From my google alert email yesterday...

I like the news I just posted about fingolimod from the Rocky Moutain MS Center's newsletter...

I don't so much care for this news that broke yesterday on Reuter's:

Patient on Novartis’ MS Drug FTY720 Gets Hemorrhaging Focal Encephalitis

April 14, 2009

Novartis (NVS) is reporting that one of its shining star drugs in development may be in trouble. Doctors in the trial for FTY720, also known as Fingolimod, have reported a case of hemorrhaging focal encephalitis in one patient. The company said the patient concerned was recruited into the study seven months before hospital admission for the reported event, before which no new disease activity had occurred.

Eric Althoff from Novartis commented on the scenario:

“As per normal procedures, this particular case was communicated in a timely fashion to health authorities and study investigators. It is difficult to interpret an isolated case report without the benefit of the full Phase III data set. At this stage, a relationship with FTY720 can neither be excluded nor confirmed.”

FTY720 works as an immunosuppressant, causing lymphopenia by preventing lymphocytes from leaving lymph nodes. The drug has already demonstrated superiority over Biogen’s Avonex and is currently in an ex-US Phase 3 study called FREEDOMS I. The trial is comparing two doses of the drug vs placebo in 1,272 MS patients.

The drug is a potential star because it is given orally (all MS drugs on the market are injection) and has already demonstrated superior efficacy over Avonex. The main concern is safety, safety and safety. Up until now, the known safety issues had been transient heart rate reductions, elevated liver enzymes, skin cancer, infections (there have already been two fatal viral infections) and minor increases in blood pressure. This is the first serious brain inflammation case in the trial which would put concerns about the drug’s safety right up there with Tysabri.

The safety issue might be a positive for Merck’s cladribine which is in a race with NVS to become the first oral MS therapy. Cladribine also had some issues earlier this year when the company reported four patients had died of cancer.

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It's weird. Even though I'm a full-fledged, professional, card-carrying Hypochodriac, the news of the bleeding brain infection (as far as I can figure, that's what Hemmorhaging Focal Encephalitis means) does not stun me into a frozen state of panic whereby I am unable to ingest my daily pill.

On the contrary, I get up and yawn and stretch with eyes still half closed (regardless that it's the crack of 9a.m.) and slug my little capsule down with a swig of decaf. Oblivious to any idea that should be swelling up in my subconscious that my brain may get infected and bleed.

I just can't seem to muster the fear. I guess it's because I tell myself that when complications like this arise, I don't know the full back story and the poor person that had these complications obviously was not well by definition since we all (in these clinical trials) have a MS diagnosis. I feel like since I quit smoking, started eating better and got on this trial, my MS has been whipped into submission and I'm actually quite healthy.

That reminds me of the one time I saw an eye doctor in the study. I forget how it came up, but I replied to whatever the question was with : "other than having MS I'm healthy as a horse."

He just stared at me before bursting out laughing. I, at first, couldn't see the humor, but I guess to someone who doesn't HAVE MS, the diagnosis must seem like the ultimate branding of Incurable Illness. I tend to see it as an annoyance and a Life Obstacle. We all have them. Mine just happens to be MS. That doesn't mean I can't be *otherwise healthy*.

So, while this isn't the greatest news for the clinical trial, I'm not personally freaking out or losing sleep or pausing before tossing back my pill.

Read the packaging insert that comes with your aspirin. Even that stuff can cause death. Everything in life is a gamble. And I'm all in on this hand.

From the Rocky Mountain MS Newsletter

I just received my copy of the Rocky Mountain MS newsletter and the very first article was an update on Fingolimod:

Fingolimod is an oral agent that is now being researched in three Phase III trials. This is the first of a new class of potential MS medications known as "S1P receptor agonists," which work by keeping certain immune cells out of circulation. It does not kill immune cells, but rather "locks" them up in the spleen and lymph nodes, which means that if patients stop the medication, their immune system will be back to normal within a week. The recently reported results of one phase III clinical trial of Fingolimod, TRANSFORMS, has shown that Fingolimod is more effective than interferon beta-1a (Avonex), which is currently a standard of care in the treatment of MS.
The study calculated the annualized relapse rate at one year in patients given one of two varying doses of Fingolimod or an injection of interferon beta-1a. Patients given Fingolimod 0.5 mg exhibited a 52% reduction in relapse compared to those given interferon beta-1a. Those given Fingolimod 1.25 mg also showed a significant reduction in relapses (38%) compared to interferon beta-1a. Both doses met their primary outcome measure – a measurement that is required by the FDA to determine the effectiveness of each study drug – and there was no statistically significant difference seen between the two doses, meaning that the higher dose did not seem to provide greater benefit than the lower dose.
The safety profile of the therapy seen in TRANSFORMS was in line with previous clinical studies. The compound was generally well-tolerated and side-effects included fatigue and headache. However, like with all study drugs there are potential risks. Fingolimod does affect other organs, including the heart, liver and eyes. The therapy suppresses the immune system and there are concerns about the development of potentially serious infections and certain types of cancer, such as skin cancer. There were 7 cases of localized skin cancer lesions seen in the TRANSFORMS study, all of which were successfully removed. The benefit to risk factor of Fingolimod is still being researched and further study on the safety profile needs to be done; more detailed information will likely be released sometime this year.
TRANSFORMS is the first of three clinical trials of Fingolimod. The three different studies collectively will involve more than 3,400 patients from around the world. The two other trials, FREEDOMS and FREEDOMS II, which are both two-year placebo-controlled studies, are underway and results are expected later this year. Novartis, the company that manufactures Fingolimod, expects to send the drug to the FDA for approval at the end of 2009. It is currently unavailable outside of clinical trials.

FYI, I am in the extension phase of the TRANSFORMS trial mentioned above.

Sounds like good news, eh?

Yet another infection

The day after my last entry (March 31) I awoke with a ticklish/scratchy feeling in my throat. Next day I was coughing and had a runny nose. 10 days later I was sitting in the waiting room of my primary care doc hoping to get squeezed into his busy schedule.

I had spent 10 days non-stop coughing. Day and night. I had almost developed 6-pack abs from all the effort, but that was the only redeeming factor in the plight that had seemed destined to become a way of life.

I'm one of these people who believe that "this too shall pass" and tend to wait out things like head colds hoping to rough it through the tough spots. But after 10 days of no sleep and barely being able to take a breath due to the coughing fit that inevitably resulted, I finally relented, suspecting an infection. Head colds don't last 10 days.

Doc saw me, listened to my chest and back, and told me it was Allergic Rhinitis which had become a sinus infection. Coughing was brought about by post nasal drip. (ewww)

I got a 5 day course of Zithromax and a script for some allergy meds, but I opted to take Benadryl instead since I know how that makes me feel. (I'm skeert to take any new meds that might make me feel dopy[er] so I usually tough it out with nothing).

But I tell you what... no cough drop or cough syrup touched my cough in all that time, yet 15 min after I took a half of my kid's melt in your mouth Benadryl strip (a quarter dose for someone my size/age) I was breathing free and my lungs could relax a little. Now 5 days after beginning the antibiotics I am back to being perfectly normal (as a oddball like me can be).

I guess this means I now have Seasonal Allergies? Nobody mentioned it, but what else could it be?

I can't believe it's been this long since I posted anything (sorry) but honestly, my life has become quite boring and Fingolimod isn't making any news.

Don't get me wrong, I'm not taking the fact that I haven't relapsed yet lightly. I still marvel on a daily basis that my body is acting normally and not shorting out.

OMG I just realized it has been TWO YEARS this month since my last relapse!!! Woohoo!! I mentioned it somewhere the other day that I hadn't relapsed in 20 months but it was definitely April of 07, so that means 24 mos. a.k.a. 2 YEARS! It's the longest I have gone since diagnosis. For real. wow.

No news is good news and you can't get much better than that. :-)