# Racura Oncology Announces Positive Safety Review Committee Recommendation in ongoing CPACS Clinical Trial

- Link: https://www.thailand-business-news.com/pr-news/racura-oncology-announces-positive-safety-review-committee-recommendation-in-ongoing-cpacs-clinical-trial
- Published: 2026-05-15T18:06:00+07:00
- Author: PR Newswire

_Safety Review Committee (SRC) gives Racura Oncology a recommendation to continue
the Cardioprotection and Anticancer Synergy (CPACS) study in advanced solid tumor
patients_

SYDNEY, May 15, 2026 /PRNewswire/ — Racura Oncology, an Australian Phase 3 stage
clinical biopharmaceutical company, today announced that the independent Safety 
Review Committee (SRC) has completed its review of safety data from Cohort 1 of 
the ongoing CPACS clinical trial, evaluating the safety and pharmacokinetics of 
RC220 alone and in combination with doxorubicin in advanced metastatic solid tumor
patients.

Following its review, the SRC recommended that the study continue, noting no safety
concerns in patients treated with 40mg/m^(2) of RC220 as monotherapy, or 40mg/m^(
2) of RC220 in combination with 60mg/m^(2) of doxorubicin, in the first patient 
cohort of this groundbreaking trial.

_"The SRC’s unanimous recommendation to proceed with the trial, along with the absence
of any safety concerns, represents an important milestone for this clinical program,"_
said Daniel Tillett, CEO of Racura Oncology. _"These findings support the continued
advancement of RC220 into the next cohorts of this study. We wish to thank the patients
and their families for their courage and generosity shown by participating in the
CPACS trial."_

Based on this positive SRC recommendation, Racura plans to proceed to screening 
of new eligible patients for enrolment in Cohort 2 (80mg/m^(2) RC220 dose level)
using an updated trial protocol, which includes an initial lead-in safety monotherapy
cycle of doxorubicin prior to the administration of RC220. This protocol update 
enables an assessment of the anthracycline-cardioprotective potential of RC220 using
a blood-based molecular test.

The Company has received the SRC’s formal written recommendation and has promptly
notified the clinical trial sites to initiate enrolment in Cohort 2, as patients
present and meet the eligibility criteria.

**About Cardioprotection and Anticancer Synergy (CPACS) Trial**

The CPACS Phase 1 solid tumor clinical trial is exploring the preclinical discovery
that RC220 can provide protection from anthracycline cardiotoxicity while improving
the anticancer activity of anthracyclines. Stage 1 of the trial is using ascending
doses of RC220 to determine the safety, tolerability, pharmacokinetics, and maximum
tolerated combined dose (MTCD) of RC220 in combination with doxorubicin in up to
33 patients using a Bayesian design. The effects on a range of clinical biomarkers,
including a blood-based measure of the cardioprotective mechanism of action of RC220,
are also being explored in the study.

After interim analysis of the data, the optimal dosage of RC220 in combination with
doxorubicin will be assessed in an additional 20 patients in Stage 2 for further
safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals.
This open-label trial is being conducted across multiple sites in Australia, Hong
Kong, and South Korea.

**About RC220 & (E,E)-bisantrene**

RC220 is a proprietary formulation of (E,E)-bisantrene designed to overcome drug
solubility issues that prevent safe peripheral intravenous infusion. (E,E)-bisantrene
is a clinical validated small molecule anticancer agent that primarily functions
via G4-DNA and RNA binding, leading to potent silencing of the important cancer 
growth regulator MYC.

**About Racura Oncology**

Racura Oncology (ASX: RAC) is a Phase 3 clinical-stage biopharmaceutical company
with a mission to silence cancer. Our lead asset, (E,E)-bisantrene, is a small molecule
anticancer agent that primarily functions via G4-DNA and RNA binding, leading to
potent silencing of the important cancer growth regulator MYC.

Racura is advancing a proprietary formulation of (E,E)-bisantrene (RC220) to address
the high unmet needs of patients across multiple oncology indications, with a Phase
3 clinical program in acute myeloid leukemia (AML), a Phase 1a/b program in mutant
epidermal growth factor receptor non-small cell lung cancer (EGFRm NSCLC), and a
Phase 1a/b program in combination with the anthracycline doxorubicin, where we aim
to deliver both cardioprotection and enhanced anticancer activity for solid tumor
patients.

Learn more at [www.racuraoncology.com](https://www.racuraoncology.com/).

**Forward-Looking Statements**

Some of the statements in this press release are forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities
Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which
involve risks and uncertainties. Forward-looking statements in this release include,
without limitation, statements regarding expectations regarding clinical development
and regulatory strategy and the Company’s ability to deliver meaningful value to
patients and shareholders. These statements relate to future events, future expectations,
plans and prospects. Although Racura believes the expectations reflected in such
forward-looking statements are reasonable as of the date made, expectations may 
prove to have been materially different from the results expressed or implied by
such forward-looking statements. Racura has attempted to identify forward-looking
statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,””
plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,””
approximately” or other words that convey uncertainty of future events or outcomes
to identify these forward-looking statements. These statements are only predictions
and involve known and unknown risks, uncertainties and other factors, including 
market and other conditions. Any forward-looking statements contained in this press
release speak only as of its date. Racura undertakes no obligation to update any
forward-looking statements contained in this press release to reflect events or 
circumstances occurring after its date or to reflect the occurrence of unanticipated
events, except as required by law.

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**Read the original article :** [Racura Oncology Announces Positive Safety Review Committee Recommendation in ongoing CPACS Clinical Trial ](http://www.prnasia.com/story/archive/4960748_CN60748_0?rand=184833)
