The Phase II MYLORAL results found that 0 of 8 men taking MYLORAL had an MS attack during the study while 6 of 7 women had attacks. They also found that 6 of 9 subjects that expressed the phenotype that produces the major histocompatibility complex antigen HLA-DR2 had attacks while 0 of 6 that did not have the phenotype had attacks. As a results the Phase III was designed with with four groups
1) Males - DR2+
2) Males - DR2-
3) Females - DR2+
4) Females - DR2-
The Phase II results would suggest that the 2nd group would be the most likely to show an effect. So, if the positive MRI results are in this group, it could be an interesting outcome. However, there is no way that the FDA approves MYLORAL when the primary disease specific endpoints were all non-significant.
The best outcome for AIMM whould be to initiate another Phase III with just Male DR- patients and do everything in their power to reduce the placebo effect. As you might recall, the problem with the Phase III results was that there were gigantic placebo effects, much larger than seen in the Phase II work. However, it is my understanding that most if not all of the MYLORAL group at AIMM has been let go. So, AIMM does not currently have the staff to restart the MYLORAL trials.
This poses and interesting dilemma for AIMM; restart, hiring people to conduct the program, and initiate another Phase III trial at very high expense, or drop a program that may yet have promise. There is no good short term solution. Remember, the Phase III trial takes 2 years. I'll bet AIMM management is doing some deep thinking on this one.
John de C |
