Race Oncology Advances RC220 Trial with Ethics Application Submission
RAC (RAC) Share Update December 2024 Wednesday 4th
Race Oncology Submits Ethics Application for Phase 1 RC220 Trial
Race Oncology Limited has submitted a crucial ethics and regulatory package for its Phase 1 clinical trial of RC220, marking a significant step forward in its cancer treatment research.
Instant Summary:
- Ethics application submitted for RC220 Phase 1 trial at Southside Cancer Care Centre.
- Trial to study RC220 in combination with doxorubicin in solid tumour patients.
- First patient recruitment expected in Q1 2025.
- Plans for up to 10 additional trial sites across Australia, Hong Kong, and South Korea.
Trial Details and Objectives
Race Oncology has submitted an ethics and regulatory package to the Bellberry Human Research Ethics Committee for a Phase 1 clinical trial of RC220. This trial will be conducted at the Southside Cancer Care Centre in Miranda, NSW, under the supervision of Dr. Mahood Alam. The trial aims to evaluate the safety and tolerability of RC220, both alone and in combination with doxorubicin, in patients with advanced solid tumours.
The study will be conducted in two stages. Stage 1 will focus on determining the maximum tolerated combination dose (MTCD) of RC220 with doxorubicin, using a Bayesian statistical design for dose escalation. This approach is expected to be more efficient than traditional methods. An interim analysis will be conducted after the last patient completes their first treatment cycle.
Future Plans and Expansion
Following ethics approval, Race plans to activate additional trial sites in Australia and prepare submissions for locations in Hong Kong and South Korea. The goal is to have up to 10 active sites for the trial. Stage 2 of the trial will focus on patients who have not previously received doxorubicin, providing further safety and efficacy data.
Race Oncology's CEO, Dr. Daniel Tillett, expressed gratitude to the team and collaborators for reaching this milestone. He emphasized the potential of RC220 to improve cancer treatment outcomes by reducing the side effects of anthracycline chemotherapy.
The submission of the ethics application is a critical step in advancing RC220's clinical development. This progress could positively impact Race Oncology's stock by demonstrating the company's commitment to advancing its pipeline. The potential for RC220 to offer cardioprotective benefits alongside cancer treatment could attract investor interest.
Investor Reaction:
Analysts are likely to view this development positively, as it indicates forward momentum in Race Oncology's clinical trials. The potential for RC220 to address unmet needs in cancer treatment could enhance investor confidence in the company's long-term prospects.
Conclusion:
Investors should keep an eye on the progress of the RC220 trial and its potential implications for Race Oncology's market position. The company's strategic advancements in cancer treatment could offer significant opportunities for growth.