On August 17, 2016 Inspyr Therapeutics, Inc. (OTCQB: NSPX), a biotech company developing a novel prodrug therapeutic for the treatment of cancer, today reported that the first patient has been treated in a Phase 2 investigator-sponsored clinical trial to evaluate the safety and activity of mipsagargin in patients newly diagnosed with prostate cancer (Press release, Inspyr Therapeutics, AUG 17, 2016, View Source [SID:1234514631]). The trial is being conducted at The University of Texas Health Science Center (UTHealth) at Houston with Robert Amato, D.O., Professor and Director, University of Texas/Memorial Hermann Cancer Centers, as principal investigator. Mipsagargin is a first-in-class agent with a novel mechanism of action that targets prostate-specific membrane antigen (PSMA), a highly expressed enzyme on the surface of prostate cancer cells.
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The open-label, single-arm Phase 2 clinical trial will enroll patients with treatment-naïve prostate cancer prior to surgical removal of the tumor. Patients in the trial will be administered mipsagargin by intravenous infusion on the first three consecutive days of a 28-day cycle, over a total of three cycles. The trial will evaluate the effect of mipsagargin on the perfusion and volume of the prostate. Inspyr expects top-line results in mid 2017.
"Mipsagargin presents a novel tumor-targeting approach to treating patients newly diagnosed with prostate cancer," said Dr. Amato. "My colleagues at UTHealth are focused on improving treatment options for prostate cancer patients, and we look forward to evaluating mipsagargin’s effectiveness in disrupting the blood supply of prostate tumors and killing prostate cancer cells, which could lead to tumor regression and potentially improved survival rates for patients diagnosed with this type of cancer."
"Dr. Amato and his colleagues at UTHealth have identified a potentially novel application of mipsagargin for prostate cancer patients, and we look to continuing our collaboration," said Chris Lowe, Inspyr’s President and Chief Executive Officer. "We believe mipsagargin’s unique mechanism of action delivers a potent therapy to the tumor site while maintaining an attractive safety profile. We look forward to reviewing the results from this study."
About the University of Texas Health Science Center at Houston
Established in 1972 by The University of Texas System Board of Regents, the University of Texas Health Science Center at Houston (UTHealth) is Houston’s Health University and Texas’ resource for health care education, innovation, scientific discovery and excellence in patient care. The most comprehensive academic health center in The University of Texas System and the U.S. Gulf Coast region, UTHealth is home to schools of biomedical informatics, biomedical sciences, dentistry, medicine, nursing and public health and includes The University of Texas Harris County Psychiatric Center and a growing network of clinics throughout the region. For more information, visit www.uth.edu.