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BioSpecifics Technologies released
results of a phase IIa study of XIAFLEX (collagenase
clostridium histolyticum or CCH)
for the potential treatment of cellulite, or
edematous fibrosclerotic panniculopathy.
The phase IIa study enrolled 150 women
between the ages of 18 and 45 in the U.S.
Each subject received up to three treatment
sessions of drug or placebo according to
randomization: five high-dose 0.84mg, five
mid 0.48mg, five low 0.06mg, three placebo.
Each treatment session was approximately
21 days apart. Up to 12 injections were
administered into cellulite dimples during
each session across an entire treatment
quadrant: left or right buttock or left or right
posterior thigh. Both the mid and high-dose
groups of CCH demonstrated a statistically
significant improvement in investigators’
assessments of the appearance of cellulite,
as measured by Global Aesthetic Improvement
Scale (GAIS) scores, with a p-value
of <0.05 v. placebo, as well as in patients’
assessments of the appearance of cellulite,
as measured by GAIS scores, with a p-value
of <0.02 v. placebo. Sixty-eight percent
of both the mid and high-dose groups
reported being “Satisfied” or “Very Satisfied”
with their cellulite treatment, compared to
only 34% of placebo patients. Both the mid
and high-dose groups of CCH demonstrated
a statistically significant improvement in
the post-hoc composite responder analysis,
as measured by combined investigator and
patient GAIS scores, with p-values of 0.021
and 0.004, respectively, v. placebo.
RXi Pharmaceuticals reported results from a phase I trial of RXI-109 for the treatment of Connective Tissue Growth Factor (CTGF), a protein that causes abnormal scarring when over-expressed in a wound. This study enrolled 15 volunteers with no known predisposition for abnormal scarring. Each subject received a single intradermal injection of RXI-109 in two 2-cm areas of the abdomen. Two areas on the other side of the abdomen were treated with placebo injections. Within 24 hours of treatment, these areas received an incision that was immediately closed again. RXI-109 was given in dose-ascending manner to five cohorts, with doses ranging from 0.5mg/cm to 5mg/cm (or total doses of RXI-109 per volunteer from 2mg to 20mg). There was a statistically significant reduction in the average CTGF protein concentration in the RXI-109 treated sites compared to placebo treated sites (p = 0.02).
Isolagen has reported 6-month interim results of their first phase III study of their Isolagen Process, the use of autologous fibroblast cells to fill facial contour deformities. Data from the ongoing study indicate that the treatment appears to be efficacious in alleviating facial contour deformities, with 77% of subjects achieving clinical response at 4 months and 82% achieving response at 6 months. The study has evaluated 146 subjects, 90.5% of whom were female and 91.8% of whom were Caucasian. Isolagen announced that the study would continue for another 6 months, and that they expected regulatory filing by Q1, 2005.
Positive phase I results were reported from testing of 5G1.1 in 13 subjects with dermatomyositis. The drug, a humanized monoclonal antibody C5 complement inhibitor in an intravenous injection formulation, appeared to be well tolerated and to improve skin rash. Treatment was given once a week for five weeks, then every two weeks for up to two months. Though safety was the primary study aim, measurements of skin rash and muscle strength were also recorded, showing consistent trends in improvement with drug administration. Few adverse events were observed, and those seen were comparable for treatment and placebo groups. 5G1.1 is being developed by Alexion Pharmaceuticals.
Preliminary phase II trial results indicate that Micrologix Biotech's MBI 594AN produced a 32% reduction in total acne lesion counts (inflammatory plus non-inflammatory lesions) compared to a 14% reduction for placebo. The randomized, double-blind trial enrolled 75 acne subjects who received twice-daily dosing with either one of two formulations of MBI 594AN (2.5% and 5%) or the product's alcohol-based vehicle alone. Subjects treated with MBI 594AN showed a 39% reduction in inflammatory acne lesion counts compared with 21% for the placebo group. In terms of non-inflammatory acne, MBI 594AN treated subjects experienced a 25% improvement in lesion reduction, compared to 10% for placebo treated subjects.