>>PRINCETON, N.J. and ANNAPOLIS, Md., Aug. 8 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) and PharmAthene, Inc., a privately held biotechnology company dedicated to the development of biodefense products, today announced the allowance of an Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for Valortim(TM) (MDX-1303), a fully human monoclonal antibody targeting the Bacillus anthracis protective antigen. Valortim was developed using Medarex's UltiMAb Human Antibody Development System® and will be the 24th UltiMAb® product candidate to enter clinical studies.
The Phase I dose-escalation trial is expected to enroll up to 46 healthy volunteers and is designed to collect safety and pharmacokinetic data. The funding of this clinical trial is supported in large part by a grant from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, awarded to Medarex for product development of Valortim as an agent to counter the bioterrorism threat of anthrax exposure.
"I am delighted with our progress. Medarex and PharmAthene have worked diligently and efficiently to reach this significant milestone for Valortim. We are extremely enthusiastic about Valortim's ability to help the U.S. Government secure effective products to protect the nation's citizens from biological terrorism," said David P. Wright, President and CEO of PharmAthene.
"We are pleased with the progress of our alliance with PharmAthene and to see Valortim advancing into clinical studies," said Donald L. Drakeman, President and CEO of Medarex.
Dr. Israel Lowy, Medarex Senior Director of Clinical Science and Infectious Disease, said, "In preclinical animal studies Valortim has been shown to protect both rabbits and monkeys against the lethal effects of infection when administered at the time of exposure at doses as low as 1 mg/kg. When administered to rabbits after the development of symptoms, Valortim also improved survival as late as 48 hours post-exposure as compared to controls."
A recently performed study in non-human primates has demonstrated the potency of Valortim in this model using the potentially most clinically useful intramuscular route of administration. In this study, the animals were challenged with a target aerosol dose of 200 times the median lethal dose of B. anthracis spores; 6 animals received no treatment, 6 animals received 1 mg/kg of Valortim intramuscularly, and 6 animals received 10 mg/kg of Valortim intramuscularly, all at the time of aerosol challenge. None of the animals were given antibiotics or other therapies. All control animals died within one week of the challenge; all treated animals in both dose groups were reported alive 60 days post-challenge. The animals continue to be observed and final analysis of the entire dataset is pending.
The program of animal efficacy studies, commercial manufacturing of Valortim and initial clinical trials, are all proceeding in accordance with the plans established by Medarex, and PharmAthene and in conformity with NIH grant requirements.
About Valortim
Valortim (MDX-1303) is a fully human antibody designed to protect against inhalation anthrax, the most lethal form of illness in humans caused by the Bacillus anthracis bacterium. The investigational antibody is designed to target a protein component known as the anthrax protective antigen of the lethal toxin complex produced by the bacterium. The anthrax protective antigen is believed to initiate the onset of the illness by attaching to cells in the infected person, and then is believed to facilitate the entry of additional destructive toxins into the cells. Valortim is designed to target anthrax protective antigen and protect the cells from damage by the anthrax toxins.
About Anthrax
According to the Centers for Disease Control and Prevention, anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis. Anthrax most commonly occurs in hoofed mammals and can also infect humans. Symptoms of disease vary depending on how the disease was contracted, but usually occur within seven days after exposure. The serious forms of human anthrax are inhalation anthrax, cutaneous anthrax, and intestinal anthrax. Initial symptoms of inhalation anthrax infection may resemble a common cold. After several days, the symptoms may progress to severe breathing problems and shock. Inhalation anthrax is often fatal, even with the use of antibiotics.<<
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Milestone for someone here? Erik must be off on his bike again.
Cheers, Tuck |
