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New clinical trial starting (CVC, phase 2)


#1

Great to see lots of research activity in PSC area. I have seen couple of new clinical trial being announced recently. This one was today:

http://www.newson6.com/story/30907229/tobira-therapeutics-announces-initiation-of-program-to-evaluate-cenicriviroc-for-the-treatment-of-primary-sclerosing-cholangitis

SOUTH SAN FRANCISCO, Calif., Jan. 7, 2016 /PRNewswire/ -- Tobira Therapeutics, Inc. (NASDAQ: TBRA), a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis (NASH) and other serious immuno-inflammatory and fibrotic diseases, announced that the U.S. Food and Drug Administration (FDA) and Health Canada have accepted the company's Investigational New Drug (IND) application and Clinical Trial Application (CTA), respectively, for cenicriviroc (CVC) for the treatment of primary sclerosing cholangitis (PSC).

The company plans to initiate a Phase 2 study later in the first quarter of 2016. The single-arm, open label, proof-of-concept clinical trial will evaluate the effects of 24 weeks of treatment with CVC 150 mg in approximately 25 patients with PSC. The primary endpoint will be the change of serum ALP (alkaline phosphatase) levels.

"Acceptance of the IND and CTA is an important step toward our goal of building a platform with cenicriviroc, a compound we believe can address multiple immuno-inflammatory and fibrotic diseases," said Laurent Fischer, M.D., chief executive officer of Tobira. "We believe CVC has promising clinical potential in patients with primary sclerosing cholangitis, and we look forward to the first clinical data in this indication to guide future development in this rare and life-threatening disease, for which no treatments have been approved and may require a liver transplant."


#2

The trial is still recruiting (25 subjects); I have passed the assessment so far and started taking the drug.


#3

Mitch,
Glad to know you were accepted into this trial. Hopefully some good things will come from it to help patients with PSC. I was in another trial for 2 years prior to transplant. One benefit of these trials is all the extra lab work, tests, etc. you get along with participating which I always shared with my hepatologist. I believe it kept an even closer check on the progression of my PSC. Take care.

Mark
Liver Transplant 7-2015 / PSC 2011


#4

Thanks for the update and good luck!
Keep us updated if you hear or learn anything interesting in the trial.

Below is the link to the clinical trial page. It includes also contact info and locations for the study, for those who are interested in joining.
I tried to get into one trial, but didn’t pass the assessment (almost normal LFTs).


#5

That’s awesome! Good luck & hope it works!! Would definitely love to hear updates!


#6

Thanks all for the support. I’m somewhat fortunate as my heptologist is overseeing the local portion of the study. I’ll update any new info if/as I receive it. Also, Mark hope you are healing/responding well to you transplant.


#7

Thanks Mitch, I’m doing great. I feel the best now than I have in 10 years. So blessed for sure!

Mark


#8

I’ve now finished the CVC trial and had encouraging results. My most recent alk Phos levels were ~150-160 (I was around 300 at the start of the trial) and were consistent for the last 3 months, other enzymes were reduced to normal levels (AST >200 and ALT >250 to qualify for the study). My understanding is alk phos is a key indicator for PSC. Here is the link to the study details, https://clinicaltrials.gov/ct2/show/NCT02653625. The results of the study should be provided later in 2017.


#9

Nice. Having the AP numbers reduced like that is excellent news.
I had a chance to participate in a clinical trial for OCA but did not like
the possible side effects. Still regret I did not participate.
Jeff


#10

I was in the CVC trials in 2017. I’ve had PSC for 17 years. Small bile ducts are very scarred and some scarring in larger ducts, moderate fibrosis. Befor the trial alk phos was about 1700. Three months in, it went down to 800. My most recent blood test shows alk. phos at about 800. Also I have had zero cholangitis attacks since the study. Unfortunately a recent ultrasound showed a small area of cirrhosis. My alk phos is still very high but alt and ast and other liver numbers are normal.
My doctor is one of the researchers but because study results aren’t published he doesn’t know the conclusions for all 25 patients. CVC has been studied for NASH and is an effective antifibrotic for NASH. It’s hard to wait knowing there is a promising drug out there.


#11

Hi Jen,
I participated in the study and was informed that it won’t proceed to stage 3 for psc. The results didn’t show definitively that it works for psc, wish I had better news.


#12

I’m sorry to hear that Mitch. I’ve read they are going ahead applying for FDA approval for NASH. Once approved for NASH doctors can prescribe off-label for PSC. But, they need to study more PSC patients before doctors will be willing to do that.