Molecular Targeting Technologies, Inc. and University of Antwerp Begin First-in-Human Study of TDURA Diagnostic for Early Detection of Response to Colon Cancer Therapy

On May 11, 2021 Molecular Targeting Technologies, Inc. (MTTI) and University of Antwerp reported the approval of a Clinical Trial Application by the European Federal Agency for Medicines and Health Products (FAMHP) (equivalent to a US IND) (Press release, Molecular Targeting Technologies, MAY 11, 2021, View Source [SID1234579714]). The clinical study will evaluate the safety, dosimetry and treatment response of TDURA (99mTc-Duramycin), in patients with advanced colorectal cancer (CRC)* .

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Colorectal cancer is the third most commonly diagnosed malignancy in the world and the second leading cause of cancer death in the United States. While a range of novel active agents has improved the prognosis of patients with colorectal cancer, 50% of advanced colorectal cancer patients die from metastatic disease.

Monitoring treatment efficacy early, within days, can significantly improve patient outcomes. Current diagnostic techniques can take weeks to months to gauge tumor killing drug efficacy. In some cases, treatment may only be effective in 40% of patients, leading to rapidly advancing cancer and higher costs while regrouping to change therapies.

Duramycin, a naturally occurring peptide that binds to phosphatidylethanolamine (PE), has been radiolabeled and used for early imaging of tumor death in animal models.

Professor Sigrid Stroobants, MD, Chair of Nuclear Medicine, U of Antwerp commented "Objective and accurate evaluation of tumor response to therapy is one of the biggest challenges in oncology. Early assessment of therapeutic ineffectiveness can avoid treatment related toxicity and could lead to improved survival through earlier treatment intensification, stopping the ineffective therapy, or starting second-line therapy."

Chris Pak, MTTI President & CEO said, "The most commonly used methods to evaluate the effectiveness of a treatment are morphological and volumetric which cannot see the effects of therapy early. If TDURA optimizes patient treatment, the benefits to the patients and savings to health care systems will be substantial."