Minnetronix Medical, Inc. — Department of Health and Human Services STTR Phase I: NIAID

Description

DESCRIPTION provided by applicant When Cryptococcus is manifested as Cryptococcal meningitis CM it creates a large burden of mortality and morbidity to the patient and is very difficult for the clinician to treat There are now US cases and over million cases of CM worldwide annually with estimated deaths of per year CM is caused when Cryptococcus neoformans a basidiomycete fungal pathogen invades the central nervous system CNS It is seen most commonly in immunocompromised patients such as those with HIV or post organ transplant Current treatments include anti fungal agents that have limited effectiveness in penetrating the CNS and various systemic side effects Reduction in pathogen burden within the first days of therapy is the best predictor of reduced morbidity and mortality Minnetronix a medical device development and manufacturing company proposes this Phase I STTR in collaboration with experts from the Infectious Diseases and Neurosurgery Departments at Duke University Phase I will focus on developing Neurapheresis a cerebrospinal fluid CSF processing platform that will rapidly clear specific pathogens for treating life threatening infections of the central nervous system CNS The objective of the proposed project is to develop a tailored system to target and remove C neoformans from the CSF and to evaluate its reduction in a CM animal model Specific Aim will focus on conducting in vitro testing using a design matrix tailored for Cryptococcus exclusion Longevity and mechanical testing will be performed to ensure safety and reliability Specific Aim will evaluate the in vivo reduction of CSF fungal CFUs in a validated rabbit CM model In summary Neurapheresis is an innovative new therapeutic option that provides direct access to the CSF and creates active circulation combined with targeted pathogen removal This treatment is intended to be complementary and does not replace standard of care SOC interventions with systemic intravenous antifungal regimens Successful completion of this Phase I STTR will provide Minnetronix with the data to justify broader preclinical studies and development of a GLP quality system for treatment of CM in Phase II During Phase II concurrent regulatory clinical planning and reimbursement work will be conducted to prepare for an investigational device exemption IDE application at the end of Phase II The long term goal of the project is to develop a novel therapeutic approach that rapidly reduces CSF fungal burden and translates to reduced morbidity and mortality for CM patients worldwide PUBLIC HEALTH RELEVANCE In this Phase I STTR Minnetronix plans to develop an innovative new therapeutic platform for treating devastating Central Nervous System CNS infections Cryptococcal meningitis CM occurs when a fungal pathogen C neoformans invades the CNS and is seen most commonly in immunocompromised patients such as those with HIV or post organ transplant CM is a deadly infectious neurological disease that affects people in the US and million people annually worldwide and results in a mortality rate This project will provide the first ever localized therapy that safely targets and eliminates pathogens affecting the CNS and save lives