cell transplant recipient in the company's Phase 2 trial of a DNA
vaccine against cytomegalovirus (CMV). After the 20th recipient's
two-month follow-up visit, an independent data safety monitoring board
will conduct an interim evaluation of safety data for all subjects
enrolled in the trial.
-- The company has initiated 30 of up to 60 planned clinical sites for the
AIMM (Allovectin-7(R) Immunotherapeutic for Metastatic Melanoma) Phase
3 pivotal trial of the Allovectin-7(R) cancer immunotherapeutic as
first-line therapy in chemotherapy-nave patients with recurrent Stage
III or IV metastatic melanoma. The trial is being funded by AnGes under
a collaborative agreement with Vical.
-- During the second quarter, the company completed the final contract
manufacturing and shipment of HIV vaccine bulk DNA under a $12 million
production order for the National Institutes of Health (NIH) for a
planned Phase 2b efficacy proof-of-concept trial expected to begin this
year with the support of the Partnership for AIDS Vaccine Evaluation
(PAVE). The PAVE trial will test a vaccine regimen combining a DNA
prime based on Vical's technology with an adenoviral vector boost in up
to 8,500 volunteers at sites in the United States, Africa, the
Caribbean and South America to determine its potential to prevent
infection or disease progression.
-- Vical was awarded a three-year, $6.0 million grant from the National
Institute of Allergy and Infectious Diseases (NIAID), part of the NIH,
for further development of a DNA vaccine manufacturing process with the
potential to produce several million doses of vaccines in a matter of
days. By using a cell-free manufacturing process, the company believes
that the RapidR
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