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BioSpecifics Announces Positive Results From Clinical Trial in Canine Lipomas
Date:1/6/2011

o BioSpecifics. If Auxilium chooses not to exercise this option, BioSpecifics plans to proceed with the development of its injectable collagenase for veterinary indications on its own.

About Chien-803 Clinical TrialThe trial will enroll 25 canines, each having two or more lipomas. To meet the primary endpoint an animal must achieve at least a 50% decrease in the drug-treated lipoma volume relative to baseline as measured by CT scan at 3 months post injection. The Company expects to announce top-line results from this trial in the second half of 2011.

Human Lipoma Study Results BioSpecifics previously conducted an open label study evaluating the safety and efficacy of injectable collagenase in the treatment of human lipoma. Eleven of the twelve subjects completed the follow up scheduled for the trial.  Patients in the study received a single injection of collagenase consisting of 1,000 units (0.058 mg) per centimeter diameter of the lipoma. Subjects were evaluated at baseline prior to the administration of study treatment and at one, three, seven and fourteen days, and one, three and six months post treatment to evaluate the overlying skin as well as the general area for untoward effects.  Results showed that there was an average reduction of lipoma size of 93% post treatment at six months.

About Canine LipomasLipomas are encapsulated fat deposits that occur under the skin. Lipomas that restrict motion in older dogs are a serious problem; the only proven therapy for this condition is surgical excision of the lipoma, which necessarily involves the use of general anesthesia; it has been estimated that up to 2% of sick dogs die as a complication of general anesthesia.(1)  Lipomas occur in 2.3% of the dog population,(2)  or in approximately 1.7 million dogs in the U.S.(3) (1) Brodbelt Vet J 2009 Dec; 182 (3): 375-6 (2) Lund JAVMA Vol. 214, No. 9, May 1, 1999(3) U.S. Pet Ownership & Demographics Sourcebook (2007 Editio
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