Discoverer of Magainins, the first of a new class of anti-infectives, to
advise Company on pexiganan development
WELLESLEY HILLS, Mass., Oct. 17 /PRNewswire-FirstCall/ -- MacroChem Corporation (OTC Bulletin Board: MACM) today announced that following its acquisition of rights to pexiganan, Michael Zasloff, M.D. has joined the company's Scientific Advisory Board. Dr. Zasloff discovered magainins in the skin of the African clawed frog while at NIH (National Institutes of Health) and later pioneered the development of magainins, and specifically pexiganan, as human anti-infective drugs.
"Along with Tom Chan, Ph.D., Chairman of our Scientific Advisory Board, we welcome Dr. Zasloff," said Robert J. DeLuccia, President and CEO of MacroChem. We are very pleased to have his knowledge and experience helping to guide us in advancing the development of pexiganan."
Michael Zasloff, M.D., Ph.D. is currently Professor of Surgery and Pediatrics at the Georgetown University School of Medicine. An internationally known biomedical researcher, Dr. Zasloff was previously Dean of Research and Translational Science at the Georgetown University Medical Center, responsible for the overall management of Georgetown's biomedical research and its translation from the laboratory to patient care. Dr. Zasloff has been a pioneer in the field of innate immunity. His studies have helped elucidate the pathophysiology of chronic infections in diseases such as cystic fibrosis. In addition, he has been the leader in the discovery of antimicrobial peptides and aminosterols of animal and human origin and their development as human therapeutics. Dr. Zasloff earned his M.D., Ph.D. at New York University School of Medicine in the Medical Scientist Training Program, sponsored by the National Institutes of Health. He served his Residency in pediatrics at the Boston Children's Hospital. In 1975 he joined the National Institutes of Health for postdoctoral studies in molecular genetics, and in 1981 was named Chief of the Human Genetics Branch of the National Institutes of Child Health and Human Development. In 1989 he left the NIH to become the Charles E.H. Upham Professor of Pediatrics and Genetics at the University of Pennsylvania School of Medicine and Chief of the Division of Human Genetics of the Children's Hospital of Philadelphia. In that same year (1989) he founded Magainin Pharmaceuticals (now Genaera) and served as Vice Chairman and Executive Vice President until 2001. Dr. Zasloff holds over forty patents, has been widely published, and has been the recipient of numerous awards. His current studies focus on the role of innate immunity in the setting of human small intestinal transplantation, and the pathways that control the expression of antimicrobial peptides in human health and disease.
"It is my pleasure to join the MacroChem team to resume the development of pexiganan," said Dr. Zasloff. The need for a topical therapy for infected diabetic foot ulcers remains more pressing than ever, both because of the increasing prevalence of diabetes, and the emergence of multidrug-resistant bacteria. Over the past several years numerous published reports have confirmed the importance of antimicrobial peptides in the natural control of human infections. In diseases like diabetes we believe these antimicrobial defenses fail, resulting in skin and soft tissue infection. As a potent broad spectrum antimicrobial peptide, pexiganan can rapidly kill the many types of microbes that infect the diabetic foot, and should not promote the appearance of resistant microbes."
Mr. DeLuccia further noted, "We believe pexiganan is a unique opportunity for MacroChem to broaden its development portfolio with a product that has already completed two Phase 3 clinical trials. It also fits our strategic focus and complements our lead product candidate, EcoNail(R) for treatment of nail fungus. EcoNail is currently in a fully enrolled Phase 2 trial and progressing on track with an interim assessment of clinical data after all patients have been treated for twenty four weeks."
Both EcoNail and pexiganan are being developed for diseases of the foot predominantly treated by the same prescribing specialists, namely podiatrists. Both products would potentially be of interest to a larger number of physician specialists and primary care physicians as well. EcoNail is the company's patented lacquer which contains the antifungal econazole and MacroChem's enhancer SEPA(R). Patients participating in the EcoNail study will receive forty-eight weeks of treatment and will undergo efficacy assessments using standard criteria of nail appearance and mycology. However, the Company will collect and evaluate twenty-four week interim data. This trial was specifically designed, with the assistance of well-known onychomycosis experts, to address three important objectives: to assess early signs of efficacy, to maintain robust clinical endpoints in the full study, and, if successful, to facilitate advancement to Phase 3 as soon as possible.
MacroChem Corporation is a specialty pharmaceutical company that develops and seeks to commercialize pharmaceutical products. Our lead product candidate is EcoNail, 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, http://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.
MacroChem: Bernard Patriacca - VP/CFO
Investor Relations: The Investor Relations Group, Inc.
Christine Berni/ Joseph Triunfo, (212) 825-3210
Bill Douglass/ Michaela Heller, (212) 825-3210
|SOURCE MacroChem Corporation|
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