FDA Authorizes TransCode's First-In-Human Clinical Trial For Solid Tumor

 

• TransCode Therapeutics Inc 
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   has received written authorization from the FDA to proceed with its First-in-Human (FIH) Phase 0 clinical trial. 
• The planned clinical trial is to evaluate TransCode's lead therapeutic candidate, TTX-MC138, in up to 12 cancer patients with advanced solid tumors. 
• ​TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, described as the master regulator of metastasis in several advanced solid tumors. 
• A Phase 0 clinical trial is an exploratory study conducted under an Investigational New Drug application. 
• In TransCode's planned clinical trial, up to 12 patients will be given a single dose of a radiolabeled TTX-MC138 followed by noninvasive positron emission tomography-magnetic resonance imaging.
• The trial is intended to quantify the amount of radiolabeled TTX-MC138 delivered to metastatic lesions and the pharmacokinetics of the therapeutic candidate in cancer patients. 
• The trial could yield critical therapeutic dose, timing, and potential safety data. This trial is not intended to demonstrate any therapeutic effect.

https://www.benzinga.com/general/biotech/22/12/30226079/fda-authorizes-transcodes-first-in-human-clinical-trial-with-solid-tumor-patients