TELESTA THERAPEUTICS INC T.TST

Missing biomarkers in MNCA trial

[LittleLadyPhD]

Dr. Ashish Kamat's study that evaluated the use of cytokine markers to predict response to BCG and identify NMIBC patients at risk of recurrence was completed between 2005 and 2009. Results from the study were epub-ed last July and the paper has just come out in this month's issue of European Urology (the link is below). As Dr. Kamat was also the senior author on the MCNA paper (which accrued patients between 2006-2011), I wonder why the MCNA study design didn't also include collection of urine samples before and after MCNA installations (as had been done for the earlier study with BCG). There is no mention in the MCNA paper of urine (or blood) sample collection at any point during the phase III trial (which from my personal perspective as someone with 30+ years experience with clinical trials in immunology/autoimmunity, would be very unusual). In fact, the lack of any biomarker studies for MCNA was highlighted as a weakness in Telesta's presentation at the FDA AdComm. The inclusion of any data on changes in cytokine levels (that identified patients as responders and/or at risk of recurrence) related to MCNA use might not only have bolstered the case for MCNA but also been very informative when compared to the results with BCG. The same multiplex cytokine testing platform by Alere could have been used in the MCNA trial so the results would have been directly comparable. I have no idea why this wasn't done. My hope is that perhaps it was done but results have not yet been released. I have no reason to believe this is the case, but I can't understand why the study wouldn't have included urine sample collection. Especially given Dr. Kamat's involvement in both studies and the importance he placed on the measurement of biomarkers for NMIBC. Here is the link to the recent paper: https://www.europeanurology.com/article/S0302-2838(15)00526-6/fulltext/cytokine-panel-for-response-to-intravesical-therapy-cyprit-nomogram-of-changes-in-urinary-cytokine-levels-predicts-patient-response-to-bacillus-calmette-guerin

[HighteawithIntrepid]

Thanks for the post. If I remember correctly ENDO  ran the trials so I would look to them for an answer. HT

[DamnYankees]

HT, Endo ran the second trial. The trial the Little Lady is referring to is P3A. That was a 100% Telesta trial was it not? I think that if you refer to your coundown calendar it ended about 3,000 days ago. Hey how many days do you think it will take management to come up with a real news release and WTF do they do will all the people in the manufacturing facility meantime? Does management just

[QuercusAlba]

LLDoc: This is an interesting point - any chance you can/will pass this along to the folks @ TST? Sounds like it's something they might want to consider. Thanks for your contribution - hope you'll stick around the board. QA

[LittleLadyPhD]

I guess most of us have 20/20 hindsight over areas we have some experience with: for me it happens when evaluating someone else's study design! This would just have been a rather obvious oversight: completely unexpected given the expertise among the authors of the MCNA paper, whom I would assume had some say in the study protocol. I have emailed Telesta a couple of times in the last few weeks,

[HighteawithIntrepid]

You might be able to get a response from Dr. Morales (sp). It is my understanding he has retired from Queens University but they might be able to give you a lead. When it came to the science I was in the land of trust me it works.

[DryBones]

Does the word BUNGLERS come to mind as an explanation.

[HighteawithIntrepid]

LLP If we are permitted to expand on our 129 warm body study, what is your best guess on the additional number of warm bodies the FDA will require? If the FDA determined MCNA is safe the logical trial would be either a one armed trial for anyone that had a bad reaction to BCG or a straight up comparison. IE: Your going to get BCG or this other product that is safe and has a higher tolerance. Are

[LittleLadyPhD]

HT: There's a great review paper in Therapeutic Advances in Urology (Feb 2016) that's very positive about MCNA...one of the authors is Steinberg who was in the PIII MCNA study (also a consultant for Endo)...it has some very useful stats. I think it would be difficult to do a 2-arm study comparing MCNA against BCG given BCG's 70% disease free survival (dfs) rate at 5 years. A more

[bayoubucks]

Can't thank you enough LL for your excellent informative professional posts.  What a breath of fresh air in an otherwise stinky BB.  Please continue to share your thoughts with us!

[LittleLadyPhD]

No worries.

[VerifiedUser001]

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