“Diffusion Pharmaceuticals”的意思、由来-开放百科全书

Gainer invented the concept of oxygen diffusion-enhancing compounds and its specific embodiment, TSC, while a Professor of Chemical Engineering at the University of Virginia. He secured the first patent on the molecule and its uses in 2000. Before TSC's invention, he and colleagues conducted research on the effects of oxygen diffusion-enhancing compounds in various animal disease models, including atherosclerosis, arthritis and cancer. At that time, crocetin, a naturally occurring carotenoid compound, was the focus of their research. With the invention of TSC, their research turned to the potential use of this synthetic oxygen diffusion-enhancing compound for the improved treatment of hemorrhagic shock (shock caused by the loss of a large volume of blood) on the battlefield.^[2]^[3]^[4] This research, which was supported financially by the United States Office of Naval Research (ONR), was conducted in Gainer’s University of Virginia laboratory. Following the company's formation by Kalergis and Gainer in 2001, both ONR^[5] and private funding^[6] was obtained, enabling company researchers to set up their own laboratory and, along with collaborators, perform further preclinical studies into uses of TSC in the treatment of hemorrhagic shock and other hypoxic conditions, such as ischemic stroke, central nervous system (CNS) disorders, and cancer.^[3]^[7]^[8]^[9]

Clinical trials

In 2007, TSC was advanced into clinical trials in humans. Clinical investigation first centered on the drug's safety and pharmacokinetic (PK) parameters in normal healthy volunteers. This was followed in 2009-2010 by a multi-center, randomized, placebo-controlled clinical trial examining TSC’s safety and efficacy in the re-oxygenation of tissues in patients affected by peripheral artery disease.^[10] The company is currently investigating the use of TSC as a radiation and chemo sensitizer in the treatment of solid cancerous tumors.

Intellectual property

Between 2008 and 2017, Diffusion Pharmaceuticals expanded its intellectual property portfolio, having been awarded new patents (in the United States and internationally) that covered the synthesis and uses of bipolar trans carotenoid salts and related compounds in peripheral artery disease, cancer and other indications.^[11] In 2011, TSC received an orphan drug designation from the United States Food and Drug Administration for the use of TSC as a radiosensitizer in the treatment of newly diagnosed GBM patients. In accordance with standard practice, the Orphan Drug designation for TSC confers benefits including enhanced patent protection and marketing rights, waiver of certain FDA filing fees and favorable tax treatment.^[12] By mid-2017, the company had been issued 14 U.S. and 46 international patents.^[11]

Awards

In 2012, Diffusion Pharmaceuticals won the Virginia Healthcare Innovators award in the “Medical Product or Device ” category for its development of TSC.^[13]

References

1. ^{{cite web | url = http://investing.businessweek.com/research/stocks/private/snapshot.asp?privcapId=8931412| publisher = Bloomberg Businessweek | date = | accessdate=November 10, 2012 |title = Company Overview of Diffusion Pharmaceuticals LLC}}
2. ^¹{{ cite patent | country = US | number = 6,060,511 | status = patent | title = Trans-sodium crocetinate, methods of making and methods of use thereof | gdate = 2000-05-09 | inventor = Gainer J}}
3. ^¹²³{{cite journal |author= Gainer, J |title= Trans-sodium crocetinate for treating hypoxia/ischemia |journal= Expert Opinion on Investigational Drugs |issue=6 |pages=917–924|year=2008 | doi=10.1517/13543784.17.6.917 | volume=17}}
4. ^{{cite journal |vauthors=Giassi L, etal |title= Trans-Sodium Crocetinate Restores Blood Pressure, Heart Rate, and Plasma Lactate after Hemorrhagic Shock |journal= Journal of Trauma-Injury Infection & Critical Care |issue=5 |pages=932–938 |year=2001 | pmid= 11706343 | volume= 51|doi=10.1097/00005373-200111000-00018}}
5. ^{{cite web|url=http://www.techjournal.org/2007/02/navy-adds-to-diffusion-pharmaceuticals-funding/ |publisher=TechJournal South |date=February 6, 2007 |accessdate=October 30, 2012 |title=Navy adds to Diffusion Pharmaceuticals funding |deadurl=yes |archiveurl=https://web.archive.org/web/20150214224036/http://www.techjournal.org/2007/02/navy-adds-to-diffusion-pharmaceuticals-funding/ |archivedate=February 14, 2015 |df=mdy }}
6. ^{{cite web | url = http://www.diffusionpharma.com/diffusion-pharmaceuticals-raises-2-1-million-in-private-equity-round-human-testing-of-its-lead-compound-tsc-planned-for-2005/| publisher = TechJournal South | date = | accessdate=October 30, 2012 |title = Diffusion Pharmaceuticals Raises $2.1 Million in Private Equity Round Human Testing of its Lead Compound TSC Planned for 2005 }}
7. ^{{cite journal |author= Lapchak P, |title= Efficacy and safety profile of the carotenoid trans sodium crocetinate administered to rabbits following multiple infarct ischemic strokes: A combination therapy study with tissue plasminogen activator | journal= Brain Research | pages=136–145|year=2010 | volume=1309 |doi= 10.1016/j.brainres.2009.10.067 |pmid= 19891959}}
8. ^{{cite journal |vauthors=Manabe H, etal |title= Protection against focal ischemic injury to the brain by trans-sodium crocetinate |journal= Journal of Neurosurgery |issue=4 |pages=802–809|year=2010 | doi= 10.3171/2009.10.JNS09562| volume=113 |pmid= 19961314 |pmc= 3380430}}
9. ^{{cite journal |author= Sheehan, Jason|title= Use of trans sodium crocetinate for sensitizing glioblastoma multiforme to radiation |journal= Journal of Neurosurgery | pages=972–978 |year=2008 | pmid= 18447715 | volume=108 |doi= 10.3171/JNS/2008/108/5/0972 |issue= 5|display-authors=etal}}
10. ^{{cite web | url = http://clinicaltrials.gov/ct2/show/study/NCT00725881| publisher = ClinicalTrials.gov |year=2008 | accessdate=October 22, 2012 |title = Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication }}
11. ^¹{{cite web | url = http://www.diffusionpharma.com/intellectual-property/| publisher = Diffusion Pharmaceuticals | date = | accessdate=October 30, 2012 |title = Diffusion Pharmaceuticals: Intellectual Property }}
12. ^{{cite web | url = http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=345911| publisher =Food and Drug Administration | date = | accessdate=October 30, 2012 |title = USFDA Results of Orphan Drug Product Designations Search }}
13. ^{{cite web| url = http://vabio.org/diffusion-pharmaceuticals-wins-2012-va-healthcare-innovators-award/| publisher = Virginia Biotechnology Association| date = | accessdate = October 30, 2012| title = Diffusion Pharmaceuticals Wins 2012 VA Healthcare Innovators Award| deadurl = yes| archiveurl = https://archive.is/20130113094208/http://vabio.org/diffusion-pharmaceuticals-wins-2012-va-healthcare-innovators-award/| archivedate = January 13, 2013| df = mdy-all}}

词条	Diffusion Pharmaceuticals
释义	Research activities Clinical trials Intellectual property Awards References External links {{Use mdy dates\|date=November 2012}}{{Infobox company \| \| name = Diffusion Pharmaceuticals Inc (NASDAQ: DFFN) \| logo = Diffusionlogo vectorizedTransparent2016.png \| type = Public \| foundation = 2001 \| location = Charlottesville, Virginia, U.S. \| key_people = David Kalergis (Co-founder and CEO) John L. Gainer (Co-founder and Chief Science Officer) \| industry = Biotechnology \| products = Trans sodium crocetinate. \| num_employees = 10 \| homepage = diffusionpharma.com}}Diffusion Pharmaceuticals Inc (NASDAQ:DFFN) is a publicly traded biotechnology and drug development company based in Charlottesville, Virginia, U.S.^[1] It was co-founded in 2001 by American life sciences entrepreneur David Kalergis and University of Virginia Chemical Engineering Professor John L. Gainer. Gainer is the inventor of the company’s platform technology of oxygen diffusion-enhancing compounds and its lead drug, trans sodium crocetinate (TSC).^[2] TSC acts to increase the rate at which oxygen moves through blood plasma by the process of diffusion,^[3] a phenomenon that forms the basis for the company's name. TSC and other oxygen diffusion-enhancing compounds, including bipolar trans carotenoid salts (the subclass to which TSC belongs), have been investigated by Diffusion Pharmaceuticals for treatment of conditions associated with reduced oxygen availability in tissues (hypoxia).^[3] Research activities Gainer invented the concept of oxygen diffusion-enhancing compounds and its specific embodiment, TSC, while a Professor of Chemical Engineering at the University of Virginia. He secured the first patent on the molecule and its uses in 2000. Before TSC's invention, he and colleagues conducted research on the effects of oxygen diffusion-enhancing compounds in various animal disease models, including atherosclerosis, arthritis and cancer. At that time, crocetin, a naturally occurring carotenoid compound, was the focus of their research. With the invention of TSC, their research turned to the potential use of this synthetic oxygen diffusion-enhancing compound for the improved treatment of hemorrhagic shock (shock caused by the loss of a large volume of blood) on the battlefield.^[2]^[3]^[4] This research, which was supported financially by the United States Office of Naval Research (ONR), was conducted in Gainer’s University of Virginia laboratory. Following the company's formation by Kalergis and Gainer in 2001, both ONR^[5] and private funding^[6] was obtained, enabling company researchers to set up their own laboratory and, along with collaborators, perform further preclinical studies into uses of TSC in the treatment of hemorrhagic shock and other hypoxic conditions, such as ischemic stroke, central nervous system (CNS) disorders, and cancer.^[3]^[7]^[8]^[9] Clinical trials In 2007, TSC was advanced into clinical trials in humans. Clinical investigation first centered on the drug's safety and pharmacokinetic (PK) parameters in normal healthy volunteers. This was followed in 2009-2010 by a multi-center, randomized, placebo-controlled clinical trial examining TSC’s safety and efficacy in the re-oxygenation of tissues in patients affected by peripheral artery disease.^[10] The company is currently investigating the use of TSC as a radiation and chemo sensitizer in the treatment of solid cancerous tumors. Intellectual property Between 2008 and 2017, Diffusion Pharmaceuticals expanded its intellectual property portfolio, having been awarded new patents (in the United States and internationally) that covered the synthesis and uses of bipolar trans carotenoid salts and related compounds in peripheral artery disease, cancer and other indications.^[11] In 2011, TSC received an orphan drug designation from the United States Food and Drug Administration for the use of TSC as a radiosensitizer in the treatment of newly diagnosed GBM patients. In accordance with standard practice, the Orphan Drug designation for TSC confers benefits including enhanced patent protection and marketing rights, waiver of certain FDA filing fees and favorable tax treatment.^[12] By mid-2017, the company had been issued 14 U.S. and 46 international patents.^[11] Awards In 2012, Diffusion Pharmaceuticals won the Virginia Healthcare Innovators award in the “Medical Product or Device ” category for its development of TSC.^[13] References 1. ^{{cite web \| url = http://investing.businessweek.com/research/stocks/private/snapshot.asp?privcapId=8931412\| publisher = Bloomberg Businessweek \| date = \| accessdate=November 10, 2012 \|title = Company Overview of Diffusion Pharmaceuticals LLC}} 2. ^¹{{ cite patent \| country = US \| number = 6,060,511 \| status = patent \| title = Trans-sodium crocetinate, methods of making and methods of use thereof \| gdate = 2000-05-09 \| inventor = Gainer J}} 3. ^¹²³{{cite journal \|author= Gainer, J \|title= Trans-sodium crocetinate for treating hypoxia/ischemia \|journal= Expert Opinion on Investigational Drugs \|issue=6 \|pages=917–924\|year=2008 \| doi=10.1517/13543784.17.6.917 \| volume=17}} 4. ^{{cite journal \|vauthors=Giassi L, etal \|title= Trans-Sodium Crocetinate Restores Blood Pressure, Heart Rate, and Plasma Lactate after Hemorrhagic Shock \|journal= Journal of Trauma-Injury Infection & Critical Care \|issue=5 \|pages=932–938 \|year=2001 \| pmid= 11706343 \| volume= 51\|doi=10.1097/00005373-200111000-00018}} 5. ^{{cite web\|url=http://www.techjournal.org/2007/02/navy-adds-to-diffusion-pharmaceuticals-funding/ \|publisher=TechJournal South \|date=February 6, 2007 \|accessdate=October 30, 2012 \|title=Navy adds to Diffusion Pharmaceuticals funding \|deadurl=yes \|archiveurl=https://web.archive.org/web/20150214224036/http://www.techjournal.org/2007/02/navy-adds-to-diffusion-pharmaceuticals-funding/ \|archivedate=February 14, 2015 \|df=mdy }} 6. ^{{cite web \| url = http://www.diffusionpharma.com/diffusion-pharmaceuticals-raises-2-1-million-in-private-equity-round-human-testing-of-its-lead-compound-tsc-planned-for-2005/\| publisher = TechJournal South \| date = \| accessdate=October 30, 2012 \|title = Diffusion Pharmaceuticals Raises $2.1 Million in Private Equity Round Human Testing of its Lead Compound TSC Planned for 2005 }} 7. ^{{cite journal \|author= Lapchak P, \|title= Efficacy and safety profile of the carotenoid trans sodium crocetinate administered to rabbits following multiple infarct ischemic strokes: A combination therapy study with tissue plasminogen activator \| journal= Brain Research \| pages=136–145\|year=2010 \| volume=1309 \|doi= 10.1016/j.brainres.2009.10.067 \|pmid= 19891959}} 8. ^{{cite journal \|vauthors=Manabe H, etal \|title= Protection against focal ischemic injury to the brain by trans-sodium crocetinate \|journal= Journal of Neurosurgery \|issue=4 \|pages=802–809\|year=2010 \| doi= 10.3171/2009.10.JNS09562\| volume=113 \|pmid= 19961314 \|pmc= 3380430}} 9. ^{{cite journal \|author= Sheehan, Jason\|title= Use of trans sodium crocetinate for sensitizing glioblastoma multiforme to radiation \|journal= Journal of Neurosurgery \| pages=972–978 \|year=2008 \| pmid= 18447715 \| volume=108 \|doi= 10.3171/JNS/2008/108/5/0972 \|issue= 5\|display-authors=etal}} 10. ^{{cite web \| url = http://clinicaltrials.gov/ct2/show/study/NCT00725881\| publisher = ClinicalTrials.gov \|year=2008 \| accessdate=October 22, 2012 \|title = Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent Claudication }} 11. ^¹{{cite web \| url = http://www.diffusionpharma.com/intellectual-property/\| publisher = Diffusion Pharmaceuticals \| date = \| accessdate=October 30, 2012 \|title = Diffusion Pharmaceuticals: Intellectual Property }} 12. ^{{cite web \| url = http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=345911\| publisher =Food and Drug Administration \| date = \| accessdate=October 30, 2012 \|title = USFDA Results of Orphan Drug Product Designations Search }} 13. ^{{cite web\| url = http://vabio.org/diffusion-pharmaceuticals-wins-2012-va-healthcare-innovators-award/\| publisher = Virginia Biotechnology Association\| date = \| accessdate = October 30, 2012\| title = Diffusion Pharmaceuticals Wins 2012 VA Healthcare Innovators Award\| deadurl = yes\| archiveurl = https://archive.is/20130113094208/http://vabio.org/diffusion-pharmaceuticals-wins-2012-va-healthcare-innovators-award/\| archivedate = January 13, 2013\| df = mdy-all}} External links {{Pharmaceutical companies of the United States}} 2 : Pharmaceutical companies of the United States\|Health care companies based in Virginia
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Research activities

Clinical trials

Intellectual property

Awards

References

External links