You are here

Directed Chemotherapy Delivery for Leptomeningeal Metastases

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA206744-01
Agency Tracking Number: R41CA206744
Amount: $224,970.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA15-270
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-01
Award End Date (Contract End Date): 2018-07-31
Small Business Information
Saint Paul, MN 55108-2703
United States
DUNS: 945753622
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (651) 917-4060
Business Contact
Phone: (651) 251-4060
Research Institution

DESCRIPTION provided by applicant Directed Chemotherapy Delivery for Leptomeningeal Metastases PI Lad Shivanand and McCabe Aaron Project Summary Leptomeningeal Metastases LM is a condition in which cells from a primary solid or hematological tumor metastasize invade the subarachnoid space and spread throughout the cerebrospinal fluid CSF resulting in seeding of the leptomeninges along the surface of the brain and spinal cord It represents a late event of cancer progression and the most frequent symptoms include multiple cranial nerve deficits motor deficits altered mental status headache and radicular pain There are now US cases annually secondary to over million annual cases of breast and lung cancer lymphoma and melanoma There is currently no cure and the outcome is invariably fatal with median survival of weeks if left untreated and months with curren therapies Reduction in tumor burden is the primary goal to extend survival and quality of life Minnetronix a medical device development and manufacturing company proposes this Phase I STTR in collaboration with experts from the Duke Cancer Institute and Neurosurgery Department at Duke University Phase I will focus on developing Neurapheresis a cerebrospinal fluid CSF processing platform that will provide rapid and targeted drug delivery with circulation of chemotherapeutic agents This proposal will demonstrate feasibility using methotrexate MTX The objective of the proposed project is to develop a tailored system to deliver lower doses of chemotherapeutics with less toxicity and maximum bioavailability throughout the subarachnoid space Specific Aim will focus on conducting in vitro testing using a design matrix tailored for targeted CSF drug delivery and broad distribution and bioavailability
Longevity and mechanical testing will be performed to ensure safety and reliability Specific Aim will evaluate the in vivo distribution of chemotherapeutic agents and reduction of CSF tumor cells in a validated rabbit LM model In summary Neurapheresis is an innovative new therapeutic option that provides direct access to the CSF and creates active circulation combined with targeted chemotherapy delivery This treatment is intended to be complementary and does not replace standard of care SOC interventions with systemic chemotherapy 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 LM 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 to improve survival for LM patients worldwide

PUBLIC HEALTH RELEVANCE Directed Chemotherapy Delivery for Leptomeningeal Metastases PI Lad Shivanand and McCabe Aaron Project Narrative In this Phase I STTR Minnetronix plans to develop an innovative new therapeutic platform for Leptomeningeal Metastases LM The most common cancers to metastasize to the leptomeninges are lung breast lymphoma and melanoma Current treatments rely on single bolus injection and passive diffusion of chemotherapeutic agents However because of the short half life and rapid clearance creating therapeutic levels without creating toxicity is challenging The median survival is approximately months and new treatment approaches are needed This project will provide an innovative directed chemotherapy delivery throughout the neuraxis

* Information listed above is at the time of submission. *

US Flag An Official Website of the United States Government