Critical Pharmaceuticals, The University of Nottingham and Nottingham University Hospitals NHS Trust Starts First Phase I Clinical Trial on a Nano-Enabled Intranasal Teriparatide for the Treatment of Osteoporosis

Nottingham, UK, (PresseBox) - Critical Pharmaceuticals, The University of Nottingham and Nottingham University Hospitals NHS Trust today announces the start of the first Phase I clinical trial in healthy post-menopausal women of a nano-enabled intranasal teriparatide product for the treatment of osteoporosis. Osteoporosis affects an estimated 200 million women world-wide and more than 180,000 patients suffer fragility fractures in the UK alone each year, at a cost of around £2 billion to the NHS.

Teriparatide is a highly-effective treatment for osteoporosis, but it currently needs to be injected every day. The project is using Critical Pharmaceuticals CriticalSorb™ technology to develop a nano-enabled nasal spray formulation of teriparatide that is easy for patients to take and improves efficacy providing optimal drug levels in the body.

Professor Tahir Masud, Consultant in Geriatric Medicine at Nottingham University Hospitals NHS Trust and Chief Investigator for the clinical trial, said: "I look forward to progressing this exciting new therapy for a very debilitating disease into the clinic. A nasal teriparatide product has the potential to significantly benefit patients, their families, carers and clinicians with improved clinical outcomes and greatly enhanced ease of use."

The clinical trial is a five-way cross-over study design in healthy post-menopausal women representative of the target patient population. The objectives of the study are to understand the levels of the drug in the body (pharmacokinetics) after intranasal administration of three doses of the teriparatide product versus subcutaneous injection of marketed product ( Identifier NCT01913834). The study will also test the performance of two different nasal delivery devices and use scintigraphic imaging to better understand how deposition can influence the levels of drug in the body over time.

Professor Alan Perkins, from The University of Nottingham's Division of Radiological and Imaging Sciences who is leading the medical imaging aspects of the study, said: "This is an exciting study assessing a new route for the administration for teriparatide. The world-leading imaging facilities in Nottingham will be used to good effect to understand the deposition and clearance characteristics of the drug formulation in the nasal cavity. We will compare delivery from two different devices and relate the results to the levels of the drug in the body to enable an optimal drug-device combination to be selected for further development."

Dr Gareth King, CEO of Critical Pharmaceuticals commented: "We are very pleased to be involved in this collaboration with the internationally-recognised team in Nottingham. We have developed a stable liquid formulation of teriparatide using Critical Pharmaceuticals patented CriticalSorb™ technology that has performed exceptionally well in preclinical studies. We look forward to understanding how this product performs in this first human clinical trial."

The project is co-funded by the UK's innovation agency, the Technology Strategy Board, Critical Pharmaceuticals and the Engineering and Physical Sciences Research Council (EPSRC) as part of their investment in nanoscale technology-enabled solutions in healthcare. Dr Richard Pearson in the School of Medicine, the University Principle Investigator on the grant award, said "I am delighted that the clinical trial has now commenced and I'm keenly awaiting the data on the nasal residency and the pharmacokinetic profile regarding the novel formulation."

About The University of Nottingham

The University of Nottingham has 43,000 students and is 'the nearest Britain has to a truly global university, with campuses in China and Malaysia modelled on a headquarters that is among the most attractive in Britain' (Times Good University Guide 2014). It is also the most popular university in the UK among graduate employers, one of the world's greenest universities, and winner of the Times Higher Education Award for 'Outstanding Contribution to Sustainable Development'. It is ranked in the World's Top 75 universities by the QS World University Rankings.

Impact: The Nottingham Campaign, its biggest ever fundraising campaign, will deliver the University's vision to change lives, tackle global issues and shape the future. More news...<BR data-mce-bogus="1">

About Nottingham University Hospitals NHS Trust

Nottingham University Hospitals NHS Trust (NUH) is one of the largest teaching hospitals in Europe.  The Trust has an annual income of £722.5 million, 87 wards and circa 1,700 beds. The organisation employs over 14,500 staff. NUH provides services to over 2.5 million residents of Nottingham and its surrounding communities. The organisation also provides specialist services to a further 3-4 million people from neighbouring counties each year. The Trust is made up of three sites spread across the city of Nottingham, namely Queen's Medical Centre, Nottingham City Hospital and Ropewalk House.

Nottingham University Hospitals (NUH) NHS Trust has identified excellence in research for the benefit of patients as a core component of its corporate vision to be the best acute teaching organisation by 2016. In order to realise this vision, NUH has formed a close research partnership with the University of Nottingham (UoN), with a common research strategy and an integrated system of research management and governance. This research partnership has been awarded two prestigious National Institute for Health Research (NIHR) Biomedical Research Units in Gastrointestinal (including Liver) Disease, Respiratory Disease and Deafness and Hearing Problems and has been outstandingly successful in other major NIHR competitions. NUH therefore expects to be at the forefront of innovation in the prevention, diagnosis and treatment of ill health and in the translation of advances in basic biomedical research into benefits for patients. NUH also hosts the East Midlands Academic Health Science Network which will facilitate the adoption of proven innovations across the EM.

About the Technology Strategy Board

The Technology Strategy Board is the UK's innovation agency. Its goal is to accelerate economic growth by stimulating and supporting business-led innovation. Sponsored by the Department for Business, Innovation and Skills (BIS), the Technology Strategy Board brings together business, research and the public sector, supporting and accelerating the development of innovative products and services to meet market needs, tackle major societal challenges and help build the future economy.

About the Engineering and Physical Sciences Research Council

The Engineering and Physical Sciences Research Council (EPSRC) is the UK's main agency for funding research in engineering and the physical sciences. EPSRC invests around £800 million a year in research and postgraduate training, to help the nation handle the next generation of technological change. The areas covered range from information technology to structural engineering, and mathematics to materials science. This research forms the basis for future economic development in the UK and improvements for everyone's health, lifestyle and culture. EPSRC works alongside other Research Councils with responsibility for other areas of research. The Research Councils work collectively on issues of common concern via Research Councils UK.

Critical Pharmaceuticals Limited

Critical Pharmaceuticals is a Nottingham UK-based clinical-stage biotechnology company developing a pipeline of unique biological drug products utilizing its patented drug delivery technologies. These technologies enable the development of sustained release injectable depot and nasal delivery of proteins and peptides and challenging small molecular weight drugs. Critical Pharmaceuticals lead product is an intranasal human growth hormone product (CP024) developed using CriticalSorb™ that has completed two Phase I clinical studies. As well as developing its own pipeline, Critical Pharmaceuticals works in partnership with other pharmaceutical and biotechnology companies to enhance the delivery of their novel drug products.

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