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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: $2,000,000.00
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
Newton, MA 02459-3605
United States
DUNS: 079591740
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (617) 373-2930
Business Contact
Phone: (617) 755-3838
Research Institution
360 HUNTINGTON AVE, 177-500
BOSTON, MA 02115-5005
United States

 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 Therapy
(LCRT) using a modified brachytherapy spacer platform in the form of a INCeRT (ImplaNts for ChemoRadiation
Therapy) spacer loaded with Docetaxel (DTX) to locally radiosensitize the prostate, enabling a synergistic cure
with the use of lower radiation doses, thereby leading to less rectal radiation toxicity and minimal
chemotherapeutic systemic side effects.Extensive results have demonstrated the efficacy and safety of the technology: (i) As monotherapy, in
PC3 tumored mice, therapeutic doses of DTX can be delivered using intratumoral INCeRT spacers that lead to
complete tumor suppression and disease free survival in 90% of animals. (ii) DTX-loaded INCeRT spacers show
sustained synergistic radiosensitization. (iii) For combined LCRT, sustained DTX release prolongs the tumor
suppression in irradiated mice. (iv) Toxicity as assessed by gross weight, and visual observation, is greatly
reduced compared with IV administration of equivalent doses of DTX. These results have demonstrated the
validity and feasibility of LCRT using INCeRT spacers.The 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 spacers. The HME spacers fabricated possessed all the desired material and drug characteristics,
as well as in vitro release, PrCa model efficacy and toxicity profiles, achieving all the aims of the project. The
Phase I project met and exceeded all its aims. In 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 aims: Specific Aim 1: Fabricate GLP quality InCeRT-DTX brachytherapy spacer
implants GLP level manufacture of InCeRT-DTX implants will be carried out. The GLP implants will be
thoroughly characterized for their physico-chemical properties. Specific Aim 2: Non-GLP therapeutic efficacy
of INCeRT spacers in clinically relevant PCa mice models. The implant spacers fabricated in SA1 will be
tested for release and therapeutic efficacy in PC3 cells and tumor models to ensure their bioactivity. Specific
Aim 3: IND-enabling GLP pharmacokinetics and toxicity evaluation of INCeRT implants with
brachytherapy in canine models. GLP level animal studies in canine models will be carried out for
demonstrating the safety of the InCeRT-DTX implants in conjunction with I125 brachytherapy seeds. Specific
Aim 4: Submission of FDA IND application An FDA IND application will be submitted and planning for a Phase
I clinical trial will be initiated.PROJECTNARRATIVE
TITLE: Drug-eluting Brachytherapy Implants for Chemo-radiation Therapy
This STTR phase II project seeks to translate drug-eluting brachytherapy implants for Local Chemo-Radiation
Therapy (LCRT) as a new modality of prostate cancer treatment. LCRT combines radiation therapy with
chemotherapy delivered locally to the prostate, utilizing drug releasing spacers similar to those currently used
in brachytherapy, to boost the overall treatment efficiency while greatly reducing toxic side effects. The
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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