Theralase Technologies Inc. V.TLT

Very Good News!

[enriquesuave]

FDA approves Adstliadrin for NMIBC.  They have 4 instillations ( not bad) but 24% CR at 12 months ( I'm not sure if it 12 months or 450 days.  They had issues with manufacturing BLA.  We will need an NDA much easier and we have way better results IMO. Already 28% CR plus 10% PR including 14 patients who should normally not be counted in analysis out of 29 patients.  https://endpts.com/fda-approves-ferrings-new-gene-therapy-for-bladder-cancer/

[enriquesuave]

In comparison we may very well qualify for AA after data on 40-50 patients IMHO.  2023 all the way!  

[RoseHeaven]

The safety and effectiveness of Adstiladrin was evaluated in a multicenter clinical study that included 157 patients with high-risk BCG-unresponsive NMIBC, 98 of whom had BCG-unresponsive CIS with or without papillary tumors and could be evaluated for response. Patients received Adstiladrin once every three months for up to 12 months, or until unacceptable toxicity to therapy or recurrent high

[RoseHeaven]

around 25.5% CR at 12 months (46% of 51%)

[RoseHeaven]

Appolozy, CR at 12 month is only 23%

[DJDawg]

I was curious about the drop off in CR over time. I couldn't find it for the most recent data but interestingly the 157 patient response mentioned above is similar to the smaller patient data reported earlier in 2021. 151 is very similar to 157 but the CR is different between the 51% CR reported here vs the above reference. Recurrence-free survival (months) CIS + /- Ta

[CancerSlayer]

Ultimately, it should only be the optimized patients that the FDA will consider in determining if we are AA eligible or not imo.  Even when considering the undertreated, our 450 day data to date reflects a 19% improvement in CR compared to Adstiladrin, which I would consider significant.  If you look at only the optimized (relevant) data, the percent improvement in CR is 100% (47% vs 23

[enriquesuave]

I believe Adstiladrin CR rate is 23.5% at 360 days  and probably less at 450 days.  It seems clearly laid out.  We already beat them and will most probably be 100% more effective and half the treatments.  Also no restrictions on immune compromised patients.  Blackrock invested $450 Million in Ferring to market Adstiladrin 2 years ago, before they got a CRL for

[ScienceFirst]

    https://www.fiercepharma.com/pharma/after-2020-rejection-ferring-finally-nabs-fda-nod-bladder-cancer-gene-therapy Since then, Ferring has been working with its partner and the FDA to bring the production process in line with the agency’s expectations, Metzger said. As with other gene therapies, Adstiladrin has a “very complicated, very long, very product-tailored"

[DeathXray33]

I have no worries & let the #'s calm us...

[enriquesuave]

Misleading on Press release, but it seems 23.5% of patients maintied CR for 12 months or more, we still beat them. Those who didn't get CR, but showed no high risk of progression were offered to continue treatment after 12 months.  11% had serious side effects. We are much better in all aspects IMHO the FDA now has something we can be compared with and if better, it should be a no brainer

[CancerSlayer]

  There are now only two intravesical or comparator treatments that have been FDA approved for high risk BCG-unresponsive NMIBC, Adstiladrin & Valrubicin....their 12 month CRs being 23.5% & 10%, respectively.  When considering all of the other/similar intravesical technologies being tested, they all require many more treatments, have more restrictions & are a lot less

[Oilminerdeluxe]

I think my January pay will go into TLT if nothing changes until then. I can't let you all be rich without me :-)

[steamfitter]

It just may be too late by then. Good luck to all. 

[ScienceFirst]

Another thing that should be in our favor, when you read this regarding Adstiladrin ... storage.  Note also that TLD1433 had a shelf life expectancy of 3y versus 3 months got Adstiladrin: 16 HOW SUPPLIED/STORAGE AND HANDLING ADSTILADRIN is shipped frozen at ≤ -60°C (≤ -76°F) in an insulated shipping box that will maintain the required temperature for a minimum of 72 hours

[Eoganacht]

Thanks for sharing that. It looks like they treated and reached 12 month evaluation for all 157 patients in this phase 3 trial.. They will continue to follow them for 5 years.

[ScienceFirst]

It bodes very well for us. Less treatments, higher efficacy %. The FDA also approve a non-BCG treatment and played its role to give more options to these patients. It bodes extremely well.