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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: 1R41CA224646-01
Agency Tracking Number: R41CA224646
Amount: $225,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-25
Award End Date (Contract End Date): 2019-09-24
Small Business Information
41 ESTY FARM RD
Newton, MA 02459-3605
United States
DUNS: 079591740
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 SRINIVAS SRIDHAR
 (617) 755-3838
 s.sridhar@neu.edu
Business Contact
 SRINIVAS SRIDHAR
Phone: (617) 755-3838
Email: theranano.info@gmail.com
Research Institution
 NORTHEASTERN UNIVERSITY
 
360 HUNTINGTON AVE, 177-500
BOSTON, MA 02115-5005
United States

 Nonprofit college or university
Abstract

Prostate cancer PCa is the second leading cause of cancer death in American men with deaths and
new cases estimated in the US in Radiation therapy is one of the standard therapies for high and
intermediate risk patients and is a non surgical therapy option for low risk patients A combined chemo radiation
therapy CRT approach has been shown in several trials to improve survival in multiple cancers compared with
monotherapies However systemic chemotherapy accompanying CRT typically come at the price of increased
toxicity and thus require synchronization of the two modalities to achieve maximum benefit Here an immediate
need exists to deliver the drug specifically at tumor site in locally recurrent patients while avoiding toxicities
associated with systemic delivery and resulting in preferential radiosensitization of the prostate compared to the
normal structures Northeastern University and Theranano LLC in collaboration with clinicians at Brigham and
Womens Hospital and Dana Farber Cancer Institute have developed an innovative combinatorial treatment
strategy of Local Chemo Radiation 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 These new INCeRT spacers
are physically similar to the inert spacers routinely used in prostate brachytherapy but now loaded with
formulations of DTX which can be tuned to release the drug payload from a week to several months The
technology has been exclusively licensed to TheraNano LLC for commercialization and translation to the clinic
The phase project goals will be achieved through the following specific aims Specific Aim Development
scale up and quality control of docetaxel loaded INCeRT brachytherapy spacers Develop INCeRT
brachytherapy spacers loaded with DTX with analysis of quality control reproducibility drug loading and drug
release using optimized SOPs Earlier work at Northeastern University has produced INCeRT spacers in batches
of andlt Here we plan to scale up the process to routinely manufacture DTX INCeRT spacers in batches of
several s in GLP conditions The study design will include setting up a pilot plant for fabrication
characterization of INCeRT spacers loaded with docetaxel and quality control assessment in terms of
reproducibility size drug loading and release kinetics under GLP conditions Specific Aim In vivo
therapeutic efficacy of combined Chemo Radiation treatment and toxicity assessment in Prostate cancer
models We will evaluate the therapeutic efficacy of INCeRT spacers combined with Brachytherapy EBRT by
locally implanting the spacers at the tumor site in PCa animal models We will also assess gross immunotoxicity
associated with the combined treatment PROJECTNARRATIVE
TITLE Drug eluting Brachytherapy Implants for Chemo radiation Therapy
This STTR phase project seeks to demonstrate the feasibility of 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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