Hawaii Biotech has initiated a Phase I clinical trial study with its West Nile vaccine candidate. The study, being conducted with healthy subjects, is the first clinical trial for the company.
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This clinical study, which will be recruiting volunteers for four treatment groups, is being conducted at a Phase I trial site in Honolulu. Results should be known within a year, the company said.
The first phase of a clinical development program is designed to assess safety, determine a dosage range and identify potential side effects. There are two additional clinical phases prior to FDA registration and a fourth post-marketing phase to gain additional information.
The Hawaii Biotech West Nile vaccine candidate is a recombinant sub-unit vaccine developed with the intent to induce protective immunity in recipients.
Elliot Parks, president and CEO of Hawaii Biotech, said: “This clinical study is an important milestone in Hawaii Biotech’s maturation into a clinical stage company.”
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