Navigation Links
TOPICA Begins Phase 2 Clinical Trial of Potent Antifungal, Luliconazole, in Athlete's Foot
Date:4/22/2009

PALO ALTO, Calif., April 22 /PRNewswire/ -- TOPICA Pharmaceuticals today announced the enrollment of patients in a Phase 2 clinical trial evaluating luliconazole for the treatment of tinea pedis (athlete's foot). Luliconazole, the company's lead product candidate, is the one of the most potent and broad spectrum molecules in the imidiazole class of antifungal agents, giving it the potential to provide physicians and patients with a needed topical solution to a variety of skin and nail fungal infections.

"The initiation of this trial represents a significant milestone for TOPICA as we begin our U.S. clinical development program of this promising drug candidate, which already has been proven in millions of patients in Japan," said Greg Vontz, president and chief executive officer of TOPICA. "We expect to complete this trial by the end of this year, potentially enabling us to initiate our pivotal Phase 3 clinical trial in 2010."

Phase 3 data from clinical studies conducted in Japan demonstrated that luliconazole successfully treated tinea pedis in half the time of commonly prescribed products. Since the 2005 approval of luliconazole in Japan for the treatment of tinea infections, more than 4 million patients have been safely treated with luliconazole. TOPICA has an exclusive license to develop and market luliconazole in the Americas and Europe.

The Phase 2, multi-center, randomized, double blind, trial is evaluating the safety and optimal duration of 1 percent luliconazole cream administered once daily for 14 or 28 days in patients with tinea pedis. The primary efficacy endpoint is to achieve complete clearance of the infection at two weeks post treatment. Currently in the U.S. available prescription medications generally require treatment once or twice a day for up to four weeks to achieve this result. The company expects to enroll approximately 120 patients in the trial, which is being conducted at 5 clinical trial sites in the United States. For more details on the trial go to http://www.topicapharma.com and clink on the link for the trials posting on www.clinicaltrials.gov.

In addition, the company is developing luliconazole for onychomycosis (nail and nail bed fungal infections) and plans to move ahead with clinical development of onychomycosis shortly. The company's successful preclinical studies of luliconazole demonstrate that it has the ability to easily penetrate the toenail achieving rapid fungal eradication in the nail bed, as measured by MedPharm's in vitro ChubTur infected nail model. Luliconazole is also unique in that the molecule doesn't require devices, procedures or "delivery enhancement" to cross the nail. Onychomycosis affects approximately 35 million people in the U.S. Of those affected, it is estimated that 47 percent are not receiving treatment. The disease can cause extreme disfigurement of nails and can often result in pain. The potential annual U.S. market for onychomycosis treatment is estimated at approximately $3.0 billion.

About Tinea Pedis

Tinea pedis (athlete's foot) is the most common fungal infection of the skin, affecting about one in every 10 people at any given time. Patients with the disease often experience itching and burning on the infected area. In severe cases, the disease can cause cracking, pain and bleeding. In 2008, the U.S. prescription market for tinea pedis was $385 million equating to approximately 22 million prescriptions. The topical prescription antifungal market has been dominated in recent years by generics due to the fact that a new prescription anti-fungal agent has been not been introduced into the market in over five years.

About TOPICA Pharmaceuticals

TOPICA is a privately held, specialty pharmaceutical company, focused on licensing, developing, and commercializing potent topical prescription products to treat the needs of patients with serious nail and skin conditions. Taking advantage of its established trans-pacific network of scientific and industry contacts, TOPICA has in-licensed its lead-product candidate, luliconazole, a topical antifungal agent that is already on the market in Japan. TOPICA is developing it for the treatment of tinea pedis (athlete's foot) and onychomycosis (nail and nail bed fungal infections). For more information, please visit http://www.topicapharma.com.


'/>"/>
SOURCE TOPICA Pharmaceuticals
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Summit VetPharm Offers New Flea Topical Vectra for Dogs & Puppies(TM) For Long-Lasting Protection
2. New Topical Painkiller Relieves Severe Pain in Minutes
3. Topical Dermatological Product Development in the USA Workshop to Be Held on June 4, 2009 in East Brunswick, New Jersey, USA
4. Chronic Pain Sufferers Report Relief: DRJ Group Teams With Adult Foster Care Facilities to Evaluate Effectiveness of Stopain Topical Analgesic
5. Topical Spray Helped Men With Premature Ejaculation
6. Perrigo Announces FDA Approval for Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)
7. Global Warming Expected to Spike Pollen and Spring Allergies - New Drug-Free Topical Gels Boost Hope for Allergy Sufferers
8. Study Shows Nonprescription LCD Topical Solution is More Effective than Prescription-Strength Calcipotriol Cream for Moderate Plaque Psoriasis
9. The Texas Institute of Dermatology Team Finds Easy-to-Apply, Topical Drug Just as Good as Injectable Compound for a Disfigurating Skin Infection
10. NanoBio to Announce Key Clinical and Preclinical Data on Its Topical Anti-infective Lotions at AAD 2009
11. American Academy of Dermatology Issues New Guidelines For The Management of Psoriasis With Topical Therapies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/17/2017)... ... January 17, 2017 , ... Kevin Harrington (one of the original Sharks ... DRTV campaigns regarding the topic of Beauty and Personal Care. , ... What better way to commit to these changes than beginning with personal care and ...
(Date:1/17/2017)... Florida (PRWEB) , ... January 17, 2017 , ... ... City, a new 21st century approach to infusing high speed technology into the ... area exclusively dedicated to the advancement of healthcare and wellness in a yet-to-be-named, ...
(Date:1/17/2017)... ... ... Mirror Mirror Beauty Boutique, Houston’s premiere CoolSculpting provider , is proud ... Rewards Program. Practice founder, Paul Vitenas, MD FACS, is delighted that Mirror Mirror Beauty ... by Zeltiq, CoolSculpting is approved by the Food and Drug Administration as a safe ...
(Date:1/17/2017)... ... January 17, 2017 , ... Peoples ... the Peoples Health network on Dec. 1, 2016. Peoples Health, a Metairie-based Medicare ... Center is an exciting addition to our provider network, and the addition will ...
(Date:1/17/2017)... ... , ... A prescription medication bottle, pocket knife, luggage and a solar-powered aluminum ... Design Challenge , the Cradle to Cradle Products Innovation Institute has announced. ... to run through early 2018. The challenges are presented by the Institute in partnership ...
Breaking Medicine News(10 mins):
(Date:1/17/2017)... IRVINE, Calif. , Jan. 17, 2017  Edwards ... leader in patient-focused innovations for structural heart disease and ... for the quarter ended December 31, 2016 after the ... host a conference call at 5:00 p.m. ET that ... in the conference call, dial (877) 407-8037 or (201) ...
(Date:1/17/2017)... KANSAS CITY, Mo. , Jan. ... (CHNC) has selected Velos and its flagship technology ... and multicenter initiatives. CHNC is a ... Neonatal Intensive Care Units at leading children,s hospitals ... consortium provides a benchmark of care and short-term ...
(Date:1/17/2017)... ReportsnReports.com adds "Anaphylaxis - Pipeline Review, ... of the Anaphylaxis,s therapeutic pipeline with comprehensive information on the ... stages, therapeutics assessment by drug target, mechanism of action (MoA), ... updates, and featured news and press releases. ... Complete report on H2 ...
Breaking Medicine Technology: