BG-12 is an experimental oral therapy in Phase III clinical development as a monotherapy for the treatment of relapsing-remitting multiple sclerosis (RRMS). BG-12, bought by Biogen Idec, received Fast Track designation in MS from the U.S. Food and Drug Administration (FDA), which may expedite U.S. regulatory review. BG-12 works by reducing the evolution of new enhancing lesions to T1-hypointense lesions in patients with multiple sclerosis.
From the Multiple Sclerosis Resource Centre's website:
BG-12, an immunomodulatory agent, reduces frequency of new gadolinium-enhancing (Gd+) lesions in relapsing multiple sclerosis (MS). This study reports the effect of 240 mg BG-12 orally three times daily (tid) for 24 weeks on the evolution of new Gd+ lesions to T1-hypointense lesions.Estriol is an estrogen hormone. Studies are ongoing to determine whether higher levels of estriol, as naturally produced during pregnancy, may treat MS. Refer back to my "Definitely Good News!" post for more information on pregnancy and MS. According to research, Estriol production in MS patients during pregnancy reduces the disease's symptoms noticeably.
Eighteen patients receiving BG-12 and 38 patients receiving placebo were included in the analysis. The analysis tracked 147 new Gd+ lesions in patients from the BG-12 group and 221 Gd+ lesions in patients from the placebo group. The percentage of Gd+ lesions that evolved to T1-hypointense lesions was 34% lower with BG-12 treatment versus placebo.
In addition to reducing frequency of new Gd+ lesions, BG-12 significantly reduced probability of their evolution to T1-hypointense lesions in patients with MS compared with placebo.
From an article on Life Extension's website:
The high levels of estriol during pregnancy have been known to alleviate some autoimmune conditions due to its ability to shift immune response. For instance, Sicotte et al. at the Reed Neurological Research Center in Los Angeles investigated the effects of pregnancy-level doses of estriol (8 mg/day) in non-pregnant women with multiple sclerosis (MS). Cerebral MRI images showed a significant reduction of gadolinium-enhancing cerebral lesions from multiple sclerosis. These lesions increased when treatment stopped and decreased when treatment was restarted. Gadolinium is a contrast agent used in certain MRI studies; gadolinium-enhancing lesions are associated with an increased inflammatory response marking disease progression in patients with MS. Lowered amount of these lesions seen on MRI with gadolinium contrast would equate to a decrease in disease progression.
This effect may also apply to men with autoimmune conditions. Another team of researchers from the Reed Neurological Research Center in Los Angeles found that estriol treatment ameliorates experimental autoimmune encephalomyelitis (EAE) in males, compared with placebo treatment. EAE is an experimental demyelinating inflammatory disease that shares numerous characteristics with MS. Estriol treatment also resulted in a decrease of proinflammatory immune markers. This is very promising news for patients and their doctors who are struggling to treat challenging neurological conditions associated with inflammation.From an article on Medical News Today's website:
Trimesta (oral estriol) has previously completed an initial 22-month, single-agent, crossover Phase I/II clinical trial in the US for the treatment of MS in relapsing remitting patients, with highly encouraging results. The results showed the total volume and number of enhancing pathogenic myelin lesions (established neuroimaging measurements of disease activity in MS) decreased during the treatment period as compared to a six-month pretreatment baseline period. The median total enhancing lesion volumes decreased by 79 percent (p=0.02) and the number of lesions decreased by 82 percent (p=0.09) within the first three months of treatment with Trimesta. Following a six-month drug holiday during which the patients weren't on any drug therapies, Trimesta therapy was reinitiated during a four-month retreatment phase of this clinical trial. The relapsing-remitting MS patients again demonstrated a decrease in enhancing lesion volumes of 88 percent (p=0.008) and a decrease in the number of lesions by 48 percent (p=0.04) compared with original baseline scores (1),(2).Some very promising research going on right now! Very exciting stuff! My next post will discuss Campath and Rituximab. Then I will finish up the future therapies discussion with Vaccination Strategies. Thanks for reading!