TELESTA THERAPEUTICS INC T.TST

The Journal of Urology (Abstract published online)

[rgonlyfactspls]

Results look solid to me (from a layman's interpretation). Note PFS rates in particular. And, recall the only FDA approved comparative is Valrubicin with a 1-year DFS rating of only 10% and for CIS patients only (Slide 20 in Bioniche Corp. PPT presentation. Be good to ask analyst as Seeking Alpha for his opinion. Anyways, let the "partnering discussions" get serious! rg Efficacy and Safety of MCNA in Patients with Non-Muscle Invasive Bladder Cancer at High-Risk of Recurrence and Progression who Have Failed Treatment with Bacillus Calmette–Guérin Accepted: September 30, 2014; Published Online: October 03, 2014; Publication stage: In Press Accepted Manuscript Results A total of 129 patients enrolled in the study; 91 had CIS, with or without papillary disease, and 38 had papillary only tumors. Most patients had high-risk disease: 107 were BCG-refractory, 68 received ≥2 prior BCG induction courses. Median duration of follow-up for all patients was 34.7 months. Overall DFS rate was 25.0% at 1 year and 19.0 at 2 years; for patients with papillary only tumors, DFS rate was 35.1% and 32.2% at 1 and 2 years, respectively. Median disease-free duration for the 30 responders was 32.7 months. PFS rate was 87.3%, 79.8% and 77.7% at 1, 2 and 3 years, respectively, with 28 patients experiencing a progression event. MCNA was very well tolerated and few AEs lead to treatment discontinuation. Conclusions Intravesical MCNA achieved significant activity in high-risk NMIBC patients who failed BCG treatment, especially in patients with papillary only tumors and in BCG-relapsing patients. Durable response is seen particularly in patients with a response at 1 year. MCNA offers an option for patients who are not candidates for or who refuse cystectomy. Definitions: Disease-free survival rates refer only to the percentage of people who experience a complete remission after finishing treatment. Progression-free survival rates describe the percentage of people who do not experience any new tumor growth or cancer spread during or after treatment, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable (the cancer is still present but not growing or spreading). https://www.cancer.net/navigating-cancer-care/cancer-basics/understanding-statistics-used-guide-prognosis-and-evaluate-treatment

[higgsboson]

Finally a post worth reading.

[Jasl]

This is the first phase 3 trial results, is it not. 129 patients. This was presented at the AUA years ago no? We have never had any info from phase 3 b trial. For some reason I thought that's the info that was going to be published. I guess it never will be as the trial never completed.  Jasl

[beechguy]

Berendt said the 39 evaluable patients from 3B will be used for safety data for final BLA submission only and (I assume) orphan submission. beech

[NoNukNuk]

you got a good memory beech