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Optimization of microparticle-based topical treatments for treating erectile dysfunction in patients refractory to oral PDE5 inhibitors

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DK121587-01
Agency Tracking Number: R41DK121587
Amount: $225,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 400
Solicitation Number: PA18-575
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-13
Award End Date (Contract End Date): 2020-09-12
Small Business Information
Greenville, SC 29601-4824
United States
DUNS: 080999429
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (908) 420-4814
Business Contact
Phone: (858) 775-6710
Research Institution
BRONX, NY 10461-1975
United States

 Domestic Nonprofit Research Organization

Radical prostatectomyRPis a commonly used treatment option for localized prostate cancerUnfortunatelythe procedure carries a risk of post surgical complications including a high risk of erectile dysfunctionEDThe main pathophysiological mechanism behind this is neuropraxia in which surgery either directly damages the cavernous nervesCNor does so indirectly through activation of an inflammatory responseGiven that phosphodiesterase inhibitorsPDE ithe mechanism of FDA approved oral treatments for EDare dependent on the production of nitric oxideNOfrom CN endingsthe majority of patients undergoing RP where CN function is perturbed or lost are refractory to this treatmentIn prior publications from our group we have demonstrated that topically applied particles delivering NO or a PDE i can generate an erectile response in animal models of aging or RPHoweverthere is a strong rationale for combining both NO and PDE i to treat ED in patients with neuropraxiaNO will initiate an erection and the PDE i will maintain cyclic guanosine monophosphatecGMPlevelswhich activates biochemical pathways resulting in a sustained erectionThe goal of the present proposal is to develop a novel therapeutic for treating EDa topically applied microparticleMPdelivery system delivering NONO MPwith the potential to act cooperatively with PDE i to treat ED in men that are refractory to current FDA approved therapiesThe goal of this proposal will be achieved through two specific aimsIn Specific AimNO MP will be formulated and optimized for clinical translationNO MP will be generated and loaded with four different concentrations of NO and tested in an animal model of RPbilateral CN transectedto assess the ability to elicit erectionsIn additionthese animals will be used to perform preliminary pathology studies to provide initial evidence of safety of the NO MPIn Specific Aimit will be determined if a greater response can be obtained with a combination of NO MP and a PDE isildenafilin promoting erectile functionAt the conclusion of this phase I studya lead NO concentration will be determined to develop a noveltopical therapeutic for neurogenic ED Radical prostatectomyRPa commonly used treatment option for localized prostate canceris unfortunately associated with a high risk of post surgical erectile dysfunctionEDThe goal of the present proposal is to develop a novel therapeutic for treating EDa topically applied microparticleMPdelivering nitric oxideNOwith the potential to enhance erectile function in combination with phosphodiesteraseinhibitorsPDE iin PDE i refractory patientsAt the conclusion of this Phase I studythe optimal NO concentration in NO MP will be identified to develop a noveltopical therapeutic for neurogenic ED

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

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