FDA MAINTAINS HOLD ON VAXGEN'S ANTHRAX VACCINE STUDY

VaxGen announced that the FDA's Center for Biologics Evaluation and Research (CBER) has informed the company that it is maintaining its clinical hold on the company's second Phase II trial for its investigational anthrax vaccine, rPA102. The hold is due to CBER's continued concerns about the vaccine candidate's stability.

CBER had imposed the hold Nov. 3 on the grounds that data submitted by the company were insufficient to determine that the investigational vaccine was stable enough to resume clinical testing.

HHS, under its contract awarded in 2004 to purchase 75 million doses of VaxGen's recombinant anthrax vaccine, had imposed a deadline of Dec. 18 for the company to initiate its next clinical trial for the vaccine candidate. The agency had amended the agreement in May to require additional studies before delivery of the vaccine.

At a recent meeting with CBER, which was also attended by HHS representatives, VaxGen presented its expanded number of methods for measuring the vaccine's potency and stability and its progress toward further enhancing the stability of the vaccine's formulation, the company said. Based on that exchange, VaxGen believes that CBER wishes to engage the company in additional discussions about its analytical methods and formulation development. However, the clinical hold will remain in place until sufficient vaccine stability has been demonstrated.