Inspyr Therapeutics Announces Mipsagargin Ph 2 Trial for Patients with Clear Cell Renal Cell Carcinoma Expressing PSMA
Second Investigator-Sponsored Trial for Mipsagargin being conducted at The University of Texas Health Science Center
Inspyr Therapeutics, Inc. (OTCQB:NSPX)
SAN ANTONIO, TX, UNITED STATES, September 6, 2016 /EINPresswire.com/ -- 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 with advanced, refractory clear cell renal cell carcinoma that expresses prostate-specific membrane antigen (PSMA). The trial is being conducted at The University of Texas Health Science Center (UTHealth) at Houston with Dr. Robert Amato, Professor and Director, University of Texas/Memorial Hermann Cancer Center, as principal investigator. Mipsagargin is a first-in-class agent with a novel mechanism of action that targets PSMA, an enzyme that is highly expressed on the surface of tumor vasculature.
The open-label, single-arm Phase 2 clinical trial will enroll up to 20 patients and PSMA will be assessed by immunohistochemical staining of each patient’s most recent available biopsy specimen. Patients in the trial will be administered Mipsagargin by intravenous infusion on the first three consecutive days of a 28-day cycle. The primary endpoints are assessment of clinical activity, defined as time of progression after beginning treatment and overall response rate. Inspyr expects top-line results second half 2017. For additional information on this study, visit www.clinicaltrials.gov, identifier NCT02607553.
“In prior clinical studies, Mipsagargin has demonstrated anti-tumor activity and we look forward to evaluating this therapy for the first time in patients with renal cell cancer,” said Dr. Amato. “Mipsagargin presents a novel, tumor-targeting approach to treating patients with advanced, refractory cancer that expresses PSMA, such as clear cell renal cancer, for which standard of care therapy does not exist. We are eager to assess Mipsagargin’s effectiveness in disrupting the blood supply of renal tumors and killing renal cancer cells to induce potent anti-tumor activity. Our goal is to offer clear cell renal cancer patients a new treatment option for this disease, where there is none at present.”
“With two ongoing Phase 2 investigator-sponsored trials led by Dr. Amato and his colleagues at UTHealth, we are expanding the body of clinical data on Mipsagargin for both renal cell carcinoma and prostate cancer,” said Chris Lowe, Inspyr’s President and Chief Executive Officer. “Mipsagargin has shown potential as a new therapeutic option that delivers a potent therapy to the tumor site while maintaining an attractive safety profile. We appreciate the interest of investigators in evaluating Mipsagargin for patients with solid tumors that express PSMA and look forward to the results of this study next year.”
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's 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’s 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's periodic reports filed with the Securities and Exchange Commission.
Inspyr Therapeutics, Inc.