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Stacy

I am confused about this drug. Wasn't this formerly Lymphostat-B, the drug that performed very poorly in Phase 1 trials? Is it possible for a drug to be reformulated but continue on to Phase 2 trials with a different name? Or is this the same formulation as Lymphostat-B which did not perform well initially?

9 months ago

Laureen

Yes it is the same drug.  However, once Human Genome Sciences started pouring over the data, they discovered that there was a subset of patients that improved dramatically and with less steroids too.  They then applied for a SPA (Special Protocol Assessment) to design another trial for that particular subset of patients..You can go to their website www.hgsi.com to see which subset of patients.  The trial was designed by HGSI and the FDA, and they have now completed both Phase I and Phase II and both were a huge success.  Lupus flares are so unpredictable and has been the problem with all previous trials for many other companies.  It appears that Human Genome Sciences has "cracked the code" on how to do a specific trial to ensure success for Lupus.   The drug has had amazing affects, little to NO side affects and originally it was thought that it would only be meant for Mod-Severe lupus patients, however now it appears it would be beneficial for the mild cases also.  I have followed this company for months now, and know many that are clinically familiar with what is going on.  We have hope!!!!  They are now going to be doing a Phase II trial with Benlysta for RA also, and quite possible for MS down the road.

8 months ago