NIH/NCI 447 – Non-invasive Device Technology Research & Development for Chemotherapy-induced Peripheral Neuropathy Management
Fast-Track proposals will be accepted.
Direct-to-Phase II proposals will NOT be accepted.
Number of anticipated awards: 1-2
Budget (total costs, per award):
Phase I: up to $400,000 for up to 12 months
Phase II: up to $2,000,000 for up to 2 years
Proposals that exceed the budget or project duration listed above may not be funded.
Summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a progressive, enduring, and often irreversible adverse effect of taxane, platinum, and vinca alkaloid chemotherapy. For example, paclitaxel which is approved by the FDA for the treatment of ovarian, breast, and lung cancer induces CIPN in an estimated one-third of recipients. For breast cancer alone, this results in an estimated 90,000 new cases of CIPN a year. Considering the other common cancers for which paclitaxel is used, and that cancer patients live longer, in many cases several decades, it is estimated that millions of people live with CIPN today. Damage to the peripheral nervous system underlies CIPN and this induces the long-term symptoms of numbness, tingling, and pain in the hands and feet, affecting the quality of life of cancer survivors, and also increasing the risk of dangerous falls for these patients.
With repair of the nerve damage underlying CIPN as yet out of reach, treatment focuses on modulating nerve activity to allow management of the symptoms. Current approaches with pain-relief drugs and procedural therapies based on common pain management approaches have failed to provide long-term relief to patients. A significant opportunity lies in exploring technologies that allow the development of affordable devices that have the potential to bring recent research advances to the home-care setting. These technologies (neurofeedback, nerve stimulation, neuromodulation, etc.) may be adopted in procedural therapies or wearable devices to manage and reduce CIPN pain in a more targeted and sustained manner.
Project Goals
The purpose of this contract topic is to solicit proposals to advance the development and/or application of new non-invasive device technologies to provide effective mitigation of CIPN and bring them to the marketplace. Such technology would improve the functionality of cancer survivors with CIPN, enhancing their quality of life and reducing the risk of further complications like falls. The ideal technology would be designed for effective mitigation of CIPN pain in a non-invasive, cost-effective, accessible manner in the home-care setting so that its long-term use can provide sustained relief to as many cancer survivors as possible. Therapeutics will not be considered under this solicitation.
Activities and deliverables envisaged under this contract topic include the developing of technology prototypes, testing these for clinical efficacy and user adoption/usability using accepted assessment tools, and benchmarking them against current practices. Next steps would include the production and testing of a marketable version of such prototypes in a limited, real-world setting, determining the impact of sustained application, and creating a path towards FDA approval.
Activities not responsive to announcement:
The development of pharmacological interventions for CIPN treatment or prevention or the development of stem-cell-based therapies for nervous system repair are considered non-responsive to this announcement.
Phase I Activities and Deliverables:
Offerors must propose to conduct activities that lead to development of a working prototype device ready for clinical evaluation, including but not limited to:
- Establish a project team, including proven expertise in pain management related to CIPN, device development, user centered design, software and hardware expertise, and other areas of expertise as appropriate for the proposed project.
- Using user-centric design principles, develop a cost-effective, non-invasive, and accessible device prototype capable of mitigating CIPN symptoms.
- Conduct studies to evaluate and test user acceptability and feasibility in intended use populations.
- Demonstrate accessibility and ease of use of device in an at-home setting with only minimal support from a health care provider.
- Benchmark the device against current practice for reduction in CIPN pain as described in the medical literature using accepted pain measures, and improvements in appropriate quality of life metrics.
- Offerors may need to establish a collaboration or partnership with a research group or medical facility that can provide relevant patient access; offerors must provide a letter of support from the partnering organization(s) in the proposal.
Phase II Activities and Deliverables:
Offerors must propose activities leading to the manufacturing and regulatory approval of the device, including but not limited to:
- Develop a well-defined, marketable device following appropriate FDA device guidelines.
- Conduct a clinical study of the device using accepted pain measures and user adoption/usability by target patient population to determine clinical efficacy.
- Determine whether sustained periodic use of the technology beyond an initial period provides ongoing clinical benefit.
- Establish a strategy for FDA regulatory approval and insurance and/or CMS reimbursement.
Receipt date: November 4, 2022, 5:00 p.m. Eastern Daylight Time
Apply for this topic on the Contract Proposal Submission (eCPS) website.