ATL1102 UPDATE; FDA Responds
In a recent post I talked about a new MS therapy that is in the works. ATL1102 is said to be as good (if not better) as Tysabri (Natalizumab) and much safer than the therapy that most people fear because of a potentially fatal brain infection called PML (Progressive Multifocal Leukoencephalopathy) that can be caused by Tysabri. This is a bold claim, one that has sparked some interest from me.
I had previously mentioned that Antisense Therapeutics Limited (the creators of ATL1102) were seeking FDA guidance on the submission of ATL1102 for Phase II clinical trials. On October 24th 2014, in a press release, Antisense Therapeutics announced that “the US Food and Drug Administration (FDA) has responded affirmatively to the Company’s plan to submit a U.S. Investigational New Drug (IND) application for initiation of longer term Phase IIb human trials of ATL1102 for the treatment of Multiple Sclerosis (MS)”.
Upon further investigation, it looks like ATL1102 is best tolerated when given by subcutaneous injection once a week. Whether this will change after the phase IIb trial is complete is a question who’s answer we will have to wait for. I have to say, a once a week subcutaneous injection for results projected to be comparable to Tysabri (and possible without the risky side effects) would be really nice. Tysabri is great but what I hate the most about it is having to schedule my life around that one infusion. I need the day off from work, I have to spend a good part of my day getting to the infusion center and sit there for an hour with a needle in my arm, and I can’t leave home for more than three and a half weeks. It was not easy traveling abroad on Tysabri because of this limitation that prevented me from being able to leave the country for the full 3 months my passport allowed me to. If I could have brought my medication with me I may have been able to travel for much longer.
ATL1102 is an antisense inhibiter (where Tysabri is a monoclonal antibody), which basically means ATL1102 can potentially help prevent leukocytes (the white blood cells that make up our immune system) from attacking the CNS. Mild side effects that were reported include flu-like symptoms and injection site reactions. That sounds like a combination of Copaxone and the interferons (Rebif, Avonex, Extavia, and Betaseron) to me but who knows, maybe they were reported in a small percentage of patients or the side effects are easily managed with hot/cold compresses and ibuprofen like the existing medications? For me, personally, if the side effects are easily managed like they were while I was on other treatments, they would be well worth not having to go in every four weeks for an infusion. If there are no risks such as PML that would be even better as that is something I worry about now that I am JCV positive (which means I am at a greater risk of developing PML). I only wonder how the transition from Tysabri to ATL1102 will work, as I am most worried about rebounding after stopping Tysabri. The rebound effect is basically the speeding up of disease activity and the increasing amount of lesions when Tysabri is stopped. So far no medication has shown to prevent a rebound once stopping Tysabri and I have no idea how I (or anyone without a caregiver) could maintain life through this rebound that many patients experience.
With all that being said, one thing is certain; the results of a phase IIb trial will be most anticipated because I for one have many questions that have no answers as of now.
How many specialists did you see before finding "The One"?