Latest news with #RC220
Herald Sun
02-05-2025
- Business
- Herald Sun
Race Oncology doses first patient in RC220 Phase 1 solid tumour trial
Don't miss out on the headlines from Stockhead. Followed categories will be added to My News. First patient dosed at lead trial site, Southside Cancer Care. Phase 1 trial to determine safety, tolerability and pharmacokinetic data, plus maximum tolerated combined dose of RC220 with chemotherapeutic doxorubicin. Up to 33 patients to be recruited in first stage across sites in Australia, Hong Kong and South Korea. Special Report: The first site in Race Oncology's Phase 1 clinical trial of RC220 in advanced solid tumours has been activated with the first patient dosed safely at Southside Cancer Care Centre in Miranda, NSW. No vein inflammation or any other adverse events were reported, clearing the way for Race Oncology (ASX:RAC) to dose more patients in this first stage of the trial. The company's goal is to establish the safety, tolerability and pharmacokinetic data – in other words, the way the drug is absorbed, distributed, metabolised and excreted – as well as the maximum tolerated combined dose of RC220 in combination with powerful chemotherapy drug doxorubicin. A second trial site at the Gosford and Wyong hospitals also recently opened for patient enrolment, with up to another 32 patients to be enrolled at sites across Australia, Hong Kong and South Korea. Race Oncology CEO Dr Daniel Tillet said the safe dosing of this first patient was a major milestone for the company, and the beginning of an important program that would assess the safety, tolerability and therapeutic potential of RC220. 'We are grateful to all the patients, investigators and clinical teams who have made this trial possible,' Tillet said. 'I would also like to thank our shareholders for their strong and loyal support that has enabled us to bring RC220 to patients in the clinic." Why combine chemotherapy with RC220? RC220 is a small molecule drug found to enhance the cancer-killing activity of chemotherapy doxorubicin in 85% of 143 cancer cell lines screened by RAC. The drug has been investigated in more than 50 clinical trials where it was found to have an effect in a range of solid and blood-based cancers including breast, ovarian, kidney, lung and various leukaemias including acute myeloid leukaemia. Importantly, RC220 demonstrates an anti-cancer effect with less cardiotoxicity compared to chemotherapy anthracyclines like doxorubicin, therefore offering a potential cardioprotective effect that could reduce damage to the heart during chemotherapy treatments, while enhancing the drugs' cancer killing effect. In Stage 2 of the trial, RAC will use an optimal dosage of RC220 in combination with doxorubicin – determined by an analysis of Phase 1 data – in 20 additional patients to establish further safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals. As the trial is open-label, patient outcomes will be available for assessment as soon as treatment is complete. RAC intends to announce progress updated on a regular basis, but not on an individual patient level. This article was developed in collaboration with Race Oncology, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions. Originally published as Race Oncology doses first patient in RC220 Phase 1 solid tumour trial
Mercury
24-04-2025
- Business
- Mercury
ASX health stocks deliver March quarter progress
Don't miss out on the headlines from Stockhead. Followed categories will be added to My News. ASX quarterly season is upon us again, with listed companies opening a window to their performance and key activities over the three months to March 31. It's a key time for investors to zero in on the finer details of ASX-listed firms and get a sense of what is on the horizon. Here, we wrap up report highlights from four standout stocks in the ASX health sector. Imricor submitted second module for premarket approval of its products to US FDA during quarter Second -generation Vision-MR Ablation Catheter receives CE mark certification under new European Medical Device Regulation After quarter end Imricor started its VISABL-VT pivotal trial at Amsterdam University Medical Centre achieving world-firsts Imricor, which has developed the world's only MRI-compatible devices for cardiac ablations, made several regulatory achievements during Q1 CY25 including submitting the second module for premarket approval of its products to the US Food and Drug Administration (FDA). Among other highlights of a milestone quarter for the company, IMR received CE Mark approval for its second generation Vision-MR Ablation Catheter under the new more stringent European Medical Device Regulation (MDR). Subsequent to quarter end, Imricor started its VISABL-VT pivotal trial at Amsterdam University Medical Centre, achieving the first-in-human ventricular ablation guided by real-time iCMR. On the commercial front, the company is rebuilding its European sales team with the first capital sales managers in the US hired in preparation for commercial launch. Imricor B.V. was established in the Netherlands with the company opening an office in Amsterdam. The company also attended the Gulf Arrhythmia Congress in Dubai and EHRA Congress in Vienna. Imricor finished Q1 FY25 with a strong cash position following a $70 million capital raising, closing with a cash balance of US$53.9m (~A$85.5m). Race's lead site of Southside Cancer Centre in NSW for phase I trial of RC220 in combination with doxorubicin receives ethics and regulatory approval Screening of patients underway at centre with treatment of first patient scheduled for this quarter Human ethics approval also received to start trial at Gosford and Wyong hospitals in New South Wales Race made significant progress in Q3 FY25 towards first patient treatment in its phase I trial of its cardioprotective therapeutic RC220 in combination with doxorubicin in patients with advanced solid tumours. Ethics and all regulatory approvals were received for the lead site of Southside Cancer Care Centre, in Miranda NSW enabling recruitment of patients. Screening of patients has begun and the treatment of the first patient with RC220 is expected in the current quarter. Human ethics approval was also received to begin the trial at the Gosford and Wyong Hospitals, in the Central Coast Local Health District of NSW. Race said ethics approval allowed both the Gosford and Wyong Hospitals to enrol patients subject to final site approvals and activation. Final approvals are expected during April. As of March 31, 2025, Race held cash and cash equivalents of $17.12m. The company said more than 70% of spending during Q3 ($1.67m) was directed toward R&D and drug manufacturing activities. "Like everyone at Race, I am looking forward to seeing the first patient treated with RC220 in this quarter and converting RC220's potential into meaningful outcomes for cancer patients and our shareholders," CEO Dr Daniel Tillett said. Clever Culture Systems targeting profitability in FY25 and building a substantial sales pipeline to underpin growth in FY26 Sales pipeline for APAS Independence Instruments exceeds 40 qualified customer opportunities in pharmaceutical market Company's APAS Independence instruments remain the only US FDA-cleared AI technology for automated culture plate reading Clever Culture CEO and managing director Brent Barnes said just over 12 months since its launched its APAS (automated plate assessment system) Independence instruments (culture plate readers) in the pharmaceutical market, the response had been "overwhelmingly positive" as it targets FY25 profitability. The company has 13 instruments sold or pre-ordered to date, representing ~$6m in revenue. That will set a base for future recurring revenue from licence fees and maintenance support. In a trading update, Clever Culture said it was building a substantial sales pipeline to underpin FY26 growth with 40 active and qualified customer opportunities within the pharmaceutical industry, representing ~$75m in potential upfront sales revenue and $15m per annum recurring revenue. The company's APAS Independence instruments remain the only US FDA-cleared AI technology for automated culture plate reading. A second purchase order has been received from an additional Bristol Myers Squibb (BMS) facility, which is expected to form a case study for the potential roll out to other BMS sites. Another big-pharma was completing an expanded 6000 plate evaluation, clearing the way for procurement discussions direct with their manufacturing sites. The company said active engagement with potential customers had accelerated noticeably since it announced the planned launch of a second APAS analysis module for analysis of the smaller contact plates (55mm) in October 2024. Combined with the existing APAS analysis module for the settle plates (90mm), the APAS Independence will be able to analyse the two plate types that make up the vast majority of tests used by pharmaceutical manufacturers in environmental monitoring. "Our strategy has been to target global pharmaceutical manufacturers that operate multiple sites globally and represent multi-instrument sales opportunities," Barnes said. Over the past three months the APAS Independence Instruments had been showcased at several leading international conferences. EZZ launches two new products during Q3 FY25 and upgrades formulas and packaging of three of its top sellers Company progresses strategic entry to US market with planned entry targeted for H2 FY25 EZZ serves up an ace with its inaugural sponsorship of the Australian Open in January covering China and Southeast Asia Genomic life sciences company EZZ successfully launched two new products during Q3 FY25, which it said leveraged consumer insights to meet evolving market trends and enhance the company's competitive positioning. EZZ also upgraded the formulas and packaging of three of its top selling products and strengthened domestic distribution by securing listings in ~70 new retail pharmacy distribution points in Australia. The company also progressed its strategic entry into the US market through comprehensive market research, collaboration with key local partners, and the development of a phased market entry plan targeted for H2 FY25. One of the highlights of Q3 was EZZ's elevated brand awareness, with the company serving an ace in its inaugural sponsorship of the Australian Open in January covering China and Southeast Asia, including influencer-hosted livestreams and content creation. EZZ said the campaign, it biggest marketing venture to date, delivered strong visibility across China and Southeast Asia, supported by prominent on-court branding. Meanwhile, the company continued to strengthen its brand positioning and consumer engagement on leading e-commerce platforms and initiated new customer loyalty initiatives to drive long-term growth in China. The company also reinforced industry presence and global networking through participation in the Cosmoprof Worldwide Bologna and the Australian Pharmacy Professional (APP) Conference nd Trade Exhibition, both held in March. Receipts from customers totalled $14.6m during Q3, which EZZ said reflected lower seasonal turnover in January and February compared to PCP, partly due to reduced digital advertising spend. The company said strong operating performance resulted in $1.5m of positive cash inflow. Cash reserves reached a record $21.1 million as at March 31 2025, with EZZ remaining debt-free, excluding lease liabilities. At Stockhead, we tell it like it is. While Imricor Medical Systems, Race Oncology, Clever Culture Systems and EZZ Life Science are Stockhead advertisers, they did not sponsor this article. Originally published as ASX Quarterly Health Wrap: Imricor starts CY25 strong, Clever Culture eyes FY25 profit
News.com.au
24-04-2025
- Business
- News.com.au
ASX Quarterly Health Wrap: Imricor starts CY25 strong, Clever Culture eyes FY25 profit
ASX quarterly season is upon us again, with listed companies opening a window to their performance and key activities over the three months to March 31. It's a key time for investors to zero in on the finer details of ASX-listed firms and get a sense of what is on the horizon. Here, we wrap up report highlights from four standout stocks in the ASX health sector. Imricor Medical Systems (ASX:IMR) Imricor submitted second module for premarket approval of its products to US FDA during quarter Second -generation Vision-MR Ablation Catheter receives CE mark certification under new European Medical Device Regulation After quarter end Imricor started its VISABL-VT pivotal trial at Amsterdam University Medical Centre achieving world-firsts Imricor, which has developed the world's only MRI-compatible devices for cardiac ablations, made several regulatory achievements during Q1 CY25 including submitting the second module for premarket approval of its products to the US Food and Drug Administration (FDA). Among other highlights of a milestone quarter for the company, IMR received CE Mark approval for its second generation Vision-MR Ablation Catheter under the new more stringent European Medical Device Regulation (MDR). Subsequent to quarter end, Imricor started its VISABL-VT pivotal trial at Amsterdam University Medical Centre, achieving the first-in-human ventricular ablation guided by real-time iCMR. On the commercial front, the company is rebuilding its European sales team with the first capital sales managers in the US hired in preparation for commercial launch. Imricor B.V. was established in the Netherlands with the company opening an office in Amsterdam. The company also attended the Gulf Arrhythmia Congress in Dubai and EHRA Congress in Vienna. Imricor finished Q1 FY25 with a strong cash position following a $70 million capital raising, closing with a cash balance of US$53.9m (~A$85.5m). Race Oncology (ASX:RAC) Race made significant progress in Q3 FY25 towards first patient treatment in its phase I trial of its cardioprotective therapeutic RC220 in combination with doxorubicin in patients with advanced solid tumours. Ethics and all regulatory approvals were received for the lead site of Southside Cancer Care Centre, in Miranda NSW enabling recruitment of patients. Screening of patients has begun and the treatment of the first patient with RC220 is expected in the current quarter. Human ethics approval was also received to begin the trial at the Gosford and Wyong Hospitals, in the Central Coast Local Health District of NSW. Race said ethics approval allowed both the Gosford and Wyong Hospitals to enrol patients subject to final site approvals and activation. Final approvals are expected during April. As of March 31, 2025, Race held cash and cash equivalents of $17.12m. The company said more than 70% of spending during Q3 ($1.67m) was directed toward R&D and drug manufacturing activities. "Like everyone at Race, I am looking forward to seeing the first patient treated with RC220 in this quarter and converting RC220's potential into meaningful outcomes for cancer patients and our shareholders," CEO Dr Daniel Tillett said. Clever Culture CEO and managing director Brent Barnes said just over 12 months since its launched its APAS (automated plate assessment system) Independence instruments (culture plate readers) in the pharmaceutical market, the response had been "overwhelmingly positive" as it targets FY25 profitability. The company has 13 instruments sold or pre-ordered to date, representing ~$6m in revenue. That will set a base for future recurring revenue from licence fees and maintenance support. In a trading update, Clever Culture said it was building a substantial sales pipeline to underpin FY26 growth with 40 active and qualified customer opportunities within the pharmaceutical industry, representing ~$75m in potential upfront sales revenue and $15m per annum recurring revenue. The company's APAS Independence instruments remain the only US FDA-cleared AI technology for automated culture plate reading. A second purchase order has been received from an additional Bristol Myers Squibb (BMS) facility, which is expected to form a case study for the potential roll out to other BMS sites. Another big-pharma was completing an expanded 6000 plate evaluation, clearing the way for procurement discussions direct with their manufacturing sites. The company said active engagement with potential customers had accelerated noticeably since it announced the planned launch of a second APAS analysis module for analysis of the smaller contact plates (55mm) in October 2024. Combined with the existing APAS analysis module for the settle plates (90mm), the APAS Independence will be able to analyse the two plate types that make up the vast majority of tests used by pharmaceutical manufacturers in environmental monitoring. "Our strategy has been to target global pharmaceutical manufacturers that operate multiple sites globally and represent multi-instrument sales opportunities," Barnes said. Over the past three months the APAS Independence Instruments had been showcased at several leading international conferences. Genomic life sciences company EZZ successfully launched two new products during Q3 FY25, which it said leveraged consumer insights to meet evolving market trends and enhance the company's competitive positioning. EZZ also upgraded the formulas and packaging of three of its top selling products and strengthened domestic distribution by securing listings in ~70 new retail pharmacy distribution points in Australia. The company also progressed its strategic entry into the US market through comprehensive market research, collaboration with key local partners, and the development of a phased market entry plan targeted for H2 FY25. One of the highlights of Q3 was EZZ's elevated brand awareness, with the company serving an ace in its inaugural sponsorship of the Australian Open in January covering China and Southeast Asia, including influencer-hosted livestreams and content creation. EZZ said the campaign, it biggest marketing venture to date, delivered strong visibility across China and Southeast Asia, supported by prominent on-court branding. Meanwhile, the company continued to strengthen its brand positioning and consumer engagement on leading e-commerce platforms and initiated new customer loyalty initiatives to drive long-term growth in China. The company also reinforced industry presence and global networking through participation in the Cosmoprof Worldwide Bologna and the Australian Pharmacy Professional (APP) Conference nd Trade Exhibition, both held in March. Receipts from customers totalled $14.6m during Q3, which EZZ said reflected lower seasonal turnover in January and February compared to PCP, partly due to reduced digital advertising spend. The company said strong operating performance resulted in $1.5m of positive cash inflow. Cash reserves reached a record $21.1 million as at March 31 2025, with EZZ remaining debt-free, excluding lease liabilities.
