New MS Drug / Dirucotide?
 

http://www.fiercebiotech.com/press-r...rucotide-mbp82


Has anyone heard of this drug? My son's girlfriend sent me an email about it.

No I haven't Kelly, but I'm always open to learning about new treatments.

Thank you for the link. :hug:

Kelly, no I have not heard of this study or drug. Sounds very interesting, and from what i think I read, its nearing its final phase in testing. Thanks for sharing this, like Anne said I am also always up for reading about a new treatment

It is MBP8298, this is probably the article referenced: http://www.medicalnewstoday.com/articles/118192.php The Maestro-02, Phase II/III study in Europe and Canada seems to have been successful.

I've heard of it. It's a synthetic make of 17 pepitdes mimicking mylein make-up. I follow the phase III trials with interest

Correction- 17 Amino acids to make up a peptide.

There's quite a bit of information about it on this site:

http://www.msrc.co.uk/index.cfm?fuse...ow&pageid=1308

"Kenneth Warren, M.D., director of the MS Clinic in Edmonton, and Ingrid Catz, M.Sc., researcher at the University of Alberta, have developed a synthetic segment of myelin basic protein called MBP8298. The researchers have been involved in the development of MBP8298 for more than 20 years. The investigators have given the product to approximately 100 people over the past 10 years in both Phase I and Phase II clinical studies. They report that of 41 people with progressive MS, 61% went into remission as measured by antibody levels in spinal fluid. The investigators report there are no clinically relevant side effects in those who have been given MBP8298 to date."

http://www.mssociety.ca/en/research/...date-dec04.htm

From info I've read/discussions I've seen:

The mode of action is apparently similar to Copaxone, but it is given via IV once every six months, and is considered very safe compared to many drugs we take.

It is thought to work by inducing immune tolerance, much like an allergy shot, i.e. "flood the body with the antigen (in this case a self-antigen, i.e. myelin) and the immune system learns to ignore it."

The drug seems to effective in those of us with HLA-DR2 or HLA-DR4 genes, but apparently about 75% of us carry this genetic type.

Cherie

IV once every 6 months? Very nice. Let's hope it continues to show such promise :)

A twice a year medication with no relevant side effects?

*standing in line early*

Apparently one of the main two intial researchers has a wife with MS. He had a vested interest. :)

The best part is if it works this well on PPMS and SPMS . . . what is the potential for RRMS?

Cherie

No kidding Cherie! Jim has been banned from any and all new therapies due to a bad reaction five years ago. He was on a chemo IV treatment and went into kidney failure exactly one month later. They have said any new therapies that have the potential to lower his immune system is off limits. He's been stuck rotating Avonex, Beta and Copax since then. He's currently on Beta and has muscle tightness and hot flashes with it but they are tolerable.

This new treatment, if it's as potentially safe as the shots, could be just what would work! And it's for SPMS and PPMS!!!!!!! Your right that if it works well for those with more progressive forms of ms, imagine what it can do for RRMS!

Any idea when this could actually become available?

Cheryl is probaly more up on clinical trials going on, but this is what I've read (on that first link I provided):

As of Aug 1/08 . . .

"BioMS Medical Corp. announced that it has completed patient recruitment in its phase III clinical trial of MBP8298 (dirucotide) for the treatment of secondary progressive MS (SPMS). The trial, named MAESTRO-03, includes approximately 510 patients, and is being conducted at 68 trial sites in the U.S."

(They've been recruiting since June/07, which isn't long...)

"MBP8298 (dirucotide) is currently being developed in three late-stage clinical trials:

1. MAESTRO-01: A pivotal phase II/III trial for secondary progressive MS (SPMS) patients in Canada and Europe.

2. MAESTRO-03: A pivotal phase III trial for SPMS patients in the United States.

3. MINDSET-01: A phase II trial for relapsing-remitting MS (RRMS) patients in Europe.

About MAESTRO-03

The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study that has completed recruitment of approximately 510 patients at 68 clinical sites who will be administered either MBP8298 (dirucotide) or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive)."

Tysabri was fast-tracked before the completion of the Phase III trials, so perhaps this treatment could be available in 1 - 2 yrs. :confused:

Cherie

That would be wonderful! :)

Another thing that is really exciting about this treatment, is the PRIMARY ENDPOINT will be measured by disability progression, not number of relapses and/or enhancing lesions. That means this might significantly impact the overall disease process, unlike the CRABs and Tysabri which focus their success mostly on the inflammatory process (a more transient measure of the disease).

Cherie

The most basic definition is that they are markers that identify cells as friendly and prevent the immune system from attacking them.

Many times you'll hear about HLA when someone is needing a bone marrow and are tested against others to identify a match. The same principle applies in that when someone is given a bone marrow transplant, the old immune system is rebooted with the "good" bone marrow.

The HLA-DR2 and/or HLA-DR4 immune response genes are seen in some with MS and may be linked to other diseases such as Diabetes. I don't know the medical background or the exact reasoning behind these genes but suspect it has something to do with how ms or other diseases are linked to them. It gets confusing and maybe someone else will come in to shed a better light on it.

A friend of mine was in an early trial of MBP8298 (dirucotide), and has been receiving the treatment since then. She has had significant improvement in pain, stamina, walking and bladder control with no progression since her first treatment in 2000.

Her neurologist is Dr. Warren, who, along with Ingrid Catz, developed this treatment. Clifford Giese, whose wife Robin has MS, and his brother Kevin, provided the financing and marketing through BioMS Medical Corp. BioMS has since partnered with Eli Lilly.

The researchers feel that since it works on SPMS, there is no reason that it shouldn't work on RRMS since one is a progression of the other. So far it hasn't been tried on PPMS.

If anyone has any questions I can run them by my friend or even put you in touch with her. She doesn't come online but loves talking about her results!

C

Carol, can you ask if they think this drug works on those who are already in a wheelchair? My hubby is considered a quad but does have limited use of his arms, not the legs. He still feels pain and touch in his legs and is able to move around comfortably in his power chair. Would this new drug potentially stop progression in someone that far advanced?

I'm about to do a "Happy MS Dance" in this thread. :D

Good news all around. Crossing my fingers on this one!

Sandy,

The drug works at any level of progression but I believe its main mechanism is stopping progression allowing your body to repair as much as it can. Judy regained a lot of function but still has some deficits. I think the pain relief and getting rid of fatigue were the biggest benefits for her. Regaining bladder control and improving her walking were bonuses.

A man she knows had been in a wheelchair and did manage to walk again but that won't be the same for everyone. One woman was in a hospital bed in the fetal position and regained the use of her arm and was able to be in a wheelchair.

I'm not on any DMD's and have high hopes for this being my drug of choice in the future. Only twice a year and no side effects means a lot when you're a drug and needle-a-phobic!

Carol

Definitely paints the picture of a drug of extreme convenience. Perhaps too this would eventually lessen the number of necessary trips to our neurologists as well :) While we've been hoping on a pill, of course that requires regular routine. This would improve the quality of life for MS'ers so significantly.

Dmplaura, happy dance!!!!!! :Dancing-Chilli::Dancing-Chilli::Dancing-Chilli::Dancing-Chilli:

Carol, thanks for the info. I usually don't get too excited about new drugs in the market but this one does have me a bit tingly, in a good way! :Head-Spin:

Wow, I can't believe I'd never heard of this treatment. It sounds like a miracle! Especially the twice a year thing.....can't get much more convenient than that.

I'm going to keep on researching this drug. Hopefully a trial will be available here in the states before too long.

Kitty, it is already here! In it's third stage!

:Doh: Why did I think that it was in Canada? :confused: I need to read the article again!!! See....I need something for my cognitive health!! :o

Cherie posted a few tidbits in this thread so you don't have to go re-read it. :hug:

I hope it works, because I'm getting so tired of the nightly stab of Copaxone that I've been slacking off a lot the past few weeks.

If all I had to do was go and get an IV two or three times a year, I'd switch to that.

I told Jim about this today and he's all ready to get his first infusion! :p

The beta is messing with his muscles big time. :(

I'm doing the happy dance with you all. Why that's the best news I've heard in a long time or ever. I'll definitely be waiting impatiently.
:Dancing-Chilli: :Dancing-Chilli:

Because the Phase II/III study is happening in Canada and Europe for SPMS as well as another study for SPMS in the States. I have been asked by my MS clinic if I would be willing to consider entering this trial. I said yes, but I have a series of tests/ assessments this upcoming month. I'm not really in a position to receive a placebo. If I find out more, I'll let everyone know.

I don't even know if I'm a carrier of the HLA markers required.

weeble, good luck with your decision hun. Much respect! :hug:

I am going to ask Jim's spinal cord doctor to look and see if Jim ever had the HLA test. We don't remember because it's been so long ago, 20 years.

I could probably do this trial too, but my neuro has given up on trying to recruit me as a guinea pig. I suppose if I could stay on LDN at the same time (she has always promised I could do that, no matter what trial she's tried to talk me into), then I might consider this particular one.

They like drug virgins, and since I don't intend to take anything else anyway, maybe this would be a good option for me.

Could you please let me know what you find out; where the trial center is, lead researcher in BC, trial criteria, etc. if they give you the documentation on it?

Thanks!

Will do. Next drug treatment plan will come after my next MRI Wed Sept 3rd.

I'd do the IV every day if it would stop my progression right where it is for the rest of my life.

This really sounds very pomising for all of you/us. Why is it always two to 5 years off.:confused:

I'm too old for trials, but too young to not, still, have hope.:) Bring it on!!!! :cool:

Keep us tuned, Kelly..:hug:

That's right Sally! Sounds like everyone will possibly benefit from this drug.

Sally, I love this positive attitude!

Multiple Sclerosis drug dirucotide (MBP8298) receives fast track designation from FDA


BioMS Medical Corp. announced that the Food and Drug Administration (FDA) of the United States has granted fast track designation for the Company's lead drug, dirucotide (MBP8298), for the treatment of secondary progressive MS (SPMS). Dirucotide (MBP8298) is currently being evaluated in a U.S. pivotal phase III trial, named MAESTRO-03, at 68 sites with approximately 510 patients.

Fast track designation is an FDA status reserved for products that are intended to treat a serious or life-threatening condition and that demonstrate the potential to address unmet medical needs for that condition. Fast track designation can potentially facilitate development and expedite the review process.

"Our receipt of fast track designation for dirucotide in the U.S. is a significant milestone for both BioMS Medical and the MS community," said Kevin Giese, President and CEO of BioMS Medical. "Based on previous clinical results, we believe dirucotide is well-positioned to become a first-in-class treatment for secondary progressive MS patients, a large patient population with very limited treatment options."

Source: BioMS Medical Corp. (04/09/08)

http://www.msrc.co.uk/index.cfm?fuse...ow&pageid=1308

The Trials are closed, fully subscribed by patients and Doctors. I believe the Canadian/European trial is finished. I believe Fast Track is what Tysabri got.