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Validation of Novel Therapeutic Approach for Leptomeningeal Metastases

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42CA206744-02A1
Agency Tracking Number: R42CA206744
Amount: $1,949,379.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA17-303
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-08-01
Award End Date (Contract End Date): 2021-07-31
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: (612) 750-1030
Research Institution
2200 W MAIN ST, SUITE 820
DURHAM, NC 27705-4673
United States

 Nonprofit College or University

Leptomeningeal Metastases (LM) is a condition in which tumor cells from a primary tumor metastasize, invade
the subarachnoid space (SAS) and spread throughout the cerebrospinal fluid (CSF), resulting in seeding along
the meninges, brain and spinal cord. LM represents a devastating event of cancer progression. There are 30,000
cases annually and currently no cure, with average survival of 3-6 months with current 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 II STTR in collaboration with experts from the Duke Cancer
Institute and Neurosurgery Department at Duke University. Phase I demonstrated the dramatic results of
Neurapheresis, a CSF processing platform, with the ability for targeted circulation of chemotherapeutics (such
as Methotrexate, MTX), along with rapid clearance of tumor cells both in vitro and in vivo, in a rabbit LM model.
Phase II will optimize and validate a tailored human system to deliver the first-ever platform for LM
patients. It will allow for circulation of chemotherapeutic agents (MTX) intrathecally, control of drug concentration
and toxicity, rapid removal of tumor cells from the CSF, sampling of CSF to follow circulating tumor cell reduction
and drainage of CSF to normalize ICP. Specific Aim 1 will understand and optimize the dosing regimen of
intraventricularly delivered MTX during Neurapheresis in a cranial/spinal model and develop a PK model.
Specific Aim 2 will demonstrate the safety and efficacy of Neurapheresis filtration and MTX circulation in a
pivotal rabbit LM model, refine the PK model, and develop a PK/PD model. Specific Aim 3 will complete the
development of the validated Neurapheresis system for intrathecal MTX circulation and targeted removal of cells
from the CSF and prepare the system for human trials.
Neurapheresis is an innovative, new therapeutic option that provides direct access to the CSF and allows for
active circulation of intraventricularly delivered intrathecal agents, combined with targeted reduction in tumor
burden. This treatment is complementary and does not replace standard of care (SOC) interventions with
systemic regimens. Successful completion of this Phase II STTR will provide Minnetronix with the ability to
complete development of a GLP-quality system for the treatment of LM patients. Concurrent regulatory and
clinical study planning 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 tumoricidal approach to reduce
morbidity and mortality for LM patients worldwide.NARRATIVE
In this Phase II STTR, Minnetronix plans to validate an innovative, new therapeutic platform for treating a
devastating central nervous system (CNS) metastatic disease. Leptomeningeal metastases (LM) is a condition
in which cells from a primary solid or hematological tumor spread throughout the cerebrospinal fluid (CSF) and
seed the leptomeninges. It affects 30,000 patients in the US annually, with a median survival of 3-6 months with
current therapies. This project will improve lives by providing the first-ever tumoricidal platform, allowing
for active circulation of chemotherapeutic agents, and safely targeting the CNS tumor burden.

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

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