Nanoengineered microneedle arrays for enhanced plasmonic photothermal therapy of basal cell carcinoma.

Basal cell carcinoma (BCC) is the most common cancer in the UK, affecting up to 39% of people at some stage in their lives. BCC is caused by skin exposure to ultraviolet radiation and, therefore, commonly affects the face. BCC is not typically fatal, as it does not metastasise to other parts of the body. However, it is locally destructive and, if not treated effectively, will invade through the skin and underlying tissues resulting in significant disfigurement, pain, ulceration, nerve damage and, potentially, loss of vision for patients with lesions around the eyes. It is estimated that 53,000 new cases are diagnosed in the UK each year. The mean cost to treat a single BCC lesion is currently around £1000. Our ageing population and ever-increasing exposure to ultraviolet radiation suggest that the incidence of BCC will continue to increase, so the estimated cost of management of BCC to the NHS is predicted to rise to around £97 million per year by 2020. Management of BCC by surgical excision can be curative in >95% of cases. However, surgery can cause unsightly scarring and ongoing pain, affecting patients' health-related-quality of life and self-esteem. Alternative treatment options are not particularly effective and are associated with numerous drawbacks.

Here, we will investigate a novel treatment based on tiny plastic needles containing microscopic, non-toxic, gold particles. These microneedle arrays will be designed to be inserted by hand into difficult-to-treat deep BCC tumours. Upon illumination with a special type of infrared light, the gold particles will heat up and this heat will diffuse from the tiny needles into the tumour, increasing its temperature enough to kill the cancer cells, but leaving the surrounding normal tissue unharmed. The microneedles containing the gold particles will then be removed intact from the skin, leaving nothing behind and the skin will heal up without scarring.

The technology developed here is unique and could potentially revolutionise treatment of the most common type of skin cancer. It offers the opportunity for dramatically improved treatment, with potential benefits for both patients and the NHS. Ultimately, commercialisation of the technology will be the primary route by which UK industry, the NHS and patients will derive benefits. In order to attract potential industrial or venture-funding partners, it is vitally important to demonstrate proof of concept for this technology, which is the over-arching aim of the present proposal.

Who will benefit from this research?
Basal cell carcinoma is the most common cancer in the UK, affecting up to 39% of people at some stage in their lives. Frequency and cost burden are increasing. Current treatment methods are far from optimal. The approach we propose here offers the opportunity for dramatically improved treatment. We will investigate a novel platform technology that will produce a sophisticated and distinctive minimally-invasive therapeutic system, modifiable for treatment of various skin conditions or externally-triggered drug delivery. This will benefit patients, the NHS and the UK pharmaceutical industry.

How will they benefit from this research?
In answering both fundamental and applied questions, this project will contribute to the UK knowledge base and economic development. This technology is likely to be of great interest to UK companies in the pharmaceuticals and medical devices sectors. The global market for pharmaceuticals is worth $980 billion per annum, with the global medical devices market set to reach $398 billion in 2017. Both markets are currently US-led. Due to its considerable scope for exploitation, the technology described here has the potential to make a significant and far-reaching impact in this field and place UK Research at the very forefront of developments, in accordance with the Government's Industrial Strategy.

Ultimately, commercialisation of the technology will be the primary route by which UK industry, the NHS and patients will derive benefits. In order to attract potential industrial or venture-funding partners, it is vitally important to demonstrate proof of concept, which is our over-arching aim. As a medical device, the time required for regulatory approval of the technology investigated here will be shorter than for a drug product. However, considering the necessity to engage with potential marketing partners, contract negotiations and out-licensing, followed by industrial scale-up, validation of GMP manufacture and clinical trials, it is likely to be at least 5 years following completion of this project before economic and patient benefit begin to be realised.

The PDRAs and Research Nurse employed on the project will have a unique opportunity to work at the interface of the biological and chemical sciences and pharmaceutical engineering, to carry out research in a challenging environment and to receive both subject-specific and generic skills training. This will undoubtedly aid their personal and professional development and, in turn, their ultimate employability.

What will be done to ensure that they benefit from this research?
Allowing for IP considerations, academic publications, both journal articles and conference presentations, are likely to attract the interest of relevant industry. However, we will also make contact with the relevant UK industry players directly. The applicants have extensive experience in collaborative research with industry and the exploitation of University research. Two potential routes to market exist for this technology. The first option is out-licensing to one or more pharmaceutical/medical devices companies on a royalty basis. The second option is to form a University spin-out company through our holding company QUBIS Ltd. Indeed, our University is ranked 1st in the UK in the revenues of spin-out companies (survey published jointly by DTI and HEFCE).