Soligenix Inc. is a late-stage biopharmaceutical company focused on developing products to treat potentially fatal side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. The company today reported the completion of enrollment of its phase 1b clinical trial of RiVax™, Soligenix’s proprietary recombinant subunit vaccine developed to protect against exposure to ricin toxin.
The company said its preliminary results indicate that RiVax appears safe at all doses tested in the company’s panel of volunteers. According to the press release, the phase 1b trial is designed to assess the duration of immune responses using an adjuvant formulation of RiVax over a period of more than one year after vaccination.
“We are very encouraged that we have demonstrated safety at the highest vaccine doses in the current trial volunteers,” Dr. Ellen Vitetta, phD, director of the University of Texas Southwestern Medical Center’s Cancer Immunobiology Center stated in the press release. “This study with the adjuvanted formulation will further guide us in determination of safe dose levels of RiVax™ that induce the highest levels of antibodies that are correlated to efficacy. We are looking forward to completing the analysis of the immune responses induced by RiVax™ in the sera of volunteers up to one year after the last vaccination.”
Results of the first phase 1 clinical trial of RiVax demonstrated the immunogen as well tolerated and efficient in inducing antibodies anticipated to protect humans from ricin exposure.
The phase 1b trial is expected to evaluate the safety and immunogenicity of an improved formulation of RiVax containing an adjuvant. The company said it anticipates longer lasting and higher levels of protective antibodies. The trial is being funded by a grant from the U.S. Food and Drug Administration’s Orphan Products Division.
“We are anticipating that the adjuvant form of the vaccine will induce antibodies in humans that are correlated with long-term immunity to ricin toxin,” said Robert N. Brey, PhD, chief scientific officer of Soligenix. “We are concurrently validating those immunological correlates in animal model systems with our team of collaborators.”
For more information visit www.soligenix.com
Let us hear your thoughts below: