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.

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

What is HLA ?

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.

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