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Soligenix Initiates Clinical Trial of its Heat Stable Ricin Toxin Vaccine
PRINCETON, N.J., Dec. 12, 2019 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on
About this update from Soligenix, Inc.
[{"type":"text","content":"PRINCETON, N.J., Dec. 12, 2019 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has opened the study titled \"A Phase 1C, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety of RiVax®, a Lyophilized Ricin Toxin A-Chain Subunit Vaccine with Alum-Adjuvant, in Healthy, Normal Adults.\" Preliminary safety results from the trial are expected in the second quarter of 2020 with longer-term safety and immunogenicity results from throughout the 6-month follow-up period expected in the fourth quarter of 2020. \nRiVax® is the Company's vaccine candidate for the prevention of death following exposure to a lethal dose of ricin toxin using a unique antigen that is completely devoid of the toxic activity of ricin. The RiVax® antigen has demonstrated safety in two previous Phase 1 clinical studies. When formulated using Soligenix's proprietary heat stabilization technology (ThermoVax®), RiVax® has demonstrated significantly enhanced thermostability and up to 100% protection in non-human primates (NHPs) in preclinical aerosol challenge models. RiVax® is being developed under the US Food and Drug Administration (FDA) \"Animal Rule\" and previous studies have identified potential immune correlates of protection between NHPs and humans that will be measured in this study.\nThe Phase 1C, double-blind, placebo-controlled, randomized study in healthy adult volunteers is designed to evaluate the safety and immunogenicity of a standard 3-dose vaccine regimen of RiVax® utilizing ThermoVax®, administered monthly, followed by a 6-month follow-up period. In addition to evaluating the overall safety and tolerability of the vaccine, immunogenicity endpoints will be measured during and after vaccination throughout the follow-up period. The study is expected to enroll 8 subjects (2 placebo, 6 RiVax®). \n\"We are pleased to initiate this study and advance our world-leading vaccine candidate to protect against ricin toxin poisoning,\" stated Richard C. Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix. \"Ricin toxin is easily made in large quantities and is lethal in extremely small quantities. RiVax® is an orphan design...