Inhalosome-C Project

Background

backgroundInhalosomes is a patented lipid based nanoparticle vesicle drug delivery technology for administrating drugs to the lungs developed by the University of Strathclyde.

Initially Inhalosome-C is being developed to deliver Cisplatin to treat  Non-Small Cell Lung Cancer (NSCLC). Cisplatin is already used as a lung cancer treatment and currently administered intravenously, which causies a number of side effects. Inhalosome-C allows the non-invasive treatment of NSCLC lung cancer and will dramatically improve the therapeutic outcome and quality-of-life.

Globally, in 2012 there were approximately 1.6 million deaths from lung cancer and an estimated 1.8 million people diagnosed with lung cancer. The majority of the cases seen are for NSCLC (88% of lung cancers). In NSCLC approximately 75% of the patients are over 65 years of age and therefore in many cases not suitable for conventional intravenous therapy due to co-morbidities and side effects.


Objective

objectiveWe propose to develop an inhaled form of the most commonly used chemotherapy agent Cisplatin for the treatment of NSCLC. Our technology, Inhalosomes, is a lipid based nanoparticle vesicle drug delivery technology, which can be used to deliver drugs directly into the lungs using a standard nebuliser. This technology will allow non-invasive treatment of lung cancer and will dramatically improve the therapeutic outcome and quality-of-life.

Our preclinical findings indicate that using inhaled Inhalosome-C therapy will overcome the barriers of Cisplatin treatment and open the use of Cisplatin to new patients, such as the elderly and infirm. As burden of disease is mostly in the age group of over 65’s the Cisplatin treatment for NSCLC is not always possible in this age group and only about 30% of patients are treated with the first-line therapy of  Cisplatin.

Inhalosome-C Ltd and the University of Strathclyde believe they are on the cusp of creating a highly innovative market ready drug delivery system that will revolutionise the treatment of NSCLC lung cancer. The delivery system consists of a novel formulation of Cisplatin that allows the drug to be administered directly to the lung using a standard nebuliser.  Innovative formulation technology – known as Inhalosomes – is a non-ionic surfactant vesicle (NIV) drug delivery technology. The Inhalosome loaded with Cisplatin will allow a non-intravenous treatment of NSCLC. The Inhalosome-Cisplatin nebulised delivery targets the chemotherapy to the lung, and decreases the plasma levels.

Benefits

benefitsDramatically improved therapeutic outcomes with negligible side-effects are expected. Our confidence is based on our preclinical research results, as the concentrations of Cisplatin in the tumours are higher compared to IV therapy. It is well known that the side effects of Cisplatin are directly proportional to plasma levels, and therefore we expect fewer and less severe known side-effects from this delivery route.

The treatment proposed will significantly reduce the overall UK Healthcare costs and free up resources. This will be achieved through shortening the length of administration from 2-8h to 5-15 min. It will reduce hospital stay – changing the scenario for the NSCLC patient from being an inpatient treatment over at least 2 days to being a day case or an outpatient treatment. This innovative drug delivery technology will also reduce any costs for the treatment of toxic events as the expected levels of these will be significantly reduced.

The benefits we expect are in particular of interest for the over 65 age group where there are limited treatments available at this time. We are confident that the high interest levels we have received from lung cancer physicians as well as from patients with lung cancer and family members will ensure this project is a major success for patients and for the sustainability of the Healthcare services in the UK and beyond. Based on type of lung cancer, age, and suitability, we believe our Inhalosome-Cisplatin product has the potential to effectively treat 1.2 million patients in 2020.

Commercialisation

Inhalosome-C Ltd intend licensing the product to a Pharmaceutical Company which has the resources to fully exploit the technology and take this particular product to market.  For further information please view our Additional Documents below.

Timeline

Clinical staff2015 – 2017* – From this stage the project timeline is 2-3 years from the point the funding is secured*. This would allow for EIS relief for Investors in the project.

2014 November – We submitted the 2nd round application for TSB Late Stage Biomedical Catalyst Fund with results coming out in the New Year 2015

2014 October – We successfully went through the first round of the application process of the TSB Late Stage Biomedical Catalyst Fund.

2013 Autumn – We signed an agreement with MacKenzies Partnership Ltd in Harrogate to assist in finding, reviewing, and assessing any potential investors for the project.

2013 November – We were given an Enterprise Award with our partners at the University of Strathclyde: University of Strathclyde Glasgow Enterprise Awards for November 2013 as the Best Academic Commercialisation Project.

2012 Autumn – We successfully acquired the Technology Strategy Board (TSB) Smart Competition funding. The project was for the development of a non-ionic surfactant vesicle platform formulation for drug encapsulation and pulmonary delivery. The benchmark test were done and proved that we could manufacture a product, it could be scaled-up, and the testing of sizing for nebulization delivery was reviewed. We can freeze dry the product for reconstitution when required on hospital sites, allowing less travel and storage issues for it to be used around the world.

2010 – The University of Strathclyde and a member of Inhalosome-C Ltd team had a meeting with the MHRA to discuss how this project should progress in its development to meet with future approval criteria. The meeting was positive to the concept.

2007 – Scottish Enterprise Proof of Concept programme was awarded and undertaken by the team at the University of Strathclyde (Carter, Ferro, Mullen) to study the Inhalosome technology. This was successful in its efficacy and inhaled pharmacokinetic studies and the preliminary formulation procedures and specifications for the pulmonary delivery of an inhalosome-cisplatin in the future to be developed for a drug in man.

1994 – Patents have been established on the Inhalosome technology.

Additional Documents

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