negative @3, 6, 9 and 12 months for Ph. 1b p#5 and p#6."

So it officially confirms what I noticed in the Ph. 2b clinical trial record, that they could present data at these different stages (like 30 days, 60 days) prior to the 90-day primary endpoint.

This could be extremely valuable when applying for a FDA designation status and also, when trying to displace BCG earlier than some might thing. Currently, with BCG, they don't even bother doing a cystoscopy before 90 days because of imflammation. Our technology being instant, maybe inflammation could already be gone @30 days for example. Just imagine showing such numbers! Who would then want to continue pushing for BCG?

Very captivating time ahead.

From the Ph. 1b record:

Other Outcome Measures:

Exploratory Efficacy Analysis: The exploratory outcome endpoint is Recurrence-Free Survival (RFS). [ Time Frame: The overall efficacy will be evaluated during the course of the study (at 3 and 6 months) ]


From the Ph. 2b record:

Primary Outcome Measures :
Efficacy, evaluated by the Complete Response (CR) rate. [ Time Frame: Throughout the study and up to the completion of the follow-up phase (12 month) ]

…

During the Follow-Up Phase, information on efficacy and safety will be collected. Assessments will be conducted at Day 0, 7, 30, 60, 90, 180, 187, 210, 240, 270 and 360.


___________________________

Claridge - (11/27/2019 9:33:51 PM)
RE:AUA October 2019 - Best AUA poster award = p. 10 and 12

Fig. 1:  This is the first time we see our PDC binding to a human bladder.  Previous images were from pre-clinical (rat) model.

Fig. 3 shows bladder shapes of 3 of our 6 patients.  That's the 2nd time we see this.  Simulations were done on 6 types of models.  Bladder sizes and forms all differ, anything but perfectly spheric, adding to the challenge of light propagation and reflectivity, so on bladder wall preservation while optimal destruction of cancer cells.  That's what this paper is all about; explaining to urologists what they did to ensure maximal chances of success, both in terms of safety, tolerability and efficacy.

This article also cites 3 things they did differently versus the 1993 Photofrin treatment.

 
___________________

Claridge - (11/27/2019 9:44:27 AM)
AUA October 2019 - Best AUA poster award = p. 10 and 12

Reaching to those that will decide to integrate that new technology into their future practices ...

AUA News October 2019 - Pages10 and 12