Group items tagged

Community pharmacy is at the heart of one of the most ambitious clinical trials ever undertaken by the UK's primary care network, says senior academic pharmacist Professor Mahendra Patel. The PANORAMIC trial has been designed to rapidly evaluate several antiviral treatments over time that could help people at high risk of Covid-19 recover sooner, prevent the need for hospital admission and so ease the burden on the NHS. The Platform Adaptive trial of NOvel antiviRals for eArly treatMent of Covid-19 In the Community (PANORAMIC) is a national priority trial led by Oxford University's Primary Care Clinical Trials Unit. Lead investigators say the study will enable early and rapid testing of novel antiviral agents and help repurpose existing drugs against Covid-19. As soon as the trial is set up for delivery, it will be open to eligible participants from across the UK. Prof Patel, a key member of the trial's core team, said: "I'm really excited with this news and also by the prospect that there is a huge potential for pharmacy teams to help play a vital role in supporting this highly ambitious trial, as they have with the PRINCIPLE trial, now the world's largest community based clinical trial for Covid19."

Walgreens Boots Alliance has announced the launch of its new clinical trials business that aims to use patient data from its pharmacies to help drive up recruitment in studies conducted by drugmakers. With patient recruitment and enrollment remain key challenges in clinical trials, further exacerbated by the COVID-19 pandemic, the company said it can proactively match diverse patient populations to trials across a range of disease areas based on race, gender, socioeconomic status and location with its patient reach and access to an extensive foundation of pharmacy and patient-authorised clinical data. The Boots owner also believes that by leveraging a tech-enabled approach to patient identification and creating a large registry of clinical trial participants, the company will be able to reduce the time it takes to match eligible patients to clinical trials. "Walgreens trusted community presence across the nation, combined with our enterprise-wide data and health capabilities, enables us to pioneer a comprehensive solution that makes health options, including clinical trials, more accessible, convenient and equitable," said Ramita Tandon, chief clinical trials officer, Walgreens.

The British scientists behind one of the major therapeutic Covid-19 trials have turned their focus to treatments for monkeypox, a viral disease that has been labelled a global health emergency by the World Health Organization. The team from Oxford University behind the so-called RECOVERY trial - which honed in on four effective Covid treatments - on Tuesday unveiled a new trial, dubbed PLATINUM, to confirm whether Siga Technologies' tecovirimat is an effective treatment for monkeypox. Although there are vaccines developed for the closely related smallpox that can reduce the risk of catching monkeypox, there are currently no treatments that have been proven to help hasten recovery in those who develop the disease. The UK has over 3,000 confirmed cases of monkeypox. The virus is transmitted chiefly through close contact with an infected person. It typically causes mild symptoms including fever, rash, swollen lymph nodes and pus-filled skin lesions. Severe cases can occur, though people tend to recover within two to four weeks. Siga's drug, branded Tpoxx, has been cleared to treat diseases caused by the family of orthopoxvirus that includes smallpox, monkeypox and cowpox by the European Union and United Kingdom, but due to limited trial data it is generally only used in severe cases in Britain.

Johnson & Johnson said on Wednesday (January 18) that it was pulling the plug on a late-stage global trial of an HIV vaccine after the shot was found ineffective at preventing infections. The failure of the trial marks yet another setback in the search for a vaccine against a virus known to mutate rapidly and find unique ways to evade the immune system, and comes more than a year after another of J&J's HIV vaccine failed a study. "It's not the outcome we had hoped for, unfortunately," said a spokesperson for the National Institute of Allergy and Infectious Diseases, a J&J partner in the trial. "The development of a safe and effective HIV vaccine has been a considerable scientific challenge, but we will learn from this study and continue forward." The trial involved administering two different types of a shot, which uses a cold-causing virus to deliver the genetic code of HIV, spread over four vaccination visits in a year. J&J used similar technology for its COVID-19 vaccine. The study, which began in 2019, was conducted at over 50 sites and included about 3,900 gay men and transgender people - groups that are considered vulnerable to the infection.

Amgen's experimental obesity drug demonstrated promising durability trends in an early trial, paving the way for a larger mid-stage study early next year, company officials said ahead of a data presentation on Saturday (December 3). The small Phase I trial found that patients maintained their weight loss for 70 days after receiving the highest tested dose of the injected drug, currently known as AMG133. Amgen shares have gained about 5% since the company said on Nov. 7 that 12 weeks of trial treatment at the highest monthly dose of AMG133 resulted in mean weight loss of 14.5%. At 150 days after the last dose, maintained weight loss had dropped to 11.2% below original weight at the start of the trial, according to findings detailed at a meeting of World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease in Los Angeles. Patients treated with AMG133 did have side effects including nausea and vomiting, but most cases were mild and resolved within a couple of days after the first dose, Amgen said.

The world's first human challenge trial in which volunteers were deliberately exposed to Covid-19 to advance research into the disease was found to be safe in healthy young adults, one of the companies running the study said on Wednesday. The data supports the safety of this model which could theoretically provide a "plug and play" platform for testing therapies and vaccines using the original Covid-19 strain as well as variants of the virus, Open Orphan, which carried out the study, said in a statement. Open Orphan is running the project, launched a year ago, with Imperial College London, the UK government's vaccines task force and the clinical company  hVIVO. The trial infected 36 healthy male and female volunteers aged 18-29 years with the original SARS-CoV-2 strain of the virus and closely monitored them in a controlled quarantined setting. They will be followed up for 12 months after discharge from the quarantine facility.

Oxford Cannabinoid Technologies Holdings plc, which specialises in developing cannabis-derived medicines with pain-relieving properties, has successfully administered the first-in-human dose of its lead pharmaceutical drug compound, OCT461201, in its phase 1 clinical trial. The company holds a portfolio of four drug candidates intended for use as licensed pain medications. The drug is a selective cannabinoid receptor type 2 agonist with the potential to treat chemotherapy-induced peripheral neuropathy and irritable bowel syndrome. The UK trial, conducted by Simbec Research Limited, part of Simbec-Orion Group Ltd., is progressing with healthy volunteers, OCTP said in a statement. Using a single ascending dose protocol, the primary objective is to demonstrate OCT461201's safety and tolerability, while providing information on its pharmacokinetic profile, to confirm its value as a potential drug. Results from the trial, funded entirely by OCTP's existing resources, are expected in the third quarter of 2023, the statement added.

The government has joined hands with Prostate Cancer UK to launch a massive screening trial in the country next year. Called TRANSFORM, the trial will use innovative screening methods like an MRI scan to detect prostate cancer, which is the most common cancer in men in the UK. The trail is scheduled for launch in Spring 2024, and recruitment is likely to begin in Autumn 2024. For the £42 million trial, the government will invest £16 million through the National Institute of Health Research, and £26m will be provided by Prostate Cancer UK. The Department of Health and Social Care (DHSC) believes that thousands of men's lives could be saved each year if prostate cancer is detected early with effective screening methods.

Pharmacy teams are being encouraged to support the ground-breaking Platform Adaptive trial of Novel antivirals for early treatment of Covid-19 In the Community (PANORAMIC) study by raising awareness among patients. The study aims to find out whether new antiviral treatments can help Covid-19 patients avoid hospital admission and support a quicker recovery. The PANORAMIC trial will allow researchers to gather data on the potential benefits of treatments to patients and will help the NHS to develop plans for rolling out the products to further patients in 2022. Anyone over the age of 50 or between 18 to 49 with certain underlying health conditions can participate in the trial after receiving a positive PCR or lateral flow test result for Covid-19. People who wish to participate in the trial can sign up themselves through the study's website and may be contacted by a member of the clinical team in a general practice that has been set up to deliver the PANORAMIC trial.

An oral drug combination by Novartis showed promise in treating a subgroup of patients suffering from a common childhood brain cancer in a trial. In the mid-stage trial, 47 per cent of the patients that were given the two drugs Tafinlar and Mekinist saw their tumours shrink, far above a rate of 11 per cent in a comparative group of participants on standard chemotherapy, the drugmaker said on Monday, June 6. The participants, aged one to 17 years, were suffering from low-grade gliomas (LGG), the most common childhood brain cancer. The trial only included those who were found to have a mutation known as BRAF V600, a genetic contributor in about 15 per cent to 20 per cent of paediatric LGG cases. Among further results of the trial with 110 participants, the median time without disease progression was 20.1 months for those given the Novartis drug combo, compared to 7.4 months on chemotherapy. The new oral treatment candidate also caused less severe side effects than burdensome chemotherapy.

AstraZeneca on Wednesday (April 5) said a combination of its cancer drugs Imfinzi and Lynparza met the main goal in a late-stage trial in patients with advanced ovarian cancer. The drugmaker said treatment with a combination of those drugs, along with chemotherapy and bevacizumab - the existing standard of care - improved progression-free survival in newly diagnosed patients with advanced ovarian cancer without certain mutations. Lynparza is jointly developed with U.S.-based Merck & Co as a treatment for breast cancer in early stage with certain mutations. Imfinzi alone, along with chemotherapy and bevacizumab, did not reach statistical significance in its interim analysis, the drugmaker added. Philipp Harter, director, Department of Gynaecology and Gynaecologic Oncology, Evangelische Kliniken Essen-Mitte, Germany and principal investigator for the trial, said: "DUO-O showcases the power of academia and industry collaboration in advancing new treatment combinations for patients with ovarian cancer. I'm grateful for the academic cooperative study groups and patients around the world that made this trial possible and look forward to sharing the results with the clinical community." Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, said: "While there has been significant progress for patients with advanced ovarian cancer, an unmet need still remains. These data from the DUO-O trial provide encouraging evidence for this this Lynparza and Imfinzi combination in patients without tumour BRCA mutations and reinforce our continued commitment to finding new treatment approaches for these patients. It will be important to understand the key secondary endpoints as well as data for relevant subgroups."

Researchers from the University of Oxford today (December 8) started recruiting for a clinical trial to test novel antiviral Covid-19 treatments for early use in the illness by people in the community and those who are at higher risk of complications. Partnering with the National Institute for Health Research (NIHR), colleagues in several UK universities, and the NHS UK-wide, the Platform Adaptive trial of NOvel antiviRals for eArly treatMent of Covid-19 In the Community (PANORAMIC), is a national priority trial, and will be open to participants from across the UK. The first treatment to be tested by the UK Antiviral Taskforce will be molnupiravir, a Covid antiviral pill already licensed by the MHRA. Britain became the first country in the world to approve molnupiravir, which was jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics, in November.

Germany's Boehringer Ingelheim said on Thursday (Aug 17) it would conduct three late-stage studies for its obesity drug candidate after it showed up to 19 per cent weight loss after 46 weeks in a mid-stage trial. The private company plans to start enrollments for the trial of the drug, survodutide, which it co-invented with Danish biotech company Zealand Pharma, before the end of the year. The trials will evaluate the drug's safety and efficacy, Boehringer said, and added that it would provide further details on the studies before initiation. Boehringer and Zealand are among global drugmakers racing to grab a share of the potential $100 billion market for obesity treatments within a decade. Survodutide works by mimicking a gut hormone called glucagon-like peptide-1 (GLP-1), which suppresses appetite, as well as imitating another gut hormone called glucagon that helps break down fat.

Denmark's Zealand Pharma and Boehringer Ingelheim said their experimental obesity treatment achieved up to 14.9% weight loss in a mid-stage trial, lining up a potential contestant in the booming obesity drug market. In a statement on Wednesday (May 10), the partners said that the Phase II dose-finding trial met its primary endpoint of weight loss after 46 weeks. Paola Casarosa, head of therapeutic areas at Germany's Boehringer Ingelheim told Reuters the partners are in discussion with regulators about the design of a planned follow-up trial in the third and last phase of testing. The enormous demand for weight-loss treatments such as Novo Nordisk's Wegovy, or potentially Eli Lilly's Mounjaro, could support as many as 10 competing products with annual sales reaching up to $100 billion within a decade, mostly in the United States, industry executives and analysts said. Lilly said about a year ago that Mounjaro was shown to reduce up to 22.5% in weight after 72 weeks of treatment in a much larger late-stage trial.

Cancer patients in the UK are being given a new immunotherapy treatment at Imperial College Healthcare NHS Trust as part of a global phase 1/2 clinical trial, which aims to evaluate its safety and potential for treating 'solid tumour' cancers such as melanoma and lung cancer. The experimental therapy, called mRNA-4359, has been designed to train patients' immune systems to recognise and fight cancer cells, according to researchers at Imperial College London. For the first time in the UK, cancer patients received the treatment at the National Institute for Health and Care Research (NIHR) Imperial Clinical Research Facility at Hammersmith Hospital. In this non-randomised trial, mRNA-4359 is administered to patients either alone or in combination with an existing cancer drug called pembrolizumab, a type of immune checkpoint inhibitor. The researchers are hopeful that this new therapeutic approach, if proven to be safe and effective in clinical trials, could lead to a new treatment option for difficult-to-treat cancers.

Britain will start to roll out Merck's molnupiravir Covid-19 antiviral pill through a drug trial later this month, Susan Hopkins, chief medical adviser at the UK Health Security Agency said on Sunday (November 7). Last week Britain became the first country in the world to approve the potentially game-changing Covid-19 antiviral pill, jointly developed by US-based Merck & Co Inc and Ridgeback Biotherapeutics. The government said in October it had secured 480,000 courses of the Merck drug, as well as 250,000 courses of an antiviral pill developed by Pfizer Inc. Asked about the molnupiravir approval, Hopkins told BBC television: "That is great news and it will start to be rolled out through a drug trial in the end of this month/the beginning of December." Hopkins said all the trials so far had been done with the unvaccinated, so this would help understand how it will work in the wider vaccinated population.

GlaxoSmithKline and Sanofi said on Wednesday (December 15) they expect data from late-stage clinical trials of its booster dose of their Covid-19 vaccine candidate in the first quarter, instead of this year, another delay for the potential shot. The news came as two companies said preliminary data from trials showed the single-dose booster provided strong immune responses. They added that they need more time to test the booster on more people who have not been infected by the virus before they can submit data to regulators. The Phase III trial for the recombinant adjuvanted Covid-19 vaccine recruited most participants in the third quarter, coinciding with a significant increase in the number of people infected globally due to the Delta variant, it said. "To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022." No safety concerns were identified. This is the latest delay for the vaccine's development, putting the companies further behind rivals in the race for Covid-19 shots.

Are you looking for a Leading Clinical Digital Solutions? Clinvigilant provides End to End Clinical Trial Solutions. Contact For EDC In Clinical Trials

Are you looking for a Patient Engagement Platform in Clinical Trials? Visit Clinvigilant- A leading clinical trial solutions provider

Looking for a Best Electronic Data Capture Solutions For Clinical Trials? Visit clinvigilant and read our blog to know more about EDC In Clinical Trials