Pipeline Previews

May 2014 | Volume 13 | Issue 5 | Feature | 631 | Copyright © 2014

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Abstract

Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.

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Mederma® PM Scar Cream

Mederma® PM Intensive Overnight Scar Cream is a new scar cream formulated to work at night. Mederma® PM is clinically shown to improve the overall appearance, size, color, and texture of scars, making them softer, smoother, and less noticeable. Mederma reports that subjects who used Mederma® PM for 8 weeks as directed saw noticeable improvement in the size of scars in as little as 2-4 weeks and a 50% reduction in the size of the scars after 8 weeks. The cream is also formulated with Tripeptol™, a skin-nourishing complex with peptides, collagen, and antioxidants that complement the increased nighttime regeneration of the skin to promote healthy looking skin.

Mederma® PM is available in the First Aid and Skin Care sections of drugstores. Mederma® PM may be used on scars on the face and the body resulting from injury, cuts, surgery, burns and acne. For best results, Mederma® PM should be applied evenly and gently rubbed into the scar once nightly for eight weeks on new scars and once nightly for three to six months on existing scars.

Quinnova Pharmaceuticals and Ecoza (Econazole Nitrate) Topical Foam, 1%

Quinnova Pharmaceuticals has announced the launch of its FDA-approved Ecoza (econazole nitrate) topical foam, 1%. Ecoza foam is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older.

Quinnova touts Ecoza foam as a novel alternative for the treatment of interdigital tinea pedis (athletes foot between the toes), combines the proven antifungal efficacy of econazole nitrate with the skin-restoring properties of Proderm Technology. The company claims that the foam is proven to kill fungi that cause interdigital tinea pedis when applied once-daily for 4 weeks.

In two double-blind, parallel-group, vehicle-controlled, multicenter clinical trials, 495 subjects aged 12 years with a clinical diagnosis of interdigital tinea pedis and fungal culture positive for a dermatophyte at baseline received ecoza foam (n=246) or foam vehicle (n=249). Subjects applied ecoza foam or foam vehicle once daily for 4 weeks. The primary endpoint was proportion of subjects who achieved a complete cure (negative KOH, negative fungal culture, no evidence of clinical disease as indicated by complete resolution of all signs and symptoms) at 2 weeks post-treatment (Day 43). Secondary endpoints included mycologic cure (negative KOH and negative culture) and effective treatment (mycologic cure + no or mild erythema and/or scaling and all other signs and symptoms absent).

The results from the clinical studies demonstrated that ecoza foam exhibited superiority over foam vehicle for the primary and secondary endpoints and demonstrated potent antifungal activity against all of the pathogens evaluated with a high mycologic cure rate. The complete cure rate at Day 43 (2 weeks post-treatment) was higher in the ecoza foam group (24.3%) than in the foam vehicle group (3.6%). In addition, higher rates of mycologic cure (67.6% vs 16.9%) and effective treatment (48.6% vs 10.8%) were observed with econazole nitrate foam 1% versus the foam vehicle. Ecoza foam was safe and well tolerated with a safety profile comparable with the foam vehicle. During clinical trials with Ecoza foam the most common adverse reactions were application site reactions, which occurred in less than 1% of subjects in both the Ecoza foam and vehicle arms.

Induction of Systemic Immunity Following Treatment of Tumors With PV-10

Provectus Biopharmaceuticals, Inc. a development-stage oncology and dermatology biopharmaceutical company, reports that on April 6, 2014, researchers from the Moffitt Cancer Center presented a poster presentation detailing significant decrease in melanoma cells in patients’ injected tumors 7-14 days after intralesional PV-10 treatment that was accompanied by similar decrease in uninjected bystander tumors. These clinical and pathologic changes were accompanied by increases in important immune cell populations detected in the patients’ peripheral blood. The poster presentation, based upon abstract #630, entitled “Induction of anti-melanoma immunity after intralesional ablative therapy,” was authored by Hao Liu, Krithika Kodumudi, Amy Weber, Amod A. Sarnaik and Shari Pilon- Thomas of the Moffitt Cancer Center.

Provectus’ investigational drug PV-10, a 10% solution of Rose Bengal, is currently being studied as a novel cancer therapeutic, and Provectus has applied to the FDA for breakthrough therapy designation of PV-10 for the treatment of melanoma based on a 7 center international single-arm trial. PV-10 is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, significantly reducing potential for systemic side effects. In melanoma patients, intralesional (IL) injection of PV-10 has led to regression of injected lesions as well as uninjected metastases. The mechanism of regression of uninjected lesions is under investigation at Moffitt Cancer Center

The Moffitt researchers presented clinical data on 8 melanoma patients that demonstrated significant decreases in melanoma cells in injected tumors and uninjected bystander tumors 7-14 days after PV-10 injection as evidenced by pathologic evaluation confirmed with immunohistochemical staining of biopsy

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