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

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

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44CA192875-04
Agency Tracking Number: R44CA192875
Amount: $999,072.00
Phase: Phase II
Program: SBIR
Awards Year: 2018
Solicitation Year: 2017
Solicitation Topic Code: NCI
Solicitation Number: CA17-024
Small Business Information
13 BRISTOL ST, Cambridge, MA, 02141-1907
DUNS: 963247924
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 MANIJEH GOLDBERG
 (978) 609-1465
 mgoldberg@privotechnologies.com
Business Contact
 MANIJEH GOLDBERG
Phone: (978) 609-1465
Email: mgoldberg@privotechnologies.com
Research Institution
N/A
Abstract
Preceding AwardNCI AwardRCAProject SummaryAccording to the Oral Cancer Foundationaboutpeople in the US will be newly diagnosed with oral cancerOCincausingdeathsOC is a severely neglected orphan disease with a lack of significant treatment advances indecadesHistoricallyOC has been present in heavy smokers and drinkersHowevermore recently OC has also become more prevalent in younger people due to an increase in cancercausing human papillomavirusHPVspread through oral sexAboutof patients die within the firstyears of diagnosisThe survival rate remains surprisingly low despite its accessibility and lack of metastasisSurvivors must manage devastating life long side effects of treatments which can lead to permanent psychological and physical damageOral cancer has either the highest suicide rate of all cancers or among the topsuicide rates of all cancersdepending on the sourcedue to permanent physical disabilities resulting from treatmentThese include permanent speech impairmentan inability to swallowand or the loss of the jawbone due to the surgical removal of the tongue and other oral tissueThe long term costs associated with the treatment and these disabilities can range from $$resulting in oral cancer persisting as one of the most expensive of all cancers to treatDespite these realitiesoral cancer remains underserved and remains on the rise in incidence both within the US and worldwideTo address this unmet needPrivo Technologies has developed a topical chemotherapy patchthe ChemoThin WaferCTWthat is applied directly to the tumorCTW consists of a mucoadhesive polymeric patch with embedded cisplatin loaded nanoparticles and a non permeable backing that facilitates unidirectional drug releaseprevents drug lossand masks tasteCisplatin is recognized as the gold standard chemotherapeutic agent for treating oral cancerHowevercisplatin s efficacy is often hindered by significant systemic toxicity resulting from traditional systemic intravenousIVadministrationThe cisplatin loaded nanoparticles in the CTW have optimized sizechargeand permeation parameters to ensure that cisplatin is locally retained within the tumor tissue and not exposed to systemic bodily circulationPrivo has performedsets of in vivo studies in numerous species of animals to examine the safety and efficacy of CTWIn all casesCTW has shown robust antitumor effect and negligible local or systemic toxicitiesThe goal of this proposal is to support the successful completion of Privo s Phaseclinical trialPrivo is confident that its team of expert scientistsbusiness leadersand collaborators can execute its defined aims with milestones and deliverables RSBIR RFA CAapplication entitledSupportive Clinical Trial Tasks for NanotechnologyBased Treatment of Oral CancerProject Narrative Privo s Nanotechnology Engineered ChemoThinWaferCTWdelivers and retains high concentration of cisplatin directly in the tumorCTW s safety and efficacy has been proven through multiple sets of preclinical studiesComplete tumor regression has been shown with this treatmentand there has been no recurrence formonths post treatmentThe treatment has been shown to be significantly safer and more effective than the standard of care chemotherapyThe CTW administration does not require any specialization training and takes less than one hourWith the funding from this proposalPrivo will conduct its Phaseclinical trial

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

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