Theralase Technologies Inc. V.TLT

Accelerated Approval ahead of AUA congress would spark

[ScienceFirst]

Accelerated Approval, instead of Breakthrough Therapy, ahead of AUA congress, would clearly spark interest and curiosity as it would mean that urologists could then immediately prescribe our treatment to patients that are not even in our Ph. 2 trial.  


By the way, Ferring's gene therapy was granted Priority Review, Breakthrough Therapy, and Fast Track designations, instead of Accelerated Approval.   Individuals who are immunosuppressed, or immune-deficient should not come into contact with Adstiladrin. 

And again, this FDA statement upon the FDA approval of Ferring's gene therapy for BCG-Unresponsive sends a powerful message that the FDA has us on its radar.

“This approval provides healthcare professionals with an innovative treatment option for patients with high-risk non-muscle invasive bladder cancer that is unresponsive to BCG therapy,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s action addresses an area of critical need. The FDA remains committed to facilitating the development and approval of safe and effective cancer treatments.”

[Eoganacht]

ScienceFirst wrote: "Accelerated Approval, instead of Breakthrough Therapy, ahead of AUA congress, would clearly spark interest and curiosity as it would mean that urologists could then immediately prescribe our treatment to patients that are not even in our Ph. 2 trial." And possibly even for other cancer indications. Roswell Park, for example, treats gynecologic malignancies, head

[CancerSlayer]

  Yes Eoganacht....off-label use is not only legal, it's quite common.  Such use is not an uncommon practice in the field of oncology wherein off-label use of a drug or combo of drugs can become the new SOC.   When considering our indication under study (BCG-unresponsive NMIBC), the current go-to treatment used by many specialists involves the off-label use of a combination

[Rumpl3StiltSkin]

Slayer, Couldn't 1433/Rutherrin be used off label for Melanoma? Almost immediately? Isn't that a HUGE market?

[Eoganacht]

I don't think pdt is used for melanoma yet although it is used for other forms of skin cancer. Dr. McFarland got a research grant for this and published a 2022 paper where she demonstrates how new next-generation NIR Ru PSs ML19B01 and ML19B02 create a strong anti-melanoma cell immune response. Hopefully, one day soon, Theralase will be able to take advantage of this research with a

[Rumpl3StiltSkin]

Thanks Eoga, Very interesting. Skin Cancers, in total, look like a promising area for TLT. And a Giant market.

[Eoganacht]

Hi Rumple - Roswell Park is already treating 3 types of skin cancer with pdt off-label - basal cell carcinoma, (the most common form of skin cancer), Bowen's disease, and Nevoid basal cell carcinoma syndrome. Since these cancers are already being treated with off-label photosenstizers, once TLD1433 is approved for NMIBC, maybe they could use TLD1433 instead. Rumpl3StiltSkin Wrote

[CancerSlayer]

  If/when TLD-1433 is proven successful, there's a very good chance that Roswell would incorporate TLD-1433 into "all" of their PDT cancer treatment protocols.  My opinion is based on their strong historical interest in/study of our photosensitizer (with the hopes of replacing Photofrin) for their NSCLC/Mesothelioma indications.   The Roswell PDT dept. is always in

[Rumpl3StiltSkin]

Especially if 1433 is an improvement of Roswells current PDTs, right? 

[Eoganacht]

Right. It's never been explained why Roswell Park chose photofrin over TLD1433 for their NSCLC trial. I'm guessing it was a strategic decision by Theralase.

[Rumpl3StiltSkin]

Yes, puzzle... Yet once 1433 is FDA approved I think Roswell or their competitors would definetly want it for various skin cancers. Since these are 'surface' cancers and it can, I think, be applied topically. No GLP study or large animal studies required.