On April 12, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported final data from the dose-escalation and dose-expansion cohorts of a Phase I trial of the investigational drug candidate Cantrixil (TRX-E-002-1) at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting (Press release, Oasmia, APR 12, 2021, View Source [SID1234577892]).
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The full Phase I data was presented in a 15-minute oral presentation by the clinical trial’s Principal Investigator, Jermaine Coward, Associate Professor, ICON Cancer Centre, located in Brisbane, Australia.
A conference call scheduled by Oasmia today at 14:00 CEST has been postponed to enable publication of the data in a peer reviewed journal.
Top-line data previously reported by Kazia Therapeutics Ltd in December 2020 from the Phase I open-label study (NCT02903771) conducted at sites in the USA and Australia confirmed that the Phase I study met its primary endpoints, establishing clinical proof of concept.
Further clinical evaluation of the data has confirmed that Cantrixil may induce ovarian cancer stem cell (OCSC) death and sensitize cancer cells to standard chemotherapy. An encouraging signal was also seen in patients with platinum-refractory ovarian cancer. The full data also confirms the maximum tolerated dose of Cantrixil to be 5.0 mg/kg when administered weekly via intraperitoneal injection.
Principal Investigator for the trial Dr. Jermaine Coward, Associate Professor, ICON Cancer Centre, commented, "Survival outcomes for patient with mid to late-stage ovarian cancer are poor when using standard cytotoxic chemotherapy and around 80% will experience disease recurrence within 2 years. This full data further underscores the potential of Cantrixil for these patients. It is particularly exciting to see a potential impact on ovarian cancer stem cells which have been heavily implicated as a potential driver of disease recurrence."
Dr. Reinhard Koenig, Oasmia’s Chief Scientific Officer added, "Oasmia has a growing pipeline of oncology programmes in clinical development. This is excellent news and supports our belief in the potential therapeutic benefits of the investigational drug candidate Cantrixil for the treatment of ovarian cancer. We look forward to progressing the programme in clinical development next year."
In March Oasmia signed an agreement with Kazia Therapeutics to acquire exclusive global development and commercialization rights for Cantrixil.
Cantrixil consists of the active molecule, a potent and selective third generation benzopyran SMETI inhibitor named TRXE-002-01, encapsulated in a cyclodextrin. It is believed to target a wide spectrum of cancer cells, including chemotherapy-resistant tumor-initiating cells that are thought to be responsible for disease relapse.