As of this morning I am Oh-ficially a guinea pig in the name of science. Yesterday was the last of the baseline data collection and when I left the doctor's office I was toting my experimental meds, the first of which I took about an hour ago.

The process of getting here has been long and bumpy, in large part because this is a new study, I am in fact the very first person involved (at least here in the states, the overseas trial locations might have gotten going already, I'm not sure). Consequently everything has been new and the poor study coordinator has been run ragged. This is also her first time running a study so she's been learning on the job. On the other hand she is quite cute and very nice, so it hasn't been all bad.

What I'm taking is a compund called BG12:

Fumapharm AG has developed a second-generation fumarate (fumaric acid) derivative, BG 12 [BG 00012, FAG-201, BG 12/Oral Fumarate], for the oral treatment of psoriasis. Biogen Idec is currently evaluating the product in clinical trials as an oral treatment for multiple sclerosis (phase II) and psoriasis (phase III) trials.BG 12 has an immunomodulatory mechanism of action. It seems that this product has been developed to reduce the adverse effects associated with a first-generation product containing fumaric acid esters (mixed dimethylfumarate and monoethylfumarate salts), Fumaderm. Fumaderm was approved in Germany in August 1994 and is currently the leading oral systemic therapy for moderate-to-severe psoriasis in Germany. One of the problems associated with Fumaderm capsules has been its gastrointestinal adverse effects (including diarrhoea and nausea). In September 2003, Biogen (now Biogen Idec) licensed exclusive worldwide rights (excluding Germany) from Fumapharm to develop and market BG 12. Biogen plans to collaborate with Fumapharm to accelerate phase III development for psoriasis and the registration programme worldwide. Financial terms of the agreement were not disclosed. Development plans for BG 12 include other autoimmune and inflammatory disorders, such as multiple sclerosis. In November 2003, Biogen and IDEC Pharmaceuticals merged to form Biogen Idec. Fumapharm completed phase II trials of this second-generation fumarate derivative for psoriasis prior to licensing of the product to Biogen, also with positive results.

That info is slightly out of date. The MS Phase II trial is finished. I'm in the Phase III trial. Look here for an explanation of the various phases. Basically they know the drug has some efficacy, they know it doesn't have obvious serious problems, now they are doing a large (>2000 patients) controlled study to determine exactly how effective it is compared to current medicines.

As it says above BG12 is based on fumaric acid:

in this specific case it is an ester of fumaric acid. An ester involves taking a hydroxide group (OH) off of the end of a molecule and replacing it with an oxygen and an alkly group. In this case the alkyl group added is another fumaric acid, hence this is a bifumaric. It's been a while since I've taken cham but I believe it would look like this:

Fumarics can cause a lot of stomach problems so it's coated in a pill casing that is supposed to dissolve in the intestine and not the stomach. Which is really the good news- it's a pill. All the current MS treatments are injections taken a few times a week.

Now why did I emphasize the word "controlled" above? Because that means there is a placebo group (our control group). In fact there are four groups-
1) one dosage level of BG12
2) a second dosage level of BG12
3) placebo pills
4) Copaxone, a current MS treatment

The point is to determine the efficacy of BG12 in different doses as compared to a well known current medication (Copaxone) as well as to control for the placebo effect (which is a fascinating subject in and of itself, particularly if you have any interest in biofeedback).

It is a double blind study, meaning neither the doctor administering the study nor I have any way of identifying which group is which (except for the Copaxone group, because it is an injection). I am in one of the three pill groups. If I show a decline in health, either because the BG12 is ineffective, or because I'm in the placebo group, then I can drop out of the study and start on a conventional treatment.

Here is a news article about the study.

As of yet, of course, I can't say much about the drug, since I've only taken one dose. More frustrating is that the chaotic nature of MS means it is very hard to make any kind of meaningful observation. I haven't had an event since last July. If I have one next month is that because the drug isn't working or because it was just time? Which is a good reason why such large studies are needed.

For the first six months I go in every four weeks for blood draws, basic physical work up and so on. I'll also be getting frequent MRIs and evaluations by another neurologist who gets no info at all about my medical history and the drug trials so he can approach the evaluations in a neutral way. After six months the schedule relaxes a little. I need to keep careful track of any kinds of symptoms I experience, regardless of how clearly they appear to be unrelated (if I fall and break my foot they want to knee).

None of this is costing me personally, the tab is being picked up for by the company developing the drug. I am also not being paid to participate. I give them my body, I get free meds. I'm cool with that because I have a respect for science, I'd like to contribute to medical advances in dealing with MS, and because the pills are preferable (I would have stayed in the study if I'd been randomized for Copaxone though).

And that's where things stand as of now. I'll probably update info in the future.