Loco-regional prevention of recurrences of pleura mesothelioma with cisplatin-hyaluronan biodegradable film following surgical removal of primary tumor

Pleural mesothelioma is a rare cancer caused by inhalation of asbestos particles in industrial or civil environment. It is a problem for countries where the use of asbestos, following the assessment of toxicity, has not promptly been banned. The expectation of life for affected persons is very short. The standard therapy for this cancerconsists in an intravenous chemotherapy and surgery resection of primary tumour. Unfortunately, this therapy increases the life expectation only of few months, since mesothelioma is a diffused tumour and completeresection is unreliable. Consequently, metastases appear where the primary tumour has been removed.

The thoracic surgeons of Parma Hospital requested PlumeStars to study a loco-regional therapy for the prevention of metastases appearance on the resected lung area. PLU invented a hyaluronate biodegradable film, loaded with cisplatin, to be intracavitary applied in the chest where the tumour was removed. The film provides a long local release of the anti-cancer drug on the operated tissue. Thus, the solution invented by PlumeStars consists in a thin, flexible and biodegradable film, loaded with cisplatin, to be stuck on pleural surfaces. Cisplatin loco-regionally released from the film, named Hyalcis, provides high and extended local drug concentrations, exactly where residual tumour could reappear. Animal studies demonstrated that the film applied on the operated mesothelial surface provided a long period of absence of tumour compared to non-treated animals and important reduction of the cisplatin toxicity.

Now, the product needs a further push in term of science, film GMPmanufacturing and development with the objective to execute the clinical plan agreed with the EMA committee of orphan medicines in the Protocol assistance document.

Key innovation and impact

Hyalcis is a novel formulation for intracavitary loco-regional drug delivery in MPM. In general, intravenous cisplatin chemotherapy is prescribed for the treatment of various cancers, but low efficacy towards solid malignancies is reported. This is due to the difficulties to reach the site where cancer is located and to locally maintain high drug concentrations. PlumeStars invented, manufactured and characterized a medicinal film loaded with cisplatin. The dosage form was a polymeric biodegradable film, loaded with cisplatin, suitable to stuckon the mesothelium surface. The film releases the cisplatin for long time. No implants for intracavitary treatment of malignant mesothelioma recurrences have been authorized yet. Hyalcis is the first on-site chemotherapy film to be applied on the tumour resected area during surgery of mesothelioma, designed by EMA and FDA as orphan medicine to be developed for the market.

Alignement with Preciseu

Thehydrophilic,thinandflexiblefilmofsodium cisplatin-hyaluronanappliedintracavitaryexactlyonpleurastaysadherenttosurfacesreleasing CisPtfor prolonged local drug concentrations, It represents a targeted precise therapy.