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

  • TransCode Therapeutics Inc RNAZ 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. 
  • Related: TransCode Therapeutics Shares Shoot Higher After Encouraging Preclinical Data From Lead Cancer Candidate.
  • 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.
  • Price Action: RNAZ shares are up 27.8% at $0.78 on the last check Thursday.
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