On June 30, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that the results from a Phase I open-label study (NCT02903771) of the investigational drug candidate Cantrixil (TRX-E-002-1) have been published in Cancers, a peer-reviewed, open access journal of oncology (Press release, Oasmia, JUN 30, 2021, View Source [SID1234584496]).
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The paper entitled ‘Maximum Tolerated Dose and Anti-Tumor Activity of Intraperitoneal Cantrixil (TRX-E-002-1) in Patients with Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer: Phase I Study Results’ can be accessed online at the following link: View Source
Oasmia acquired the exclusive global development rights for the Cantrixil ovarian cancer program from Kazia Therapeutics Ltd earlier this year. Top-line data from the Phase I study previously reported by Kazia Therapeutics Ltd in December 2020 and presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2021 confirmed that the Phase I study met its primary endpoints, establishing clinical proof of concept.
The study was conducted at sites in the USA and Australia under the leadership of clinical trial’s Principal Investigator, Jermaine Coward, Associate Professor, ICON Cancer Centre, located in Brisbane, Australia. The study aimed to define the maximum tolerated dose, tolerability, and antitumor activity of Cantrixil when administered via an intraperitoneal (IP) port. Cantrixil was well tolerated even in patients with heavily pre-treated disease.
The study demonstrates the potential for prolonged survival in advanced ovarian cancer by inducing ovarian cancer stem cells’ death and sensitizing cancer cells to standard chemotherapy with IP-administered Cantrixil.
Dr. Heidi B. Ramstad, CMO of Oasmia, commented: "These data are encouraging and has demonstrated the potential for prolonged survival in some patients with advanced ovarian cancer. By inducing ovarian cancer stem cell death and sensitizing cancer cells to standard chemotherapy, Cantrixil may improve survival outcomes in this patient population. Ovarian cancer remains one of the most aggressive cancers and are proven difficult to treat in advanced stages. We look forward to the forthcoming Phase 2 trial investigating Cantrixil in combination with first-line chemotherapy with an aim to improve survival rates in ovarian cancer."