Researchers from Genocea Biosciences, Inc. recently finished enrollment for a Phase 2 clinical trial study of dose optimization for GEN-003, a treatment for genital herpes.
The Phase 2 study involves more than 300 patients from 17 facilities across the U.S. Subjects were randomly assigned to one of six dosage groups – 25, 30, 50, 60 or 75 micrograms of the test drug, or a placebo. Subjects took three doses of the GEN-003 medication or the placebo for 21 days.
Then scientists observed the rate of viral shedding in the baseline, which shows the amount of anti-viral activity occurring within the body. Researchers also watched how the treatment influenced genital lesion rates, safety and immunogenicity.
Researchers will continue to study the subjects for a full 12 months after their final dosage.
"The objective of this trial is to build upon the impressive results observed in the prior Phase 1/2a trial,” Seth Hetherington, the chief medical officer of Genocea, said. “Our goal is to replicate the results of the best-performing vaccine dose in that trial, and test other combinations of proteins and adjuvant. By achieving these objectives, we will identify and fully justify the best dose to take forward based on an optimal balance of safety and anti-viral activity.”
Genocea plans to report more data from the post-vaccination observation period in the late second quarter of 2015.
"The patient response and rapid enrollment we experienced underscore the unmet medical need for new treatment options with novel mechanisms of action for this lifelong disease,” Hetherington said.