has anyone else heard of ONO-4641?

[soshime]

Here's a link from drugs.com:
http://www.drugs.com/clinical_trials...nts-13353.html

It's supposed to work differently than other meds out there right now by keeping lymphocytes trapped, but they won't get their next phase of testing done until 2014 (I think it's phase III), so it'll be a while before we hear more talk about it. There's a link on the gov't clinical trials for it, but trials are by invite-only (fancy!):

http://clinicaltrials.gov/ct2/show/NCT01226745


Just wondering if anyone's herd anything from their neuros at all, or done any research and dug something up. Adverse events: "appeared to be generally dose related. Of note was a slower heartbeat and atrioventricular blocks associated with the initiation of treatment, which were asymptomatic, transient and did not require ONO-4641 discontinuation. Other notable adverse events included liver enzyme elevations. In addition, Grade 4 lymphopenia, which is an abnormally low level of lymphocytes in the blood, occurred in 4 percent of patients receiving the 0.15 mg dose of ONO-4641 and in 1 percent of those receiving the 0.10 mg dose".

I guess the neuros will be talking about it (and other stuff!) this week @ the American Academy of Neurology’s 64th Annual Meeting. Fingers crossed, all!

[sugarcookie]

i have actually just heard of this medication and i was under the impression that they are accepting trial subjects.

i plan on talking to my dr to see what she knows about this and what her opinion is for me using this, as my only other option at this time is waiting out campath.

p.s. we know each other irl so if you talk to the dr before me i'd love to hear what she has to say about it.

<3 bubbles

[agate]

It was written up in the MS Foundation's newsletters, MSFYi, May 1:

Another Oral Drug Shows Promise in Trial


A study of an experimental oral drug called ONO-4641 reduced the number of lesions in people with relapsing-remitting MS by as much as 92 percent, Colorado researchers have reported. However, the drug must undergo a larger clinical trial before it can be submitted for FDA approval for general use.

ONO-4641, developed by Ono Pharmaceutical Co. Ltd. of Osaka, Japan, works differently than existing MS drugs. It traps destructive lymphocytes (white blood cells) in the lymph nodes, preventing them from reaching myelin and damaging it.

Dr. Timothy Vollmer and his colleagues at the University of Colorado in Denver studied 407 adults with relapsing-remitting MS, giving them one of three different diseases of the drug daily for 26 weeks. All of them had had either two relapses in the previous two years or at least one in the year prior to the onset of the study.

Vollmer reported at a New Orleans meeting of the American Academy of Neurology that 92 percent of participants receiving the most-effective dose of the drug, 0.1 mg, had 92 percent fewer lesions at the end of the study as measured by a MRI.

Side effects included slower heartbeat, blood pressure changes, and a block in electrical conduction between the atria and ventricles of the heart. About 1 percent of the people receiving the most-effective dose developed abnormally low levels of lymphocytes in the blood.

Merck KGaA has the license to develop the medicine globally, excluding Japan, South Korea, and Taiwan.

[Cherrymom]

Ono trials

I have been in the Ono trial for almost 2 years. I feel like I have been doing pretty good. I have had a couple relapses but good recovery. No major side effects - headaches the first few weeks and a slower heartbeat. we are just about to phase 3 which will allow my neuro to see my MRIs and then we will decide whether to continue or not. I love the "no needle"

[CougarMama]

I've been reading up on this med and it appears to function in a very similar way to Gilenya. (even the side effects are similiar). I've seen the article posted below but another review that was done of all of the meds in the MS pipeline listed ONO, Gilenya and a third drug as having similar modes of action. What would be great is if it is as effective as Gilenya without the side effects!