KZIA up almost 20% on this news.
ASX RELEASE
9 December 2020
TOP-LINE FINAL DATA FROM CANTRIXIL PHASE I STUDY CONFIRMS PRIOR
POSITIVE EFFICACY AND SAFETY SIGNALS
Sydney, 9 December 2020 – Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an
Australian oncology-focused biotechnology company, is pleased to share top-line final data
from its phase I study of Cantrixil (TRX-E-002-1) in patients with persistent or recurrent
ovarian cancer (NCT02903771).
Key Points
• 25 patients with advanced metastatic ovarian cancer received at least one dose of
Cantrixil at six sites in the United States and Australia, comprising 11 patients in Part
A (dose escalation) and 14 patients in Part B (dose expansion)
• Trial achieved its primary objective, determining the maximum tolerated dose (MTD)
of Cantrixil to be 5 mg/kg
• Overall, 16 patients were evaluable for efficacy. One patient demonstrated a
complete response (CR) and two patients experienced a partial response (PR),
according to industry-standard RECIST criteria, making an overall response rate
(ORR) of 19%
• The patient who experienced a complete response remains in remission some three
years after her last dose of Cantrixil
• The drug was generally well-tolerated, with primarily gastrointestinal toxicities
observed (abdominal pain, vomiting, and nausea)
Australian lead investigator, Associate Professor Jim Coward, commented, “this was a
heavily pre-treated population, comprising patients with very advanced disease. Existing
treatment options for such patients are limited, and there remains an urgent need for new
therapies. My colleagues and I are excited by the potential for Cantrixil to provide benefit
here, and we look forward to seeing the drug move forward in its development.”
Kazia expects the full data to be presented at a suitable academic conference and published
in a peer-reviewed journal in 1H CY2021. In accordance with common practice, the full data
will remain embargoed until they are formally published, in order not to prejudice the
appropriate dissemination of the data, and only top-line data are discussed here.
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