Inspyr Therapeutics Announces the Initiation of a Phase 2 Clinical Trial of Mipsagargin for Newly Diagnosed Prostate Cancer Patients
New Investigator-Sponsored Trial Being Conducted at The University of Texas Health Science Center
SAN ANTONIO-- Inspyr Therapeutics, Inc. (OTCQB: NSPX), a biotech company developing a novel prodrug therapeutic for the treatment of cancer, today announced 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. 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.
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.
About Inspyr Therapeutics
Inspyr Therapeutics, Inc. is developing a novel technology platform that combines a powerful therapeutic (thapsigargin) with a patented prodrug delivery system that targets the release of drugs within solid tumors. Mipsagargin, its lead drug candidate, has been studied in a Phase 2 clinical trial in patients with advanced hepatocellular carcinoma (liver cancer) and has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) in this indication. Mipsagargin is currently being evaluated in Phase 2 clinical studies in patients with glioblastoma (brain cancer), prostate cancer, and clear cell renal cancer. For additional information on Inspyr Therapeutics, visit www.inspyrtx.com.
Cautionary Statement Regarding Forward-Looking Information
This communication may contain forward-looking statements. Investors are cautioned that statements in this document regarding potential applications of Inspyr Therapeutics’ technologies or the future prospects of the company constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights and the acceptance of Inspyr Therapeutics’ proposed therapies by the health community. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties will be detailed from time to time in Inspyr Therapeutics’ periodic reports filed with the Securities and Exchange Commission.
Inspyr Therapeutics, Inc.
Linda Coker, 210-479-8112
Source: Inspyr Therapeutics, Inc.