Positive Phase 2a results from Barrier Therapeutics, Inc.'s (BTRX) study of pramiconazole, its novel oral broad-spectrum antifungal product candidate in patients with onychomycosis (nail fungus) of the toenails, boosted shares at Friday's open from a 52-week low on Thursday. Results indicate a marked onset of clinical improvement in total signs and symptoms of onychomycosis as measured by nail plate thickening, discoloration and overall appearance of the affected toenail. One month after completing once weekly treatment for 12 weeks, indicate a marked onset of clinical improvement in total signs and symptoms of onychomycosis as measured by nail plate thickening, discoloration and overall appearance of the affected toenail.
The prevalence of onychomycosis in America is about 2-3%, but some have reported it as high as 13%. Even at a low estimate of 2%, this accounts for 6 million Americans with toenail fungus. Toenail fungus affects men twice as often as it affects women. The prevalence among elderly individuals and diabetics is 25%.
Dr. Braham Shroot, Chief Scientific Officer said, "Pramiconazole could address an unmet need for a new, more convenient, and possibly safer once weekly treatment option for the 35 million people in the United States who suffer from this chronic, recurring condition."
The most common current oral anti-fungal medications are Janssen Pharmaceuticals' Sporonox(R)(itraconazole) and Novartis' (NVS) Lamisil(R)(terbinafine). Both medications can be quite expensive as they need to be taken once daily for at least 3 months. The effectiveness of the medications ranges from 60% to 80%, with a recurrence rate of 15%. Lamisil appears to be more effective and has fewer drug interactions than Sporonox. Other oral agents, such as Pfizer's (PFE) Diflucan(R), are not considered as effective.
Penlac(R)(ciclopirox) 8% solution remains the sole prescription topical antifungal therapy effective for nail fungus. It is marketed by sanofi-adventis' (SNY) U.S. dermatology business, Dermik. Penlac works best for containing and treating very early nail fungus limited to a very few nail plates. Consistent daily application and immaculate nail grooming are necessary to maximize results.
Pramiconazole has also demonstrated positive results in clinical studies in tinea pedis (athlete's foot), tinea corporis (ring worm), tinea cruris (jock itch), tinea versicolor, vaginal candidiasis and seborrheic dermatitis.
Two other products in development include Hyphanox(TM), an oral tablet formulation of itraconazole for the treatment of onychomycosis in Pase 3; and Oral Rambazole(TM), an oral formulation of Rambazole that is being developed for the treatment of psoriasis.
Barrier's marketed products are: Xolegel(TM)(ketoconazole, USP) 2% Gel, a topical gel for the treatment of seborrheic dermatitis; Vusion(R)(0.25% miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum) Ointment, a topical ointment indicated for the treatment of infants and children with diaper dermatitis infected by a yeast called Candida; and Solage(R)(mequinol 2.0% and tretinoin 0.01%) Topical Solution, a topical solution indicated for the treatment of solar lentigines, commonly known as "age spots."
As of June 30, 2007, the Company had an accumulated deficit of $235.3 million and cash/marketable securities of 37.1 million. It recently completed a direct offering of its common stock for approximately $31.9 million in gross proceeds.
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