A UCLA researcher says that giving the pregnancy hormone estriol to multiple sclerosis patients along with their regular medications helped reduce the number of relapses the group suffered from. And now she's hunting for enough financial support to put her work to a pivotal clinical test.
The work of the UCLA team was inspired by the observation that women with MS in the second half of their pregnancies were much less likely to suffer a relapse leading up to the birth of their children. And the same protective response has been noted in other autoimmune conditions, such as psoriasis and rheumatoid arthritis.
UCLA's Rhonda Voskuhl theorized that women's bodies used estriol to suppress their immune systems, so they wouldn't reject fetuses swarming with the father's "foreign" proteins.
That theory checked out in a preclinical model of the disease, which laid the foundation for a pilot program in which Voskuhl noted a dramatic drop in lesions among 10 women enrolled. A Phase II study was begun in 2007, with the estriol arm plus regular meds demonstrating a drop in relapses of one third to one half, with only one recorded side effect: irregular menstruation.
The National Institutes of Health and the National Multiple Sclerosis Society funded the midstage trial, and now the researcher wants to find enough cash to pay for Phase III in an attempt to gain FDA approval.
"The beauty of estriol is that it is not a shot and can be taken in pill form, and also that it's not a new drug. It has decades of safety behind it," said Voskuhl, who works in the UCLA Department of Neurology. "Also, current MS treatments are very complex to manufacture. These findings hopefully will pave the way for oral, safe treatments that are more widely accessible, since estriol is simple and naturally occurring."