Windtree, Eleison Announce Study Results of Delivering Inhaled Lipid Cisplatin

Windtree Therapeutics and Eleison Pharmaceuticals jointly announced positive results of the feasibility study using Windtree's proprietary Aerosol Delivery System (ADS) aerosolization technology to deliver Eleison's inhaled lipid cisplatin (ILC).

Eleison has an exclusive worldwide license to ILC, a novel, sustained-release formulation of cisplatin in a nanoscale lipid-based complex administered via inhalation or intraperitoneally. ILC, when administered by inhalation, can deliver high levels of sustained release cisplatin targeted to the lung, with minimal systemic-related toxicities. Eleison is developing ILC for lung cancer and completed a phase 2 study of ILC in patients with bone cancer (osteosarcoma) metastatic to the lung.

Windtree has licensed and further developed its ADS utilizing innovative aerosolization technology to deliver pulmonary surfactants (alone or in combination with any other pharmaceutical compound(s)) as an active ingredient for the prevention or treatment of respiratory indications. The ADS has been shown to deliver high aerosol output rates, small and uniform particle size, and consistent aerosol characteristics throughout extended dosing periods, including particularly difficult to aerosolize substances like lipids. The ADS is the technology used in the medical device component of Windtree's AEROSURF® combination drug/device product candidate currently being studied in premature infants with respiratory distress syndrome (RDS).

The feasibility assessment demonstrated that Windtree's ADS technology can effectively aerosolize ILC and at a higher volume compared to conventional nebulizer technology. In the feasibility study, the ADS technology produced in 20 minutes approximately the same volume of aerosolized ILC that required approximately two hours to produce in a phase 2 clinical trial treating osteosarcoma lung metastases with ILC delivered by conventional nebulizer technology. It is expected that a more rapid aerosol delivery rate has the potential to improve the treatment experience for patients receiving ILC. The feasibility study also confirmed the aerosolized drug produced by the ADS technology had the characteristics and particle size appropriate for delivering drug to the lung and was comparable to the aerosolized drug used in the prior ILC clinical trial. Importantly, the cytotoxicity of the aerosolized ILC measured in an appropriate cell line was maintained. The feasibility study also raised the possibility that the ADS technology has the potential to improve the efficiency of dosing and decrease the wasted product inherent in conventional nebulizer technology.

"Combining faster delivery time with our aerosolized ILC and using less volume and having less waste would have the potential to enhance the usability and acceptance of ILC. We are very excited about the prospects of this innovative combination to further differentiate our program and look forward to continued opportunities for collaboration between Eleison and Windtree," said Edwin Thomas, Eleison's CEO.

"We are very encouraged by this research collaboration to date, which has demonstrated the drug delivery potential of our device technology beyond treating premature infants with RDS," said Craig Fraser, CEO of Windtree Therapeutics. "The ADS is an innovative platform that we plan to continue to study in our AEROSURF development program and potentially in additional acute care drug delivery uses, starting with this important area of oncology and Eleison's unique product candidate ILC".

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