FDA rejects Magainin application for Locilex

PLYMOUTH MEETING, Pa., July 26 - Magainin Pharmaceuticals Inc. (Nasdaq: MAGN) announced on Monday that the U.S. Food and Drug Administration had considered non-approvable its new drug application for Locilex, an ingenious new topical antibiotic cream for the treatment diabetic foot ulcers.

On March 4, an "advisory committeee" to the anti-infectives division of the FDA - without diabetic representation - recommended 7-4 against the antibiotic cream. Despite unanimous agreement about the drug's safety, the committee apparently was not absolutely convinced that it was the drug or the comparator which healed the wounds' infections as opposed to "debridement." Nevertheless, this study design had been approved by the division prior to initiation of trials.

The panel recommended that Magainin - despite being misled by the division and short of funds - conduct a new study comparing patients taking Locilex to those taking a placebo rather than another antibiotic. The FDA anti-infectives division cowardly and unscrupulously followed the mindless advice of this panel thus allowing itself to be (1) untrue to its word, (2) a dishonor to its government, and (3) a disgrace to its people -especially to those hapless diabetics who may otherwise forfeit their limbs...and life.

FDA REJECTS UNIQUE AND COMPLETELY SAFE TOPICAL MEDICATION - AS EFFICACIOUS AS AN ACTIVE SYSTEMIC ANTIBIOTIC - INDICATED FOR THE TREATMENT OF DIABETIC FOOT ULCERS

  • Complete Version of Advisory Committee Transcript (RTF )
  • Reviewing officer NOT even an MD
  • Company completely complied with all FDA requests and now is being asked to do another trial
  • Company is very small and a start-up
  • We believe you should notify your congressman of this outrageous abuse of power

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Magainin Peptides

The first magainins (c.f. Hebrew magain or "shield") were isolated from the African frog Xenopus laevis by Dr. Michael A. Zasloff, the Vice Chairman and Executive Vice President of Magainin, while conducting genetic and molecular biological research at the National Institutes of Health (NIH) in 1987.

In connection with his research, Dr. Zasloff was performing surgery on African clawed frogs in his laboratory. After suturing the frogs and returning them to their aquarium tank, he noticed that the incisions healed without infection, inflammation or notable scarring, despite being exposed to the bacteria-filled aquarium water. Dr. Zasloff deduced that the frogs produced a substance that protected them against infection. Eventually, he isolated, from the skin, two related peptides, which he called magainins and which were later shown to kill a variety of pathogens, including bacteria, amoeba, fungi and parasites.

Magainins are peptides. A peptide is a chain of molecules, known as amino acids, which are considered to be one of the basic building blocks of the human body. Chains of two to 50 amino acids are generally referred to as peptides, while longer chains are referred to as proteins. The Company has modified natural peptides by rearranging the order and combination of amino acids and by substituting and deleting additional amino acids to produce magainins having a broader spectrum of therapeutic activity and improved potency. Magainins have demonstrated broad activity against a variety of pathogens in preclinical studies.

An increasing problem in the antibiotic field is resistance, the process by which antibiotics lose their effectiveness over time as bacteria, through mutation, develop the means to produce enzymes capable of diminishing the antibiotic utility. To date, the Company has not noted the development of resistance to magainins. The Company believes this is due to the unique mechanism of action of magainins, which differs from traditional antibiotics. In the presence of a cell membrane, rich in acidic phospholipids and poor in cholesterol, such as bacterial membranes, magainins twist into two-sided, spiral shaped molecules (helices), with one side soluble in the fat-like substance that comprise cell membranes and the other side soluble in water. Individual magainin peptides then aggregate and line up to form a channel in the membrane of a pathogen. Once formed, this aggregate punctures the cell membrane, breaks down the integrity of the cell and kills the pathogen.
Michael A. Zasloff, M.D., Ph.D.

Vice Chairman and Executive Vice President

Dr. Zasloff has served as Executive Vice President of the Company and President of the Magainin Research Institute, since July 1992. In July 1996, Dr. Zasloff was appointed Vice Chairman of the Board. From 1988 until Dr. Zasloff joined the Company on a full-time basis in July 1992, Dr. Zasloff was the Company's Chief Scientific Advisor and served as the Charles E.H. Upham Professor, Department of Pediatrics and Genetics, University of Pennsylvania School of Medicine, and Chief, Division of Human Genetics and Molecular Biology, The Children's Hospital of Philadelphia. From 1982 until 1988, Dr. Zasloff was Chief, Human Genetics Branch, National Institutes of Child Health and Human Development, National Institutes of Health. Dr. Zasloff currently also serves as Adjunct Professor, Department of Human Genetics and Orthopedics, University of Pennsylvania School of Medicine.

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