GenVec, Inc NEUER 50-100% Biotechzock? - 500 Beiträge pro Seite
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Feedback
seit ca 1 Stunde Megavolumen in dem Teil
bin gespannt wo wir heute Abend stehen
bin gespannt wo wir heute Abend stehen
aktuell 0,798
Gibt es heute noch einen Endspurt?
wenn ja dann könnte der $ drinnen sein
wenn ja dann könnte der $ drinnen sein
ist jemand dabei?
Schlußkurs 0,82$ Nachbörslich 0,83-0,85
wird ein toller Montag
wird ein toller Montag
Trading Spotlight
Antwort auf Beitrag Nr.: 37.333.480 von printguru am 05.06.09 22:06:39Ist ein toller Montag, v.a. gegen den Mainstream 
Antwort auf Beitrag Nr.: 37.344.003 von vanillamilkshake am 08.06.09 15:39:45Ist wohl noch nicht das Ende der Fahnenstange!
Antwort auf Beitrag Nr.: 37.333.480 von printguru am 05.06.09 22:06:39schönen wert hatest da ausgegraben, hab mich zum gestrigen sk zu 84 ins bid gestellt, leider nur ne kleine teilausführung bekommen.. hätt n netter zock werden können, viel glück euch!
mal schauen ob man morgen was zocken kann
hab noch n paar andere schweinepest-werte auf der wl:
Hemispherx HEB
Novavax NVAX
Generex GNBT - drugs in pipeline for general influenza
Biocryst BCRX - products still in clinical trials
Good Luck @ all!
Hemispherx HEB
Novavax NVAX
Generex GNBT - drugs in pipeline for general influenza
Biocryst BCRX - products still in clinical trials
Good Luck @ all!
älter aber nicht schlecht
------------------
Wednesday, March 25, 2009
GenVec may end deal with British firm
Washington Business Journal - by Vandana Sinha Staff Reporter
GenVec Inc. is considering whether to end a two-year manufacturing agreement it had signed with a United Kingdom company six months earlier than planned.
The Gaithersburg biotech said it’s suspending the manufacturing activities of its key anticancer product, TNFerade, with Cobra Biomanufacturing PLC, in part to help cap its expenses and make it a more attractive prospect for potential partners.
The companies first entered into their agreement in January 2008 for Cobra to help GenVec scale up its production capacity of TNFerade at its plant in Oxford, England. At the time, GenVec paid a $1 million advance fee to Cobra for a two-year contract whose value could rise as much as $9.4 million depending on the services provided. Last year, GenVec said it paid Cobra $3.4 million.
But GenVec has been in discussions with other larger players to partner with the smaller company and help it fund its clinical trials and anticipated launch of TNFerade, which is in its third and most expensive phase of human tests as a pancreatic cancer treatment.
“We don’t need this [manufacturing agreement with Cobra] to continue the clinical trial,” said Doug Swirsky, senior vice president, chief financial officer, treasurer and corporate secretary for GenVec (NASDAQ: GNVC), declining to comment on whether a partnership deal is imminent. “If we partner with someone who has that manufacturing capability, we would want to transfer the process to them and work with them, so this provides us flexibility.”
GenVec said it will pay Cobra $1.8 million for any manufacturing services through June of this year, when it will decide whether or not to end the contract. If it does put an end to it, GenVec will pay Cobra a final termination fee of $350,000, a significant decrease that the local company negotiated from the one-time maximum fee amount of $2.3 million.
But the company said this also helps it slash costs during a harsh economic environment. In January, the company said it cut discretionary spending, as well as 22 positions, bringing its head count down to 98 full-time people and extending its cash lifeline from 18 months to two years.
“We’re trying to be as efficient as possible,” Swirsky said. “We did see an attractive way to limit our continuing contractual obligations.”
http://www.bizjournals.com/washington/stories/2009/03/23/dai…
------------------
Wednesday, March 25, 2009
GenVec may end deal with British firm
Washington Business Journal - by Vandana Sinha Staff Reporter
GenVec Inc. is considering whether to end a two-year manufacturing agreement it had signed with a United Kingdom company six months earlier than planned.
The Gaithersburg biotech said it’s suspending the manufacturing activities of its key anticancer product, TNFerade, with Cobra Biomanufacturing PLC, in part to help cap its expenses and make it a more attractive prospect for potential partners.
The companies first entered into their agreement in January 2008 for Cobra to help GenVec scale up its production capacity of TNFerade at its plant in Oxford, England. At the time, GenVec paid a $1 million advance fee to Cobra for a two-year contract whose value could rise as much as $9.4 million depending on the services provided. Last year, GenVec said it paid Cobra $3.4 million.
But GenVec has been in discussions with other larger players to partner with the smaller company and help it fund its clinical trials and anticipated launch of TNFerade, which is in its third and most expensive phase of human tests as a pancreatic cancer treatment.
“We don’t need this [manufacturing agreement with Cobra] to continue the clinical trial,” said Doug Swirsky, senior vice president, chief financial officer, treasurer and corporate secretary for GenVec (NASDAQ: GNVC), declining to comment on whether a partnership deal is imminent. “If we partner with someone who has that manufacturing capability, we would want to transfer the process to them and work with them, so this provides us flexibility.”
GenVec said it will pay Cobra $1.8 million for any manufacturing services through June of this year, when it will decide whether or not to end the contract. If it does put an end to it, GenVec will pay Cobra a final termination fee of $350,000, a significant decrease that the local company negotiated from the one-time maximum fee amount of $2.3 million.
But the company said this also helps it slash costs during a harsh economic environment. In January, the company said it cut discretionary spending, as well as 22 positions, bringing its head count down to 98 full-time people and extending its cash lifeline from 18 months to two years.
“We’re trying to be as efficient as possible,” Swirsky said. “We did see an attractive way to limit our continuing contractual obligations.”
http://www.bizjournals.com/washington/stories/2009/03/23/dai…
cobra scheint auch geschichte zu sein.
Hier nix mehr los? GenVec läuft im Moment nicht schlecht
Antwort auf Beitrag Nr.: 38.502.028 von mosbach am 03.12.09 13:47:07bin gespannt was kommt.
volumen und anstieg ist ja schon mal nicht schlecht.
volumen und anstieg ist ja schon mal nicht schlecht.
Antwort auf Beitrag Nr.: 38.673.074 von Jano57 am 06.01.10 10:09:12pre-market 1,59 $
Roth-Capital stuft GenVec auf buy
Roth-Capital stuft GenVec auf buy
Antwort auf Beitrag Nr.: 38.683.168 von Jano57 am 07.01.10 13:45:03GenVec bleibt weiterhin an der Nasdaq gelistet
http://www.bizjournals.com/washington/stories/2010/01/04/dai…
http://www.bizjournals.com/washington/stories/2010/01/04/dai…
Antwort auf Beitrag Nr.: 38.738.510 von Jano57 am 14.01.10 19:05:57http://www.finanznachrichten.de/nachrichten-2010-01/15905281…
sieht gut aus!
bin mal dabei.
ist ja komisch....Hammernews und keinen interessierts 
GenVec Inc. in Gaithersburg and drug giant Novartis AG have formed a development partnership to advance treatments for hearing loss and balance disorders.
GenVec said that it would receive $5 million upfront from Novartis as well as additional development funding. GenVec would also be eligible to receive royalties on futures sales and could earn up to $213 million in milestone payment if certain goals are met.
Under terms of the agreement, GenVec is licensing the world-wide rights to its preclinical hearing loss and balance disorders program to Novartis. GenVec said that results from the effort suggest that delivery of the atonal gene using GenVec's innovative adenovector technology may have the potential to restore hearing and balance function.
As part of the partnership, Novartis purchased $2 million in GenVec common stock. The shares (NASDAQ: GNVC), which were threatened with delisting less than a month ago, rallied as much as 42 cents, or 24 percent, to $2.16 in Tuesday trading. The shares have quadrupled in the last 12 months.
GenVec is not the only Washington-area biotech that has piqued Novartis’ interest. In October 2009, Vanda Pharmaceuticals signed a development and sales agreement with Novartis for a schizophrenia drug that could yield as much as $465 million for the Rockville-based biotech.
GenVec Inc. in Gaithersburg and drug giant Novartis AG have formed a development partnership to advance treatments for hearing loss and balance disorders.
GenVec said that it would receive $5 million upfront from Novartis as well as additional development funding. GenVec would also be eligible to receive royalties on futures sales and could earn up to $213 million in milestone payment if certain goals are met.
Under terms of the agreement, GenVec is licensing the world-wide rights to its preclinical hearing loss and balance disorders program to Novartis. GenVec said that results from the effort suggest that delivery of the atonal gene using GenVec's innovative adenovector technology may have the potential to restore hearing and balance function.
As part of the partnership, Novartis purchased $2 million in GenVec common stock. The shares (NASDAQ: GNVC), which were threatened with delisting less than a month ago, rallied as much as 42 cents, or 24 percent, to $2.16 in Tuesday trading. The shares have quadrupled in the last 12 months.
GenVec is not the only Washington-area biotech that has piqued Novartis’ interest. In October 2009, Vanda Pharmaceuticals signed a development and sales agreement with Novartis for a schizophrenia drug that could yield as much as $465 million for the Rockville-based biotech.
Antwort auf Beitrag Nr.: 38.766.615 von Jano57 am 19.01.10 17:55:19und sie rennt und rennt und rennt
RT = 2,20$
RT = 2,20$
Antwort auf Beitrag Nr.: 38.793.294 von Jano57 am 22.01.10 17:28:01was für ne freude
http://www.prnewswire.com/news-releases/data-from-tnferadetm…
http://www.prnewswire.com/news-releases/data-from-tnferadetm…
Antwort auf Beitrag Nr.: 38.794.703 von lamona am 22.01.10 19:53:31
sehr gute News!!!!
Denke dieses Baby wird einer der Highflyer 2010 werden
sehr gute News!!!!
Denke dieses Baby wird einer der Highflyer 2010 werden
Bin mal gespannt wie der erste Kurs am Montag sein wird, nach der American Society of Clinical Oncology's wo neueste Daten bekannt gegeben werden sollen
http://www.genvec.com/download/2010%201.7%20FINAL%20OUT%20AS…
http://www.genvec.com/download/2010%201.7%20FINAL%20OUT%20AS…
Antwort auf Beitrag Nr.: 38.795.958 von Jano57 am 22.01.10 22:13:32meinst du eher positiv oder negativ?
Antwort auf Beitrag Nr.: 38.799.451 von tHe_mIcHi am 24.01.10 12:04:19Die Daten waren positiv, allerdings gab es Freitag als Reaktion auch schon einen Kurssprung auf 3,29$
Aktien Tip. Cipher pharmac. steht kurz vor der Zulassung.Gehört hier nicht rein.Wollte euch mal eine alternative zu genvec nennen. Da habt ihr eher Chancen.Die Zulassung ist ziemlich sicher.Trotzdem müsst ihr selbst wissen was ihr mit eurem geld macht.
Da habt ihr eher Chancen.Die Zulassung ist ziemlich sicher.Trotzdem müsst ihr selbst wissen was ihr mit eurem geld macht.
Durchaus möglich, dass heute ein kräftiger "Rebound" begonnen hat!
Antwort auf Beitrag Nr.: 38.930.324 von Investdevil am 11.02.10 22:16:40Hallo !
Was haltet Ihr von der gestrigen (11.02.) SEC-Mitteilung mit den
150 Mio.? Werden in dieser Größenordnung neue Aktien ausgegeben
oder hab ich da was falsch verstanden.
Gruß.
Was haltet Ihr von der gestrigen (11.02.) SEC-Mitteilung mit den
150 Mio.? Werden in dieser Größenordnung neue Aktien ausgegeben
oder hab ich da was falsch verstanden.
Gruß.
Sehr schöner Anstieg heute
Überlege hier einzusteigen. Wäre über eure Meinungen zu Zeitpunkt und Price Targets dankbar!
Und das nächste Opfer nach Antisoma .....
http://finance.yahoo.com/news/GenVec-Discontinues-Phase-3-pr…
http://finance.yahoo.com/news/GenVec-Discontinues-Phase-3-pr…
Antwort auf Beitrag Nr.: 39.241.697 von BrauchGeld am 30.03.10 00:28:38JA heftig, nun auch GNVC.
Und beide waren von Ihrem Produkt in der Phase 3 überzeugt.
Verbrennt sich Novartis nun die Finger oder haben sie nun zwei Übernahmekandidaten?
Und beide waren von Ihrem Produkt in der Phase 3 überzeugt.
Verbrennt sich Novartis nun die Finger oder haben sie nun zwei Übernahmekandidaten?
Wo ist die "ALL IN " Truppe die sofort irgendwo dabei sind sobald eine Aktie einbricht ???
Antwort auf Beitrag Nr.: 39.249.372 von BrauchGeld am 30.03.10 20:47:19Der Thread ist hier nicht unter den meist diskutierten Aktien von WO!
Antwort auf Beitrag Nr.: 39.249.372 von BrauchGeld am 30.03.10 20:47:19ICh Frage mich ob deren TNFerade TEchnologie nun wirklich was bringt, leider.
mit dem Kurseinbruch ist der Wert wieder da, wo er vor der Spekulation auf den Erfolg dieses einen Produkts war. Langzeitig ist die Firma hoch interessant wegen der Pipeline und beim derzeitigen Kurs DIE Gelegenheit zum Nachlegen
ich glaube so langsam aber sicher steigt sie wieder...
werde versuchen für 0,5€ erste stücke zu bekommen.
af
werde versuchen für 0,5€ erste stücke zu bekommen.
af
die Gefahr von der Nasdaq delistet zu werden belastet den Kurs.
Wer noch Geld übrig hat, freut sich über die günstigen Stücke.
Ich werde diese Woche noch einmal nachkaufen, sobald ich Luft zum Umschichten habe.
Wer noch Geld übrig hat, freut sich über die günstigen Stücke.
Ich werde diese Woche noch einmal nachkaufen, sobald ich Luft zum Umschichten habe.
hier könnte in der kommenden woche eine Erholung bevorstehen!
Chart sieht auch gut aus..
Chart sieht auch gut aus..
GenVec Announces New Agreement with Global Pharmaceutical Company
2010-08-06 07:24 ET - News Release
GAITHERSBURG, Md., Aug. 6 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC) today announced a new agreement for the supply of services relating to development materials with Novartis, related to the companies' collaboration in hearing loss and balance disorders. Under this new agreement, GenVec could receive approximately $13 million over four years to manufacture clinical trial material for up to two lead candidates.
"This contract supports our ongoing collaborative efforts with Novartis to uncover solutions to the unfortunate and widespread problems of hearing loss and balance disorders," said Dr. Paul Fischer, GenVec's President and Chief Executive Officer. "This new agreement with Novartis will enable the manufacture of a potential product candidate to address this important unmet medical need." Preclinical results suggest that delivery of the atonal gene using GenVec's innovative adenovector technology may have the potential to restore hearing and balance function.
On January 13, 2010, GenVec entered into a worldwide licensing and collaboration agreement with Novartis, to discover and develop novel treatments for hearing loss and balance disorders. Under the companies' Research, Collaboration and License Agreement, Novartis is responsible for manufacturing. All research conducted under the collaboration will be funded by Novartis.
About GenVec
GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec uses proprietary drug discovery and development technologies to support a portfolio of product programs that address the prevention and treatment of a number of major diseases. In collaboration with Novartis, GenVec is developing novel treatments for hearing loss and balance disorders. GenVec also develops and is evaluating the potential of TNFerade for the treatment of certain cancers and is developing vaccines for infectious diseases including influenza, HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV), and HSV-2. Additional information about GenVec is available at www.genvec.com and in the Company's various filings with the Securities and Exchange Commission.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding funding, manufacturing the development of products and the success of the collaboration with Novartis, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to the early stage of GenVec's product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of GenVec's proposed product candidates; uncertainties related to the outcome and process of GenVec's previously announced strategic review, dependence on the efforts of third parties; dependence on intellectual property; and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.
Investor Contact:
Media Contact:
GenVec, Inc.
Tiberend Strategic Advisors, Inc.
Douglas J. Swirsky
Andrew Mielach
(240) 632-5510
(212) 827-0020
dswirsky@genvec.com
amielach@tiberendstrategicadvisors.com
SOURCE GenVec, Inc.
Guten Morgen @all
auf Wunsch reaktiviere ich diesen Thread hier.
Gruß
CaveModem
auf Wunsch reaktiviere ich diesen Thread hier.
Gruß
CaveModem
Antwort auf Beitrag Nr.: 43.628.723 von CaveModem am 21.09.12 06:39:44Vielen Dank.
Die Aktie hat im Jahre 2010 noch bei rund 33 US$ notiert und seit dem 95% an Wert verloren und nach dem dead cat bounce der letzten Jahre nunmehr zuletzt bei 1.34 US$ ihr Allzeittief markiert.
Bereits im letzten Jahr sind die Insider eingestiegen - und begannen bereits bei 2.87 US$ je Aktie zu kaufen.
Die aktuelle marcet cap liegt auf Niveau der Barmittel des Unternehmens.
Somit wird weder dem 206 Millionen US$ Deal mit Novartis Rechnung getragen, noch den anderen Medikamenten bzw. Therapeutica in der Produktpipeline.
Die FMD-Vakzine wurde in der Zwischenzeit erfolgreich durch das Zulassungsverfahren der FDA gebracht und auslizensiert. Hier dürften zukünftig erste Royalities fliessen.
Die aktuelle Marcet Cap ist so niedrig, dass man auch von einer krassen Unterbewertung sprechen kann.
Ähnliche Biotechwerte werden normalerweise mit 100-250 Millionen US-Dollar am Markt bewertet - teilweise auch bis zu 500 Millionen US-Dollar.
Zum Vergleich - die marcet cap liegt derzeit bei lediglich knapp 21 Millionen US-Dollar.
Die Aktie ist somit ein potentieller Tenbagger bzw. ein potentielles Übernahmeziel.
Mit Atoh1- Genetransfer mittels Adenoviren besteht die Chance zusammen mit Novartis einen potentiellen Blockbuster zu entwickeln und auf den Weg zu bringen - und zwar auf eine wahre Revolution in Sachen Wiederherstellung des Cortiorgans des Innenohrs und von verloren geglaubten Haarzellen des Innenohrs und Gleichgewichtsorgans.
Hier drin steckt für wahr ein wahrhaft revolutionärer Therapieansatz, der die gesamte Welt der HNO-Ärzte weltweit verändern kann und der Alptraum der Gehörgeräteakustiker sein dürfte.
Ein Leben ohne Hörgerät - durch Regeneration verlorengelaubter Sinneszellen im Innenohr? Klingt wie Science Fiction, ist aber in Tierversuchen bereits wiederholt erfolgreich angewendet worden. Ich gehe davon aus, dass diese Form der Therapie auch beim Menschen funktioniert. Wenn dem so ist werden damit jedes Jahr Milliarden verdient.
M.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
Die Aktie hat im Jahre 2010 noch bei rund 33 US$ notiert und seit dem 95% an Wert verloren und nach dem dead cat bounce der letzten Jahre nunmehr zuletzt bei 1.34 US$ ihr Allzeittief markiert.
Bereits im letzten Jahr sind die Insider eingestiegen - und begannen bereits bei 2.87 US$ je Aktie zu kaufen.
Die aktuelle marcet cap liegt auf Niveau der Barmittel des Unternehmens.
Somit wird weder dem 206 Millionen US$ Deal mit Novartis Rechnung getragen, noch den anderen Medikamenten bzw. Therapeutica in der Produktpipeline.
Die FMD-Vakzine wurde in der Zwischenzeit erfolgreich durch das Zulassungsverfahren der FDA gebracht und auslizensiert. Hier dürften zukünftig erste Royalities fliessen.
Die aktuelle Marcet Cap ist so niedrig, dass man auch von einer krassen Unterbewertung sprechen kann.
Ähnliche Biotechwerte werden normalerweise mit 100-250 Millionen US-Dollar am Markt bewertet - teilweise auch bis zu 500 Millionen US-Dollar.
Zum Vergleich - die marcet cap liegt derzeit bei lediglich knapp 21 Millionen US-Dollar.
Die Aktie ist somit ein potentieller Tenbagger bzw. ein potentielles Übernahmeziel.
Mit Atoh1- Genetransfer mittels Adenoviren besteht die Chance zusammen mit Novartis einen potentiellen Blockbuster zu entwickeln und auf den Weg zu bringen - und zwar auf eine wahre Revolution in Sachen Wiederherstellung des Cortiorgans des Innenohrs und von verloren geglaubten Haarzellen des Innenohrs und Gleichgewichtsorgans.
Hier drin steckt für wahr ein wahrhaft revolutionärer Therapieansatz, der die gesamte Welt der HNO-Ärzte weltweit verändern kann und der Alptraum der Gehörgeräteakustiker sein dürfte.
Ein Leben ohne Hörgerät - durch Regeneration verlorengelaubter Sinneszellen im Innenohr? Klingt wie Science Fiction, ist aber in Tierversuchen bereits wiederholt erfolgreich angewendet worden. Ich gehe davon aus, dass diese Form der Therapie auch beim Menschen funktioniert. Wenn dem so ist werden damit jedes Jahr Milliarden verdient.
M.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
J Cell Mol Med 2012 Sep;16(9):1970-7. doi: 10.1111/j.1582-4934.2012.01540.x .
Vestibular regeneration - experimental models and clinical implications.
Albu S, Muresanu DF
Source
Second Department of Otolaryngology, University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania.
Abstract
Therapies aimed at the protection and/or regeneration of inner ear hair cells are of great interest, given the significant monetary and quality of life impact of balance disorders. Different viral vectors have been shown to transfect various cell types in the inner ear. The past decade has provided tremendous advances in the use of adenoviral vectors to achieve targeted treatment delivery. Several routes of delivery have been identified to introduce vectors into the inner ear while minimizing injury to surrounding structures. Recently, the transcription factor Atoh1 was determined to play a critical role in hair cell differentiation. Adenoviral-mediated overexpression of Atoh1 in culture and in vivo has demonstrated the ability to regenerate vestibular hair cells by causing transdifferentiation of neighbouring epithelial-supporting cells. Functional recovery of the vestibular system has also been documented following adenoviral-induced Atoh1 overexpression. Experiments demonstrating gene transfer in human vestibular epithelial cells reveal that the human inner ear is a suitable target for gene therapy.
Vestibular regeneration - experimental models and clinical implications.
Albu S, Muresanu DF
Source
Second Department of Otolaryngology, University of Medicine and Pharmacy Cluj-Napoca, Cluj-Napoca, Romania.
Abstract
Therapies aimed at the protection and/or regeneration of inner ear hair cells are of great interest, given the significant monetary and quality of life impact of balance disorders. Different viral vectors have been shown to transfect various cell types in the inner ear. The past decade has provided tremendous advances in the use of adenoviral vectors to achieve targeted treatment delivery. Several routes of delivery have been identified to introduce vectors into the inner ear while minimizing injury to surrounding structures. Recently, the transcription factor Atoh1 was determined to play a critical role in hair cell differentiation. Adenoviral-mediated overexpression of Atoh1 in culture and in vivo has demonstrated the ability to regenerate vestibular hair cells by causing transdifferentiation of neighbouring epithelial-supporting cells. Functional recovery of the vestibular system has also been documented following adenoviral-induced Atoh1 overexpression. Experiments demonstrating gene transfer in human vestibular epithelial cells reveal that the human inner ear is a suitable target for gene therapy.
Genvec reduziert seine Ausgaben durch Stellenabbau.
http://www.bizjournals.com/washington/news/2012/09/25/genvec…
Das ist begrüssenswert, da damit Aktionärsfreundlich Mittel für sinnvolle Massnahmen ausgegeben werden.
Genvec ist bei der aktuellen Marcet Cap weiterhin unterebewertet - die gesamte Produktpipeline gibt es derzeit quasi für lau.
Dabei ist allein der Deal mit Novartis 206 Millionen US$ wert - also das zehnfache der aktuellen Market Cap.
Ich gehe davon aus, dass hier demnächst neue Meilensteinzahlungen kommen werden, sofern Genvec nicht kurzerhand aufgekauft wird.
M
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
http://www.bizjournals.com/washington/news/2012/09/25/genvec…
Das ist begrüssenswert, da damit Aktionärsfreundlich Mittel für sinnvolle Massnahmen ausgegeben werden.
Genvec ist bei der aktuellen Marcet Cap weiterhin unterebewertet - die gesamte Produktpipeline gibt es derzeit quasi für lau.
Dabei ist allein der Deal mit Novartis 206 Millionen US$ wert - also das zehnfache der aktuellen Market Cap.
Ich gehe davon aus, dass hier demnächst neue Meilensteinzahlungen kommen werden, sofern Genvec nicht kurzerhand aufgekauft wird.
M
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
SARS ist zurück...
...die ersten beiden Menschen sind bereits in Saudi-Arabien verstorben - ein dritter kämpft in England um sein Leben.
http://nachrichten.rp-online.de/wissen/neue-sars-faelle-beun…
Es handelt sich offenbar um ein neues Virus.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
...die ersten beiden Menschen sind bereits in Saudi-Arabien verstorben - ein dritter kämpft in England um sein Leben.
http://nachrichten.rp-online.de/wissen/neue-sars-faelle-beun…
Es handelt sich offenbar um ein neues Virus.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
Antwort auf Beitrag Nr.: 43.644.701 von Macrocosmonaut am 25.09.12 20:43:402003 hat man ja bereits an einem Impfstoff gegen SARS gearbeitet.
Mal sehen, ob das Programm reaktiviert wird.
M.
Mal sehen, ob das Programm reaktiviert wird.
M.
Antwort auf Beitrag Nr.: 43.644.701 von Macrocosmonaut am 25.09.12 20:43:40Hier noch der Link zum SARS Impfstoff bei Genvec:
http://www.genvec.com/go.cfm?do=Press.View&prid=60
http://www.genvec.com/go.cfm?do=Press.View&prid=60
Adv Otorhinolaryngol. 2009;66:52-63. Epub 2009 Jun 2.
Repair of the vestibular system via adenovector delivery of Atoh1: a potential treatment for balance disorders.
Baker K, Brough DE, Staecker H.
Source
University of Maryland School of Medicine, Baltimore, MD, USA.
Abstract
Loss of auditory and vestibular hair cells is a common cause of hearing loss and balance disorders. A variety of strategies have been proposed to restore function to damaged inner ear neuroepithelium. Delivery of the atonal homolog, atoh1, has been demonstrated to induce recovery of auditory and vestibular hair cells using a variety of delivery methods and model systems. We have developed a mouse model of vestibular aminoglycoside ototoxicity and demonstrated that delivery of an advanced generation adenovector that expresses atoh1 results in the regeneration of vestibular hair cells. Additionally, mice treated with atoh1 recover balance function. Currently vestibular diseases have few treatment options and several lines of evidence suggest that regeneration of hair cells may be more easily accomplished in the vestibular system. Development of atoh1-based gene therapy for vestibular hair cell loss may provide an initial opportunity for developing gene therapy for inner ear disease.
Repair of the vestibular system via adenovector delivery of Atoh1: a potential treatment for balance disorders.
Baker K, Brough DE, Staecker H.
Source
University of Maryland School of Medicine, Baltimore, MD, USA.
Abstract
Loss of auditory and vestibular hair cells is a common cause of hearing loss and balance disorders. A variety of strategies have been proposed to restore function to damaged inner ear neuroepithelium. Delivery of the atonal homolog, atoh1, has been demonstrated to induce recovery of auditory and vestibular hair cells using a variety of delivery methods and model systems. We have developed a mouse model of vestibular aminoglycoside ototoxicity and demonstrated that delivery of an advanced generation adenovector that expresses atoh1 results in the regeneration of vestibular hair cells. Additionally, mice treated with atoh1 recover balance function. Currently vestibular diseases have few treatment options and several lines of evidence suggest that regeneration of hair cells may be more easily accomplished in the vestibular system. Development of atoh1-based gene therapy for vestibular hair cell loss may provide an initial opportunity for developing gene therapy for inner ear disease.
Innerhalb der kommenden 2 1/2 Jahre rechne ich mit einer Verzwangifachung des Kurses bei Genvec, sofern Novartis, die dieser Tage wieder ein Pharmaunternehmen aufgekauft haben, Genvec nicht vorher aufkaufen.
Bis zum Jahr 2020 wird sich der Kurs dann wahrscheinlich verhundertfacht haben, wenn die Aktie dem Beispiel von Regeneraon folgt.
Viele Grüsse.
M.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
Bis zum Jahr 2020 wird sich der Kurs dann wahrscheinlich verhundertfacht haben, wenn die Aktie dem Beispiel von Regeneraon folgt.
Viele Grüsse.
M.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
Novartis will weiter zukaufen und Unternehmen übernehmen:
http://www.aktiencheck.de/news/Artikel-Novartis_Aktie_hoeher…
http://www.aktiencheck.de/news/Artikel-Novartis_Aktie_hoeher…
Das sind hervorragende Studienergebnisse die Genvec da heute veröffentlicht hat
Co announced that data were presented on GenVec's respiratory syncytial virus (RSV) vaccine program at the "8th Annual International Respiratory Syncytial Virus Symposium," which took place in Santa Fe, New Mexico from September 27-30, 2012. Data presented at the conference demonstrated GenVec's universal RSV vaccine candidate is highly immunogenic and produces durable and broad protection from a single intramuscular administration. Protection in cotton rat and mouse models was characterized by functional RSV neutralizing antibodies and no disease potentiation was observed. GenVec's RSV vaccine candidate utilizes a proprietary adenovirus that is capable of generating a broad immune response while avoiding the problems of vector specific immunity that has hampered other vectored vaccines.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
Co announced that data were presented on GenVec's respiratory syncytial virus (RSV) vaccine program at the "8th Annual International Respiratory Syncytial Virus Symposium," which took place in Santa Fe, New Mexico from September 27-30, 2012. Data presented at the conference demonstrated GenVec's universal RSV vaccine candidate is highly immunogenic and produces durable and broad protection from a single intramuscular administration. Protection in cotton rat and mouse models was characterized by functional RSV neutralizing antibodies and no disease potentiation was observed. GenVec's RSV vaccine candidate utilizes a proprietary adenovirus that is capable of generating a broad immune response while avoiding the problems of vector specific immunity that has hampered other vectored vaccines.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
Antwort auf Beitrag Nr.: 43.666.407 von Macrocosmonaut am 01.10.12 20:53:38Ein paar Zahlen zum Marktpotential eines RSV-Impfstoffes um zu verdeutlichen wie gross das Marktpotential in diesem Segment ist:
Palizumab machte in 2011 rund 900 Millionen US-Dollar Jahresumsatz, und wird in diesem Jahr von Motavizumab mit rund 1.3 Milliarden US$ Jahresumsatz übertroffen. Der Motavizumab wird bis 2015 auf rund 1.8 Milliarden jährlich ansteigen - allerdings ist davon auszugehen, dass mit Einführung eines Impfstoffes grosse Teile dieser Umsäte an den Impfstoffhersteller wandern werden.
Ich gehe daher davon aus, dass bis 2020 der RSV-Impfstoffmarkt Umsätze von jährlich bis zu 2 Milliarden US-Dollar erwirtschaften kann - gemessen auf der Grundlage der Ausgaben für die derzeitigen o.g. Therapeutika.
Jährlich werden in den Industrienationen mehr als 3.5 Millionen Menschen mit RSV-infiziert. Mehr als 175000 Erwachsene müssen zur Behandlung stationär aufgenommern werden, mehr als 125000 Kinder sind ebenfalls stationär behandlungspflichtig und mehr als 90000 Säuglinge ebenfalls.
Die Zahlen stammen aus Nature -
Quelle: Respiratory syncytial virus market
Shane Storey
Nature Reviews Drug Discovery 9, 15-16 (January 2010)
Palizumab machte in 2011 rund 900 Millionen US-Dollar Jahresumsatz, und wird in diesem Jahr von Motavizumab mit rund 1.3 Milliarden US$ Jahresumsatz übertroffen. Der Motavizumab wird bis 2015 auf rund 1.8 Milliarden jährlich ansteigen - allerdings ist davon auszugehen, dass mit Einführung eines Impfstoffes grosse Teile dieser Umsäte an den Impfstoffhersteller wandern werden.
Ich gehe daher davon aus, dass bis 2020 der RSV-Impfstoffmarkt Umsätze von jährlich bis zu 2 Milliarden US-Dollar erwirtschaften kann - gemessen auf der Grundlage der Ausgaben für die derzeitigen o.g. Therapeutika.
Jährlich werden in den Industrienationen mehr als 3.5 Millionen Menschen mit RSV-infiziert. Mehr als 175000 Erwachsene müssen zur Behandlung stationär aufgenommern werden, mehr als 125000 Kinder sind ebenfalls stationär behandlungspflichtig und mehr als 90000 Säuglinge ebenfalls.
Die Zahlen stammen aus Nature -
Quelle: Respiratory syncytial virus market
Shane Storey
Nature Reviews Drug Discovery 9, 15-16 (January 2010)
Antwort auf Beitrag Nr.: 43.666.440 von Macrocosmonaut am 01.10.12 21:00:29Die Zahlen für das Jahr 2020 sind eine Schätzung von mir und beruhen auf der Annahme, dass die Umsätze, die derzeit mit der Symptombehandlung verdient werden bis zum Ende des Jahrzehnts zum grossen Teil in den Impfstoffmarkt für einen RSV-Impfstoff wandern werden.
Viele Grüsse.
M.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
Viele Grüsse.
M.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
Je mehr man liest umso mehr findet man. Da hat sich eine Menge in den letzten Jahren getan. Ist wirklich fazinierend, welche neuen Möglichkeiten sich da eröffnen.
Beispiel AIDS-Impfstoff:
Published online 2012 April 4. doi: 10.1371/journal.pone.0033969
PMCID: PMC3319553
Decreased Pre-existing Ad5 Capsid and Ad35 Neutralizing Antibodies Increase HIV-1 Infection Risk in the Step Trial Independent of Vaccination
Cheng Cheng,1 LingShu Wang,1 Jason G. D. Gall,3 Martha Nason,2 Richard M. Schwartz,1 M. Juliana McElrath,4,5 Steven C. DeRosa,4,5 John Hural,4,5 Lawrence Corey,4,5 Susan P. Buchbinder,5,6 and Gary J. Nabel1,*
Author information ► Article notes ► Copyright and License information ►
This article has been corrected. See PLoS One. 2012 May 31; 7(5):
Abstract
Background
The Step trial raised the possibility that uncircumcised men with pre-existing Ad5 neutralizing antibodies carried an increased risk of HIV infection after vaccination. Thus, understanding Ad seropositivity in humans is important to the development of an AIDS vaccine. Here, we analyze the impact of different Ad5-specific neutralizing antibodies on immune function and clinical outcome.
Methods and Findings
Ad seropositivity in the Step trial volunteers was analyzed using chimeric rAd5/35 vectors to characterize their specificity for Ad5 fiber and non-fiber external (capsid) proteins. Immune responses and HIV seropositivity were correlated with the specificity of Ad5-neutralizing antibodies. Neutralizing antibodies induced by the vaccine in Ad5 seronegative subjects were directed preferentially to Ad5 capsid proteins, although some fiber-neutralizing antibodies could be detected. Pre-vaccination Ad5 serostatus did not affect the capsid-directed response after three vaccinations. In contrast, anti-fiber antibody titers were significantly higher in volunteers who were Ad5 seropositive prior to vaccination. Those Ad5 seropositive subjects who generated anti-capsid responses showed a marked reduction in vaccine-induced CD8 responses. Unexpectedly, anti-vector immunity differed qualitatively in Ad5 seropositive participants who became HIV-1 infected compared to uninfected case controls; Ad5 seropositive participants who later acquired HIV had lower neutralizing antibodies to capsid. Moreover, Ad35 seropositivity was decreased in HIV-infected subjects compared with uninfected case controls, while seroprevalence for other serotypes including Ad14, Ad28 and Ad41 was similar in both groups.
Conclusions
Together, these findings suggest that the case subjects were less immunologically responsive prior to infection. Subjects infected during the Step trial had qualitative differences in immunity that increased their risk of HIV-1 infection independent of vaccination.
Beispiel AIDS-Impfstoff:
Published online 2012 April 4. doi: 10.1371/journal.pone.0033969
PMCID: PMC3319553
Decreased Pre-existing Ad5 Capsid and Ad35 Neutralizing Antibodies Increase HIV-1 Infection Risk in the Step Trial Independent of Vaccination
Cheng Cheng,1 LingShu Wang,1 Jason G. D. Gall,3 Martha Nason,2 Richard M. Schwartz,1 M. Juliana McElrath,4,5 Steven C. DeRosa,4,5 John Hural,4,5 Lawrence Corey,4,5 Susan P. Buchbinder,5,6 and Gary J. Nabel1,*
Author information ► Article notes ► Copyright and License information ►
This article has been corrected. See PLoS One. 2012 May 31; 7(5):
Abstract
Background
The Step trial raised the possibility that uncircumcised men with pre-existing Ad5 neutralizing antibodies carried an increased risk of HIV infection after vaccination. Thus, understanding Ad seropositivity in humans is important to the development of an AIDS vaccine. Here, we analyze the impact of different Ad5-specific neutralizing antibodies on immune function and clinical outcome.
Methods and Findings
Ad seropositivity in the Step trial volunteers was analyzed using chimeric rAd5/35 vectors to characterize their specificity for Ad5 fiber and non-fiber external (capsid) proteins. Immune responses and HIV seropositivity were correlated with the specificity of Ad5-neutralizing antibodies. Neutralizing antibodies induced by the vaccine in Ad5 seronegative subjects were directed preferentially to Ad5 capsid proteins, although some fiber-neutralizing antibodies could be detected. Pre-vaccination Ad5 serostatus did not affect the capsid-directed response after three vaccinations. In contrast, anti-fiber antibody titers were significantly higher in volunteers who were Ad5 seropositive prior to vaccination. Those Ad5 seropositive subjects who generated anti-capsid responses showed a marked reduction in vaccine-induced CD8 responses. Unexpectedly, anti-vector immunity differed qualitatively in Ad5 seropositive participants who became HIV-1 infected compared to uninfected case controls; Ad5 seropositive participants who later acquired HIV had lower neutralizing antibodies to capsid. Moreover, Ad35 seropositivity was decreased in HIV-infected subjects compared with uninfected case controls, while seroprevalence for other serotypes including Ad14, Ad28 and Ad41 was similar in both groups.
Conclusions
Together, these findings suggest that the case subjects were less immunologically responsive prior to infection. Subjects infected during the Step trial had qualitative differences in immunity that increased their risk of HIV-1 infection independent of vaccination.
Und es kommen noch mehr Nachrichten.
Diesmal zum Malaria Impfstoff. Klasse Sache - habe dazu die medizinische Literatur letzte Woche schon durchgeforstet.
Die Aktie bleibt gandenlos unterbewertet in meinen Augen.
GENVEC INC
Symbol U : GNVC
Recent Sedar Documents
GenVec Enters Into $3.5 Million Contract With Naval Medical Research Center To Advance Malaria Program
2012-10-02 06:55 ET - News Release
GAITHERSBURG, Md., Oct. 2, 2012 /PRNewswire/ -- GenVec, Inc. (Nasdaq: GNVC) announced today that it has signed an agreement worth approximately $3.5 million with the Naval Medical Research Center (NMRC) to support malaria vaccine development.
Under the terms of the agreement, GenVec is responsible for producing clinical supplies of its malaria vaccine, which utilizes its novel, proprietary technology. NMRC plans to use this clinical material to assess the safety and efficacy of these next-generation vectored vaccines using the clinical challenge model developed by NMRC and the Walter Reed Army Institute of Research (WRAIR) malaria vaccine programs, which now are unified as the US Military Malaria Vaccine Program (USMMVP). GenVec retains the right to commercialize this novel technology. GenVec's malaria vaccine candidate utilizes a novel, proprietary adenovector delivery system that is capable of generating strong immune responses while avoiding the problems of vector-specific immunity that has hampered other vectored vaccines.
In April 2010, encouraging clinical data were presented from a Phase 1 malaria vaccine trial conducted by NMRC and WRAIR using GenVec adenovector technology coupled with DNA plasmid priming. Data indicate this DNA/adenovector malaria vaccine given to malaria-naive adults was safe and well-tolerated with minimal local or systemic reactions and no serious vaccine-related adverse reactions. Sterile protection, a complete absence of parasites in the blood, was seen in 4 out of 15 volunteers that had been inoculated with the vaccine and subsequently challenged with the malaria parasite.
"We appreciate the US military's continued commitment to the worldwide problem of malaria and its support of malaria vaccine development," said Dr. Joseph Bruder, Director of Research and head of GenVec's malaria program. "Work under this agreement will build upon the encouraging clinical results previously demonstrated in malaria with our vaccines."
About Malaria
Malaria is one of the world's most widespread and burdensome infectious diseases. This life-threatening parasitic infection is transmitted to humans through the bite of an infected mosquito. Malaria parasites initially invade liver cells and, after multiplying, release tens of thousands of new parasites, which invade red blood cells, multiply again, and then destroy these cells. High fever, headache, and shaking chills appear approximately nine to fourteen days after the infectious bite. If untreated, the infection can progress rapidly and become life threatening—destroying red blood cells, causing severe anemia, and blocking capillaries that nourish the brain and other vital organs, resulting in multisystem failure, coma and death. Malaria causes approximately 243 million acute illnesses and 863,000 deaths annually, mostly among children under the age of five. Malaria is a major health risk for travelers and the military.
About GenVec
GenVec is a biopharmaceutical company using differentiated, proprietary technologies to create superior therapeutics and vaccines. A key component of our strategy is to develop and commercialize our product candidates through collaborations. GenVec is working with leading companies and organizations such as Novartis, Merial, and the U.S. Government to support a portfolio of product programs that address the prevention and treatment of a number of significant human and animal health concerns. GenVec's development programs address therapeutic areas such as hearing loss and balance disorders; as well as vaccines against infectious diseases including respiratory syncytial virus (RSV), herpes simplex virus (HSV), dengue fever, malaria, and human immunodeficiency virus (HIV). In the area of animal health we are developing vaccines against foot-and-mouth disease (FMD). Additional information about GenVec is available at www.genvec.com and in the Company's various filings with the Securities and Exchange Commission.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding funding, grants, collaborations, revenues, cash burn rates, the development of products and the success of the Company's collaborations, including with Novartis and Merial, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to the early stage of GenVec's product candidates under development; uncertainties relating to research and development activities; risks relating to the commercialization, if any, of GenVec's proposed product candidates; dependence on the efforts of collaborators and third parties; dependence on intellectual property; currently unanticipated expenses, and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.
Diesmal zum Malaria Impfstoff. Klasse Sache - habe dazu die medizinische Literatur letzte Woche schon durchgeforstet.
Die Aktie bleibt gandenlos unterbewertet in meinen Augen.
GENVEC INC
Symbol U : GNVC
Recent Sedar Documents
GenVec Enters Into $3.5 Million Contract With Naval Medical Research Center To Advance Malaria Program
2012-10-02 06:55 ET - News Release
GAITHERSBURG, Md., Oct. 2, 2012 /PRNewswire/ -- GenVec, Inc. (Nasdaq: GNVC) announced today that it has signed an agreement worth approximately $3.5 million with the Naval Medical Research Center (NMRC) to support malaria vaccine development.
Under the terms of the agreement, GenVec is responsible for producing clinical supplies of its malaria vaccine, which utilizes its novel, proprietary technology. NMRC plans to use this clinical material to assess the safety and efficacy of these next-generation vectored vaccines using the clinical challenge model developed by NMRC and the Walter Reed Army Institute of Research (WRAIR) malaria vaccine programs, which now are unified as the US Military Malaria Vaccine Program (USMMVP). GenVec retains the right to commercialize this novel technology. GenVec's malaria vaccine candidate utilizes a novel, proprietary adenovector delivery system that is capable of generating strong immune responses while avoiding the problems of vector-specific immunity that has hampered other vectored vaccines.
In April 2010, encouraging clinical data were presented from a Phase 1 malaria vaccine trial conducted by NMRC and WRAIR using GenVec adenovector technology coupled with DNA plasmid priming. Data indicate this DNA/adenovector malaria vaccine given to malaria-naive adults was safe and well-tolerated with minimal local or systemic reactions and no serious vaccine-related adverse reactions. Sterile protection, a complete absence of parasites in the blood, was seen in 4 out of 15 volunteers that had been inoculated with the vaccine and subsequently challenged with the malaria parasite.
"We appreciate the US military's continued commitment to the worldwide problem of malaria and its support of malaria vaccine development," said Dr. Joseph Bruder, Director of Research and head of GenVec's malaria program. "Work under this agreement will build upon the encouraging clinical results previously demonstrated in malaria with our vaccines."
About Malaria
Malaria is one of the world's most widespread and burdensome infectious diseases. This life-threatening parasitic infection is transmitted to humans through the bite of an infected mosquito. Malaria parasites initially invade liver cells and, after multiplying, release tens of thousands of new parasites, which invade red blood cells, multiply again, and then destroy these cells. High fever, headache, and shaking chills appear approximately nine to fourteen days after the infectious bite. If untreated, the infection can progress rapidly and become life threatening—destroying red blood cells, causing severe anemia, and blocking capillaries that nourish the brain and other vital organs, resulting in multisystem failure, coma and death. Malaria causes approximately 243 million acute illnesses and 863,000 deaths annually, mostly among children under the age of five. Malaria is a major health risk for travelers and the military.
About GenVec
GenVec is a biopharmaceutical company using differentiated, proprietary technologies to create superior therapeutics and vaccines. A key component of our strategy is to develop and commercialize our product candidates through collaborations. GenVec is working with leading companies and organizations such as Novartis, Merial, and the U.S. Government to support a portfolio of product programs that address the prevention and treatment of a number of significant human and animal health concerns. GenVec's development programs address therapeutic areas such as hearing loss and balance disorders; as well as vaccines against infectious diseases including respiratory syncytial virus (RSV), herpes simplex virus (HSV), dengue fever, malaria, and human immunodeficiency virus (HIV). In the area of animal health we are developing vaccines against foot-and-mouth disease (FMD). Additional information about GenVec is available at www.genvec.com and in the Company's various filings with the Securities and Exchange Commission.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding funding, grants, collaborations, revenues, cash burn rates, the development of products and the success of the Company's collaborations, including with Novartis and Merial, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to the early stage of GenVec's product candidates under development; uncertainties relating to research and development activities; risks relating to the commercialization, if any, of GenVec's proposed product candidates; dependence on the efforts of collaborators and third parties; dependence on intellectual property; currently unanticipated expenses, and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.
Antwort auf Beitrag Nr.: 43.666.607 von Macrocosmonaut am 01.10.12 21:34:28PLoS One. 2012;7(8):e41936. Epub 2012 Aug 3.
A Phase I Double Blind, Placebo-Controlled, Randomized Study of a Multigenic HIV-1 Adenovirus Subtype 35 Vector Vaccine in Healthy Uninfected Adults.
Keefer MC, Gilmour J, Hayes P, Gill D, Kopycinski J, Cheeseman H, Cashin-Cox M, Naarding M, Clark L, Fernandez N, Bunce CA, Hay CM, Welsh S, Komaroff W, Hachaambwa L, Tarragona-Fiol T, Sayeed E, Zachariah D, Ackland J, Loughran K, Barin B, Cormier E, Cox JH, Fast P, Excler JL.
Source
University of Rochester School of Medicine and Dentistry, Rochester, New York, United States of America.
Abstract
BACKGROUND:
We conducted a phase I, randomized, double-blind, placebo-controlled trial to assess the safety and immunogenicity of escalating doses of two recombinant replication defective adenovirus serotype 35 (Ad35) vectors containing gag, reverse transcriptase, integrase and nef (Ad35-GRIN) and env (Ad35-ENV), both derived from HIV-1 subtype A isolates. The trial enrolled 56 healthy HIV-uninfected adults.
METHODS:
Ad35-GRIN/ENV (Ad35-GRIN and Ad35-ENV mixed in the same vial in equal proportions) or Ad35-GRIN was administered intramuscularly at 0 and 6 months. Participants were randomized to receive either vaccine or placebo (10/4 per group, respectively) within one of four dosage groups: Ad35-GRIN/ENV 2×10(9) (A), 2×10(10) (B), 2×10(11) (C), or Ad35-GRIN 1×10(10) (D) viral particles.
RESULTS:
No vaccine-related serious adverse event was reported. Reactogenicity events reported were dose-dependent, mostly mild or moderate, some severe in Group C volunteers, all transient and resolving spontaneously. IFN-γ ELISPOT responses to any vaccine antigen were detected in 50, 56, 70 and 90% after the first vaccination, and in 75, 100, 88 and 86% of Groups A-D vaccine recipients after the second vaccination, respectively. The median spot forming cells (SFC) per 10(6) PBMC to any antigen was 78-139 across Groups A-C and 158-174 in Group D, after each of the vaccinations with a maximum of 2991 SFC. Four to five HIV proteins were commonly recognized across all the groups and over multiple timepoints. CD4+ and CD8+ T-cell responses were polyfunctional. Env antibodies were detected in all Group A-C vaccinees and Gag antibodies in most vaccinees after the second immunization. Ad35 neutralizing titers remained low after the second vaccination.
CONCLUSION/SIGNIFICANCE:
Ad35-GRIN/ENV reactogenicity was dose-related. HIV-specific cellular and humoral responses were seen in the majority of volunteers immunized with Ad35-GRIN/ENV or Ad35-GRIN and increased after the second vaccination. T-cell responses were broad and polyfunctional.
TRIAL REGISTRATION:
ClinicalTrials.gov NCT00851383.
Über Genvec´s Ad35 Entwicklungen wird man wahrscheinlich noch mehr hören - funktioniert nach einen Recherchen besser als die bis dato viel untersuchte ad5 Ansatz bei anderen Studien.
M.
A Phase I Double Blind, Placebo-Controlled, Randomized Study of a Multigenic HIV-1 Adenovirus Subtype 35 Vector Vaccine in Healthy Uninfected Adults.
Keefer MC, Gilmour J, Hayes P, Gill D, Kopycinski J, Cheeseman H, Cashin-Cox M, Naarding M, Clark L, Fernandez N, Bunce CA, Hay CM, Welsh S, Komaroff W, Hachaambwa L, Tarragona-Fiol T, Sayeed E, Zachariah D, Ackland J, Loughran K, Barin B, Cormier E, Cox JH, Fast P, Excler JL.
Source
University of Rochester School of Medicine and Dentistry, Rochester, New York, United States of America.
Abstract
BACKGROUND:
We conducted a phase I, randomized, double-blind, placebo-controlled trial to assess the safety and immunogenicity of escalating doses of two recombinant replication defective adenovirus serotype 35 (Ad35) vectors containing gag, reverse transcriptase, integrase and nef (Ad35-GRIN) and env (Ad35-ENV), both derived from HIV-1 subtype A isolates. The trial enrolled 56 healthy HIV-uninfected adults.
METHODS:
Ad35-GRIN/ENV (Ad35-GRIN and Ad35-ENV mixed in the same vial in equal proportions) or Ad35-GRIN was administered intramuscularly at 0 and 6 months. Participants were randomized to receive either vaccine or placebo (10/4 per group, respectively) within one of four dosage groups: Ad35-GRIN/ENV 2×10(9) (A), 2×10(10) (B), 2×10(11) (C), or Ad35-GRIN 1×10(10) (D) viral particles.
RESULTS:
No vaccine-related serious adverse event was reported. Reactogenicity events reported were dose-dependent, mostly mild or moderate, some severe in Group C volunteers, all transient and resolving spontaneously. IFN-γ ELISPOT responses to any vaccine antigen were detected in 50, 56, 70 and 90% after the first vaccination, and in 75, 100, 88 and 86% of Groups A-D vaccine recipients after the second vaccination, respectively. The median spot forming cells (SFC) per 10(6) PBMC to any antigen was 78-139 across Groups A-C and 158-174 in Group D, after each of the vaccinations with a maximum of 2991 SFC. Four to five HIV proteins were commonly recognized across all the groups and over multiple timepoints. CD4+ and CD8+ T-cell responses were polyfunctional. Env antibodies were detected in all Group A-C vaccinees and Gag antibodies in most vaccinees after the second immunization. Ad35 neutralizing titers remained low after the second vaccination.
CONCLUSION/SIGNIFICANCE:
Ad35-GRIN/ENV reactogenicity was dose-related. HIV-specific cellular and humoral responses were seen in the majority of volunteers immunized with Ad35-GRIN/ENV or Ad35-GRIN and increased after the second vaccination. T-cell responses were broad and polyfunctional.
TRIAL REGISTRATION:
ClinicalTrials.gov NCT00851383.
Über Genvec´s Ad35 Entwicklungen wird man wahrscheinlich noch mehr hören - funktioniert nach einen Recherchen besser als die bis dato viel untersuchte ad5 Ansatz bei anderen Studien.
M.
Hab mal recheriert ob sich zu Genvec einstmals potentiellen Blockbuster neues ergeben hat. Habe dabei folgendes aus diesem Jahr gefunden, was ich ausgesprochen interessant finde:
Gastrointest Endosc. 2012 Jun;75(6):1139-46.e2. Epub 2012 Apr 18.
Phase I evaluation of TNFerade biologic plus chemoradiotherapy before esophagectomy for locally advanced resectable esophageal cancer.
Chang KJ, Reid T, Senzer N, Swisher S, Pinto H, Hanna N, Chak A, Soetikno R.
Source
University of California, Irvine, H.H. Chao Comprehensive Digestive Disease Center, Orange, California, USA.
Abstract
BACKGROUND:
Neoadjuvant chemoradiotherapy followed by surgery is the primary treatment option for patients with locally advanced esophageal cancer. This multicenter phase I trial examined intratumoral injection of TNFerade biologic, an adenoviral vector that expresses the human tumor necrosis factor-α gene, with chemoradiotherapy in locally advanced esophageal cancer.
OBJECTIVES:
To assess pathologic complete response (pCR), time to disease progression, progression-free survival, survival, and safety and tolerance in patients treated with preoperative chemoradiation combined with endoscopy or EUS-guided intratumoral injection of TNFerade biologic.
DESIGN/INTERVENTION:
Five weekly injections of TNFerade biologic, dose-escalated logarithmically from 4 × 10(8) to 4 × 10(11) particle units (PU), were given in combination with cisplatin 75 mg/m(2) and intravenous 5-fluorouracil 1000 mg/m(2)/d for 96 hours on days 1 and 29, and concurrent radiation therapy to 45 Gy. Surgery was performed 9 to 15 weeks after treatment.
SETTING:
U.S. multicenter study.
PATIENTS:
Patients with stage II and III esophageal cancer were enrolled.
MAIN OUTCOME MEASUREMENTS:
Primary outcome measures were safety, feasibility, tolerability, and rate of pCR. Secondary outcome measures were overall survival (OS) and disease-free survival.
RESULTS:
Twenty-four patients with a median age of 61 years were enrolled; 88% of the patients were men, 21% were stage II, and 79% were stage III. Six (29%) had a pCR, observed among 21 patients (20 who underwent esophagectomy and 1 at autopsy). Dose-limiting toxicities were not observed. The most frequent potentially related adverse events were fatigue (54%), fever (38%), nausea (29%), vomiting (21%), esophagitis (21%), and chills (21%). At the top dose of 4 × 10(11) PU, thromboembolic events developed in 5 of 8 patients. The median OS was 47.8 months. The 3- and 5-year OS rates and disease-free survival rates were 54% and 41% and 38% and 38%, respectively.
LIMITATIONS:
We included primarily adenocarcinoma.
CONCLUSIONS:
Preoperative TNFerade, in combination with chemoradiotherapy, is active and safe at doses up to 4 × 10(10) PU and is associated with long survival. This regimen warrants additional studies.
Es scheint so als ob TNFerade beim Speiseröhrenkrebs einen lebensverlängernden Effekt hat.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
Gastrointest Endosc. 2012 Jun;75(6):1139-46.e2. Epub 2012 Apr 18.
Phase I evaluation of TNFerade biologic plus chemoradiotherapy before esophagectomy for locally advanced resectable esophageal cancer.
Chang KJ, Reid T, Senzer N, Swisher S, Pinto H, Hanna N, Chak A, Soetikno R.
Source
University of California, Irvine, H.H. Chao Comprehensive Digestive Disease Center, Orange, California, USA.
Abstract
BACKGROUND:
Neoadjuvant chemoradiotherapy followed by surgery is the primary treatment option for patients with locally advanced esophageal cancer. This multicenter phase I trial examined intratumoral injection of TNFerade biologic, an adenoviral vector that expresses the human tumor necrosis factor-α gene, with chemoradiotherapy in locally advanced esophageal cancer.
OBJECTIVES:
To assess pathologic complete response (pCR), time to disease progression, progression-free survival, survival, and safety and tolerance in patients treated with preoperative chemoradiation combined with endoscopy or EUS-guided intratumoral injection of TNFerade biologic.
DESIGN/INTERVENTION:
Five weekly injections of TNFerade biologic, dose-escalated logarithmically from 4 × 10(8) to 4 × 10(11) particle units (PU), were given in combination with cisplatin 75 mg/m(2) and intravenous 5-fluorouracil 1000 mg/m(2)/d for 96 hours on days 1 and 29, and concurrent radiation therapy to 45 Gy. Surgery was performed 9 to 15 weeks after treatment.
SETTING:
U.S. multicenter study.
PATIENTS:
Patients with stage II and III esophageal cancer were enrolled.
MAIN OUTCOME MEASUREMENTS:
Primary outcome measures were safety, feasibility, tolerability, and rate of pCR. Secondary outcome measures were overall survival (OS) and disease-free survival.
RESULTS:
Twenty-four patients with a median age of 61 years were enrolled; 88% of the patients were men, 21% were stage II, and 79% were stage III. Six (29%) had a pCR, observed among 21 patients (20 who underwent esophagectomy and 1 at autopsy). Dose-limiting toxicities were not observed. The most frequent potentially related adverse events were fatigue (54%), fever (38%), nausea (29%), vomiting (21%), esophagitis (21%), and chills (21%). At the top dose of 4 × 10(11) PU, thromboembolic events developed in 5 of 8 patients. The median OS was 47.8 months. The 3- and 5-year OS rates and disease-free survival rates were 54% and 41% and 38% and 38%, respectively.
LIMITATIONS:
We included primarily adenocarcinoma.
CONCLUSIONS:
Preoperative TNFerade, in combination with chemoradiotherapy, is active and safe at doses up to 4 × 10(10) PU and is associated with long survival. This regimen warrants additional studies.
Es scheint so als ob TNFerade beim Speiseröhrenkrebs einen lebensverlängernden Effekt hat.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
Ein must read.
TNF-erade wurde ja vom Markt schon abgeschrieben - aber offenbar wirkt es bei anderen Tumorentitäten.
Speiseröhrenkrebs:
http://locationguide.info/2012/07/29/genvec-presents-encouraging-data-on-tnferadetm-in-esophageal-cancer/
Mediane Überlebensrate bei Stadium III und IV Patienten auf über 48 Monate erhöht - ohne TNF-erade liegt die Überlebenszeit in der Kontrolle offenbar nur in einer Range von 9-18 Monaten.
M.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
TNF-erade wurde ja vom Markt schon abgeschrieben - aber offenbar wirkt es bei anderen Tumorentitäten.
Speiseröhrenkrebs:
http://locationguide.info/2012/07/29/genvec-presents-encouraging-data-on-tnferadetm-in-esophageal-cancer/
Mediane Überlebensrate bei Stadium III und IV Patienten auf über 48 Monate erhöht - ohne TNF-erade liegt die Überlebenszeit in der Kontrolle offenbar nur in einer Range von 9-18 Monaten.
M.
Wie immer meine eigene Einschätzung und ohne Gewähr. Die gemachten Angaben stellen keine Handelsaufforderung dar. Aktien können steigen oder fallen. Jeder Investor handelt auf eigenes Risiko.
Curr Opin Neurol. 2012 Feb;25(1):57-60.
Cochlear gene therapy.
Lustig LR, Akil O.
Source
Department of Otolaryngology-Head & Neck Surgery, University of California, San Francisco, San Francisco, California 94115, USA. llustig@ohns.ucsf.edu
Abstract
PURPOSE OF REVIEW:
This review highlights recent advances in cochlear gene therapy over the past several years. Cochlear gene therapy has undergone tremendous advances over the past decade. Beginning with some groundbreaking work in 2005 documenting hair cell regeneration using virally mediated delivery of the mouse atonal 1 gene, gene therapy is now being explored as a possible treatment for a variety of causes of hearing loss.
RECENT FINDINGS:
Recent advances in cochlear gene therapy include improved methods of gene delivery with a better delineation of viral vectors that are suitable for this purpose, additional improvements in hair cell regeneration, and directed research toward autoimmune hearing loss, ototoxicity, spiral ganglion survival, and genetic forms of hearing loss.
SUMMARY:
If successful, cochlear gene therapy will dramatically alter our ability to treat a variety of forms of acquired and genetic hearing loss.
Cochlear gene therapy.
Lustig LR, Akil O.
Source
Department of Otolaryngology-Head & Neck Surgery, University of California, San Francisco, San Francisco, California 94115, USA. llustig@ohns.ucsf.edu
Abstract
PURPOSE OF REVIEW:
This review highlights recent advances in cochlear gene therapy over the past several years. Cochlear gene therapy has undergone tremendous advances over the past decade. Beginning with some groundbreaking work in 2005 documenting hair cell regeneration using virally mediated delivery of the mouse atonal 1 gene, gene therapy is now being explored as a possible treatment for a variety of causes of hearing loss.
RECENT FINDINGS:
Recent advances in cochlear gene therapy include improved methods of gene delivery with a better delineation of viral vectors that are suitable for this purpose, additional improvements in hair cell regeneration, and directed research toward autoimmune hearing loss, ototoxicity, spiral ganglion survival, and genetic forms of hearing loss.
SUMMARY:
If successful, cochlear gene therapy will dramatically alter our ability to treat a variety of forms of acquired and genetic hearing loss.
Je mehr man die Entwicklungen in der Gentherapie der letzten Jahre liest, umso mehr kommt man zu dem Schluss dass wir vor einer medizinischen Revolution stehen, wohl der grössten seit der Entdeckung der Antibiotika.
Man lese sich nur mal die Arbeiten zur Leber´schen Amaurose durch, einer Erkrankung die bislang als nicht behandelbar galt und zur Erblindung führt.
Hum Gene Ther. 2011 Oct;22(10):1179-90. Epub 2011 Aug 10.
Long-term preservation of cones and improvement in visual function following gene therapy in a mouse model of leber congenital amaurosis caused by guanylate cyclase-1 deficiency.
Mihelec M, Pearson RA, Robbie SJ, Buch PK, Azam SA, Bainbridge JW, Smith AJ, Ali RR.
Source
Department of Genetics, University College London, Institute of Ophthalmology, London, United Kingdom.
Abstract
Leber congenital amaurosis (LCA) is a severe retinal dystrophy manifesting from early infancy as poor vision or blindness. Loss-of-function mutations in GUCY2D cause LCA1 and are one of the most common causes of LCA, accounting for 20% of all cases. Human GUCY2D and mouse Gucy2e genes encode guanylate cyclase-1 (GC1), which is responsible for restoring the dark state in photoreceptors after light exposure. The Gucy2e(-/-) mouse shows partially diminished rod function, but an absence of cone function before degeneration. Although the cones appear morphologically normal, they exhibit mislocalization of proteins involved in phototransduction. In this study we tested the efficacy of an rAAV2/8 vector containing the human rhodopsin kinase promoter and the human GUCY2D gene. Following subretinal delivery of the vector in Gucy2e(-/-) mice, GC1 protein was detected in the rod and cone outer segments, and in transduced areas of retina cone transducin was appropriately localized to cone outer segments. Moreover, we observed a dose-dependent restoration of rod and cone function and an improvement in visual behavior of the treated mice. Most importantly, cone preservation was observed in transduced areas up to 6 months post injection. To date, this is the most effective rescue of the Gucy2e(-/-) mouse model of LCA and we propose that a vector, similar to the one used in this study, could be suitable for use in a clinical trial of gene therapy for LCA1.
Man lese sich nur mal die Arbeiten zur Leber´schen Amaurose durch, einer Erkrankung die bislang als nicht behandelbar galt und zur Erblindung führt.
Hum Gene Ther. 2011 Oct;22(10):1179-90. Epub 2011 Aug 10.
Long-term preservation of cones and improvement in visual function following gene therapy in a mouse model of leber congenital amaurosis caused by guanylate cyclase-1 deficiency.
Mihelec M, Pearson RA, Robbie SJ, Buch PK, Azam SA, Bainbridge JW, Smith AJ, Ali RR.
Source
Department of Genetics, University College London, Institute of Ophthalmology, London, United Kingdom.
Abstract
Leber congenital amaurosis (LCA) is a severe retinal dystrophy manifesting from early infancy as poor vision or blindness. Loss-of-function mutations in GUCY2D cause LCA1 and are one of the most common causes of LCA, accounting for 20% of all cases. Human GUCY2D and mouse Gucy2e genes encode guanylate cyclase-1 (GC1), which is responsible for restoring the dark state in photoreceptors after light exposure. The Gucy2e(-/-) mouse shows partially diminished rod function, but an absence of cone function before degeneration. Although the cones appear morphologically normal, they exhibit mislocalization of proteins involved in phototransduction. In this study we tested the efficacy of an rAAV2/8 vector containing the human rhodopsin kinase promoter and the human GUCY2D gene. Following subretinal delivery of the vector in Gucy2e(-/-) mice, GC1 protein was detected in the rod and cone outer segments, and in transduced areas of retina cone transducin was appropriately localized to cone outer segments. Moreover, we observed a dose-dependent restoration of rod and cone function and an improvement in visual behavior of the treated mice. Most importantly, cone preservation was observed in transduced areas up to 6 months post injection. To date, this is the most effective rescue of the Gucy2e(-/-) mouse model of LCA and we propose that a vector, similar to the one used in this study, could be suitable for use in a clinical trial of gene therapy for LCA1.
Medizin Nobelpreis 2012 für die Umprogrammierung von Zellen - in diesem Fall zu Stammzellen.
http://www.spiegel.de/wissenschaft/medizin/nobelpreis-medizi…
So sieht die die Zukunft aus - Zellen werden "umprogrammiert".
Das werden spannende Zeiten.
M.
http://www.spiegel.de/wissenschaft/medizin/nobelpreis-medizi…
So sieht die die Zukunft aus - Zellen werden "umprogrammiert".
Das werden spannende Zeiten.
M.
Es tun sich immer mehr Möglichkeiten auf, wo die Gentherapie überall helfen kann. In der Augenheilkunde zum Beispiel:
http://todayhealth.today.com/_news/2012/09/19/13942501-dna-i…
Faszinierend - und die Mainstreammedien reden nur über Schulden, dabei sind die Entwicklungen bei der Behandlung von Krankheiten mittels Gentransfer rasant.
Wenn die ASCO - Daten zu TNF-erade bei Speiseröhrenkrebs bestätigen, dann ist das schon revolutionär - mal ganz abgesehen von den anderen Projekten.
M.
http://todayhealth.today.com/_news/2012/09/19/13942501-dna-i…
Faszinierend - und die Mainstreammedien reden nur über Schulden, dabei sind die Entwicklungen bei der Behandlung von Krankheiten mittels Gentransfer rasant.
Wenn die ASCO - Daten zu TNF-erade bei Speiseröhrenkrebs bestätigen, dann ist das schon revolutionär - mal ganz abgesehen von den anderen Projekten.
M.
Antwort auf Beitrag Nr.: 43.693.486 von Macrocosmonaut am 09.10.12 14:08:55Gastrointest Endosc. 2012 Jun;75(6):1139-46.e2. Epub 2012 Apr 18.
Phase I evaluation of TNFerade biologic plus chemoradiotherapy before esophagectomy for locally advanced resectable esophageal cancer.
Chang KJ, Reid T, Senzer N, Swisher S, Pinto H, Hanna N, Chak A, Soetikno R.
Source
University of California, Irvine, H.H. Chao Comprehensive Digestive Disease Center, Orange, California, USA.
Abstract
BACKGROUND:
Neoadjuvant chemoradiotherapy followed by surgery is the primary treatment option for patients with locally advanced esophageal cancer. This multicenter phase I trial examined intratumoral injection of TNFerade biologic, an adenoviral vector that expresses the human tumor necrosis factor-α gene, with chemoradiotherapy in locally advanced esophageal cancer.
OBJECTIVES:
To assess pathologic complete response (pCR), time to disease progression, progression-free survival, survival, and safety and tolerance in patients treated with preoperative chemoradiation combined with endoscopy or EUS-guided intratumoral injection of TNFerade biologic.
DESIGN/INTERVENTION:
Five weekly injections of TNFerade biologic, dose-escalated logarithmically from 4 × 10(8) to 4 × 10(11) particle units (PU), were given in combination with cisplatin 75 mg/m(2) and intravenous 5-fluorouracil 1000 mg/m(2)/d for 96 hours on days 1 and 29, and concurrent radiation therapy to 45 Gy. Surgery was performed 9 to 15 weeks after treatment.
SETTING:
U.S. multicenter study.
PATIENTS:
Patients with stage II and III esophageal cancer were enrolled.
MAIN OUTCOME MEASUREMENTS:
Primary outcome measures were safety, feasibility, tolerability, and rate of pCR. Secondary outcome measures were overall survival (OS) and disease-free survival.
RESULTS:
Twenty-four patients with a median age of 61 years were enrolled; 88% of the patients were men, 21% were stage II, and 79% were stage III. Six (29%) had a pCR, observed among 21 patients (20 who underwent esophagectomy and 1 at autopsy). Dose-limiting toxicities were not observed. The most frequent potentially related adverse events were fatigue (54%), fever (38%), nausea (29%), vomiting (21%), esophagitis (21%), and chills (21%). At the top dose of 4 × 10(11) PU, thromboembolic events developed in 5 of 8 patients. The median OS was 47.8 months. The 3- and 5-year OS rates and disease-free survival rates were 54% and 41% and 38% and 38%, respectively.
LIMITATIONS:
We included primarily adenocarcinoma.
CONCLUSIONS:
Preoperative TNFerade, in combination with chemoradiotherapy, is active and safe at doses up to 4 × 10(10) PU and is associated with long survival. This regimen warrants additional studies.
Phase I evaluation of TNFerade biologic plus chemoradiotherapy before esophagectomy for locally advanced resectable esophageal cancer.
Chang KJ, Reid T, Senzer N, Swisher S, Pinto H, Hanna N, Chak A, Soetikno R.
Source
University of California, Irvine, H.H. Chao Comprehensive Digestive Disease Center, Orange, California, USA.
Abstract
BACKGROUND:
Neoadjuvant chemoradiotherapy followed by surgery is the primary treatment option for patients with locally advanced esophageal cancer. This multicenter phase I trial examined intratumoral injection of TNFerade biologic, an adenoviral vector that expresses the human tumor necrosis factor-α gene, with chemoradiotherapy in locally advanced esophageal cancer.
OBJECTIVES:
To assess pathologic complete response (pCR), time to disease progression, progression-free survival, survival, and safety and tolerance in patients treated with preoperative chemoradiation combined with endoscopy or EUS-guided intratumoral injection of TNFerade biologic.
DESIGN/INTERVENTION:
Five weekly injections of TNFerade biologic, dose-escalated logarithmically from 4 × 10(8) to 4 × 10(11) particle units (PU), were given in combination with cisplatin 75 mg/m(2) and intravenous 5-fluorouracil 1000 mg/m(2)/d for 96 hours on days 1 and 29, and concurrent radiation therapy to 45 Gy. Surgery was performed 9 to 15 weeks after treatment.
SETTING:
U.S. multicenter study.
PATIENTS:
Patients with stage II and III esophageal cancer were enrolled.
MAIN OUTCOME MEASUREMENTS:
Primary outcome measures were safety, feasibility, tolerability, and rate of pCR. Secondary outcome measures were overall survival (OS) and disease-free survival.
RESULTS:
Twenty-four patients with a median age of 61 years were enrolled; 88% of the patients were men, 21% were stage II, and 79% were stage III. Six (29%) had a pCR, observed among 21 patients (20 who underwent esophagectomy and 1 at autopsy). Dose-limiting toxicities were not observed. The most frequent potentially related adverse events were fatigue (54%), fever (38%), nausea (29%), vomiting (21%), esophagitis (21%), and chills (21%). At the top dose of 4 × 10(11) PU, thromboembolic events developed in 5 of 8 patients. The median OS was 47.8 months. The 3- and 5-year OS rates and disease-free survival rates were 54% and 41% and 38% and 38%, respectively.
LIMITATIONS:
We included primarily adenocarcinoma.
CONCLUSIONS:
Preoperative TNFerade, in combination with chemoradiotherapy, is active and safe at doses up to 4 × 10(10) PU and is associated with long survival. This regimen warrants additional studies.
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