Niclosamide phase 1 b trial showing m... - Advanced Prostate...

Advanced Prostate Cancer

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Niclosamide phase 1 b trial showing more promise for CRPC than phase 1 trial

Graham49 profile image
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It might also be of interest that a clinical trial is being funded to investigate whether the tapeworm drug Niclosamide can prevent Covid-19 causing serious illness in high risk kidney patients. Source Kidney Research UK.

Open Access

Published: 18 March 2021

Phase Ib trial of reformulated niclosamide with abiraterone/prednisone in men with castration-resistant prostate cancer

Mama Parikh, Chengfei Liu, Chun-Yi Wu, Christopher P. Evans, Marc Dall’Era, Daniel Robles, Primo N. Lara, Neeraj Agarwal, Allen C. Gao & Chong-Xian Pan

Scientific Reports volume 11, Article number: 6377 (2021) Cite this article

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Abstract

Niclosamide has preclinical activity against a wide range of cancers. In prostate cancer, it inhibits androgen receptor variant 7 and synergizes with abiraterone. The approved niclosamide formulation has poor oral bioavailability. The primary objective of this phase Ib trial was to identify a maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of a novel reformulated orally-bioavailable niclosamide/PDMX1001 in combination with abiraterone and prednisone in men with castration-resistant prostate cancer (CRPC). Eligible patients had progressing CRPC, adequate end-organ function, and no prior treatment with abiraterone or ketoconazole. Patients were treated with escalating doses of niclosamide/PDMX1001 and standard doses of abiraterone and prednisone. Peak and trough niclosamide plasma levels were measured. Common Terminology Criteria for Adverse Events (CTCAE) v4.0 and Prostate Cancer Working Group 2 criteria were used to evaluate toxicities and responses. Nine patients with metastatic CRPC were accrued, with no dose-limiting toxicities observed at all dose levels. The recommended Phase II dose of niclosamide/PDMX1001 was 1200 mg orally (PO) three times daily plus abiraterone 1000 mg PO once daily and prednisone 5 mg PO twice daily. Trough and peak niclosamide concentrations exceeded the therapeutic threshold of > 0.2 µM. The combination was well tolerated with most frequent adverse effects of diarrhea. Five out of eight evaluable patients achieved a PSA response; two achieved undetectable PSA and radiographic response. A novel niclosamide/PDMX1001 reformulation achieved targeted plasma levels when combined with abiraterone and prednisone, and was well tolerated. Further study of niclosamide/PDMX1001 with this combination is warranted.

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Graham49
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tango65 profile image
tango65

Thanks for posting.

Link to the full article:

ncbi.nlm.nih.gov/pmc/articl...

MateoBeach profile image
MateoBeach

Niclosamide is very interesting. Also as a Zinc iontophore. As for this study:

1. That is a wholloping big dose of it.

2. They were abiraterone naive and started on that at the same time. So the clinical response might have been entirely from abiraterone possibly.

3. You can get topical niclosamide very inexpensively now combined with hydrocortisone for eczema. That is what I use 2-3 times per week after bathing. (Much lower dose however.)

Would prefer a Phase In with niclosamide alone. Then a randomized with and without the abiraterone.

Kevinski65 profile image
Kevinski65 in reply toMateoBeach

I bought NICLOSAMIDE for cats, 2 boxes. I still see them on the shelf. I was afraid I would sprout claws.

MateoBeach profile image
MateoBeach in reply toKevinski65

Where did you buy it? I see the veterinary formulations. Niclomax is 75% niclosamide. So that would provide access to a sufficient concentration as used in the early trials to overcome AV-7 and enzalutamide resistance. They used 1600 mg three times daily (!) but had no side effects and continued enzalutamide which overcame the resistance. Are you enzalutamide resistant? Claws could be cool.

Kevinski65 profile image
Kevinski65 in reply toMateoBeach

Not yet, but might try if Xtandi started to fade. You're risking things. I've read it's well tolerated but some say it makes you puke. That might scare u...

j-o-h-n profile image
j-o-h-n

My plan is to disconnect my kitchen sink , chop it up to granular size pieces and swallow some each day with a glass of water. This way I can tell my doctor I took every med there is including the kitchen sink..... I betcha he'll be impressed..... The sink needs replacing anyway....

Good Luck, Good Health and Good Humor.

j-o-h-n Sunday 04/18/2021 2:05 PM DST

Graham49 profile image
Graham49 in reply toj-o-h-n

I haven't seen any clinical trials on kitchen sink extract.

in reply toj-o-h-n

How old is the sink?...if it's real old, it might be made of zinc. In that case, be careful of a zinc overdose.

j-o-h-n profile image
j-o-h-n in reply to

Yes, too much zinc before you go swimming may make you sink (I think)......

(As we once agreed "thank God we are not next door neighbors")....

Good Luck, Good Health and Good Humor.

j-o-h-n Monday 04/19/2021 8:38 PM DST

monte1111 profile image
monte1111 in reply toj-o-h-n

Reading Dr. Seuss lately?

j-o-h-n profile image
j-o-h-n in reply tomonte1111

I'd rather hang loose from a knotted noose then read Dr. Seuss known to abuse a lonely goose riding in the caboose.

And btw.... he was a racist..........

Good Luck, Good Health and Good Humor.

j-o-h-n Monday 04/19/2021 9:53 PM DST

in reply toj-o-h-n

And your caboose is bustin loose and you can blame Dr Suess for spilling juice.

j-o-h-n profile image
j-o-h-n in reply to

Ok TomTom no more Barnum just hit bottom can't responsum so sholom....

p.s. I just realized that Dr. Suess is not a racist....... I am....

Good Luck, Good Health and Good Humor.

j-o-h-n Tuesday 04/20/2021 1:09 PM DST

in reply toj-o-h-n

You have me confused with an ex neighbor.

j-o-h-n profile image
j-o-h-n in reply to

I think so....... His ID was MotMot1111.....

Good Luck, Good Health and Good Humor.

j-o-h-n Tuesday 04/20/2021 1:12 PM DST

in reply toj-o-h-n

Not Monte1111?...It would explain some things.

j-o-h-n profile image
j-o-h-n in reply to

No he's still 3 card............

Good Luck, Good Health and Good Humor.

j-o-h-n Tuesday 04/20/2021 6:43 PM DST

in reply toj-o-h-n

I use to be known as 5 card...

in reply to

Now my friends call me Go Fish

j-o-h-n profile image
j-o-h-n

Harder to get Plumbers than Doctors..... Plus they charge more..........

Good Luck, Good Health and Good Humor.

j-o-h-n Monday 04/19/2021 12:49 PM DST

in reply toj-o-h-n

The urologist that implanted tubes into my kidneys told me” We ‘re just plumbers”, also “ this isn’t our fault , so don’t sue us”! we know how important the plumbing is now . I’m pretty sure the uro surgeons makes much more than a union plumber . 😷

j-o-h-n profile image
j-o-h-n

You're forgetting overtime pay....and "stuff" they take for free.....

Good Luck, Good Health and Good Humor.

j-o-h-n Tuesday 04/20/2021 12:50 PM DST

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