biologics

New Psoriasis Guidelines Address Comorbidities and Biologic Treatment

The American Academy of Dermatology (AAD) and the National Psoriasis Foundation (NPF) collaborated on—and have published—new guidelines of care for psoriasis, which are being published in the Journal of the American Academy of Dermatology. An expert work group composed of several dermatologists, as well as a cardiologist, a rheumatologist and patient representatives developed the guidelines.

Positive Data From Phase 2a Study Of Injectable Cellulite Treatment

Positive Data From Phase 2a Study Of Injectable Cellulite Treatment

Auxilium Pharmaceuticals has announced positive results from a randomized, double-blind Phase 2a study of injectable collagenase clostridium histolyticum (CCH) for the treatment of cellulite. The study included 150 women between the ages of 18 and 45. All three doses of CCH—low (0.06mg), mid (0.48mg) and high (0.84mg)—showed an improvement in the appearance of cellulite as measured by investigator trial endpoints and the Global Aesthetic Improvement Scale (GAIS).

Adipose-Derived Mesenchymal Stem Cell Ratios Maintained with Age

Three Generations

The isolating ratio of adipose-derived mesenchymal stem cells remains the same among infants, adults and the elderly. But angiogenic factors are more highly expressed in infant stem cells than other age groups, say researchers Wei Wu, DDS, PhD, et al, of the Yale University School of Medicine. For the study, “The Effects of Age on Human Adipose-Derived Stem Cells” (Plastic and Reconstructive Surgery, January 2013), adipose cells were harvested from subjects in three age groups--infant, adult and elderly.

Phase II Results Released for Biologic Acne Treatment

Phase II Results Released for Biologic Acne Treatment

XBiotech, a privately held biotechnology company, has announced positive Phase II clinical trial results for True Human monoclonal antibody MABp1in the treatment of acne vulgaris. The trial was conducted as an open label study using True Human—the first biologic therapy targeting the inflammatory cytokine IL-1α —in patients with moderate to severe acne. The company reports that patients enrolled in the study demonstrated continual improvement in lesions over the course of therapy, with up to 42% reduction in eight weeks.

Published Data Show “Significant Improvement” With LAVIV

Pivotal clinical trial data demonstrating the effectiveness of LAVIV (azficel-T) in the treatment of moderate-to-severe nasolabial fold wrinkles has been published by the Dermatologic Surgery journal (online, March 2012). The data includes the combined results of two identically designed, Phase III, multicenter, randomized, double-blind, placebo-controlled studies of 421 patients.

Biologic Response

FDA-approved LaViv may offer long-lasting wrinkle relief, but will patients pay to wait six months or more for unknown results?
LaViv

When the United States Food & Drug Administration (www.fda.gov) cleared LaViv (azficel-T, Fibrocell Science, www.fibrocellscience.com) in June 2011 for the treatment of moderate to severe nasolabial folds, it was hailed as a more natural alternative to Botox. Unlike neuromodulators or hyaluronic acid-based dermal fillers, LaViv does not offer instant relief from wrinkles. Its effects depend on a biologic process. The physician extracts skin cells from behind the patient’s ear.