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Supportive Clinical Trial Tasks for Nanotechnology-Based Treatment of Oral Cancer

Award Number: R44CA192875
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/12/2015
PERIOD OF PERFORMANCE END DATE: 07/31/2021

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Supportive Clinical Trial Tasks for Nanotechnology-Based Treatment of Oral Cancer - Preceding Award: NCI Award 1R44CA192875-02 Project Summary: According to the Oral Cancer Foundation, about 50,000 people in the US will be newly diagnosed with oral cancer (OC) in 2017, causing 9,700 deaths[1]. OC is a severely neglected orphan disease with a lack of significant treatment advances in 4 decades[1]. Historically, OC has been present in heavy smokers and drinkers. However, more recently OC has also become more prevalent in younger people due to an increase in cancer- causing human papillomavirus (HPV) spread through oral sex[1]. About 64% of patients die within the first 5 years of diagnosis. The survival rate remains surprisingly low despite its accessibility and lack of metastasis. Survivors must manage devastating life long side effects of treatments which can lead to permanent psychological and physical damage. Oral cancer has either the highest suicide rate of all cancers or among the top 3 suicide rates of all cancers (depending on the source) due to permanent physical disabilities resulting from treatment. These include permanent speech impairment, an inability to swallow, and/or the loss of the jawbone due to the surgical removal of the tongue and other oral tissue. The long term costs associated with the treatment and these disabilities can range from $100,000-$250,000, resulting in oral cancer persisting as one of the most expensive of all cancers to treat. Despite these realities, oral cancer remains underserved and remains on the rise in incidence both within the US and worldwide. To address this unmet need, Privo Technologies has developed a topical chemotherapy patch, the ChemoThin Wafer (CTW) that is applied directly to the tumor. CTW consists of a mucoadhesive polymeric patch with embedded cisplatin-loaded nanoparticles and a non-permeable backing that facilitates unidirectional drug release, prevents drug loss, and masks taste. Cisplatin is recognized as the gold standard chemotherapeutic agent for treating oral cancer. However, cisplatin’s efficacy is often hindered by significant systemic toxicity resulting from traditional systemic intravenous (IV) administration. The cisplatin-loaded nanoparticles in the CTW have optimized size, charge, and permeation parameters to ensure that cisplatin is locally retained within the tumor tissue and not exposed to systemic bodily circulation. Privo has performed 12 sets of in vivo studies in numerous species of animals to examine the safety and efficacy of CTW. In all cases, CTW has shown robust antitumor effect and negligible local or systemic toxicities. The goal of this proposal is to support the successful completion of Privo’s Phase 2 clinical trial. Privo is confident that its team of expert scientists, business leaders, and collaborators can execute its defined aims with milestones and deliverables.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Cancer Treatment Research	000	6	8/26/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,000,447 )
2020	2020	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Cancer Treatment Research	001	6	8/21/2020	NON-COMPETING CONTINUATION	$790
2020	2020	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Cancer Treatment Research	000	6	6/22/2020	NON-COMPETING CONTINUATION	$999,657
														Subtotal = $1,000,447

Issue Date FY: 2019 ( Subtotal = $1,186,165 )
2019	2019	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Cancer Treatment Research	000	4	1/11/2019	SUPPLEMENT FOR EXPANSION	$98,000
2019	2019	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Cancer Treatment Research	002	5	7/19/2019	SUPPLEMENT FOR EXPANSION	$4,318
2019	2019	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Cancer Treatment Research	001	5	6/24/2019	NON-COMPETING CONTINUATION	$1,083,847
														Subtotal = $1,186,165

Issue Date FY: 2018 ( Subtotal = $999,072 )
2018	2018	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Cancer Treatment Research	001	4	7/17/2018	COMPETING CONTINUATION	$999,072
2018	2017	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Cancer Treatment Research	000	3	5/1/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $999,072

Issue Date FY: 2017 ( Subtotal = $1,170,342 )
2017	2017	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Cancer Treatment Research	001	3	2/1/2017	NON-COMPETING CONTINUATION	$1,170,342
2017	2015	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Cancer Treatment Research	000	1	1/31/2017	NEW	$0
														Subtotal = $1,170,342

Issue Date FY: 2016 ( Subtotal = $960,707 )
2016	2016	PRIVO TECHNOLOGIES, LLC	13 BRISTOL STREET, UNIT 1	CAMBRIDGE	MA	02141	MIDDLESEX	USA	Cancer Treatment Research	000	2	1/13/2016	EXTENSION WITH OR WITHOUT FUNDS	$708,789
2016	2016	PRIVO TECHNOLOGIES, LLC	13 BRISTOL STREET, UNIT 1	CAMBRIDGE	MA	02141	MIDDLESEX	USA	Cancer Treatment Research	001	2	2/12/2016	EXTENSION WITH OR WITHOUT FUNDS	$54,577
2016	2016	PRIVO TECHNOLOGIES, LLC	13 BRISTOL STREET, UNIT 1	CAMBRIDGE	MA	02141	MIDDLESEX	USA	Cancer Treatment Research	002	2	7/22/2016	EXTENSION WITH OR WITHOUT FUNDS	$197,341
														Subtotal = $960,707

Issue Date FY: 2015 ( Subtotal = $293,491 )
2015	2015	PRIVO TECHNOLOGIES, LLC	13 BRISTOL STREET, UNIT 1	CAMBRIDGE	MA	02141	MIDDLESEX	USA	Cancer Treatment Research	000	1	6/12/2015	NEW	$293,491
														Subtotal = $293,491

Grand Total All Awards = $5,610,224

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Supportive Clinical Trial Tasks for Nanotechnology-Based Treatment of Oral Cancer

Award Number: R44CA192875

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/12/2015

PERIOD OF PERFORMANCE END DATE: 07/31/2021

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