Technetium (99mTc)

LONDON, Sept. 10, 2024 /PRNewswire/ -- Serac Healthcare Limited ("Serac Healthcare" or "the Company"), a clinical radiopharmaceutical company developing innovative molecular imaging technologies, and the University of Exeter today announce that the first patient has been scanned with a novel molecular SPECT imaging agent 99mTc-maraciclatide in a Phase II study titled 'PRospective Evaluation of Interstitial Lung Disease progression with quantitative CT (PREDICT-ILD)'. The primary objective of the ongoing main study is to evaluate the efficacy of quantitative computed tomography (CT) for the detection of interstitial lung disease (ILD) progression. A sub-study has now commenced evaluating 99mTc-maraciclatide as an imaging marker for disease prognostication in a sub-set of PREDICT-ILD participants. PREDICT-ILD is currently recruiting patients across three NHS sites in the south-west: North Bristol NHS Trust (NBT), Royal United Hospitals (RUH) NHS Foundation Trust and Royal Devon University Healthcare NHS Foundation Trust. Co-chief investigators on the study, which is being run by the University of Exeter, a world-leading research centre for lung disease, are Professor Chris Scotton, Associate Professor in Respiratory Biomedicine, and Dr Giles Dixon, Senior Clinical Research Fellow, both at the University of Exeter. PREDICT-ILD is majority funded by the Wellcome Trust GW4-CAT HP PhD Programme for Health Professionals. To assess the primary endpoint in the sub-study examining the feasibility of using 99mTc-maraciclatide to evaluate disease activity, the uptake of the imaging agent will be compared between participants with idiopathic pulmonary fibrosis (IPF) and non-IPF fibrosing-ILD and age, sex and ethnicity matched healthy controls. Secondary endpoints include the evaluation of the ability of 99mTc-maraciclatide to identify αvβ3 activity and to predict disease progression in participants with fibrosing ILD. Sixty-nine participants will be recruited in total, 15 of these in the sub-study. Interstitial lung diseases are a heterogenous group of over 200 irreversible conditions with varying degrees of inflammation that, without treatment, lead to scarring (fibrosis) of the lining of the lungs. It affects more than 150,000 people in the UK, with an incidence of 2,000-4,000 and causes significant morbidity and mortality. It is estimated that lung scarring results in 1% of deaths in the UK. ILD progression is unpredictable, making prognostication challenging and creating barriers to effective drug development. Therapies are available that can slow disease progression in some patients, however current limitations in diagnosis mean that determining the most suitable treatment is challenging, and prescribing the wrong treatment can make the condition worse. For example, certain medications are known to be effective at treating inflammation (which can be a feature of this disease) but can be detrimental in patients with fibrotic disease. Understanding the mechanisms that drive the progression of ILD is an urgent research priority. David Hail, Chief Executive of Serac Healthcare commented : "The distinction between ILD conditions which are characterised by scarring and inflammation is crucial as this determines the appropriate treatment. A molecular imaging marker with the potential to differentiate between early-stage inflammation and the fibrosis it causes could have a significant impact on improving patient outcomes, as well as the development of new therapies. We are looking forward to working with the University of Exeter to evaluate maraciclatide's potential in this new indication." Professor Michael Gibbons, Senior Investigator Fellow, NIHR Exeter Biomedical Research Centre, Consultant Respiratory Physician, Royal Devon University Healthcare NHS Trust, and Clinical Lead on the study said: "Being able to detect disease progression sooner and thereby enabling earlier access to disease modifying treatments to appropriate patients would represent a step change in the treatment of this incurable condition. We are excited to be working with Serac Healthcare to evaluate whether maraciclatide could play a part to bring precision medicine to this patient population." The sub-study is being facilitated by the Nuclear Medicine Department at the RUH, Bath and is supported by specialist radiologists Dr David Little and Dr Jonathan Rodrigues and specialist ILD physicians Dr Shaney Barratt and Professor Michael Gibbons. The study is also supported by the University of Exeter's EPSRC Hub for Quantitative Modelling in Healthcare under the guidance of Professor Krasimira Tsaneva-Atanasova. Dr Michael Gibbons is also a Senior Investigator Fellow at the NIHR Exeter Biomedical Research Centre. 99m Tc-maraciclatide is for investigational use only and is not approved by the FDA or UK and European regulatory authorities. For more information, please contact: David Hail, Chief Executive Officer +44 (0)208 948 0000 [email protected] Francetta Carr, Communications +44 (0)7711 010 820 [email protected] University of Exeter Press Office  +44 (0)1392 722405 or 722062  [email protected] Notes to Editors About Serac Healthcare Ltd Serac Healthcare is a clinical radiopharmaceutical company with deep expertise in discovering, developing, and commercialising innovative molecular imaging technologies to accelerate diagnosis, improve monitoring and enable earlier and more effective treatment decisions. Serac Healthcare is using these targeted technologies to underpin personalised medicine in two primary indications: endometriosis and inflammatory arthritis; a pilot study is also underway in interstitial lung disease. Serac Healthcare is a wholly owned subsidiary of Serac Life Sciences Limited. About 99mTc-maraciclatide 99mTc-maraciclatide is a radio-labelled tracer which binds with high affinity to αvβ3 integrin, a cell-adhesion molecule which is up-regulated on activated vascular endothelial cells, activated macrophages and osteoclasts. Maraciclatide has already been shown to successfully image inflammation in patients with rheumatoid arthritis. In a Phase II study (INIRA), maraciclatide uptake in the inflamed synovium of hand and wrist joints of 50 patients was highly correlated with power Doppler ultrasound images (PDUS). Details on the PREDICT-ILD study can be found at : NCT05609201 About the University of Exeter The University of Exeter is a Russell Group university that combines world-class research with high levels of student satisfaction. Exeter has over 30,000 students and sits within the Top 15 universities in The Complete University Guide 2025, and tenth in the world in the Times Higher Education (THE) Impact Rankings. In the 2021 Research Excellence Framework (REF), more than 99% of our research were rated as being of international quality, and our world-leading research impact has grown by 72% since 2014, more than any other Russell Group university. Logo: SOURCE Serac Healthcare Limited

LONDON, July 2, 2024 /PRNewswire/ -- Serac Healthcare Limited, a clinical radiopharmaceutical company developing an innovative molecular imaging agent, announced today that the US Food and Drug Administration (FDA) has granted Fast Track Designation to 99mTc-maraciclatide as a diagnostic SPECT-CT agent for the visualisation and diagnosis of superficial peritoneal endometriosis in women of 16 years and older. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat (or in our case, diagnose) serious conditions and fill an unmet medical need. Criteria include improving the diagnosis of a serious condition where early diagnosis results in an improved outcome. Endometriosis is a common inflammatory disease that affects up to one in 10 women of childbearing age, about 190 million women worldwide. Endometriosis occurs when tissue similar to the lining of the uterus is found outside the uterus, usually in the pelvis, but sometimes also elsewhere in the body (e.g. the lungs). The presence of this tissue can lead to significant pain and infertility. It can be difficult to diagnose endometriosis because the symptoms can vary considerably, and mimic those of other conditions. This leads to an average delay of 7.5 years from first symptom onset to diagnosis. Furthermore, superficial peritoneal endometriosis (SPE) is the earliest and most common form of endometriosis, comprising approximately 80% of all diagnoses. However, due to the plaque-like nature and generally small size of lesions, SPE is not well visualised with current non-invasive imaging tools (ultrasound and MRI) and definitive diagnosis requires laparoscopy. Previously presented preliminary data from the "Detecting Endometriosis expressed integrins using technetium-99m" (DETECT) imaging study, demonstrated that 99mTc-maraciclatide correctly identified superficial peritoneal endometriosis in those who went on to have this early-stage endometriosis confirmed by laparoscopy. The ongoing Phase II study will complete later this year. Benefits of Fast Track designation include: Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval More frequent written communication from FDA about such things as the design of the proposed clinical trials Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. All of which is intended to reduce the time to approval in the US and enable patients to benefit sooner. David Hail, Chief Executive Officer of Serac Healthcare, said: "Granting Fast Track designation to maraciclatide highlights the FDA's recognition of the critical need for improved diagnosis of endometriosis. The average delay for diagnosis of this condition, which affects 190 million women worldwide, is seven and a half years and is often only possible with laparoscopy. We are committed to working closely with the FDA and clinicians to complete the development of 99mTc-maraciclatide. A non-invasive test which could be used for earlier diagnosis of endometriosis would represent a major advance in women's healthcare." About 99mTc-maraciclatide 99mTc-maraciclatide is a radio-labelled tracer which binds with high affinity to the cell adhesion protein αvβ3 integrin and images angiogenesis (new blood vessel formation) which is known to be critical to the establishment and growth of endometriotic lesions. Clinical trials in a range of conditions, including breast cancer, bone metastases and rheumatoid arthritis, in which angiogenesis plays a key role, have shown the agent to perform as expected and be well tolerated. Maraciclatide is for investigational use only and is not approved by the FDA or UK and European regulatory authorities. For more information, please contact: Serac Healthcare Ltd David Hail, Chief Executive +44 (0)20 8948 0000 [email protected] Francetta Carr, Communications +44 (0)7711 010820 [email protected] Notes to Editors About Serac Healthcare Ltd Serac Healthcare is a clinical radiopharmaceutical company with deep expertise in discovering, developing and commercialising innovative molecular imaging technologies. Using these targeted technologies to underpin personalised medicine in the fields of endometriosis and inflammatory arthritis, Serac Healthcare is focused on bringing to market effective tools to accelerate diagnosis, and to deliver earlier and more effective treatment decisions. Serac Healthcare Ltd is a wholly owned subsidiary of Serac Life Sciences Limited. About Fast Track designation About the DETECT study The study is jointly sponsored by the Oxford Endometriosis CaRe Centre and the Nuffield Department of Women's and Reproductive Health, Oxford University, and funded by Serac Healthcare Ltd who are providing the experimental imaging marker 99mTc-maraciclatide. Further details are available on ClinicalTrials.gov here. Logo - SOURCE Serac Healthcare Limited