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Sunday 16 June 2019
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Topic: Clinical trials

May 30, 2019
QUARTZ is the first completed study of the Phase III PLATINUM clinical development program which evaluates both QMF149 and QVM149 (indacaterol acetate, glycopyrronium bromide and mometasone furoate)
Novartis has announced the first study results from the Phase III PLATINUM clinical development program assessing the safety and efficacy of QMF149, an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate (IND - a long-acting beta agonist [LABA]) and mometasone furoate (MF - an anti-inflammatory (ICS)).
 
April 23, 2019
Scientists from the Cancer Research UK Manchester Institute at The University of Manchester showed that a small volume of blood can contain up-to-date genetic information about a patient's cancer to inform treatment choices

Scientists could help match cancer patients with no other treatment options to clinical trials with experimental medicines, by analysing the genetic faults in a sample of their blood, according to research published in Nature Medicine.
 

February 27, 2019
The largest study ever to look at why an expensive and commonly used group of drugs fails patients with Crohn’s disease has concluded that standardised drug doses are often too low

A UK wide collaboration led by the University of Exeter and the Royal Devon & Exeter NHS Foundation Trust, part-funded by Crohn’s & Colitis UK and Guts UK, and supported by the NIHR  has concluded that trials are needed to investigate whether early personalised dosing, guided by blood level monitoring, might help reduce the rate of treatment failure.
 

July 4, 2018
A clinical trial to treat female diffuse hair loss has been kick started by US regenerative medicine company Histogen.

A clinical trial to treat female diffuse hair loss has been kick started by US regenerative medicine company Histogen.
 
This month [June 2 2018], the organisation announced the launch of a Phase I Clinical Trial of its lead product, Hair Stimulating Complex, to treat the condition.
 

June 27, 2018
Oral Semaglutide demonstrates significant reduction in blood sugar versus placebo in trial

A once-daily tablet could reduce blood sugar in adults with type 2 diabetes, a study has shown.
 
Oral semaglutide, an investigational GLP-1 analogue from global healthcare company Novo Nordisk,achieved “significant reductions in blood sugar versus placebo in adults with type 2 diabetes”, according to the PIONEER 1 phase 3a trial.
 
The trial evaluated the efficacy and safety of 3, 7 and 14 mg oral semaglutide compared with placebo as monotherapy over 26 weeks in adults with type 2 diabetes. [1] 
 

June 21, 2018
Targeted therapy to block a protein that suppresses T cell activity could improve cancer treatment with immune checkpoint inhibitors

A targeted therapy to block a protein that suppresses T cell activity could improve cancer treatment with immune checkpoint inhibitors, researchers have found.
 
EZH2 is elevated in immune T cells in patients after treatment with ipilimumab, a team at the University of Texas MD Anderson Cancer Center showed. The drug unleashes an immune response by blocking the activity of CTLA-4 on T cells – white blood cells that serve as the ‘targeted warriors’ of the adaptive immune system.
 

March 7, 2018
Danish pharmaceutical company Novo Nordisk’s diabetes drug, semaglutide, which could also be used to treat obesity, has passed its first Phase III clinical trial. Semaglutide is taken once daily as a tablet and works by increasing insulin production

As rates of diabetes continue to rise, the hunt for new drugs to tackle the metabolic disease is imperative. In 2014 there were an estimated 422 million people with diabetes, compared to just 108 million in 1980.

 

Although there are a range of treatment options available for type 2 diabetes, many target the symptoms rather than the root cause and may have adverse side effects. A further difficulty is the close connection between diabetes and obesity, which is causing cases to increase.

 

March 3, 2018
A briefing warns that unless the right deal is reached, collaborative trials, networks and research activities of benefits to patients across Europe may be set back after Brexit

Children and rare disease patients could be excluded from lifesaving clinical trials and networks when the UK leaves the EU, according to the Brexit Health Alliance.

February 23, 2018
The CHAMPION trial is assessing the effectiveness and safety of heat-stable carbetocin versus oxytocin, the current standard of care, for preventing postpartum haemorrhage after vaginal birth

Ferring Pharmaceuticals and MSD, through its MSD for Mothersinitiative, has announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention), a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO).

 

February 19, 2018
New data from VOYAGE 2 trial shows high efficacy response rates were achieved with continuous guselkumab treatment versus withdrawal

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced new data that showed a vast majority of patients with moderate to severe plaque psoriasis receiving Tremfya® (guselkumab), who achieved at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at week 28, maintained a PASI 90 response with continuous treatment through week 72.1

 

February 16, 2018
Nusinersen demonstrated stabilisation or improvement from baseline in motor function in individuals with 5q spinal muscular atrophy where the natural history of the disease is a decline in motor function over time

Biogen and Ionis Pharmaceuticals, Inc have announced end of study results from CHERISH, the Phase III study evaluating Spinraza® (nusinersen) for the treatment of individuals with later-onset 5q spinal muscular atrophy (SMA), were published in The New England Journal of Medicine.

 

The full manuscript titled, “Nusinersen Versus Sham Control in Later-Onset Spinal Muscular Atrophy,” appears in the 15 February 2018 issue of The New England Journal of Medicine.

 

February 15, 2018
Each year, around 25,000 people take part in a clinical trial that is supported by Cancer Research UK

Cancer Research UK has announced that £45million will be invested into its network of clinical trials units across the UK, one of the charity's largest investments in clinical research to date.
 

Cancer Research UK’s clinical trials units (CTUs) bring together world leading researchers and clinicians to find life-saving new treatments and tests for cancer patients.
 

February 15, 2018
Each year, around 25,000 people take part in a clinical trial that is supported by Cancer Research UK

Cancer Research UK has announced that £45million will be invested into its network of clinical trials units across the UK, one of the charity's largest investments in clinical research to date.
 

Cancer Research UK’s clinical trials units (CTUs) bring together world leading researchers and clinicians to find life-saving new treatments and tests for cancer patients.
 

February 9, 2018
Phase III SPARTAN data showed apalutamide improved median metastasis-free survival by over two years compared to placebo

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).

 

February 9, 2018
XGEVA successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma

Amgen has announced results from the XGEVA® (denosumab) Phase III ‘482 study, the largest international multiple myeloma trial for the prevention of skeletal-related events ever conducted (n=1718), were published in The Lancet Oncology.

 

In this study, XGEVA successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma (HR=0.98, 95% CI: 0.85-1.14).
 

February 1, 2018
The study showed that eslicarbazepine acetate monotherapy was non-inferior to twice-daily controlled-release carbamazepine, the current standard of care

Bial and Eisai have announced that leading clinical journal, Epilepsia, has published positive results from a pivotal Phase III monotherapy study of once-daily Zebinix® (eslicarbazepine acetate) in newly diagnosed focal epilepsy patients.1
 

January 29, 2018
A study led by the University of Warwick in the UK could help thousands of headache sufferers

Researchers at Warwick Medical School are investigating whether a new education and self-management programme will help improve quality of life for people living with chronic headaches.
 

The study, Chronic Headache Education and Self-management Study (CHESS), is funded by the National Institute for Health Research, and is led by Professor Martin Underwood.  
 

January 23, 2018
Randomised controlled trial to compare two different treatments and aims to reduce reliance on strong painkillers

The University of Warwick in the UK is starting a trial to improve the lives of long-term strong painkiller users.

 

Researchers from the University’s Warwick Medical School and The James Cook University Hospital, Middlesbrough, have developed a support programme that they hope will help people with long term pain reduce their dependency on strong pain killers (opioids) and improve their quality of life.

 

January 23, 2018
The trial met its primary endpoint of percentage of patients on erenumab (AMG 334) achieving at least a 50% reduction of migraine days versus placebo, and all secondary endpoints

Novartis has announced positive results from the Phase IIIb LIBERTY study assessing the efficacy and safety of erenumab (AMG 334) 140mg in patients with episodic migraine who had experienced two to four previous preventive treatment failures, due to lack of efficacy or intolerable side effects.

 

December 13, 2017
Results from the pooled analysis presented at the American Epilepsy Society Annual Meeting 2017 in Washington DC, USA

Bial and Eisai have announced new real-world audit data presented at the American Epilepsy Society (AES) Annual Meeting 2017, which add to the existing clinical trials examining the effectiveness and tolerability of Zebinix® (eslicarbazepine acetate).

 

December 1, 2017
Combining two different immunotherapy treatments could dramatically improve lymphoma survival, according to a Cancer Research UK funded study published in Cancer Cell

Researchers from the University of Southampton have tested different combinations of antibodies in the lab to see how they interact with each other and what effect this has on how the immune system fights cancer.


They found one combination – anti-CD27 and anti-CD20 – greatly increased life expectancy in mice with cancer. While most of the mice given just one of the antibodies died within 80 days, nearly all mice given both antibodies survived beyond 100 days.

October 12, 2017
Although still at a very early stage of research, the development programme aims to improve current treatments for patients with primary cancer

Researchers from the UCL Cancer Institute and BTG plc have begun the first clinical trial of an experimental treatment for liver cancer using X-ray imageable microscopic beads loaded with a targeted anti-cancer drug placed directly in the liver.

 

September 14, 2017
Romosozumab followed by alendronate reduced the incidence of new vertebral, clinical, non-vertebral and hip fractures compared to alendronate alone

UCB and Amgen have announced detailed results from the Phase III ARCH study showing that 12 months of romosozumab followed by alendronate was superior in reducing new vertebral, clinical, non-vertebral and hip fracture risk in postmenopausal women with osteoporosis at high risk for fracture, compared with alendronate alone.

 

August 24, 2017
Early phase trial will test the safety and tolerability of the drug and establish the recommended dose for patients with a variety of cancers including advanced bowel, lung, ovarian, urothelial, pancreatic, breast, head and neck, and oesophageal

A clinical trial to test a new cancer drug in patients with advanced solid tumours, has launched in four centres across the UK, through Cancer Research UK’s Centre for Drug Development.


This early phase trial will test the safety and tolerability of the drug and establish the recommended dose for patients with a variety of cancers including advanced bowel, lung, ovarian, urothelial, pancreatic, breast, head and neck, and oesophageal cancer.

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