ERX-315-001 SITE INITIATION VISIT @TKCC
Sydney, Australia – September 4, 2024: The Etira team, led by Founder Dr. Ganesh Raj, and the clinical Contract Research Organization Novotech successfully performed the site initiation visit at the Kinghorn Cancer Center (TKCC) in Sydney Australia for the ERX-315-001 Phase 1 clinical trial. The study related protocol, procedures, processes, monitoring plan and study logistics ranging from patient selection to drug compounding to patient monitoring after administration were reviewed with the clinical trials team at TKCC.
The clinical trial titled “A Phase 1 Trial of ERX-315 in Participants with Advanced Solid Tumors” was approved by the Australian regulatory authorities in August. The trial will evaluate the safety and tolerability of ERX-315 in in patients with advanced solid tumors, who have progressed on prior approved systemic therapies. Interested individuals can learn more about the trial, eligibility criteria, and how to participate by visiting the link here: ERX-315 Clinical Trial.
The Site Initiation Visit confirms TKCC’s readiness to conduct the trial. Following final approvals by TKCC, the recruitment to the trial at the TKCC will commence later this month and will be overseen by the overall trial principal investigator, Dr. Rasha Cosman, the Head of Early Phase Clinical Trials Unit and the Clinical Lead of Oncology Clinical Trials at TKCC.
TKCC is a major Australian cancer center focusing on translational research and personalised cancer care with a mission to align world-class cancer research with rapid translation to the clinic. TKCC is located in Darlinghurst suburb of Sydney and affliated with St Vincent’s Hospital Sydney, a world-class public hospital.
Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase. Novotech has worked closely with Etira in advancing ERX-315 to clinical trials.
Etira will provide updates on the continued progress of the ERX-315 clinical trial and activation in additional clinical trial sites in Australia. This clinical trial represents a significant step forward in Etira’s pursuit of effective treatments for patients with metastatic therapy-resistant cancers.
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.
