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FDA stopping shipments of TSO
The FDA has issued an Import Alert (IA 57-21) for TSO, effectively stopping its importation into the U.S until an IND (Investigational New Drug) application is filed. The import alert is based on one article and a follow-up article that cite concerns about TSO, but which ignore the safety data from the Crohn’s and UC studies. The error in these articles are pointed out in a reply from the authors of the Crohn’s studies. In addition, the FDA cites concerns over the possible contamination of the agent or the accompanying solution, evidently not aware that the manufacturer of TSO (Ovamed GmbH) obtained a GMP (Good Manufacturing Process) designation from the national regulatory agencies in the European Union.
An IND is being put together for a planned upcoming trial of TSO in Multiple Sclerosis. The IND should be filed before the end of the year. Once the IND is filed and TSO has investigational new drug status the FDA should lift this Import Alert.
Comments
By D Clayman MD on 2007 11 19
How can we follow the progress of the IND?
By SJohnson on 2007 11 20
I am trying to determine this now. I should know more in a couple of days, after I’ve spoken directly to the doctor doing the MS trial.
By SJohnson on 2007 11 21
It is my understanding that the IND will be filed next week, and that the FDA review will take 30 days. The FDA import alert should be lifted sometime in January. I should be able to find out when the IND has actually been submitted; I will post on this site. Regards, Stewart
By D Clayman MD on 2007 11 21
Would it be helpful to contact our Representatives or Senators in this matter?
By SJohnson on 2007 11 21
I doubt it. The FDA is really not doing anything unusual here; the whole purpose of an Investigational New Drug application is to allow studies and clinical trials of new drugs or biologicals. No one involved in this process thinks that the FDA will shut this down - just the opposite. I think they will move forward quickly as soon as they have reviewed the IND application. When they carefully examine the safety record of TSO they will see no reason to prevent its use for serious disorders like MS, autism, etc.
By D Clayman MD on 2007 11 22
What is happening with the autism trial and funding?
By SJohnson on 2007 11 27
We filed an NIH-CAM grant application for a 50 person double blind placebo controlled study back in February. The first filing was rejected; we are in the process of responding to the reviewers concerns, which we believe are easily addressed. The application will be re-filed shortly. We are also pursuing other potential sources of funding simultaneously.
By Monica on 2007 11 29
Hi Stewart,
just wanted to say my son took his first 2500 dose this morning so we are all excited and of course anxious to see how the next 2 months go everyone please keep your fingers crossed I will keep you all posted Monica