Intended Use: For the treatment of relapsing-remitting MS
Profile of User: Currently, trials of the drug are being done with patients who have been diagnosed with relapsing-remitting MS (RRMS) in last three years, are from 18-45 years old, and have an Expanded Disability Status Scale (EDSS) score of 0-3.5. The trials are taking place in the United States, so most participants are American. If the drug makes it to the marketing stage, it will be aimed at people with RRMS.
What it Is: An autologous vaccine. What this means is that it is a vaccine made from the recipients own blood. Tovaxin consists of the patientÃ’s T-cells (a type of immune cell) that (when one has MS), attacks the nervesÃ’ myelin.
How It Works: Once blood has been taken from the patients, tests are done to find T-cells in the blood that attack myelin. Those T-cells are replicated and are irradiated so they cannot reproduce. Once there are enough replicated T-cells (approximately 45 million), they are injected back into the patient. The body responds to this by producing antibodies that target and eliminate those specific types of T-cells (the oneÃ’s that attack the myelin) throughout the patientÃ’s body. Therefore this vaccine addresses the underlying causes of myelin attack.
History: o In the mid 1990Ã’s Dr. Jingwu Zhang began conducting trials of T-cell vaccines in Belgium. o Shortly after, Dr. Zhang was recruited by the Baylor College of Medicine in Houston Texas and in the late 1990Ã’s began a clinical trial involving 114 R-RMS patients. o In 2001, Baylor gave exclusive license to Opexa Pharmaceuticals (a company that was formed around this license), to further develop the T-cell therapy. Opexa began more clinical trials. o On November 9, 2004, Opexa is bought by PharmaFrontiers. o On September 30, 2005, PharmaFrontiers presents data at the 21st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the 10th Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) congress held in Thessaloniki, Greece that shows Tovaxin to reduce relapses by 92%. o In March of 2006, PharmaFrontiers prepares to begin Phase IIb trials of Tovaxin in the U.S. Once these trials are complete, the next step is to enter in to longer Phase III trials before Tovaxin can gain FDA approval. o March 22, 2006, PharmaFrontiers announces that it will present more data on Tovaxin at the 20th Consortium of MS CentersÃ’ annual meeting held in Arizona from may 31-June 3 2006.
Benefits: So far, there seems to be a 92% reduction in relapses. Also, once the body is no longer under attack and able to heal itself, many lost functions can be restored. For a wonderful story about the benefits of Tovaxin, please see TimÃ’s story at ihavems.com.
Administration: Subcutaneous injection approximately four times a year.
Cost: I have not been able to find much information on the cost. Apparently, it should be much less expensive than other MS drugs (yipeee!).
Side Effects/Disadvantages: I have not found much on this subject either. Patients do need to be monitored in case there is some strange reaction and their immune system becomes depleted, but because the vaccine is made from the patientÃ’s own cells and the action is so specific, there does not appear to be any side effects.
I guess that points towards the wounder drug side of the scale. Yet again thankyou for this Steph. Your father seems like such a great bloke for mailing me. I hope your both doing well and your looking after each other! Tomorrow I would like to go toward alternate therapies as I have been looking into a few. I have now had experience in one this week and cannot wait to get it up here! I have a few more from Steph(as she is fantastic!) and then I will get back to some rock(sorry!lol)!
Name: personallog! Home: St. Annes, Lancashire, United Kingdom About Me:
I am 6ft 3" skinny and not well. I was diagnosed with ms in 2004 and I would like to speak with others who have ms. I have a want to raise money for ms charities. We have to find a cure for this hell!!!!
See my complete profile
