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Highly focused loco-regional chemotherapy for oral cancer - IND 132234 - October 01 2017

Award Number: R01FD006325
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2019
PERIOD OF PERFORMANCE END DATE: 06/30/2022

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Highly focused loco-regional chemotherapy for oral cancer - IND 132234 - October 01 2017 - Project Summary According to the National Cancer Institute, about 50,000 people in the US will be newly diagnosed with oral cancer (OC) in 2018, causing over 9,700 deaths. OC is a severely neglected orphan disease with a lack of significant treatment advances in 4 decades and about 64% of patients die within the first 5 years of diagnosis. 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. The current standard of care (SOC) for patients with early stage disease is surgical intervention. However, this can result in disfiguring side effects that impair oral form and function such as the ability to speak and swallow. Surgical treatment of OC also has an exceptionally high rate of recurrence, due in part to tumor margins which are difficult to identify or access. To address this unmet need, Privo Technologies has developed a topical chemotherapy patch, PRV111 that is applied directly to the tumor. PRV111 consists of a mucoadhesive polymeric patch with embedded cisplatin-loaded particles (CPs) and a non-permeable backing that facilitates unidirectional drug release, prevents drug loss, and masks taste. Cisplatin is recognized as the gold standard chemotherapeutic for treating oral cancer. However, cisplatin’s efficacy is often hindered by significant systemic toxicity resulting from traditional systemic intravenous (IV) administration. CP’s 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 5 species of animals to examine the safety and efficacy of PRV111. In all cases, PRV111 has shown robust antitumor effect and no local or systemic toxicities. The goal of this proposal is the successful completion of Privo’s clinical trial. The results of this study will be published to share its findings with the scientific and medical community. 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: 2023 ( Subtotal = $0 )
2023	2021	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Food and Drug Administration Research	000	3	11/14/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $99,660 )
2021	2021	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Food and Drug Administration Research	000	3	6/30/2021	NON-COMPETING CONTINUATION	$99,660
														Subtotal = $99,660

Issue Date FY: 2020 ( Subtotal = $498,400 )
2020	2020	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Food and Drug Administration Research	000	2	6/25/2020	NON-COMPETING CONTINUATION	$498,400
														Subtotal = $498,400

Issue Date FY: 2019 ( Subtotal = $449,307 )
2019	2019	PRIVO TECHNOLOGIES, INC.	200 CORPORATE PLACESUITE6B	PEABODY	MA	01960	ESSEX	USA	Food and Drug Administration Research	000	1	9/5/2019	NEW	$449,307
														Subtotal = $449,307

Grand Total All Awards = $1,047,367

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Highly focused loco-regional chemotherapy for oral cancer - IND 132234 - October 01 2017

Award Number: R01FD006325

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2019

PERIOD OF PERFORMANCE END DATE: 06/30/2022

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