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Excaliard issued positive results from a phase II trial of EXC 001 for the reduction of fibrosis following surgery. This US-based, randomized, double blind, placebo controlled trial, EXC 001-202, enrolled subjects undergoing an elective abdominoplasty. EXC 001 or placebo was administered intradermally adjacent to the surgical incision. The primary endpoint was to assess the efficacy of EXC 001 on reducing scar severity at 12 weeks post-surgery. The data showed statistically significant improvements in scarring for EXC 001 compared to placebo in both physician and patient reported outcomes (p values ranged from 0.017 to 0.002). In addition, EXC 001 was well tolerated with no clinically important adverse events.
Renovo released positive combined results from three phase I/II trials of intradermal avotermin for the prevention of wound scarring. These double-blind, placebo-controlled studies (1002, 1005 and 0036) enrolled 243 healthy subjects. The subjects received placebo or intradermal avotermin (concentrations ranging from 0.25 to 500 ng/100 µL per linear cm wound margin) administered to both margins of 1 cm, full-thickness skin incisions, before wounding and 24 hours later. Primary endpoints were visual assessment of scar formation at 6 months and 12 months after wounding in two studies, and from week 6 to month 7 after wounding in the third study. In two studies, avotermin 50 ng/100 µL significantly improved median score on a 100 mm visual analogue scale (VAS) by 5 mm (p≡0.001) at month 6 and 8 mm (p≡0.0230) at month 12. In the third study, avotermin significantly improved total scar scores at all concentrations versus placebo (mean improvement: from 14.84 mm at 5 ng/100 µL per linear cm to 64.25 mm at 500 ng/100 µL per linear cm). Nine (60%) scars treated with avotermin 50 ng/100 µL showed 25% or less abnormal orientation of collagen fibers in the reticular dermis versus five (33%) placebo scars. After six weeks from wounding, avotermin 500 ng/100 µL per linear cm improved VAS score by 16.12 mm. Adverse events at wound sites were similar for avotermin and placebo.
Isolagen announced 12 month follow-up data from a phase III trial of their Isolagen Process, which utilizes autologous fibroblasts to treat facial contour deformities. Study data yielded significant evidence of efficacy, with 57.0%, 79.6%, 77.1%, and 82.2% of patients responding (response was classified as a 2 point improvement on a 7 point standardized photoguide scale) at 1, 2, 4 and 6 months respectively, vs. 38.2% at 6 months for placebo (p<0.0001). Follow-up analysis at 12 months yielded an 82.4% response rate. This double-blind, placebo controlled trial enrolled 151 patients with eight types of facial defects, including acne scarring and rhytids, across 10 US sites. These results were in line with those observed in previously completed European and Australian phase III studies, and supports ongoing US phase III studies being conducted under an SPA with the FDA, with an expected BLA filing date during the second half of 2005.
QLT announced positive results of both a phase III efficacy trial and a long term safety study of their investigational acne medication Aczone (dapsone topical gel) at the Annual Meeting of the American Academy of Dermatology in New Orleans. Results from a phase III safety and efficacy study indicated that the drug produced significant reductions in the incidence of both inflammatory and non-inflammatory lesions and in total lesion count, compared to vehicle gel. Secondary efficacy assessment, using a five point static Physicians Global Assessment Scale, also yielded positive results. Results from a long-term safety study indicated that long-term Aczone treatment was well tolerated, with no increases in adverse events or laboratory abnormalities over time. Plasma drug levels remained consistently low plasma. The multicenter, double-blind, phase III study randomized 496 patients to receive either Aczone (n=330) or vehicle gel (n=166) twice daily for 12 weeks. The multicenter, open-label, non-comparative safety study enrolled 506 patients to receive twice daily topical Aczone application for 12-months; 340 completed the full course of therapy.
Procyon BioPharma reported results of a phase IIb analysis of their tissue transglutaminase inhibitor Fibrostat (topical 1,4 diaminobutane di-hydrochloride), for the prevention of hypertrophic scarring. Preliminary data from the trial failed to meet their primary endpoint, a significant improvement in the appearance of hypertrophic scars vs. placebo (p>0.05). Subgroup analysis of subjects with more severe scars (Manchester Scar Scale rating of 13 or higher, n=27) also failed to achieve significance, but did show a slight trend towards improvement (p=0.088), and significance was achieved in this subgroup in baseline-dose interaction (p=0.017). The drug was safe and well tolerated. The placebo-controlled, double-blind, randomized trial enrolled a total of 209 subjects across 12 sites in the US and Canada, of which 136 were randomized and 132 completed the trial. Subjects were randomized to receive either Fibrostat 0.8% or placebo daily. The study has announced plans for a trial investigating the drug’s clinical utility in preventing scarring, based on these results.