TransCode Therapeutics Announces IRB Approval for FDA Cleared First-In-Human Clinical Trial
Excerpt from the Press Release:
BOSTON, April 27, 2023 (GLOBE NEWSWIRE) — TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a leading clinical-stage oncology company committed to using its proprietary delivery system platform to defeat cancer, announced today that it has received written approval from the Dana Farber Cancer Institute Institutional Review Board (IRB) to proceed with its First-in-Human (FIH) Phase 0 clinical trial. The planned clinical trial is to evaluate delivery of TransCode’s lead therapeutic candidate, TTX-MC138, to metastatic lesions 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 a number of advanced solid tumors. TransCode believes that TTX-MC138 could become a treatment for many of these cancers.
“We are very pleased to have received IRB Approval for our FIH clinical trial,” said TransCode’s Chief Executive Officer and co-founder, Michael Dudley. “We are hopeful that this trial will demonstrate successful delivery of our lead therapeutic candidate to metastatic lesions in patients with advanced solid tumors. The delivery of RNA therapeutics to sites other than the liver has remained a significant challenge for decades. Overcoming this challenge would represent an unprecedented step in unlocking therapeutic access to a variety of well documented genetic targets involved in a range of cancers and beyond.”
The Company believes that TTX-MC138 has the potential to dramatically improve clinical outcomes in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas, and others. In a preclinical murine model of triple-negative breast cancer, treatment with low-dose chemotherapy and TTX-MC138 eliminated pre-existing local metastases in 100% of treated animals representative of stage II/III metastatic cancer.
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