Xilonix phase III trial, for those of us who have run out of options

[skypup]

I am posting info about this drug because I believe in the importance of CT as a repository of our collective knowledge.

I have started this trial. Here is a summary of the info I have been able to uncover about it. The drug was originally intended for cachexia patients only, but it was discovered in early phase trials that it was much more robust. It doesn't aim to cure, rather to improve QOL and, in later trials, to extend life. It acts on interleukin-1alpha, is a fully human monoclonal antibody, and works by alleviating the state of chronic inflammation that cancer creates and requires to do some of its dirty work. It is a very mild drug; in early phase trials there were zero grade 3 or 4 toxicities.

PHASE I/II TRIAL (at MD Anderson)
"It was reported that overall, patients constitutional symptoms improved, including reduction in pain and fatigue. A highlight of the report was the finding that almost two-thirds of patients assessed with a new form of X-ray imaging demonstrated physical recovery of lean body mass (which is another way of referring to muscle mass) but moreover, that these same patients had dramatic improvement in overall survival."

"XBiotech is announcing that results from its Phase I/II oncology study conducted at MD Anderson Cancer Center in Houston, TX were published today in Lancet Oncology. The featured article describes the outcome in 52 advanced cancer patients treated with Xilonix™, XBiotech’s novel, non-cytotoxic, anti-tumor therapy. The so called true human antibody therapy was reported to have an excellent safety profile. The report describes comprehensive measures of patient performance during therapy with Xilonix. It was reported that overall, patients constitutional symptoms improved, including reduction in pain and fatigue. A highlight of the report was the finding that almost two-thirds of patients assessed with a new form of X-ray imaging demonstrated physical recovery of lean body mass (which is another way of referring to muscle mass) but moreover, that these same patients had dramatic improvement in overall survival."

PHASE 1 NSCLC (LUNG CANCER) TRIAL
"Self-reported outcomes revealed reductions in pain, fatigue and improvement in appetite. Median survival was 7.6 (IQR 4.4-11.5) months, stratification based on prior anti-EGFR therapy revealed a median survival of 9.4 months (IQR 7.6-12.5) for those pretreated (N = 10) versus a survival of 4.8 months (IQR 4.3-5.7) for those without (N = 6, logrank p = 0.187)."
Note that previous anti-EGFR therapy (Erbitux, Vectibix) improved outcomes even more that just Xilonix alone -- important since many of us have had anti-EGFR therapy.

PHASE III FAST-TRACK STATUS
"XBiotech, a privately held biotechnology company, announced today that the company has been granted Fast Track designation for its anti-cachexia drug Xilonix. The Company's groundbreaking therapeutic antibody was shown in a previous clinical study at MD Anderson Cancer Center in Texas to stop or reverse cachexia in about a third of all advanced cancer patients treated. Anti-tumor and anti-cachexia effects were seen in many different types of cancer. In patients with advanced colorectal cancer, the reversal of cachexia resulted in a dramatic improvement in life expectancy, with patients that responded to treatment having a median survival of 474 days, versus a median of 72 days in others."

PHASE III TRIAL, INTERIM RESULTS
The phase III trial, designed for mCRC patients with cachexia, was halted for interim analysis with the following result:
"The Company disclosed it has used the interim overall survival data in a model to predict the statistical significance of the survival benefit over the projected complete course of the study. This model is said to indicate that, based on the current effect seen with Xilonix, a highly significant result would be obtained upon study completion, well beyond what is necessary for registration."

PHASE 3 TRIAL REOPENED WITH NO CACHEXIA CONSTRAINT
In short, it was so effective that the FDA approved reformulating criteria and continuing the trial without the cachexia constraint. This is big news for us CRC folk.
"The new protocol is said to permit recruitment of all advanced refractory colorectal cancer patients and will be randomized 2:1 against placebo. XBiotech is expecting patients to be enrolled under the revised protocol as early as October this year."
I joined the trial almost immediately after it reopened and have had one infusion of either the drug or the placebo.
The trial is being run by US Oncology, so has many, many centers where it is available throughout the States (and some in Europe, I believe.)

THE CLINICALTRIALS.GOV ENTRY
https://clinicaltrials.gov/ct2/show/stu ... ocs=Y#locn


In my opinion, this is a kind of turning point for cancer research. The drug was formulated to serve a much ignored population: those of us who have run out of chemo options and are facing QOL issues towards end of life. But also very exciting is that such a tolerable drug is showing that it also extends life -- from what I can tell from the reports, more than the new chemo drugs have done (though that won't be known for sure until the trial process is completed.)

[O Stoma Mia]

Skypup -

Thank you for posting this important information. I think many members will be interested in this, especially in view of the fact that there appear to be very few Grade 3 or Grade 4 side effects reported.

I look forward to any updates you might have in the future.

[Steph20021]

Very cool, thanks for sharing skypup. Hope you are feeling well.

[Jack&KatiesMommy]

SkyPuo
THANK YOU so much for sharing. This sounds so promising for so many of us. I hadn't heard anything about this before. Please keep us posted. I think of you often. Thank you for all that you do for everyone here.
Cynthia

[DK37]

Thank you so much for posting all of this info Skypup!!!

Here are two column/blog posts I wrote about Xilonix a few months ago to try to explain in layman's terms how it is believed to work & with hyperlinks to original data sources. I think both links are different but important in their own ways..

http://fightcolorectalcancer.org/resear ... tion-fire/

http://adventuresinlivingterminallyopti ... tion-fire/

Cheers & thanks again,
-DK

[CRguy]

Indeed, I agree with Tom ... many thanks to you for sharing this info and your own hands-on experience with this new trial.

Best wishes coming your way skypup
Harmony
CRguy

[lpas]

So great to hear from you, Skypup. Thanks for posting this. Sounds like it could be an important step forward.

[ieowi]

thank you for sharing skypup.

[peanut_8]

That's really exciting to see. Thanks for bringing it to our attention.

Hope everything works out for you, and that you're getting the drug and not the placebo.

Best Wishes, peanut

[midlifemom]

Skypup,
Great to hear from you.
I hope you're getting the real deal and that you have fantastic results.

I get ct scan results tomorrow morning and am in an absolute panic that life as I know it will come crashing down tomorrow. (Ct from last week ER visit showed my "multiple" mets in lungs have increased to "innumerable". Tho there is still a slight chance it's pneumonia not cancer. Anyway,,,, the reason for my saga is your post has given me hope that something else is available if I find that previous and current regimens have truly failed. Thanks so much.

[Ajane]

Thanks for posting, Skypup. Think of you of often and will continue to keep you in my thoughts and prayers. Jane

[Badass]

Hi Skypup,
Thank you for sharing these encouraging findings. I hope you got the Xilonix and are feeling better.

Jane

[vilca11]

Dear Theresa, our sweet Puppy, I am so happy that you are in this trial! I happened to believe in this trial from their mid stage, when Maya informed us about it first time - I think, it is the only good one to consider on today's clinical trial scene... I so hope that you get the drug, not the placebo... I tried to send a PM to you, but you have no "contact" now, I have been thinking about you...
Please do let us know how you feel... Love, Vilca