Navigation Links
Biogen Idec's oral compound BG-12 achieves development milestones in MS and RA

CAMBRIDGE, Mass. December 7, 2009 Biogen Idec (NASDAQ: BIIB) today announced that its oral compound BG-12 (dimethyl fumarate) achieved key milestones in clinical trials for multiple sclerosis (MS) and rheumatoid arthritis (RA). In recent months, the last patient was enrolled in the CONFIRM trial, the second of two Phase III trials designed to evaluate the efficacy and safety of BG-12 as a monotherapy in patients with relapsing-remitting multiple sclerosis (RRMS). Both the DEFINE and CONFIRM Phase III trials are now fully enrolled and will evaluate the effect of BG-12 on clinical relapse, disability progression, various MRI measures of disease activity, and safety.

The last patient was also enrolled in a Phase II study to evaluate the safety, tolerability and efficacy of BG-12 in combination with methotrexate in subjects with active RA who had an inadequate response to conventional disease-modifying antirheumatic drug (DMARD) therapy.

"There is significant unmet need in both the MS and RA communities for additional treatment options," said Kate Dawson, M.D., senior director, Medical Research, Biogen Idec. "The Phase IIb study of oral BG-12 in patients with MS showed promising MRI results regarding the compound's ability to reduce inflammation and its potential for neuroprotection. We look forward to results from the DEFINE and CONFIRM Phase III MS studies, as well as the proof-of-concept trial in RA."

BG-12 has been shown to activate the Nrf2 transcriptional pathway, which pre-clinical studies have shown defends against oxidative-stress induced neuronal death, protects the blood-brain barrier and supports maintenance of myelin integrity in the central nervous system. Central nervous system inflammation and damage may trigger the symptoms common in RRMS such as fatigue, cognitive deterioration and physical disability. Because of BG-12's unique effect on the Nrf2 pathway and its oral delivery, BG-12 is also being considered for future MS combination therapy studies.

Additionally, as an oral compound, BG-12 holds promise for patients with RA. Its combination of anti-inflammatory and potential cytoprotective properties support the compound's evaluation in RA.

BG-12 is an oral formulation of dimethyl fumarate. Fumaderm, a therapeutic for the treatment of psoriasis in Germany, includes dimethyl fumarate as one of the active ingredients. Fumaderm has more than 14 years of post-marketing experience and approximately 100,000 patient years of use.


Contact: Tracy Vineis
GCI Health

Related biology news :

1. The cooperative view: New evidence suggests a symbiogenetic origin for the centrosome
2. New microsensor measures volatile organic compounds in water and air on-site
3. Naturally-occurring apple compounds reduce risk of pancreatic cancer
4. Chemical compound present in detergents produce bacteria alterations in agricultural soils
5. Synthetic compound promotes death of lung-cancer cells, tumors
6. Natural compound in broccoli could treat devastating genetic skin disorder
7. New form of compound stimulates research on hydrogen storage
8. Protein protects brain against compound in lead poisoning, liver disease
9. A compound extracted from olives inhibits cancer cells growth and prevents their appearance
10. UDs Bobev receives NSF Early Career Award for research on novel compounds of rare Earth metals
11. UF scientists discover compound that could lead to new blood pressure drugs
Post Your Comments:
(Date:10/29/2015)... , Oct. 29, 2015   MedNet Solutions , ... entire spectrum of clinical research, is pleased to announce ... Tech Association (MHTA) as one of only three finalists ... "Software – Small and Growing" category. The Tekne Awards honor ... have shown superior technology innovation and leadership. ...
(Date:10/29/2015)... RESTON, Va. , Oct. 29, 2015 ... announced today that it has released a new version ... Daon customers in North America ... gains. IdentityX v4.0 also includes a FIDO UAF ... customers are already preparing to activate FIDO features. These ...
(Date:10/29/2015)... BOSTON , Oct. 29, 2015  Connected health ... phenomena driving the explosion of technology-enabled health and wellness, ... his new book, The Internet of Healthy ... apps, sensors or smartphones even existed, Dr. Kvedar, vice ... model of health care delivery, moving care from the ...
Breaking Biology News(10 mins):
(Date:11/24/2015)... Florida (PRWEB) , ... November 24, 2015 , ... ... biggest event of the year and one of the premier annual events for ... and ran from 8–11 November 2015, where ISPE hosted the largest number of ...
(Date:11/24/2015)... India , November 24, 2015 ... a new market research report "Oligonucleotide Synthesis Market by ... Application (PCR, Gene Synthesis, Diagnostic, DNA, RNAi), End-User (Research, ... 2020", published by MarketsandMarkets, the market is expected to ... Million in 2015, at a CAGR of 10.1% during ...
(Date:11/24/2015)... 24, 2015 SHPG ) announced today that ... Piper Jaffray 27 th Annual Healthcare Conference in ... at 8:30 a.m. EST (1:30 p.m. GMT). --> SHPG ... will participate in the Piper Jaffray 27 th Annual Healthcare ... Tuesday, December 1, 2015, at 8:30 a.m. EST (1:30 p.m. GMT). ...
(Date:11/24/2015)... QUEBEC CITY , Nov. 24, 2015 /PRNewswire/ ... (the "Company") announced today that the remaining 11,000 ... Common Share Purchase Warrants (the "Series B Warrants") ... agreement were exercised on November 23, 2015, which ... Common Shares.  After giving effect to the issuance ...
Breaking Biology Technology: