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Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.26M | Year: 2016

DESCRIPTION provided by applicant In this proposal Privo describes its research and development plans in order to obtain Food and Drug Administration FDA Investigational New Drug IND status for its localized nanoparticle based chemotherapy wafer for safely treating oral cancer According to the Oral Cancer Foundation over Americans will be diagnosed with oral and pharyngeal cancer this year causing over deaths roughly one person every hour In over new oral cancer cases were diagnosed worldwide and only half will live more than years after initial diagnosis By the annual worldwide incidence is predicted to increase to over a rise and the annual mortality to increase to nearly approximately a increase Currently cisplatin is at the forefront of platinum based chemotherapeutics for treating oral cancer However its successful administration is frequently hindered by its significant systemic toxicity as a result of traditional bolus systemic intravenous IV administration Privo Technologies is a company with roots in MITandapos s Langer Lab which has developed a nanoengineered ChemoThin Wafer CTW c for topical and local delivery of chemotherapy agent cisplatin CIS to oral cancer tumors This technology has been awarded more than $ million in non dilutive funding including a recent approval of $ million funding from the National Cancer Institute NCI for its IND enabling preclinical studies Privoandapos s treatmen has been shown to be safer and more effective than the gold standard intravenous IV cisplatin CTW c is easy to administer and takes only hour to complete the application It has caused complete tumor regression in animals after treatments In this proposal Privo requests funding from NIDCR which when combined with the NCI funding will provide Privo the adequate resources to obtain its FDA Investigational New Drug IND status This proposal includes performing the Chemistry Manufacturing and Control CMC process required prior to clinical trials developing required assays including the identity assay potency assay of the active pharmaceutical ingredient cisplatin and purity assay the establishment of GMP manufacturing and sourcing pharmaceutical grade raw materials Privo believes that its CTW c aligns closely with the aims of NIDCR in providing a safer more effective and less costly treatment for oral cancer PUBLIC HEALTH RELEVANCE Privoandapos s nano engineered topical ChemoThin Wafer CTW c treatment will deliver highly concentrated cisplatin topically and locally in a targeted manner directly to oral cancer tumors In three sets of in vivo studies CTW c has proven to be more effective and significantly safer than the current gold standard intravenous chemotherapy It is cost effective simple to administer and the procedure takes only one hour Complete tumor regression has been achieved with six doses of CTW c with no recurrence within months post treatment Privo aims to obtain the FDAandapos s Investigational New Drug IND status at the completion of this proposal


Grant
Agency: NSF | Branch: Standard Grant | Program: | Phase: | Award Amount: 184.93K | Year: 2013

This Small Business Innovation Research (SBIR) Phase I project seeks to develop a novel drug delivery platform using an effective nano-encapsulation method capable of delivering a variety of drugs locally and systemically through buccal mucosa. The drug-loaded nanoparticles (NPs) are protected and housed in a bio-matrix sponge, which can also hold permeation enhancers and specific targeting motifs. A combination of these components will result in a successful buccal delivery platform that can reduce toxicity, increase efficacy and significantly improve patient compliance and quality of life.


The broader impact/commercial potential of this project wil be a new technology for oral administration of different drugs, such as chemotherapeutics, antibiotics or vaccines, The projects will focus initially is oral cancer because this indication, treatment and developmental path will offer the fastest and greatest chance of licensing and commercialization. The technology can then be customized to meet the specific needs of other markets. By modifying NP?s properties and payloads, the platform can be optimized for variety of products, various diseases and purposes.


Grant
Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 149.95K | Year: 2013

This Small Business Innovation Research (SBIR) Phase I project seeks to develop a novel drug delivery platform using an effective nano-encapsulation method capable of delivering a variety of drugs locally and systemically through buccal mucosa. The drug-loaded nanoparticles (NPs) are protected and housed in a bio-matrix sponge, which can also hold permeation enhancers and specific targeting motifs. A combination of these components will result in a successful buccal delivery platform that can reduce toxicity, increase efficacy and significantly improve patient compliance and quality of life. The broader impact/commercial potential of this project wil be a new technology for oral administration of different drugs, such as chemotherapeutics, antibiotics or vaccines, The projects will focus initially is oral cancer because this indication, treatment and developmental path will offer the fastest and greatest chance of licensing and commercialization. The technology can then be customized to meet the specific needs of other markets. By modifying NP?s properties and payloads, the platform can be optimized for variety of products, various diseases and purposes.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 220.68K | Year: 2014

DESCRIPTION (provided by applicant): According to the Oral Cancer (OC) Foundation, oral and pharyngeal cancer will cause 8,000 deaths this year, killing roughly one person per hour. Currently, cisplatin (CIS) is at the forefront of platinum- based chemotherapeutics for treating OC. However, its efficacy is often hindered by its significant systemic toxicity as a result of traditional bolus systemic intravenous (IV) doses. In this proposal, Privo's specific aims focus on developing and optimizing an effective and safe nano engineered drug delivery platform, i.e., chemo-wafer (CW) that reformulates a known anticancer chemotherapy agent ( e.g. cisplatin) for the local and topical treatment of OC, thus replacing injection, increasing the drug's efficacy and significantly reducing its systemic toxicity. The CW platform contains FDA approved chemotherapy drugs and generally recognized as safe (GRAS) materials. It utilizes nano-encapsulation techniques to incorporate drugs into NPs with a controlled-release d


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 960.71K | Year: 2016

DESCRIPTION provided by applicant According to the Oral Cancer OC Foundation oral and pharyngeal cancer will cause deaths this year in the US killing roughly one person per hour Currently cisplatin CIS is at the forefront of platinum based chemotherapeutics for treating OC However its efficacy is often hindered by its significant systemic toxicity as a resut of traditional bolus systemic intravenous IV doses In this proposal entitled andquot Fast track IND enabling studies for Oral Cancerandquot the critical path is performing the studies required by the FDA to successfully achieve the the IND status for safety trials Privoandapos s specific aims for phase I focs on conducting in vivo studies to further fine tune the dosing of Privoandapos s lead optimized formulation for its ChemoThin Wafer CTW c For the Phase II of this project the focus is on conducting IND enabling studies to prepare Privo for human safety trial Privoandapos s CTW c contains anticancer chemotherapy agent cisplatin which is the gold standard chemotherapy drug for oral cancer It is designed and optimized for local and topical treatment of OC thus replacing injection increasing the drugandapos s efficacy and significantly reducing its systemic toxicity The CTW c platform contains FDA approved chemotherapy drugs and generally recognized as safe GRAS materials It utilizes nano encapsulation techniques to incorporate drugs into NPs with a controlled release design that releases chemo drugs at fully tunable and pre determined rates The year survival of patients with OC has not significantly improved over the past several decades Moreover the survival rate for early detection is significantly higher than later stages vs Therefore for patients with pre malignant to non metastasized malignant OC this reformulated nano encapsulated CTW c delivery platform has the opportunity to considerably reduce the morbidity and mortality rate of this devastating cancer The ultimate objective of Privo Technologies is to develop and commercialize effective safe and convenient chemotherapy treatments accessible to many patients PUBLIC HEALTH RELEVANCE SBIR R R application entitled andquot Fast Track IND enabling studies for Oral Cancerandquot Project Narrative Privoandapos s nano engineered topical ChemoThin Wafer CTW c treatment has the potential to deliver a very high concentration of the chemotherapy drug while significantly limiting its toxicity It is mainly intended for topical and local treatmet of pre malignant and malignant oral cancer tumors that have not yet metastasized to distant organs This CTW c may also provide a necessary alternative to patients who are unable to receive conventional chemotherapy due to suffering from chronic diseases such as compromised kidney


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 1.06M | Year: 2016

DESCRIPTION provided by applicant According to the Oral Cancer OC Foundation oral and pharyngeal cancer will cause deaths this year in the US killing roughly one person per hour Currently cisplatin CIS is at the forefront of platinum based chemotherapeutics for treating OC However its efficacy is often hindered by its significant systemic toxicity as a resut of traditional bolus systemic intravenous IV doses In this proposal entitled andquot Fast track IND enabling studies for Oral Cancerandquot the critical path is performing the studies required by the FDA to successfully achieve the the IND status for safety trials Privoandapos s specific aims for phase I focs on conducting in vivo studies to further fine tune the dosing of Privoandapos s lead optimized formulation for its ChemoThin Wafer CTW c For the Phase II of this project the focus is on conducting IND enabling studies to prepare Privo for human safety trial Privoandapos s CTW c contains anticancer chemotherapy agent cisplatin which is the gold standard chemotherapy drug for oral cancer It is designed and optimized for local and topical treatment of OC thus replacing injection increasing the drugandapos s efficacy and significantly reducing its systemic toxicity The CTW c platform contains FDA approved chemotherapy drugs and generally recognized as safe GRAS materials It utilizes nano encapsulation techniques to incorporate drugs into NPs with a controlled release design that releases chemo drugs at fully tunable and pre determined rates The year survival of patients with OC has not significantly improved over the past several decades Moreover the survival rate for early detection is significantly higher than later stages vs Therefore for patients with pre malignant to non metastasized malignant OC this reformulated nano encapsulated CTW c delivery platform has the opportunity to considerably reduce the morbidity and mortality rate of this devastating cancer The ultimate objective of Privo Technologies is to develop and commercialize effective safe and convenient chemotherapy treatments accessible to many patients PUBLIC HEALTH RELEVANCE SBIR R R application entitled andquot Fast Track IND enabling studies for Oral Cancerandquot Project Narrative Privoandapos s nano engineered topical ChemoThin Wafer CTW c treatment has the potential to deliver a very high concentration of the chemotherapy drug while significantly limiting its toxicity It is mainly intended for topical and local treatmet of pre malignant and malignant oral cancer tumors that have not yet metastasized to distant organs This CTW c may also provide a necessary alternative to patients who are unable to receive conventional chemotherapy due to suffering from chronic diseases such as compromised kidney


Privo Technologies LLC | Entity website

Welcome to Privo Technologies, Inc. At Privo Technologies, we are developing an entirely new class of targeted treatments such as chemotherapy drugs, radiation sensitizers and radiation protectors and mitigators ...


Privo Technologies LLC | Entity website

John Ripple John Ripple is the owner of Ripple Biotech, which advises early stage biomedical companies on strategy, business development, and fundraising. His other business experiences include medical device marketing and management consulting ...


Privo Technologies LLC | Entity website


Privo Technologies LLC | Entity website

Careers at Privo Technologies Privo Technologies, Inc. is currently fully staffed ...

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