Clinical Trials Resource Center
New Medical Therapies™
Patient Medical Areas
Birken reported results of three phase
III trials of Oleogel-S10 for patients with
partial thickness wounds. The three phase III
trials, conducted in parallel and enrolling a
total of 280 patients in 48 European centers,
included observer-blinded evaluation based
on photographs. In the studies, patients’
wounds were divided into two halves,
enabling a direct intra-individual comparison
of differences between Oleogel-S10 and
standard of care treatment, and avoiding
confounding factors such as individual
differences in wound depth and individual
patient health status. In each of the three
clinical phase III trials, the primary endpoint
was achieved with a statistical significance
of p<0.0001 (BBW-11 trial in grade 2a burn
wounds and BSH-12 trial in split-thickness
skin graft donor site wounds) and p=0.0232
(BSG-12 trial in split-thickness skin graft
donor site wounds). The phase III results
demonstrate a faster wound healing with
Oleogel-S10 compared to current standard
of care consisting mainly of applying wound
dressing materials. Birken currently is
preparing the submission of the marketing
authorization application to the EMA. After
approval, Oleogel-S10 will be available for
marketing and distribution in the E.U. in the
first half of 2016.
Cardiovascular Biotherapeutics released results from a phase IIa and IIb trial evaluating CVBT-141B for the treatment of chronic ischemic diabetic wounds. In the phase IIa trial, diabetic wounds treated with CVBT-141B healed approximately 4.5 times faster than wounds treated with placebo or standard of care, including debridement. In the phase IIb trial, all of the diabetic wounds treated with CVBT-141B achieved 100% closure within five months or less, while one-third of the placebo-treated wounds remained open at the end of the same treatment period. In addition, 57% of subjects treated with CVBT-141B had complete closure of their diabetic wounds at eight weeks, versus 0% for the placebo group. Both trials demonstrated statistical significance to placebo (p<0.05).
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.
ZymoGenetics reported positive data from a clinical trial of Recothrom in subjects undergoing skin grafting for burns. This multiple site, single-arm, open-label study enrolled 72 subjects receiving partial- or full-thickness autologous sheet or mesh graft following burn injury. Recothrom was applied to newly excised wounds (graft recipient sites) using a ZymoGenetics pump spray device. Adverse events, skin graft survival and formation of anti-Recothrom antibodies were measured at baseline and Day 29 after application of Recothrom. Treatment was generally well tolerated; adverse events occurred in 63 (88%) of the subjects and were typical of adverse events seen following acute burn wound treatment. One subject had antibodies to Recothrom at baseline (1.4%); another subject developed specific antibodies to Recothrom at Day 29 resulting in a low rate of antibody formation (1.6%). The antibodies detected did not neutralize human thrombin.
IsoTis OrthoBiologics announced positive results of their phase II study of Allox, a wound closure facilitator for the treatment of chronic skin ulcers and chronic wounds. The trial found that Allox was significantly more efficacious than placebo in closing chronic wounds. The double-blind, dose-escalating trial, which enrolled 110 subjects at 20 sites worldwide, randomized subjects to receive one of 6 doses of Allox or placebo for 16 weeks. 43 of 95 subjects receiving one of the doses of Allox (45%) achieved complete closure after 16 weeks, compared to 5 of 15 (33.3%) for placebo. The dosing regimen found to be optimal achieved the most significant results, with 57% achieving full wound closure. The study found the drug to be safe and well tolerated. IsoTis announced that it planned to submit an IND for phase III trials.
Ortec International reported positive preliminary results from a pivotal trial investigating OrCel, a bilayered cellular matrix for the treatment of wounds. Results showed that 64% (16/25) of subjects treated with OrCel achieved complete wound closure compared to 39.1% (9/23) of subjects treated with standard care. Data revealed a 35% average improvement for OrCel treated subjects compared to 10% with standard care. In addition, the treatment group had a 24% larger wound area compared to the standard care group (5.92 vs. 4.75cm2). The ongoing randomized study has so far enrolled 67 out of the targeted 102 subjects with hard to heal ulcer wounds. Subjects were administered a single application of OrCel plus compression therapy or compression therapy alone for up to five weeks.