Burn Treatment
BioMarin Pharmaceutical Inc, Novato, CA, has announced positive results from a Phase Ib clinical trial of Vibrilase (vibriolysin), an investigational topical enzyme for the treatment of serious burns. Data from the trial suggest the treatment is generally safe, well-tolerated, and effective in debriding partial-thickness burns.
The open-label trial enrolled 19 patents with partial-thickness burns covering 1% to 2% of total body surface. Conscious patients were treated daily for 3 days with 1 of 3 dosages of topically applied Vibrilase. Patients were followed for a total of 28 days, or until the wound completely healed.
The average time to complete debridement of wound eschar was 2.9 days. No consistent trend related to the dose was observed due to the small number of evaluable patients.
The average time to 90% epithelialization was 16.4 days. There were no serious adverse events related to treatment with Vibrilase.
Pain scores recorded 30 minutes after application of Vibrilase were not significantly different from pain scores recorded prior to application, irrespective of dose. Manageable, short-term pain unrelated to dose was experienced by some patients upon application of Vibrilase to the wound, but generally did not persist.
Information: http://www.bmrn.com
Wound Product
IsoTis OrthoBiologics, Lausanne, Switzerland, and Irvine, CA, has reported positive results for the Phase II dose escalation trial of its chronic wound treatment product Allox.
Delivered as a spray, Allox established complete wound closure in 57% of patients with the optimal dose. The product is a combination of keratinocytes, fibroblasts, and fibrin.
The randomized, double blind, placebo-controlled, dose-escalation study included 110 eligible patients with hard-to-heal ulcers of 16 weeks' duration. One of the main study objectives was to establish with which proportion of the product the highest efficacy could be achieved.
Allox is part of the product portfolio of EpiSource, IsoTis's wholly owned wound management subsidiary, and subject to a licensing agreement with DFP/HEALTHPOINT.
Information: http://www.isotis.com
Incontinence
Results of a new study published in the August issue of Urology show that women with mixed incontinence, a combination of overactive bladder and stress incontinence, reported a greater treatment benefit from DETROL LA than placebo. This is the first study of DETROL LA in women with mixed incontinence, which is the most common type of urinary incontinence. DETROL LA (tolterodine tartrate extended release capsules) is manufactured by Pfizer, Inc., New York, NY.
The double blind, randomized, placebo-controlled trial included 854 women who experienced urgency, frequency, and at least 5 episodes of urge incontinence per week in combination with stress incontinence. They received 8 weeks of treatment with DETROL LA or placebo once a day. Patients treated with DETROL LA experienced a 77% reduction in weekly urge incontinence episodes, compared with 51% for those receiving placebo.
Information: http://www.pfizer.com