tPA-Nanoconstructs for Treating Acute Ischemic Stroke: a Technical and Commercial Analysis

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Acute ischemic strokes result from the occlusion of cerebral vessels by blood clots causing neurological complications, brain damage and death. Based on WHO reports, stroke affects 17M people per year worldwide, with 6M deaths and 5M survivors suffering long-lasting disabilities. Recent statistics estimate an EU direct healthcare cost for stroke of €20B and indirect costs, due to disabilities and lost productivity, of €25B. The two current treatments – thrombolysis and thrombectomy – come with limitations and considerable side effects. Thrombolysis can be safely administered only to a small cohort of patients (about 5%) whereas thrombectomy induces disabilities in 50% of the cases. Moved by the societal, economical, and emotional burden associated with stroke, this proposal aims at developing and validating more effective and less toxic therapies via the combination of the clinically approved molecule tPA and rationally-designed, discoidal polymeric nanoconstructs (DPNs). As compared to tPA, the proposed thrombolytic nano-agents (tPA-DPNs) are expected to provide faster blood clot dissolution; safer administration profile; longer blood circulation and stability. On the technical side, tPA-DPNs will be re-designed to improve their biodegradation and excretion profiles; validated in FDA-recognized stroke models for neurotoxicity and therapeutic efficacy. On the commercial side, a patent portfolio covering the fabrication and utilization of tPA-DPNs will be secured, together with thorough market and business analyses. This will facilitate the interaction with pharmaceutical companies that are investing in the fast growing markets of high-tech drug delivery systems and stroke diagnostics and therapies. tPA-DPNs are expected to alleviate the economic burden on healthcare systems, increase the total sale of thrombolytic agents, revolutionize the medical protocols for stroke management, and diminish the societal and emotional impact of stroke.