BioSpecifics Technologies Corp
) recently announced encouraging top-line data on Xiaflex from a
phase II dose escalation clinical trial for the treatment of
The phase II open label single-center dose escalation study
(n=14) assessed the safety and efficacy of Xiaflex in patients
with lipoma, divided into four dose cohorts. The data from the
trial showed reduction of lipoma size in patients following its
treatment with Xiaflex.
Xiaflex, developed in collaboration with
Auxilium Pharmaceuticals, Inc
), is approved in the U.S. and EU (EU trade name: Xiapex) for
Dupuytren's Contracture (DC) and Peyronie's disease (PD).
We note that Xiaflex has been granted Orphan Drug Designation
in the U.S. by the Food and Drug Administration (FDA) for DC and
Based on encouraging data from the phase I and phase II trials
for the indication of human lipoma, BioSpecifics plans to
initiate a placebo-controlled study to further assess the
efficacy and safety of Xiaflex for the treatment of human lipoma
in the first half of 2014.
Meanwhile, Auxilium Pharma has the option to exclusively
license development and marketing rights for the human lipoma
indication following the completion of a new trial. The
completion of the new trial will trigger an opt-in payment and
potential future milestone and royalty payments from Auxilium
Auxilium Pharma recently announced that interim data from its
phase IV retreatment study evaluating Xiaflex in adult patients
with DC and a recurrent contracture with a palpable cord will be
presented at the American Association for Hand Surgery (AASH)
2014 Annual Meeting.
The open label phase IV study is evaluating patients (n=51)
who had recurrence of a contracture in a joint that was
previously effectively treated with Xiaflex. The interim analysis
was conducted after all patients had completed their 30-day
follow up assessments.
Auxilium Pharma aims to evaluate the efficacy of Xiaflex
following a recurrence in DC that was initially treated with this
We believe investor focus will remain on the efforts to expand
BioSpecifics Technologies, a biopharmaceutical company,
carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the
biopharma space are
Sucampo Pharmaceuticals Inc
). Both stocks carry a Zacks Rank #1 (Strong Buy).
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