Biotech Values

[DonShimoda]

XOMA Initiates Gevokizumab Phase 2 Study for Moderate to Severe Acne Vulgaris

**Note: Results from this trial were expected 4Q2012 so I suspect we'll see the data shortly. This is the first of three PoC programs that will read-out during 2013 ( the other two being erosive osteoarthritis of the hand and non-infectious anterior scleritis)

BERKELEY, Calif., Dec. 21, 2011 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA) today announced it has begun dosing patients in its Phase 2 proof-of-concept study to evaluate the efficacy and safety of gevokizumab (XOMA 052), a potent inhibitor of interleukin-1 beta (IL-1 beta), for the treatment of the inflammatory lesions seen in moderate to severe acne vulgaris. Approximately 170 patients will be randomized to receive one of two dose levels of gevokizumab or placebo administered subcutaneously over a three-month period. The primary study efficacy endpoint is the mean absolute change from baseline in inflammatory facial lesion count after three months of therapy. Additional study information has been submitted for publication on www.clinicaltrials.gov

"XOMA's Phase 2 proof-of-concept program is designed to expand the value of gevokizumab, the company's lead clinical asset, by demonstrating its potential in diseases characterized by interleukin-1 beta over-expression. This is the first in a series of clinical studies that we plan to conduct in separate indications over the next 12 to 18 months," commented John Varian, Interim Chief Executive Officer of XOMA Ltd. "Upon completion of this series of proof-of-concept studies, we believe we will have sufficient evidence to initiate a further development program in at least one of these indications."

Moderate to severe acne vulgaris is estimated to affect approximately three to four million people in the U.S. Acne is characterized by the presence of a bacteria known as Proprionumbacterium acne, which promotes the production of proinflammatory substances including IL-1 beta in experimental models of the disease.

Moderate to severe acne that does not respond to topical agents is often treated with orally administered antibiotics. For the most severe, non-responsive acne, isotretinoin (an oral retinoid drug) treatment may be prescribed, although it is only available through a restricted distribution program due to its side effect profile.
http://investors.xoma.com/releasedetail.cfm?ReleaseID=634770