Etira Expands Clinical Trial Sites
Sydney, Australia – June 2, 2025: Etira, a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies, announced the activation of a new trial site at Macquarie University Hospital (MUH) in Sydney, New South Wales. The facility joins The Kinghorn Cancer Centre and Cancer Research South Australia as an active recruitment site for Etira’s ongoing ERX-315-001 Phase 1 clinical trial.
MUH is a 181-bed facility distinguished as Australia’s first fully digital private hospital. Uniquely positioned on a university campus, MUH operates a comprehensive Clinical Trials Unit within the Faculty of Medicine, Health and Human Sciences. The facility currently supports more than 200 active clinical trials, exemplifying its commitment to integrating cutting-edge research, medical education, and patient care delivery.
The site activation follows a comprehensive initiation visit during which teams reviewed the study protocol, safety monitoring procedures, patient eligibility criteria, and clinical logistics. MUH is now authorized to begin patient recruitment in close coordination with Etira’s clinical team.
“The MUH site will significantly enhance our recruitment capabilities and broaden patient access to this promising investigational therapy,” said Russell Hayward, CEO of Etira. “Etira will continue to provide updates on the ERX-315 trial.”
ERX-315 represents Etira’s first-in-class small molecule therapy engineered to induce endoplasmic reticulum (ER) stress, thereby promoting targeted cancer cell death across multiple tumor types. The ongoing Phase 1 study, formally titled “A Phase 1 Trial of ERX-315 in Participants with Advanced Solid Tumors” (NCT06533332), received approval from Australian regulatory authorities in 2024. The trial is designed to evaluate the safety, tolerability, and pharmacokinetic profile of ERX-315 in patients with advanced solid tumors who have experienced disease progression despite standard-of-care treatments.
Learn more or view eligibility criteria: ERX-315 Clinical Trial
Forward-Looking Statements:
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events, Etira’s future operating performance and goals, the anticipated benefits of therapies, expectations, beliefs and development objectives for Etira’s product pipeline and clinical trials. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Etira and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: Etira has limited experience conducting clinical trials (and will rely on a third party to operate its clinical trials) and may not be able to complete the clinical trial (including opening clinical trial sites, dosing additional patients, and enrolling and dosing an adequate number of clinical trial participants) when expected and may not generate results (including final or initial safety, tolerability and efficacy data in the anticipated timeframe (or at all); benefits of product candidates seen in preclinical analyses may not be evident when tested in clinical trials or when used in broader patient populations (if approved for commercial sale); Etira has a limited operating history and has not generated any revenue to date from product sales, and may never become profitable; other companies may be able to identify and develop product candidates more quickly than the Company and commercially introduce the product prior to the Company; the Company may not be able to file INDs for development candidates on time, or at all, due to technical or financial reasons or otherwise; the Company may utilize cash resources more quickly than anticipated; Etira will need to raise capital in the future and if we are unable to raise capital when needed or on attractive terms, we would be forced to delay, scale back or discontinue some of our development programs or future commercialization efforts (which may delay filing of INDs, dosing patients, reporting clinical trial results and filing new drug applications); we may be unable to advance our preclinical development programs into and through the clinic for safety or efficacy reasons or commercialize our product candidates or we may experience significant delays in doing so as a result of factors beyond Etira’s control; the Company may not be able to realize the benefits of Fast Track designation (and such designation may not advance any anticipated approval timelines); Etira may expend limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success; our products candidates may cause adverse or other undesirable side effects (or may not show requisite efficacy) that could, among other things, delay or prevent regulatory approval; our dependence on third parties for conducting clinical trials and producing drug product; our ability to obtain and maintain patent and other intellectual property protection for our technology and product candidates or the scope of intellectual property protection obtained is not sufficiently broad; and delays and other impact on the clinical trial. You should not place undue reliance on forward-looking statements in this presentation, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Etira specifically disclaims any duty to update these forward-looking statements
