The FDA froze biodefense company PharmAthene's anthrax vaccine, sending shares tumbling 17% to $1.21 in recent premarket trading, The Wall Street Journal reports.
Initially expecting to move SparVax rPA into Phase II trials by the end of the year, the company has yet to enroll any subjects to date. The company offered no reason for the hold, but will receive a letter from the FDA within 30 days. PharmAthene ($PIP) will continue to provide the FDA with analytical data from its recently produced GMP lot of material.
The second-generation recombinant vaccine showed protection between 90% and 100% when given on a 6- or 12-month booster dose regime in previous clinical and preclinical trials, according to FierceVaccines. Back in June, Thomas Fuerst, executive vice president and CSO said, "SparVax has previously been evaluated in two separate Phase II clinical trials involving approximately 770 subjects. This latest Phase II trial, which we expect will commence in the second half of this year, will be a dose-ranging and schedule study designed to evaluate the safety and immunogenicity of SparVax in approximately 300 healthy subjects."
With the FDA hold, PharmAthene stock has dropped 27% in the past 12 months, according to the WSJ.
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