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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA192875-04
Agency Tracking Number: R44CA192875
Amount: $2,185,237.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: CA17-024
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-08-01
Award End Date (Contract End Date): 2020-07-31
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
 (978) 609-1465
Business Contact
Phone: (978) 609-1465
Research Institution
Preceding Award NCI Award R CA Project Summary According to the Oral Cancer Foundation about people in the US will be newly diagnosed with oral cancer OC in causing deaths OC is a severely neglected orphan disease with a lack of significant treatment advances in decades 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 About of patients die within the first 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 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 $ $ 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 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 clinical trial Privo is confident that its team of expert scientists business leaders and collaborators can execute its defined aims with milestones and deliverables R SBIR RFA CA application entitled Supportive Clinical Trial Tasks for Nanotechnology Based Treatment of Oral Cancer Project Narrative Privo s Nanotechnology Engineered ChemoThinWafer CTW delivers and retains high concentration of cisplatin directly in the tumor CTW s safety and efficacy has been proven through multiple sets of preclinical studies Complete tumor regression has been shown with this treatment and there has been no recurrence for months post treatment The treatment has been shown to be significantly safer and more effective than the standard of care chemotherapy The CTW administration does not require any specialization training and takes less than one hour With the funding from this proposal Privo will conduct its Phase clinical trial

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

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