Research

Our technology stems from many years of research within the field of transdermal drug delivery systems, drug development and -design.

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Research background

The Swedish Pharma research team has investigated the design, physicochemical characterization and clinical evaluation of a new drug delivery system for PDT treatment. A novel and versatile bioadhesive drug delivery system with the ability to adhere to dry or wet skin as well as moist mucosa was developed and tested on skin models and in clinical studies using the generic pharmaceutical 5-aminolevulinic acid (5ALA).

The results showed significantly increased drug release in comparison with current proprietary creams containing an equivalent amount of the drug. The cumulative ALA release profile amounted to more than a 100% of that of a cream, 100 minutes after application, and the high drug loading in the bioadhesive patch enables treatment of significantly deeper tumors. The novel drug delivery system also improved the accuracy and localization of the delivered dose of photosensitizers. 

Clinical studies

Our patch technology has been tested clinically in successful photodynamic therapy of vulval Paget’s disease and vulval lichen sclerosis. PDT, mediated by the patch, induced histological improvement in 48% of women with vulval intraepithelial neoplasia.

Therapeutic benefits

Our patch as a vehicle for 5ALA increases skin penetration and therefore enable treatment of deeper neoplastic lesions and improve patient compliance and comfort during treatment on both easy to target and challenging human surfaces.

Further research

Our technology can serve as an ideal platform for the delivery of pharmaceuticals within a wide range of therapeutic areas. Please contact us if you are interested in co-operating in further vertical research or commercial projects with your proprietary active substances.

WHAT DO WE MEAN BY PHOTODYNAMIC TREATMENT (PDT)?

Photodynamic treatment (PDT) is a medical treatment by which a combination of a photosensitizing drug substance and visible light causes targeted cellular destruction. The efficacy and patient-benefits of PDT in the treatment of a wide range of neoplastic disease stages has clearly established PDT as an alternative to excisional surgery, cryosurgery, curettage and others. One of the most established procedures in PDT treatment is topical administration of 5-aminolevulinic acid (5ALA) for actinic keratosis and very superficial

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basal cell carcinomas. Effective cutaneous delivery of 5ALA is problematic, given its significant aqueous solubility – causing challenges to achieve greater skin penetration than 1-2 mm. As a result, only the most superficial AK- and BCC-lesions are currently treatable with PDT. In addition, the current ointment-based application brings a high level of uncertainty regarding the delivered dose, exact localization and patient discomfort during delivery to challenging areas (e.g. mucosa or genitals) as well as immobility after application.

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Non-melanoma skin cancer

We have our skin to thank for a lot of things. Through its smart contexture it protects our inner organs from injuries, sunlight, heat and infections whilst it controls our body temperature and keeps storage of water, fat and vitamins. In fact – the skin in itself is the largest organ of the human body. The skin is built upon several layers where the outer layer is called the epidermis. This is where skin cancers are first developed – often caused by the exposure to ultraviolet radiation from the sun or by a weakened immune system. The types of cancer differ depending on where in the epidermis the neoplasms (tumor) originates. The most rare and dangerous form of skin cancer is melanoma – which begin in the skin’s pigment cells (melanocytes). In 2015, more than 70,000 people where diagnosed with melanoma skin cancer in the US. Basal cell carcinoma (BCC) and squamous cell carcinoma (SCC),

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also referred to as non-melanoma skin cancers, represent the two most common types of skin cancers – accounting for over 3,5 million diagnoses annually in the US. About 40% of the US population who live to the age of 65 will be diagnosed with BCC or SCC at least once in their lifetime. As opposed to melanoma – BCC and SCC seldom metastasize and lead to fatal consequences (2% mortality in the case of SCC). However, the neoplastic lesions may cause serious disfigurement to the skin leading to significant patient discomfort. Actinic keratosis (AK) is a precancerous stage to SCC and BCC, which appears as scaly lesions on skin often exposed to the sun. About 60% of Americans aged 40 years or older, 40-60% of all Australians and 11-25% of the population in the northern hemisphere are estimated to have at least one actinic keratosis lesion.

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List of publications

Photodynamic Therapy of Vulval Intraepithelial Neoplasia using Bioadhesive Patch-based Delivery of Aminolevulinic acid.

McCarron, P.A., Donnelly, R.F., Woolfson, A.D., Zawislak, A. (2003).
Drug Delivery Systems and Sciences, 3, 59-64.

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