Dec 14, 2019 : Soligenix announced that it has opened the study titled “A phase 1C, double-blind, placebo-controlled, randomised study to evaluate the safety of RiVax, a Lyophilized Ricin Toxin A-Chain subunit vaccine with the Alum-Adjuvant, in healthy, normal adults.” initial safety results from the trial are expected in the second quarter of 2020 with longer-term safety and immunogenicity results from all the way through the 6-month follow-up period expected in the fourth quarter of 2020.
RiVax is the company’s vaccine candidate for the prevention of the death following exposure to a lethal dose of ricin toxin using a unique antigen that is totally devoid of the toxic activity of ricin.
The RiVax antigen has confirmed safety in two previous phase 1 clinical studies. When formulated by using Soligenix’s proprietary heat stabilization technology (ThermoVax), RiVax has demonstrated considerably enhanced thermostability and up to 100% protection in non-human primates (NHPs) in preclinical aerosol challenge models.
RiVax contains a genetically distorted version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule.
A phase 1A clinical trial was conducted with the formulation of RiVax that did not contain an adjuvant. This trial exposed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers.
The adjuvant-free formulation of RiVax induced toxin neutralizing antibodies that lasted up to 127 days after third vaccination in the several individuals. http://www.pharmabiz.com/NewsDetails.aspx?aid=119946&sid=2
