On January 7, 2020 4D pharma plc (AIM: DDDD), a pharmaceutical company that leads the development of Live Biotherapeutics, reported the opening of a clinical study to assess clinical safety and efficacy of MRx0518 in combination with preoperative radiotherapy in 15 patients with resectable pancreatic cancer (Press release, 4d Pharma, JAN 7, 2020, https://www.prnewswire.com/news-releases/actualizacion-clinica-4d-anuncia-un-nuevo-estudio-de-mrx0518-en-cancer-pancreatico-828920161.html [SID1234552748]).
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The study is being conducted at The University of Texas MD Anderson Cancer Center and is the second open as part of a strategic collaboration to evaluate the Live Biotherapeutic oncology line of 4D in a number of cancer centers. Cullen M. Taniguchi , MD, Ph.D., assistant professor of radiation oncology at MD Anderson, is the lead investigator of the study.
Subjects will receive their daily treatment with MRx0518 for one week before and during radiotherapy, up to 24 hours before surgical resection. In addition to the main conclusion of safety and tolerability, the study will evaluate the preliminary clinical efficacy of the combination, including the evaluation of the main pathological response, progression-free survival and overall survival. Additional secondary and exploratory findings will evaluate changes in tumor infiltration lymphocytes (TILs) and the intestinal microbiome.
Alex Stevenson , 4D scientific director, commented:
"Pancreatic cancer carries a poor prognosis and remains a field of important need not covered. Prompted by promising initial signs in our other clinical studies, we believe that MRx0518 has the potential to offer new treatment options and dramatically improve outcomes for patients with pancreatic cancer. This third study demonstrates 4D’s current commitment to oncology. "
4D recently announced clinical observations of its current open label study of MRx0518 in combination with KEYTRUDA (pembrolizumab) in patients with solid tumors that have progressed in previous therapy of control inhibitors with no known alternative treatment options. The combination is well tolerated without side effects related to the drug and currently has partial induced responses in two of six evaluable patients and stable disease in a third patient.