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Archive for category: Featured Articles

Featured Articles

New gene therapy appears to cure haemophilia

, 21 July 2022/in E-News, Featured Articles /by panglobal

gene therapy cure for haemophilia

A Phase I/II multi-centre clinical trial, called B-AMAZE, has found that a single gene therapy injection dramatically reduces the bleeding risk faced by people living with haemophilia B and enabled trial participants to stop their regular blood clotting factor replacement therapy.

The study is published in the July 21, 2022 issue of the New England Journal of Medicine.

Of the 10 male patients selected to take part in the trial, all showed dose-dependent increases in factor IX levels. At a median follow-up of 27.2 months, sustained factor IX activity was observed in all the patients except one.

Haemophilia B is a rare and inherited genetic bleeding disorder caused by low levels of the blood clotting factor IX (FIX) protein.

The gene responsible for making FIX protein is located on the X chromosome, so the severe form of haemophilia B is much more common in men.

Currently, patients with haemophilia B need to inject themselves regularly – usually weekly – with recombinant FIX, a regular replacement therapy to prevent excessive bleeding. Despite advances in treatment, patients may continue to see debilitating joint damage.

The B-AMAZE trial and the related long-term follow up study found that one-time treatment with FLT180a led to sustained production of FIX protein from the liver in nine of ten patients, across four different dose levels. They no longer required weekly injections of FIX protein. They are also all enrolled in the long-term follow up study to assess safety and durability of FIX expression for 15 years.

FLT180a AAV gene therapy

FLT180a (verbrinacogene setparvovec) is a liver-directed adeno-associated virus (AAV) gene therapy. AAV gene therapy works by using a packaging from the proteins found in the outer membrane of the virus, to deliver a functional copy of a gene directly to patient tissues – in this case the liver. Newly synthesised proteins – in this case the FIX protein – are released into the blood. A one-time infusion can achieve long-lasting effects.

Lead author Professor Pratima Chowdary of the Royal Free Hospital, UCL Cancer Institute, said: “Removing the need for haemophilia patients to regularly inject themselves with the missing protein is an important step in improving their quality of life. The long term follow up study will monitor the patients for durability of expression and surveillance for late effects.”

Immunosuppression

Patients in the trial needed to take immune suppressing drugs over several weeks to several months, to prevent their immune systems from rejecting the therapy, and all reported known side effects. While the treatment was generally well tolerated, all patients experienced some form of adverse events, with an abnormal blood clot in one who received the highest FLT180a dose and had the highest levels of FIX protein.

Freeline Therapeutics co-founder Professor Amit Nathwani (UCL Medical Sciences), who co-authored the study, said: “Gene therapy is still a young field that pushes the boundaries of science for people with severe genetic diseases.

“The B-AMAZE long-term data add to the growing body of evidence that gene therapy has the potential to free patients from the challenges of having to adhere to lifelong therapy or could provide treatment where none exists today.”

Pamela Foulds, MD, Chief Medical Officer of Freeline, said: “The B-AMAZE long-term data continue to support our confidence that a single dose of FLT180a could protect people with haemophilia B from bleeding and the need for lifelong FIX replacement through durable expression of FIX at protective levels.”

The Phase I/II trial was sponsored by University College London and funded by Freeline Therapeutics, a clinical-stage biotechnology company developing AAV vector-mediated systemic gene therapies.

A Phase I/II dose-confirmation trial of FLT180a called B-LIEVE to finalize a dose for a Phase 3 pivotal trial is in progress.

https://interhospi.com/wp-content/uploads/sites/3/2022/07/gene.jpg 1701 1701 panglobal https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png panglobal2022-07-21 10:58:482022-07-21 11:00:52New gene therapy appears to cure haemophilia
Concept image of Paragraf diagnostic handset and test cartridge

UK company to develop world’s first graphene-based rapid in-vitro diagnostic test

graphene, in-vitro tests, 20 July 2022/in E-News, Editors' Picks, Featured Articles /by panglobal
Concept image of Paragraf diagnostic handset and test cartridge

Concept image of Paragraf diagnostic handset and test cartridge — © Paragraph 2022

 

Cambridgeshire, UK-based Paragraf, the first company in the world to deliver a scalable approach to graphene electronic device manufacturing, has announced a plan to develop a new generation of graphene-based, in-vitro diagnostic products that will give results within a few minutes.

With the support of a £550,000 Biomedical Catalyst grant award from Innovate UK, Paragraf initiated a two-year programme to develop a proof-of-concept combined PCT (procalcitonin) and CRP (C-reactive protein) test, on a single panel. On March 1 this year Paragraf raised US$60 million in a Series B financing round.

The company is collaborating with the universities of Liverpool, Manchester and Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust and Manchester University NHS Foundation Trust (MFT), on the development.

Clinical study of graphene-based PCT/CRP test

A clinical study of the combined PCT/CRP test will be delivered at MFT’s Diagnostics and Technology Accelerator (DiTA) in mid-2023. DiTA aims to address unmet needs, transform patient care and improve efficiency within the NHS, by facilitating the rapid translation and adoption of new innovations into the healthcare system. The project is expected to be completed by the end of May 2024.

Paul Dark, Professor of Critical Care Medicine at The University of Manchester, and Honorary NHS Consultant at Salford Royal, part of Northern Care Alliance NHS Foundation Trust, said: “We expect to show that our proposed acute inflammatory marker test will have the capability to deliver accurate results for emergency patient care within a few minutes, from a small sample of blood. The accuracy of the test is envisaged to be at least comparable with hospital centralised lab-based immunoassay tests which can take hours to provide results back to emergency services.”

Prof. Dark also leads the National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre (BRC), Respiratory Non-fungal Infections Programme, which is focused on providing more accurate, rapid diagnosis for patients with severe respiratory infections.

Malcolm Stewart, Paragraf Diagnostics Business Development Director

Malcolm Stewart, Paragraf Diagnostics Business Development Director

Antimicrobial stewardship

Malcolm Stewart, Paragraf Diagnostics Business Development Director, said: “This graphene-based diagnostic test is expected to become the first test in the world to give clinicians the ability to identify patients who need an antibiotic treatment within the space of a regular 15-minute clinic appointment. It encourages antimicrobial stewardship by giving clinicians the insight into when not to prescribe antibiotics as the test result differentiates viral from bacterial infections.”

The role of graphene in the in-vitro test

Commenting on the role of graphene in the test, Stewart explained that graphene enhances the test by having the ability to detect very low levels of the target protein (in this case). “Graphene is one of the most conductive substances ever discovered. The almost immediate electrical conductivity change in the graphene when only picogram levels of the target (in this case PCT) are detected is the difference the graphene makes. Simply put, graphene allows us to detect much lower concentrations of target analytes and in single digit minutes than is conventionally possible – and in a piece of equipment that will be handheld in size.

“We can make the graphene into chip-like devices – called graphene field effect transistors (GFETS) – which allow us to detect multiple analytes on one chip, a technique called multiplexing. This first test we are working on will detect two analytes on one chip – PCT and CRP. In future, tests we will be multiplexing more than six analytes on one chip in the cartridge.

“Graphene is also biocompatible meaning that we can deposit samples without having to pre-prepare them. So in this case, for the PCT/CRP test, we will only require a couple of drops of blood directly into the test cartridge. The reduction in pre-analytical errors is vital for tests like this one being used in critical care areas where time to result is important. Once this test is being used in primary care the lack of pre-preparation of the sample makes the test feasible in a GP surgery or even in a patient’s home,” Stewart explained.

Enitan Carrol, Professor of Paediatric Infectious Diseases at the University of Liverpool, reiterated this point: “This technology reduces the time and complexity of sample preparation which, together with its rapid measurement speed, provides clinicians with accurate results in a timeframe that allows immediate decisions to be made on antimicrobial prescribing. This is especially important for the treatment of children and neonates.”

Paragraf

Paragraf

Manufacturing the graphene in-vitro tests

Explaining the manufacturing process, Stewart said: “As we scale up our business, the graphene will be deposited on to larger wafers – 20 or 30cm diameter – in the future. We then make GFETS from the wafers.

“Our process is called MOCVD (metal oxide chemical vapour deposition) and is not unique to us. But the way we do it and the ingredients we use makes it unique. We can make graphene that is contamination free, because or graphene is directly formed on the wafer rather than transferred from another metal like copper in other graphene manufacturing processes.

“We believe we have a technique that is scalable to millions of chips a year when we are manufacturing our chips on 30cm wafers.”

Plans for series of tests for disease biomarkers

Paragraf plans to deliver a series of high sensitivity, rapid tests for disease biomarkers in areas including cardiovascular disease, oncology, and infectious diseases.

The ambition is to develop a comprehensive suite of tests that could be used in almost any environment or healthcare setting. The tests are designed to provide ultra-fast answers to diagnostic challenges and to create a complete diagnostic toolkit at the point of care.

https://interhospi.com/wp-content/uploads/sites/3/2022/07/Paragraf-Diagnostics-Device-Concept_1.jpg 957 1701 panglobal https://interhospi.com/wp-content/uploads/sites/3/2020/06/Component-6-–-1.png panglobal2022-07-20 11:13:022022-07-20 11:14:28UK company to develop world’s first graphene-based rapid in-vitro diagnostic test

EU sets out new regulations on in vitro diagnostic medical devices

, 4 July 2022/in Featured Articles /by panglobal

As of 26 May 2022, new rules on in vitro diagnostic medical devices (IVDR) such as HIV tests, pregnancy tests or COVID-19 tests, are applicable across the European Union. The rules will better protect public health and patient safety in respect to these devices, bringing EU law in line with technological advances and progress in […]

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PSMA PET highlights need for updated prostate cancer therapy guidelines

, 4 July 2022/in Featured Articles /by panglobal

Current guidelines used to plan salvage radiation treatments in patients with local recurrence of prostate cancer should be updated to take into consideration information derived from novel imaging modalities, such as PSMA PET, according to research presented at the Society of Nuclear Medicine and Molecular Imaging 2022 Annual Meeting. The study showed that PSMA PET […]

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Targeted radionuclide treatment achieves high response rate, minimal toxicities for advanced-stage neuroendocrine tumours

, 4 July 2022/in Featured Articles /by panglobal

A targeted radionuclide alpha therapy, 225Ac-DOTATATE, has been shown to have long-term anti-tumour effects in patients with advanced-stage gastroenteropancreatic neuroendocrine tumours (GEP-NETs). Results from the Phase II study showed promising survival rates, high response rates and an acceptable toxicity profile, making 225Ac-DOTATATE a potential treatment option for patients who have exhausted other forms of therapy. […]

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Novel radiopharmaceutical pair detects and treats melanoma; Study shows potential for broad application in solid tumours

, 4 July 2022/in Featured Articles /by panglobal

Novel radiopharmaceutical pair detects and treats melanoma; Study shows potential for broad application in solid tumours

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Virtual CT scans cut patient radiation exposure in half during PET/CT studies

, 4 July 2022/in Featured Articles /by panglobal

A novel artificial intelligence method can be used to generate high-quality “PET/CT” images and subsequently decrease radiation exposure to the patient. Developed by the U.S. National Cancer Institute, the method bypasses the need for CT-based attenuation correction, potentially allowing for more frequent PET imaging to monitor disease and treatment progression without radiation exposure from CT […]

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Novel ultra-low dose PET technique significantly reduces radiation exposure

, 4 July 2022/in Featured Articles /by panglobal

A new PET imaging technique can greatly reduce the amount of patient radiation exposure by eliminating the need for an accompanying CT scan. Without the CT scan, the amount of radiation delivered to the patient is cut dramatically, which benefits all patients, but in particular the paediatric population and those in need of multiple scans. […]

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Molecular imaging biomarker predicts response to CAR T cell therapy

, 4 July 2022/in Featured Articles /by panglobal

A new PET imaging agent, 18F-AlF-FAPI-74, has been found to effectively monitor and predict treatment response of an up-and-coming cancer therapy. This non-invasive imaging approach has the potential to help inform important clinical decision-making early in the course of treatment – including re-dosing of therapy, dose optimization, change of therapeutic course, and many more – […]

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Revolutionary technology shortens cardiac scan time, provides high-quality SPECT images

, 4 July 2022/in Featured Articles /by panglobal

A cardiac SPECT imaging system using self-collimation performs scans 10 to 100 times faster than current SPECT systems, according to new research presented at the Society of Nuclear Medicine and Molecular Imaging 2022 Annual Meeting. The advantages of selfcollimation SPECT include dramatically shortened scan time, better image quality, increased patient throughput, and reduced radiation exposure […]

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