Penederm Begins Phase III Study on New Topical Antifungal Combination Therapy; Favorable Phase II Clinical Data Reported at Dermatology Seminar in Santa Fe, N.M.FOSTER CITY, Calif.--(BW HealthWire)--Oct. 29, 1997--Penederm today announced that the Company has commenced two pivotal Phase III human clinical trials, involving 32 sites and 1600 patients, evaluating a new topical antifungal combination therapy (project name: 501 Cream). The decision to begin pivotal trials is a result of encouraging Phase II human clinical data recently reported at a meeting of the Skin Disease Education Foundation in Santa Fe, N.M., demonstrating that 501 cream effectively treats tinea pedis tinea ped·is n. See athlete's foot. Tinea pedis Fungal infection of the feet of the skin characterized by dry, scaly lesions. (athlete's foot athlete's foot: see ringworm. athlete's foot Form of ringworm that affects the feet. In the inflammatory type, the infection may lie inactive much of the time, with occasional acute episodes in which blisters develop, mostly between the toes. ) when applied twice daily for only seven days. 501 cream contains butenafine HCl 1% cream and betamethasone betamethasone /be·ta·meth·a·sone/ (ba?tah-meth´ah-son) a synthetic glucocorticoid, the most active of the antiinflammatory steroids; used topically as the benzoate, dipropionate, or valerate salts as an antiinflammatory, topically or dipropionate 0.05% cream and Penederm's patented topical drug Topical drug Drug or medication applied to a specific area of the skin and affecting only the area to which it is applied. Mentioned in: Minoxidil delivery technology, Topicare Delivery Compounds(R). "We are extremely pleased with the results of a Phase II study of 501 cream and have decided to accelerate Phase III studies with a goal to file a New Drug Application in the second half of 1998," stated Lloyd Malchow, President and Chief Executive Officer of Penederm. "501 cream addresses a significant market and could offer safety and compliance advantages over current 28-day therapies that may expose patients to steroids for a very long dosing period." Prolonged use of topically applied steroids can result in the pronounced appearance of capillaries and veins, skin thinning, redness, bruising, and irreversible streaking of the skin, sometimes referred to as `stretch marks.' A total of 78 patients with culture-confirmed interdigital interdigital between two digits. interdigital cysts see interdigital pyoderma, pododermatitis. interdigital dermatitis 1. the early lesion in the development of infectious footrot in sheep; called also sheep scald. tinea pedis were evaluated in the Phase II multi-center, parallel-group, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blinded study. Of the 78 patients who completed the study, 25 applied the combination therapy, 25 applied 1% butenafine cream alone and 28 applied a vehicle without active ingredient twice daily for one week. Patients were evaluated at days 3, 8, 14, and 49. Investigators in the study included: Debra Breneman, Md., Cincinnati, Ohio; Richard L. De Villez, Md., San Antonio, Texas “San Antonio” redirects here. For other uses, see San Antonio (disambiguation). San Antonio is the second most populous city in Texas, the third most populous metropolitan area in Texas, and is the seventh most populous city in the United States. As of the 2006 U.S. ; Terry Jones, Md., Bryant, Texas; Blas Reyes, Md., Miami, Fla.; and Eduardo Tschen, Md., Albuquerque, N.M. As early as Day 8 in the study, the combination therapy improved symptoms in more patients than butenafine alone or the vehicle. The differences in healing rates continued even six weeks after treatment was discontinued, at which time more patients in the combination group exhibited improved symptoms than patients in either the butenafine group or the vehicle group. In addition, results on Day 49 showed that the combination therapy provided a statistically significantly higher effective treatment than the antifungal alone or the vehicle. Butenafine is the first of a new class of antifungal agents antifungal agents, n.pl agents that inhibit, control, or kill fungi. The most common yeastlike fungus occurring in or near the oral cavity is C. albicans. known as the benzylamines, which are chemically and pharmacologically related to the allylamine antifungal drugs. This new class of antifungals has shown better efficacy with shorter treatment periods and less frequent dosing than existing fungistatic fun·gi·stat·ic adj. Having an inhibiting effect upon the growth and reproduction of fungi without destroying them. drugs. Penederm acquired exclusive rights to the active compound in North, Central, and South America and semi-exclusive rights for other geographies. Betamethasone dipropionate is a synthetic adrenocorticosteriod which is widely used in dermatology to reduce inflammation. Topicare Delivery Compounds are liquid polymers that deposit and hold drugs and other skin-care agents in the upper layers of the skin. Penederm Inc. is a specialty pharmaceutical company located in Foster City, Calif., which focuses on the commercialization of dermatology products. Any statements contained in this release that relate to future plans, events or performance, including the scheduled NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any filing date and the potential advantages of the 501 cream, are forward-looking statements that involve risks and uncertainties, including, but not limited to, risks associated with product development efforts and clinical trials, market acceptance risks, product manufacturing risks, risks associated with the establishment and management of a contract sales force, the impact of competitive products and pricing, the results of financing efforts, developments regarding intellectual property rights and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , risks of product nonapproval or delays or post-approval reviews by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. or foreign regulatory authorities, and other risks identified in the Company's Securities and Exchange Commission filings. Actual results, events or performance may differ materially. Readers are cautioned not to place undo reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. CONTACT: Penederm Inc. Michael A. Bates Bates , Katherine Lee 1859-1929. American educator and writer best known for her poem "America the Beautiful," written in 1893 and revised in 1904 and 1911. , 415/358-0100 www.Businesswire.com/cnn/derm.htm or Feinstein Kean Partners Inc. Douglas MacDougall, 617/577-8110 |
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