Positive Results for FTY720 - MS Oral Drug!

I got this update in an email today. It's also available from the NMSS site. It's exciting to see the results going so well!

Sep 30, 2009
Positive Results Announced from Phase 3 Trial of Fingolimod Pills in Relapsing MS
Novartis International AG announced today that oral FTY720 (fingolimod) was able to significantly reduce relapse rates and slow disability progression over two years in a large-scale, phase 3 trial involving 1,272 people with relapsing-remitting MS. According to a company press release, safety data confirmed a positive benefit-risk profile for the lower of two doses tested, and the company plans to submit applications to drug regulatory agencies for marketing approval of the potential therapy at the end of 2009.
Background: FTY720 binds to a docking site (sphingosine-1-phosphate receptor, or S1P receptor) on immune cells, including T cells and B cells, that have been implicated in causing nervous system damage in MS. The drug appears to induce immune cells to remain in lymph nodes, where they can do little harm, preventing them from migrating into the brain and spinal cord.
Positive results from an earlier phase 2 study led to several large-scale phase 3 trials. Initial positive results from the TRANSFORMS study, comparing two different doses of fingolimod with Avonex® (interferon beta-1a, Biogen Idec) over only one year were presented at the American Academy of Neurology meeting in spring 2009. Adverse side effects seen more often in the fingolimod treatment groups in this trial included temporary reductions in heart rate at the start of therapy, small increases in blood pressure, and a few cases of macular edema (swelling of the back of the eye). Two deaths from herpes infections occurred in the group taking the higher dose of fingolimod, and seven cases of localized skin cancer occurred in the fingolimod groups.
This Study: The FREEDOMS study involved 1,272 people who had had symptoms of relapsing-remitting MS for an average of 8.2 years at the start of the trial. The participants were randomly assigned to one of two different daily oral doses of fingolimod or inactive placebo. The primary endpoint established for the study was the rate of relapse. Other endpoints measured included changes in disability progression, safety and disease activity detected with MRI scanning of the brain.
According to a company press release, results showed that after two years, the drug significantly reduced the annualized relapse rates by 54% (lower dose) and 60% (higher dose) compared with placebo, and reduced progression of disability by 30% (lower dose) and 32% (higher dose) over placebo. In terms of safety, the press release stated that there were no cases of macular edema or melanoma in those taking the lower dose, but further information about these potential adverse events was not provided in these initial results. There were reversible elevations of liver enzymes, lung infections, and mild elevation in blood pressure observed in those on active therapy. Three people died during the trial, one on the higher dose and two on placebo, but these deaths were not thought to be attributable to the therapy. The press release states that future development of FTY720 will focus on the lower dose.
Further details about both benefits and adverse events are expected to be released at an upcoming medical meeting in 2010. Other phase 3 clinical trials of fingolimod, including one involving people with primary progressive MS, are still under way, as are extension studies involving those who’ve completed trials. These should provide additional data on safety and efficacy.
Comment: “This is potentially a breakthrough study, and we look forward to seeing further details when they are available,” said John R. Richert, MD, Executive Vice President of Research and Clinical Programs at the National MS Society. “Having oral therapies in the MS pipeline is real progress, and it should increase the number of people who choose to begin therapy earlier and who stay on therapy, which our experts say is the best way to combat future disease activity.”
Avonex is a registered trademark of Biogen Idec

Doc Day

Ok, I am sick and tired of being sick and tired! And I don't want to keep taking things that might hurt my baby. I've resigned myself to going to the doctor. I'm a bit nervous, because I also want to ask them about getting a flu shot. I've gotta stop coughing all the time. It hurts my body. I know that it's not supposed to be able to hurt the fetus, but I don't want to take any chances... and I want to stop coughing!
Doctor's office, here I come.

Sinus Sickness

I've been sick for a number of days. I'd say since Wednesday night. Wednesday the 16th. So, yes. It's been over 7 days since it started. I was going to get my fluu shots done, but it seems that since I'm since I'm not going to. It wasn't supposed to last this long, urgh. It sucks, but it's getting better every day. It was getting worse, but now I'm better. It's just major drainage. I wasn't able to lay down, I had to sleep sitting up, which is not that comfortable. I was waking up every couple of hourse, and still do, but now it's every four hours, not two. I'm taking all sorts of medicine, yes meds that are okay for preggers. Tylenol and some Sudafed. It was so bad I actually struggled to breathe a little bit without coughing when I was sleeping. I was grinding my teeth to ease the pressure, but that's not good, so I even had to go get a mouth/teeth guard.

New Computer

Yeah! I've got a new computer! I'm so very excited.
But you know me, of course I'm debating if I got the right one. It was between this one, witht he blue-ray player and bigger screen, or the one that was more compact. I'm pretty sure I got the right one, because it's got all the bells and whistels. The only reason I debate the other still is the compactness. I had complained a lot about my last one (which is the same size) being so big and heavy, and thus hard to tote around. And the fact that this one is the same size kind of makes me go... hmmm, maybe I should have gone with the smaller one, except it doesn't have the bells and whistles. So I ask, did I make the right decision?
Yeah, of course I did... right?

Light Headed

On the 9th I fainted... while at work. Today, I started to get spots in front of my eyes again and had to sit down. It got really bad, my eyesight was harsh.
Just an update.
The doctors said it was due to a lack of protein in my diet. But I'm starting to wonder about stuff.

Myself

I haven't been feeling the best about myself lately. I haven't been feeling ill, per-see, just not myself. I can tell I'm not on the manic meds, and I'm noticing a reversion back to who I was, and not that I didn't enjoy being myself. I just feel I've matured since then. Now, though, there's a sense of undoing. I don't want to be on the medication while I'm pregnant, so I'm just having to keep a closer eye on myself. It's an odd concept, and I'm not sure many others understand. It's hard to explain. There's two sides of me battling for the rights over who gets to control me. Just imagine the little devil and angel on each sholder. That's what it's like.