Theralase Technologies Inc. V.TLT

Preliminary Results from BCG-Unresponsive NMIBC Treatment

[Eoganacht]

Preliminary results for a phase 2 trial of CG0070 used in conjunction with Keytruda were announced today at the AUA meeting. In the first 22 patients 8 achieved a CR at 12 months (36%) and 6 achieved a durable response (27%). As a standalone treatment in previous phase 1 and 2 trials CG0070 achieved a 12 month CR rate of just under 30%. Results seem to be very close to those of the combined use of BCG and N-803 announced on Friday. 

Results of CG0070 Combined With Pembrolizumab in BCG-Unresponsive NMIBC

[ScienceFirst]

Combo produced less convincing data??? ____________________ Eoganacht - (5/16/2022 8:37:01 PM) Preliminary Results from BCG-Unresponsive NMIBC Treatment Preliminary results for a phase 2 trial of CG0070 used in conjunction with Keytruda were announced today at the AUA meeting. In the first 22 patients 8 achieved a CR at 12 months (36%) and 6 achieved a durable response (27%). As a

[Eoganacht]

No, the combo had a 6% higher CR rate at 12 months than the standalone.

[CancerSlayer]

Per CG Oncology:   Summary of Interim Clinical Results As of the interim analysis, based on a data cutoff on April 28, 2022, 22 patients were evaluable for efficacy with a minimum of 3 months follow up. 91% of patients evaluable for efficacy (n=20/22) have achieved complete response (CR) at the initial 3-month timepoint. Of those patients evaluable for CR at additional timepoints,

[CancerSlayer]

  I interpret the data differently.  75% of "evaluable" patients at 12 months (n=8) achieved a CR.  I don't believe all 22 patients have reached the 12 month mark/assessment as of the date of this release. CG0070 used as a stand-alone single agent (monotherapy) achieved a 27% CR at 12 months for CIS +/- Ta/T1 disease.   The above data certainly indicates

[CancerSlayer]

  Just imagine how our ACT could perform in combo with either Pembrolizumab or CG0070...I think we could at least match or possibly surpass our competitors...with significantly fewer instillations/treatments required.  I see great potential in our ACT as both a stand-alone & combination treatment.

[Eoganacht]

Hi CancerSlayer, I just reread Dr. Li's comments and I think you're right. I think 8 of the 22 patients have reached 12 months and 6 of those 8 are CR which is 75%

[CancerSlayer]

Yep...6 of 8 evaluable patients (75%) at 12 months, 8 of 10 (80%) at 9 months, 13 of 15 (87%) at 6 months & 20 of 22 (91%) at 3 months.  

[fredgoodwinson]

‘CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Day 1 to Week 6. If the patient shows persistent high-grade disease at Week 12, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 12 (e.g., complete response) then the patient will

[Legit62]

TLT, one or very few treatments, very safe, high CR's, to me this is best treatment option once we get approval, we just need to be patient till end of year, once we get BTD and approvals we are moving up. I would not want to go through the treatment option just posted, no way

[Rumpl3StiltSkin]

I agree, If TLT can get their CR numbers up, especially in the optimized group, They can show their true potential for treating NMIBC and other indications.

[Oilminerdeluxe]

Any hopes of an update soon. Perhaps in time for the AGM? Anyone going?

[consultant99]

Q1 financial reporting should be out later this month. I hope the notes included with the results to provide some further scan results. We have the AGM in June and then the Q2 results sometime in July/August. By then we should be very close to having the minimum necessary results to apply for BTD. No idea where the AGM will be held but might be one to go to.

[LaserStock29]

upcoming Patient #16 hits 1 year this Friday March 25th Patients # 17 & 18 hit 1 year April 27 Patient # 19 on May 28th for 1 year June 11th is patient # 20's 1 year. Guess it's no big deal.. if we roll into the AGM at sub .20 so those who flipped get their price.. what's the plan to get the price up or is it more incessant reading breakdown after breakdown of

[fredgoodwinson]

With the age profile of bladder cancer many could end up being excluded. In the age group from 60 to 79, 70.2% of men and 70.9% of women have some type of cardiovascular disease. By age 80 and above, that increases to 83% of men and 87.1% of women. Plus up to 23.5 million Americans (more than seven percent of the population) suffer from an autoimmune disease—and the prevalence is rising. Just

[ScienceFirst]

That's probably for all these reasons that the FDA, at the August 2021 meeting with TLT, indicated TLT that Breakthrough designation (and most probably Accelerated Appproval program) would be possible, given the simplicity and efficacy of our treatment. 6 key attributes impossible for the FDA and big pharmas to pass over: - the impressive safety track record of TLD

[skys1]

I agree Legit. IMO,  Dr Sherri's statement of  "Literally No Side Effects", is the single most important and advantageous factor in TLT's ACT. After watching two neighbors endure agony for about six months with Ketruda treatments then die, if I were to be beset with that terrible diesease, I would opt for "quality of life" and forgo that agony and treatment

[Gooseybear]

My Urologist was adamantly against treatment for my bladder cancer with Keytruda due to side effects.

[Rumpl3StiltSkin]

Yeah, I wonder IF the Keytruda treatments and this CG treatment can be given at the same appointment? If not then patients will always be at the cancer center. 

[patience69]

I am sure that we all agree that these are very good results. Obviously still a horrible & no doubt very expensive regimen. This is only part way through phase 2. Sort of like us. I dont understand why our results are top secret?  Why does it take a group of detectives on our boards to see where we stand. Should our partial results not be more in the public forum like these?

[Eoganacht]

Right. 20 out of 22 CR at 3 months is 91% CR. 15 out of 22 CR at 6 months is 68% CR. And 8 out of 22 CR at 12 months is 36% CR.

[Rumpl3StiltSkin]

CG Oncology can't do basic math? Or do I need another cup o joe? n=8 /= 75% of 22. I'm pretty sure.... ;-)