Theralase Technologies Inc. V.TLT

Alternate Symbol(s): V.TLT.W | TLTFF

Healthcare Medical Devices

Theralase Technologies Inc. is a Canada-based clinical-stage pharmaceutical company. The Company is engaged in the research and development of light activated compounds and their associated drug formulations. The Company operates through two divisions: Anti-Cancer Therapy (ACT) and Cool Laser Therapy (CLT). The Anti-Cancer Therapy division develops patented, and patent pending drugs, called Photo Dynamic Compounds (PDCs) and activates them with patent pending laser technology to destroy specifically targeted cancers, bacteria and viruses. The CLT division is responsible for the Company’s medical laser business. The Cool Laser Therapy division designs, develops, manufactures and markets super-pulsed laser technology indicated for the healing of chronic knee pain. The technology has been used off-label for healing numerous nerve, muscle and joint conditions. The Company develops products both internally and using the assistance of specialist external resources.

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Theralase Technologies Inc. > FDA Decision on ImmunityBio's Anktiva tomorrow?

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Post by Eoganachton Apr 22, 2024 1:12pm

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Post# 36001592

FDA Decision on ImmunityBio's Anktiva tomorrow?

The deadline for FDA review of Anktiva (N-803) is tomorrow - April 23. If Anktiva becomes the newest FDA approved treatment for BCG-unresponsive NMIBC in the next few days it's good to keep in mind that Ruvidar PDT offers equivalent, (probably better), efficacy after only 2 treatments as opposed to Ankita's 18 treatments and also that the Anktiva treatment relies on BCG which we all know is in short supply

As a reminder, here are the CR results of Anktiva vs. Ruvidar PDT:

Endpoint	N-803 CIS Cohort	Optimized Ruvidar PDT
Complete Response at any time	71%	64%
Duration of Response
Duration = 3 months	55%	62%
Duration = 6 months	56%	60%
Duration = 12 months	45%	40%
Duration = 15 months	?	39%
Duration = 18 months	33%	?

At 18 months Ruvidar should have a higher durable CR rate than N-803 as Ruvidar efficacy is unlikely to drop much between 15 and 18 months.

Treatment with Anktiva (N-803) is dependent on BCG (which is in short supply), and to attain these results, patients must endure 18 treatments. Once the treatments stop it remains to be seen how long the CR will endure. The CR rate drops12% between 12 and 18 months. Not coincidentally, the last treatment is at the end of 13 months. Here is the treatment description.

"All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus N-803 weekly for 6 consecutive weeks (induction). Patients without disease progression at Months 3, 6, 9 and 12 are eligible for continued BCG + N-803 treatment (maintenance). The study duration is 24 months."

Here is a list of the treatments:

Induction Treatments

Study Day 1 (start of Week 1)

Study Day 8 (start of Week 2)

Study Day 15 (start of Week 3)

Study Day 22 (start of Week 4)

Study Day 29 (start of Week 5)

Study Day 36 (start of Week 6)

Maintenance Treatments

Month 4 (~Week 13-14*):

Month 4 (~Week 14-15):

Month 4 (~Week 15-16):

Month 7 (~Week 28)