Molecular Targeting Technologies, Inc. (MTTI) and University of Antwerp today announced the approval of a Clinical Trial Application by the European Federal Agency for Medicines and Health Products (FAMHP) (equivalent to a US IND). The clinical study will evaluate the safety, dosimetry and treatment response of TDURA (^99mTc-Duramycin), in patients with advanced colorectal cancer (CRC)*.

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.”

UAntwerp-MICA was founded in 2010 as a joint effort by UAntwerp and UZA and has become one of the leaders in translating molecular imaging research from bench to patient, UAntwerp is not an island: it builds bridges to secondary education, to industry and, by extension, to society as a whole. With over 5,000 members of staff, UAntwerp is one of the most important employers in Antwerp, Flanders’ largest city. More information: www.uantwerp.be

Molecular Targeting Technologies, Inc. is a privately held, clinical stage biotechnology company, developing radiotherapeutics and diagnostics for cancers. MTTI has received an exclusive worldwide license from the National Institutes of Health to commercialize its EvaThera platform . MTTI is committed to building value by translating innovative imaging and theranostic assets to improve human health, reduce healthcare costs and reward stakeholders. More information: www.mtarget.com

**Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Number R01CA226531.

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