MacroChem Announces Presentation of Pexiganan Phase 3 Study Results for Topical Treatment of Diabetic Foot InfectionCombined data from two Phase 3 trials show clinical success rates statistically equivalent to oral antibiotic therapy
WELLESLEY HILLS, Mass., March 13, 2008 /PRNewswire-FirstCall/ -- MacroChem Corporation announced today the presentation of a poster entitled "Topical versus Systemic Antimicrobial Therapy for Treating Infected Diabetic Foot Ulcers: A Randomized, Controlled, Double-Blinded, Multicenter Trial of Pexiganan Cream." The poster will be presented at the Diabetic Foot Global Conference 2008 in Los Angeles on March 13 to 15 by Benjamin A. Lipsky, MD, FACP, FIDSA, Professor of Medicine, University of Washington and Director, Primary Care Clinic, VA Puget Sound Health Care System.
The poster presents results of two Phase 3 clinical studies, individually and combined, comparing the efficacy of an investigational topical antimicrobial peptide preparation, pexiganan acetate cream, against systemic therapy with an oral fluoroquinolone antibiotic, ofloxacin, for mildly infected diabetic foot ulcers. The authors conclude, in part, that, "The rates of clinical cure or improvement (the primary outcome of the trial) for topical pexiganan and oral ofloxacin were statistically equivalent for the combined studies."
Dr. Lipsky commented that, "To my knowledge, these combined studies are the largest on treatment of diabetic foot infections ever conducted, the only ones that have compared these two routes of therapy, and the first to demonstrate the efficacy of a topical antimicrobial in treating diabetic foot infection in active-controlled trials. Furthermore, having an effective topical therapy available as an alternative to systemic treatment focuses attention on the wound and, in the case of pexiganan, uses a new antimicrobial, while avoiding adverse systemic effects and the promotion of antibiotic resistance."
"We are very pleased that these newly analyzed data are being presented for the first time at such a prestigious scientific meeting for professionals devoted to diabetic foot complications, including early recognition and treatment of diabetic foot infections," stated Robert J. DeLuccia, President and CEO of MacroChem. He continued, "We have initiated manufacturing and formulation programs to scale-up for an anticipated undertaking of one more Phase 3 trial, the design of which is to be confirmed upon meeting with the FDA later this year."
He further stated, "We believe that, if approved, pexiganan would be welcomed by physicians and patients. Diabetes is an enormous and growing problem worldwide and, as a result, there is an increasing number of diabetic foot infections. Diabetic foot ulcers are a major concern and burden to the approximately 20 million persons with diabetes in the US alone, as well as for the healthcare system. Additionally, there are currently no other topical anti-infectives that have been proven to be effective in treating diabetic foot infections. Accordingly, we believe that pexiganan could fill an important unmet medical need and provide a significant commercial opportunity for an addressable market of millions of diabetic foot infections annually, which translates to a potential estimated one-half billion dollar market in just the US."
The poster presentation is available on MacroChem's website http://www.macrochem.com.
The DFCON 2008 meeting is an interdisciplinary diabetic foot conference held annually in North America. The meeting is designed for a wide spectrum of generalist and specialist physicians who diagnose and manage complications of the diabetic foot. It features presentations on diagnostic and interventional strategies for diabetic foot ulcers and amputation prevention. Featuring a world-renowned faculty, it offers the opportunity to review state- of-the-art concepts and techniques. http://www.dfcon.com
Pexiganan is a 22-amino acid linear peptide. It is formulated as a cream and has a novel mechanism of action based on its ability to disrupt the integrity of bacterial cell membranes. It has antimicrobial activity against Gram positive (methicillin resistant staphylococcus aureus (MRSA)) and Gram negative organisms that commonly infect skin and soft tissue. It has a low potential for induction of resistance and no cross-resistance with existing therapeutic antibiotics as a consequence of its mechanism of action.
About Diabetes and Diabetic Foot Infection
According to the U.S. Centers for Disease Control and Prevention (CDC), there are about 20.8 million people with diabetes in the U.S. (in 2005). Current estimates are that about 7% of all Americans have diabetes, and that prevalence is expected to increase each year. Among the complications caused by diabetes are foot disorders.
It is estimated that up to about 25% of persons with diabetes will develop a foot ulcer in their lifetime of which about 60% get infected. Diabetic foot ulcers generally result from the consequences of peripheral neuropathy, with loss of protective sensations and foot deformities. The presence of peripheral vascular disease, increased biomechanical stress and acute trauma further increase the risk of foot ulcers. It usually takes several months for an ulcer to heal, and during this period there is a continual risk of foot infection. Infected foot ulcers can result in bone infection (osteomyelitis) or progressive gangrene, and are the major immediate cause of lower limb amputation. Diabetes is now the top cause of non-traumatic leg amputations in the developed world. Furthermore, foot ulcers are now the most frequent cause of diabetes-related hospitalizations. Thus, diabetic foot ulcers and infection are a major burden to both the patient and the healthcare system resulting in long-term disabilities and high demands on the healthcare system.
MacroChem Corporation is a specialty pharmaceutical company that develops and seeks to commercialize pharmaceutical products. Our lead product candidates are EcoNail(R) and pexiganan. EcoNail is a topically applied SEPA- based econazole lacquer for the treatment of onychomycosis, a condition commonly known as nail fungus. We recently acquired exclusive worldwide license rights to pexiganan, a novel topical anti-infective for the treatment of diabetic foot infection, which has already completed two Phase 3 trials. Our other clinical stage product candidate, Opterone(R), is a topically applied SEPA-based testosterone cream designed to treat male hypogonadism. Our pipeline of clinical-stage and early-stage product candidates is based on our SEPA, MacroDerm(TM) and DermaPass(TM) drug delivery technologies. For more information visit our website, www.macrochem.com.
With the exception of historical information contained in this press release, the matters described herein are forward-looking statements that involve risks and uncertainties. MacroChem's actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed or referred to in the section entitled "Risk Factors" in MacroChem's Annual Report on Form 10-K, as well as those discussed elsewhere therein, and include, without limitation, risks regarding product development, the timing and results of clinical trials, the regulatory approval process, capital requirements, financial condition, patent protection and dependence on third parties for development and licensing arrangements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. MacroChem undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. For more information visit our website, http://www.macrochem.com.
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Posted: March 2008