Avillion LLP has announced that full results from the MANDALA phase 3 trial of AstraZeneca’s PT027 have been published.

PT027 is a novel, fixed-dose combination of albuterol and budesonide. AstraZeneca’s drug, at two different strengths of budesonide, demonstrated a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue in patients with moderate-to-severe asthma.

Over 176 million asthma attacks are experienced worldwide every year. UK scientists are currently analysing the complete genetic make-up – or whole genome sequence – of tumours from about 12,000 patients in the country.

The team says that the unprecedented amount of data allowed them to discover new patterns in the DNA of cancer, hinting at causes that are not yet understood. They add that the genetic clues are likely to help improve diagnosis and treatment.

The research was published in Science and led by the University of Cambridge. The research team analysed anonymised DNA data provided by the 100,000 Genomes Project – a nationwide initiative to sequence the whole genomes of patients affected by cancer and rare diseases.

Researchers were able to detect specific combinations of genetic alterations – so-called ‘mutational signatures’, which may be key to the growth of cancers. Through comparing the data to other international genetic cancer projects, the researchers confirmed patterns that are already known, while also uncovering 58 new ones.

The scientists also created a computer programme to help scientists and doctors check whether patients who have had whole genome sequencing have any of the newly discovered mutational clues.

Professor Matt Brown, chief scientific officer of Genomics England, explained: “Mutational signatures are an example of using the full potential of whole genome sequencing. We hope to use the mutational clues seen in this study and apply them back into our patient population, with the ultimate aim of improving diagnosis and management of cancer patients.”

Lead researcher, Professor Serena Nik-Zainal, a consultant at Cambridge University Hospitals, said the study was like an “archaeological dig” of people’s cancer.

Around 4,500 people in the UK will be eligible for a new oral treatment for uterine fibroids. It follows the National Institute for Health and Care Excellence (NICE) recommendation of relugolix with estradiol and norethisterone acetate, also known as Ryeqo.

The oral treatment is made by Gedeon Richter UK and offers an alternative to surgery and injectable gonadotrophin-releasing hormone agonists.

The exact cause of fibroids is unknown, but they have been linked to oestrogen. Uterine fibroids are a non-cancerous growth that occur in or around the uterus, in about one in three 16 to 50-year-olds. They generally shrink after the menopause.
Helen Knight, interim director of medicines evaluation at the NICE Centre for Health Technology Evaluation, explained: “Uterine fibroids can have a profound effect on quality of life. Along with the many debilitating symptoms, there is a real lack of long-term options.

“This treatment has the potential to improve quality of life. As well as effectively reducing symptoms, it can be taken at home and is therefore more convenient than the injectable treatment, given in a hospital setting.

“It can also be used long term, which could mean improved and sustained symptom relief, it is well-tolerated, and it will mean thousands of women can avoid invasive surgery which always carries some risk.” she added.

Symptoms of uterine fibroids can include prolonged heavy menstrual bleeding, pelvic pain and pressure and fertility problems. There are currently limited long-term treatment options.

Minister for women’s health, Maria Caulfield, noted: “This is another groundbreaking step forward to not only improve women’s quality of life and reduce symptoms, but to give them greater choice in the medication available and options for alternative, less invasive treatment.”