Xoma Halts Acne Therapy XMP.629 Development, Will Evaluate BPI Program
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Xoma is evaluating all of its existing bactericidal/ permeability increasing protein (BPI) programs in the wake of "inconclusive" Phase II results for the acne treatment XMP.629, the company said.
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Xoma is evaluating all of its existing bactericidal/permeability increasing protein (BPI) programs in the wake of "inconclusive" Phase II results for the acne treatment XMP.629, the company said. "Xoma does not plan to initiate additional clinical trials with XMP.629," the company announced Aug. 16. In the Phase II trial of the topical BPI-derived antimicrobial peptide, "there was no discernible dose response and the vehicle response was higher than anticipated," Xoma reported. The study enrolled 253 patients with mild to moderate acne. Patients were randomized to vehicle gel or XMP.629 gel in .01%, .05%, or .1% strengths, administered nightly for 12 weeks. The study's primary endpoint examined change in lesion counts from baseline to 12 weeks. CEO John Castello referred to XMP.629 as Xoma's "lead proprietary product candidate" as recently as the company's Aug. 10 earnings call. Xoma's evaluation of its early-stage BPI programs could result in partnerships or collaborations, the company indicated. Xoma started to focus on the BPI platform following the final discontinuation of its anti-sepsis monoclonal antibody E5 in 1997. The first BPI-derived product, Neuprex (opebacan, or rBPI-21), was discontinued for hemorrhagic trauma in 1999 after failing to meet criteria in a Phase III trial. In 2000, FDA deemed Phase III data in pediatric meningococcal sepsis insufficient to support a BLA. Baxter, which licensed worldwide rights to Neuprex in 2000, returned the rights to Xoma in July 2003. Xoma is awaiting reports of the analysis of a Baxter-sponsored pilot Phase II trial in Crohn's disease. Neuprex is currently in an investigator-sponsored Phase I/II trial in pediatric patients with congenital heart abnormalities requiring open heart surgery associated with cardiopulmonary bypass. Research on BPI-derived compounds for retinal disorders has been conducted by the Joslin Diabetes Center under an ongoing collaboration. Xoma is evaluating the data. [Editor's Note: A version of this story first appeared in 1 "The Pink Sheet" DAILY Aug. 17, 2004. Visit our website, www.ThePinkSheetDAILY.com, to sign up for a free trial.] ¨ ¨ |