The first-in-human clinical trial assessing the safety and tolerability of Miltuximab (MIL-38) — a radiolabeled antibody designed to image prostate, bladder, and pancreatic cancer — is proceeding to its second part, according to Minomic International.
Miltuximab is a chimeric version of Minomic’s MIL-38 antibody, linked to the radioactive isotope Gallium-67. A chimeric antibody is one that includes human and mouse parts, which ensures the patient’s immune system does not recognize and reject the antibody as foreign.
The antibody is directed against Glypican-1 (GPC-1), a protein which has been found to be over-expressed in multiple kinds of cancer, including esophageal cancer and gliobastoma. In preclinical studies, it has shown strong reactivity to prostate, bladder, and pancreatic cancer cells, which makes it suitable to detect cancer in imaging exams.
The MILGa study, based in Australia, is evaluating the safety and tumor targeting ability of Miltuximab in patients suffering from metastatic prostate, bladder, and pancreatic cancer. The primary endpoints in the clinical trial are safety and tolerability. Secondary endpoints include tumor targeting, dosing, and the way the drug behaves in patients’ blood.
An initial analysis of safety data from the first half of the two-part trial has already demonstrated that the therapy was well tolerated and had no adverse events related to the drug in two patients with pancreatic cancer and four with prostate cancer.
The trial’s independent Drug Safety Monitoring Committee, comprised of radiopharmaceutical and oncology groups at two major public hospitals in Sydney, Australia, has formally approved the continuation of the trial, which will enroll six additional patients for a total of 12 subjects.
“The results from this trial are providing us with important safety data as well as telling us how well the antibody targets different tumor types,” Dr. Brad Walsh, Minomic’s CEO, said in a press release. “We will use this information to guide the future development of this drug.”
“Passing this key formal stage in our trial is very encouraging,” he added. “There are no approved antibody therapies for prostate or pancreatic cancer, whilst bladder cancer remains extremely expensive to treat. There is therefore the potential for major advances in the treatment of these cancers.”
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