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Drug-eluting Brachytherapy Implants for Chemo-radiation Therapy

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42CA224646-02
Agency Tracking Number: R42CA224646
Amount: $1,007,156.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 102
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): 2021-08-31
Small Business Information
41 ESTY FARM RD, Newton, MA, 02459-3605
DUNS: 079591740
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (617) 373-2930
Business Contact
Phone: (617) 755-3838
Research Institution
 360 HUNTINGTON AVE, 177-500
BOSTON, MA, 02115-5005
 Nonprofit college or university
Theranano LLC in collaboration with internationally renowned prostate brachytherapy clinicians at Brigham and Womens Hospital and Dana Farber Cancer Institute and biomaterials experts at Northeastern University have developed an innovative combinatorial treatment strategy of Local ChemoRadiation TherapyLCRTusing a modified brachytherapy spacer platform in the form of a INCeRTImplaNts for ChemoRadiation Therapyspacer loaded with DocetaxelDTXto locally radiosensitize the prostateenabling a synergistic cure with the use of lower radiation dosesthereby leading to less rectal radiation toxicity and minimal chemotherapeutic systemic side effectsExtensive results have demonstrated the efficacy and safety of the technologyiAs monotherapyin PCtumored micetherapeutic doses of DTX can be delivered using intratumoral INCeRT spacers that lead to complete tumor suppression and disease free survival inof animalsiiDTX loaded INCeRT spacers show sustained synergistic radiosensitizationiiiFor combined LCRTsustained DTX release prolongs the tumor suppression in irradiated miceivToxicity as assessed by gross weightand visual observationis greatly reduced compared with IV administration of equivalent doses of DTXThese results have demonstrated the validity and feasibility of LCRT using INCeRT spacersThe Phase I STTR project demonstrated the feasibility of a solvent free hot melt extrusion process of fabrication of InCeRT DTX spacers thus providing proof of principle of reproducible scale up of manufacturing of INCeRT spacersThe HME spacers fabricated possessed all the desired material and drug characteristicsas well as in vitro releasePrCa model efficacy and toxicity profilesachieving all the aims of the projectThe Phase I project met and exceeded all its aimsIn this Phase II STTR project Theranano will partner with outstanding collaborators to carry out IND enabling GLP level manufacture and pre clinical animal studies through the following aimsSpecific AimFabricate GLP quality InCeRT DTX brachytherapy spacer implants GLP level manufacture of InCeRT DTX implants will be carried outThe GLP implants will be thoroughly characterized for their physico chemical propertiesSpecific AimNon GLP therapeutic efficacy of INCeRT spacers in clinically relevant PCa mice modelsThe implant spacers fabricated in SAwill be tested for release and therapeutic efficacy in PCcells and tumor models to ensure their bioactivitySpecific AimIND enabling GLP pharmacokinetics and toxicity evaluation of INCeRT implants with brachytherapy in canine modelsGLP level animal studies in canine models will be carried out for demonstrating the safety of the InCeRT DTX implants in conjunction with Ibrachytherapy seedsSpecific AimSubmission of FDA IND application An FDA IND application will be submitted and planning for a Phase I clinical trial will be initiated PROJECTNARRATIVE TITLEDrug eluting Brachytherapy Implants for Chemo radiation Therapy This STTR phase II project seeks to translate drug eluting brachytherapy implants for Local Chemo Radiation TherapyLCRTas a new modality of prostate cancer treatmentLCRT combines radiation therapy with chemotherapy delivered locally to the prostateutilizing drug releasing spacers similar to those currently used in brachytherapyto boost the overall treatment efficiency while greatly reducing toxic side effectsThe treatment has the potential to improve the lives of all of the thousands of men with localized prostate cancer who are treated each year with radiation therapy

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

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