Preliminary Clinical Trial Data for "Xilonix" - Currently in Phase 3 Trials for mCRC

[DK37]

Knowing that I write about experimental CRC treatments in clinical trials, the Colon Club asked me if I knew anything about the experimental drug “Xilonix” that is currently in randomized Phase 3 clinical trials for mCRC https://clinicaltrials.gov/ct2/show/NCT ... nix&rank=2

Ironically I didn’t, it was under my radar – but upon looking into it, I thought it was worth posting about it here, in case anyone wants to discuss this trial with their MD.

Xilonix is not a “typical” anti-cancer molecule. It is a monoclonal antibody which neutralizes “interleukin-1α”. I won’t go into the scientific details here but a reasonable overview is at this link here from the company developing it: http://www.xbiotech.com/clinical/oncology.html The mechanism of action is unique since it has the “theoretical potential” to do a number of good things in advanced cancer patients, for example 1.) Direct anti-cancer activity 2.) Anti-metastatic activity 3.) Reverse cachexia/improve quality of life.

They published their Phase 1 clinical trial results last year in the journal “Lancet Oncology” http://www.sciencedirect.com/science/ar ... 451470155X . It was an “all-comers” dose escalation trial but it included 14 CRC patients. There were hints of activity in the trial – a mixture of quality of life/lean body mass improvements plus “hints” of anti-cancer activity in CRC (1/14 patients had tumor regression, the overall survival length on average for others was trending towards better than historical averages) – but interpretation of the data is limited due to the small number of patients in the trial.

They just released preliminary data from their much larger (in progress) randomized mCRC Phase 3 trial last week (on their website, not peer-reviewed).
http://www.xbiotech.com/about/news/xbio ... urope.html

There are signs of activity in CRC patients in this preliminary analysis. 61/98 evaluable patients had an increase in body mass (so reversing cachexia). 60% of patients reported improved quality of life. 2/93 RECIST evaluable patients had tumor shrinkage and 23/93 had stable disease. This data is only preliminary and has not been peer-reviewed but it is showing some potentially promising trends.

In theory it is an interesting drug because it not only could have a direct anti-cancer effect but it also could help in a quality of life/palliative sense for late stage patients with e.g. cachexia. It looks to me like it has the potential to be a positive addition to metastatoc disease management/quality of life if these trends continue and are confirmed upon final clinical trial analysis, in comparison to the placebo arm.

-DK

[rwightman]

Tom, as usual, you're a boss! Thanks for keeping all of us in the loop!

[pukalania]

Thank you so much for posting this !!! We are looking into this trial right now

[Ceebo]

Thanks for the great information, Tom! We appreciate it so much! --Cindie

[DK37]

I just found out that Maia had been keeping an updated thread on this drug for a couple years - so more good historical info in her thread below

viewtopic.php?t=39860

-DK

[smalltownmess]

My mom was scheduled to begin this trial on Wednesday but was unable to because of her hospitalization. Will be meeting with her MD on Monday and hopefully he will let us know when she can start. Thanks for posting this DK, hoping for good results!

[MWiener]

Patients can use the attached link to find facilities in their area that either have the study open or are able to open the study. Use the "Continue" button at the bottom to determine qualification and receive more information.


http://xcitecolontrial.com/clinical-qua ... tionnaire/

info@xcitecolontrial.com

[daniel.qin]

Thanks for the great information!

I will start this trail tomorrow.

-Daniel

[DK37]

If possible, please let us know your experiences with Xilonix Daniel - that kind of information is invaluable to fellow patients on this board!

Good luck & take care,
-DK

[Ceebo]

Daniel, may I ask what location you are at to be in the trial?

We look forward to hearing more about your clinical trial journey. My husband and I are actively looking for a clinical trial for him to get into since chemo is no longer working for him.

Thanks,
Cindie