An Italian start-up, that works in the pharmaceutical sector, invented a novel drug delivery system for local release of anticancer drugs. This new system is based on a biocompatible and biodegradable polysaccharide film for application at the tumour resection site during surgery. They are looking for medical product manufacturer in order to achieve the industrialization of the film throughout a financial, joint venture or licence agreements.
An Italian innovative start-up has developed a thin and flexible polymeric film, sufficiently resistant to be applied intrapleural or in other districts, adhering to the mesothelial or epithelial surfaces.
The startup conduct research in the areas of solid dosage forms (tablets and powder), pulmonary and nasal, with particular reference to pressurized forms or dry powder, liquid forms (eye drops) and transdermal (patches and films).
The intracavitary medicinal product, suitable for the control of cisplatin release and with characteristics for its use during surgery, is a polymeric thin film loaded with the anticancer drug. Cisplatin for injection USP grade is employed for the first film manufacturing. The drug was loaded at two concentrations, i.e. 0.5 or 1% w/w. The pharmaceutical development had as main objective the construction of a film flexible, adhesive and slowly dissolving to control drug release. The film, having a dimension of 10x10 cm, has a mass of about 10 mg/cm2, corresponding to a cisplatin content of 50 or 100 µg/cm2, for the lower and higher drug loading, respectively. The dose is adjusted to patient weight or surface area of the body.
The polymer used for the manufacturing was sodium hyaluronate. The manufacturing was carried out at laboratory level in aseptic conditions by lamination, i.e. a thin layer deposition, of a viscous polymer solution followed by drying. The procedure is typical for the production of transdermal patches. Films were prepared in a Class II Biosafety cabinet, dried, sandwiched through two liner sheets and packaged immediately into thermosealed aluminium bag. The film-forming solution was prepared by dissolving in distilled water sorbitol. Then, the film-forming agent PVA 84300 was added, heating at 75° C under stirring for 2h, until complete dissolution. Under laminar flow hood, weighed cisplatin (30 mg per 100 ml) was added to film forming solution. The mixture was stirred until complete dissolution of drug. Then, the solution was sterilized by filtration. Under the laminar flow, sterile sodium hyaluronate was added and left to dissolve. Subsequently the solution was laminated on a polyester backing placed on a glass plate. The drying period is about two days, at ambient temperature, under a laminar flow hood. Sterilization of the product by other means (heat, gamma irradiation, ethylene oxide) will be studied in detail during the pharmaceutical development.
Cisplatin films were characterized for physico-chemical (thickness, drug content and weight per unit surface, residual water content), mechanical (elongation at break, tensile strength), drug loading and release (drug content uniformity, release rate) characteristics. Product specifications have been defined in order to set a quality standard on subsequent batches to be manufactured.
This novel technology could be applied to other chemotherapeutic drugs. The films could be implanted in other body districts for different tumours such as ovarian, peritoneal or other solid accessible tumours, alone or in combination by using different loaded films. The release rate of drug from the film depends on the film area in contact with the body tissue. A number of films can be used in order to cumulate the dose of the chemotherapeutic agent. Finally, the film could be also implanted after a minimal surgery procedure in situation in which the subject cannot bear a radical and invasive surgery. This alternative implies that the application can be easily repeated.
The start-up is looking for a financial or a joint venture agreements with a medicinal product manufacturer in order to:
start clinical studies on patients;
obtain the orphan drug designation for malignant pleural mesothelioma from EMA;
start the industrialization of the film.
The start-up is also open to consider a license agreement.
- Specific area of activity of the partner: The start-up is looking for a financial or a joint venture agreements with a medicinal product manufacturer in order to: start clinical studies on patients; obtain the orphan drug designation for malignant pleural mesothelioma from EMA; start the industrialization of the film. The start-up is also open to consider a license agreement.
Nowadays the treatment of solid tumors is a combination of surgery, radiotherapy and chemotherapy. Often it is required of a combination of two or more anticancer drugs having multiple side effects. The technology proposed here allows to administer the chemotherapy locally during primary tumor surgical resection offering the opportunity to achieve high local concentrations and spare healthy tissues.
Preclinical studies in rat and sheep confirmed the efficacy and safety of this approach, evidencing a reduced toxicity for an anticancer drug such as cisplatin in situations where after primary tumor ablation the application of the polymeric film in the pleural cavity prevented the tumor recurrence with metastases.
The technology find an application in the therapy of solid tumors and in particular of malignant pleural mesothelioma. The drug delivery platform can be adapted to the release of conventional or biopharmaceutical drugs.
The technology also answers to the necessity of delivering drugs in surgical settings, on mucosal tissues or body cavities. The control of the released drug is obtained by the selection of polymers and excipients.
Prototype available for demonstration - The medicinal product obtained the European Medicines Agency (EMA) orphan medicine designation in 2017. EMA gave also the protocol assistance for the preparation of the registration dossier. The application for orphan drug has been sent to Food and Drug Administration (FDA).
Exclusive Rights - The orphan designation allows to the owner an exclusive market for 10 years in EU and 7 in USA.