Ocrelizumab

[DPL2014]

I just got home from my neurologist appointment at Rush University in Chicago and I'm so excited I just had to come and write. My doctor calls Ocrelizumab a "game changer" in MS treatment. He says it should be available by 2017. What do you guys know? I've done a little research and it's very exciting. NO side effects and up to 96% reduction in relapses????? Wowza. Where do I sign up?!

[JerryD]

Hi and Happy New Year, DPL2014. I found out about this drug a few months ago after reading about it in a NMSS magazine. Then, I started to investigate. I saw that it had been through phase 1 and 2 clinical trials named OPERA I and OPERA II. Then it was going to phase III trials in Basel, Switzerland. Then, I found out that the OPRA trials were conducted in other foreign countries, as well. So I put in a call to my neurologist. He said that if I can find the trial site, nearby, (meaning in the U.S.,), he would be glad to work on getting me in. I , then, contacted the NMSS and asked why there was no coverage in ANY of their publications about these trials, you know the number of participants, the negative side effects, etc.
There isn't ANY word about Dr. Burt's clinical trials on HSCT, either! He has been doing these Stem cell procedures for about 10 years. I'll bet you never heard about them, not from our advocates, the NMSS ! I am sick to death of this disease and the subversive culture that has grown up around it ! I hope this year will show some changes in MonSter eradication ! Happy New Year !

[DPL2014]

Hi and Happy New Year, DPL2014. I found out about this drug a few months ago after reading about it in a NMSS magazine. Then, I started to investigate. I saw that it had been through phase 1 and 2 clinical trials named OPERA I and OPERA II. Then it was going to phase III trials in Basel, Switzerland. Then, I found out that the OPRA trials were conducted in other foreign countries, as well. So I put in a call to my neurologist. He said that if I can find the trial site, nearby, (meaning in the U.S.,), he would be glad to work on getting me in. I , then, contacted the NMSS and asked why there was no coverage in ANY of their publications about these trials, you know the number of participants, the negative side effects, etc.
There isn't ANY word about Dr. Burt's clinical trials on HSCT, either! He has been doing these Stem cell procedures for about 10 years. I'll bet you never heard about them, not from our advocates, the NMSS ! I am sick to death of this disease and the subversive culture that has grown up around it ! I hope this year will show some changes in MonSter eradication ! Happy New Year !

Happy New Year, Jerry!!! I heard about Dr. Burt's trials during my own research, but you're right, the NMSS hasn't said anything. I don't get it. Makes me so sad and frustrated. They're talking about Ocrelizumab overseas a lot....but not here, even though it will soon be available to us all. Are you part of the trial? I wonder why not much is being said about Ocrelizumab here on MSWorld? Part of me thinks people are just jaded from all the talk of "miracle drugs" and "potential cures". The only reason I'm excited about this one is because my neurologist is excited about it. The other "potential breakthroughs" I've asked him about didn't phase him one bit (High dose Biotin, Vitamin D, etc). He is convinced that Ocrelizumab is the real deal.

[JerryD]

Happy New Year, right back to you, DPL2014 ! Thanks for responding . So many people on this board don't bother ! And that's annoying !
So, getting to the point, what's the deal with the NMSS ? And all of the other unanswered questions that abound ?
There has been a stem cell replacement trial going on at Tisch MS center of NYU since August or September of this year, or whatever , conducted by Dr. Saud Sadiq, a notable neurologist. There has been no mention of the progress of the trials in NMSS publications ! So all of this stuff is like 'ghost' stuff! I'm sick of it and I want truthful information that is relevant. I don't think that's too much to expect !

[DPL2014]

Well I dont know how we can get notifications when people have responded to our posts? I only know because I checked back again today. I'll always respond if I know about it. 😊

Do you follow Wheelchair Kamikaze? He talks about Tisch a lot!

[JerryD]

Yes, I occasionally read the blog. I also read Richard Cohen's blog. He is the husband of Meredith Viera, the talk show host and news correspondent. They are both patients of Dr. Sadiq. No mention from NMSS ! Disappointing !!

[hunterd]

try looking here, http://www.mymsaa.org/
just type in the drug in the search

[deb2238]

Hi. We're y'all able to find out any news on ocrelizumab in your cities. I just took my first infusion of the medicine on February 1 go back on 15 for second dose. No side effects so far.

[Marco]

It's doubtful that Ocrelizumab will be available in 2016, and I do not want to wait so I am pushing for Rituximab! I hope to be on Rituximab in the next few months. The two medications have many similarities and Ocrelizumab could be called Rituximab 2.0. Many believe that Ocrelizumab was a necessary invention for patent protection purposes considering Rituximab's patent protection was already set to expire. This would be quite similar to provigil, nuvigil or Copaxone and Copaxone-40. I could then swithc to Ocrelizumab when it became available or stay on Rituximab provided I responded well to it.

[J-Bo]

Conflicting info?

During my appointment at a very well-known, research-oriented MS center last Friday, I was told that there is a fairly good chance that Ocrelizumab could be approved as soon as June of this year. I can't imagine that the doctor who told me this is uninformed about FDA-approval and all of that, but on the other hand, this does seem pretty fast track. I do recall, however, and just now went back to verify that Marc of Wheelchair Kamikaze fame had said a while back with regard to Ocrelizumab, that:

"Roche is targeting the first quarter of 2016 for regulatory approval in both RRMS and PPMS."

So that's two sources who I respect and pretty much expect to know what they're talking about. So I wonder, could it truly be so?

Even if it is, the numbers aren't fantastic, but given what we've been offered up until now, this drug and high dose biotin are looking a lot better than the big, fat goose egg we have for treatment now. I'm already taking 200 mg biotin, and will make sure I'm in line for Ocrelizumab if that comes online any time soon.

At the bottom of their Ocrelizumab article, they did offer this contact info if anyone wanted to ask what it means: For more information or to speak with a trained Client Services Specialist, please call MSAA's Helpline at (800) 532-7667, extension 154. Questions to MSAA's Client Services department may also be emailed to MSquestions@mymsaa.org.

[deb2238]

Hi. We're y'all able to find out any news on ocrelizumab in your cities. I just took my first infusion of the medicine on February 1 go back on 15 for second dose. No side effects so far.

Had 2nd treatment today. No side effects. Yay!!!

[Marco]

J-Bo,
I am not claiming to know more than your stellar neurologist or Marc. I was just stating my opinion and here's my rationale:

1. Unless I missed something, Roche has not submitted Ocrelizumab to the FDA
   
2. The FDA has already stated they would hasten the approval process, but it's the government in an election year
3. After approved, Roche will need to get marketing materials done, ramp up production, train infusion centers, patient assistance programs put in place
   
4. Insurance companies will need to add Ocrelizumab to formularies. Some insurance companies update monthly and others quarterly so some patients will be able to get on it sooner.
   
5. Patients will need to get into their neurologists, medication ordered, any wash-out periods completed
   
6. Whatever delays I missed ....

So even if Ocrelizumab is approved, I do not believe it will be readily available this year. I hope that I am wrong, but these approvals normally take a bit longer than any of us want.

I wish you well!

[JerryD]

My neurologist says that Ocrelizumab is a reformulation of Rituxan (Rituximab) which was previously on the market. He says that he doesn't have much faith in the drug. But who knows, maybe this will be the 'holy grail' ! I could surely use some help !

[Marco]

My neurologist says that Ocrelizumab is a reformulation of Rituxan (Rituximab) which was previously on the market. He says that he doesn't have much faith in the drug. But who knows, maybe this will be the 'holy grail' ! I could surely use some help !

It wasn't worth spending the money on trials for Rituximab because the patent is expiring. Enter Ocrelizumab with full patent-protection and the near identical method of operation. Ocrelizumab won't be the holy grail, but it will help a decent amount of patients that previously had no progressive option. I hope to be Rituximab-infused by April, but still butting heads with my neurologist.

[KoKo]

My neurologist says that Ocrelizumab is a reformulation of Rituxan (Rituximab) which was previously on the market. He says that he doesn't have much faith in the drug. But who knows, maybe this will be the 'holy grail' ! I could surely use some help !

In the Olympus Trial (Rituximab trial for patients with PPMS), there were negative results for halting progression.

But there was a suggestion of a potential decrease in progression in younger patients with PPMS (younger than 51 yrs old), especially in those with inflammatory lesions.

So if Rituximab = Ocrelizumab for PPMS, then for me (older than 51 and no inflammatory lesions), I will hold off my excitement until the final Ocrelizumab results for PPMS.