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IMUC - ImmunoCellular Therapeutics Ltd(NYSEAMEX:IMUC)
- Creatore Discussione legolego
- Data di inizio
cacchio di bancaora non mi da' nemmeno i valori del titolo... solo un grafico... spero funzioni quando dovro' vendere...
beh sull'amex anche con fineco sono quazzii
maumal
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Titolo istericochiusura con puntatina in su... mi piace.
per oggi basta così
(pensare che sono uscito da htm perche' mi annoiava)
Pre-market: 0.820 +0.080 (10.84%)
Dec 19, 8:37AM EST
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Adesso appena fa +2%
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Informazioni varie
ImmunoCellular (IMUC) is a development stage biotechnology company engaged in the development of dendritic cell based cancer vaccines. The company has recently announced a disappointing phase II result which has put the pipeline under question. ICT-107 is pretty similar to Northwest Biotherapeutics' (NWBO) DCVax-L as both target GBM and use patients own dendritic cell to generate immune response, and produce DC based vaccines. I have already covered Northwest multiple times which is why I wanted to give the followers of both stocks a comparative view of the their respective candidates.
The Business
ImmunoCellular Therapeutics Limited is a biotechnology company focused on developing immune-based cancer therapies, specifically for brain, ovarian and solid tumors. It has three candidates in it pipeline, with the most advanced one in phase II. The company targets not only the cancer antigens, but also the cancer stem cells responsible for tumor growth. These candidates are being developed using the company's dendritic cell (DC) based platform, which was licensed from University of Pennsylvania.
The company has acquired certain worldwide exclusive licenses including certain cellular based therapy technology from Cedars-Sinai Medical Center; technology for mesothelin specific cancer immunotherapies from The John Hopkins University; patent technology for DC based vaccines from University of Pennsylvania; and intellectual property for EphA2, a tyrosine kinase receptor, from the University of Pittsburgh. Additionally, the company also acquired monoclonal antibody technology from Molecular Discoveries LLC., which also includes certain monoclonal antibody candidates in pre-clinical stage potentially for small cell lung, ovarian, pancreatic, and multiple myeloma cancers.
The competitors of the company include Agenus Inc. (AGEN), Northwest Biotherapeutics , Dendreon Corp. (DNDN), and Stemline Therapeutics Inc. (STML), among others.
Technology
The company develops cancer immunotherapies by using their autologous dendritic cell (DC) based vaccines, that not only target the tumor cells but also the cancer stem cells, triggering a powerful immune response. The cancer stem cells (CSCs) are subsets of cancer cells, with functions similar to normal stem cells, and generate tumors. These cancer stem cells are only 5% of the tumor, but are resistant to chemotherapy and radiation. Thus even after treatment these cells self-renew and are responsible for the recurrence of cancer, despite the removal of tumor. The company's DC-based vaccines target not only the multiple antigens associated with cancer, but also these CSCs, thus making it a more effective treatment. These vaccines are developed using the patient's own blood cells, processed in the laboratory to produce a number of potent mature DCs. These DCs are then processed with tumor associated antigens and inoculated back in the patient, thus activating the T-cells that destroy relevant cancer cells.
ImmunoCellular (IMUC) is a development stage biotechnology company engaged in the development of dendritic cell based cancer vaccines. The company has recently announced a disappointing phase II result which has put the pipeline under question. ICT-107 is pretty similar to Northwest Biotherapeutics' (NWBO) DCVax-L as both target GBM and use patients own dendritic cell to generate immune response, and produce DC based vaccines. I have already covered Northwest multiple times which is why I wanted to give the followers of both stocks a comparative view of the their respective candidates.
The Business
ImmunoCellular Therapeutics Limited is a biotechnology company focused on developing immune-based cancer therapies, specifically for brain, ovarian and solid tumors. It has three candidates in it pipeline, with the most advanced one in phase II. The company targets not only the cancer antigens, but also the cancer stem cells responsible for tumor growth. These candidates are being developed using the company's dendritic cell (DC) based platform, which was licensed from University of Pennsylvania.
The company has acquired certain worldwide exclusive licenses including certain cellular based therapy technology from Cedars-Sinai Medical Center; technology for mesothelin specific cancer immunotherapies from The John Hopkins University; patent technology for DC based vaccines from University of Pennsylvania; and intellectual property for EphA2, a tyrosine kinase receptor, from the University of Pittsburgh. Additionally, the company also acquired monoclonal antibody technology from Molecular Discoveries LLC., which also includes certain monoclonal antibody candidates in pre-clinical stage potentially for small cell lung, ovarian, pancreatic, and multiple myeloma cancers.
The competitors of the company include Agenus Inc. (AGEN), Northwest Biotherapeutics , Dendreon Corp. (DNDN), and Stemline Therapeutics Inc. (STML), among others.
Technology
The company develops cancer immunotherapies by using their autologous dendritic cell (DC) based vaccines, that not only target the tumor cells but also the cancer stem cells, triggering a powerful immune response. The cancer stem cells (CSCs) are subsets of cancer cells, with functions similar to normal stem cells, and generate tumors. These cancer stem cells are only 5% of the tumor, but are resistant to chemotherapy and radiation. Thus even after treatment these cells self-renew and are responsible for the recurrence of cancer, despite the removal of tumor. The company's DC-based vaccines target not only the multiple antigens associated with cancer, but also these CSCs, thus making it a more effective treatment. These vaccines are developed using the patient's own blood cells, processed in the laboratory to produce a number of potent mature DCs. These DCs are then processed with tumor associated antigens and inoculated back in the patient, thus activating the T-cells that destroy relevant cancer cells.
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Ebbene con questo che conclusioni ne trai??Informazioni varie
ImmunoCellular (IMUC) is a development stage biotechnology company engaged in the development of dendritic cell based cancer vaccines. The company has recently announced a disappointing phase II result which has put the pipeline under question. ICT-107 is pretty similar to Northwest Biotherapeutics' (NWBO) DCVax-L as both target GBM and use patients own dendritic cell to generate immune response, and produce DC based vaccines. I have already covered Northwest multiple times which is why I wanted to give the followers of both stocks a comparative view of the their respective candidates.
The Business
ImmunoCellular Therapeutics Limited is a biotechnology company focused on developing immune-based cancer therapies, specifically for brain, ovarian and solid tumors. It has three candidates in it pipeline, with the most advanced one in phase II. The company targets not only the cancer antigens, but also the cancer stem cells responsible for tumor growth. These candidates are being developed using the company's dendritic cell (DC) based platform, which was licensed from University of Pennsylvania.
The company has acquired certain worldwide exclusive licenses including certain cellular based therapy technology from Cedars-Sinai Medical Center; technology for mesothelin specific cancer immunotherapies from The John Hopkins University; patent technology for DC based vaccines from University of Pennsylvania; and intellectual property for EphA2, a tyrosine kinase receptor, from the University of Pittsburgh. Additionally, the company also acquired monoclonal antibody technology from Molecular Discoveries LLC., which also includes certain monoclonal antibody candidates in pre-clinical stage potentially for small cell lung, ovarian, pancreatic, and multiple myeloma cancers.
The competitors of the company include Agenus Inc. (AGEN), Northwest Biotherapeutics , Dendreon Corp. (DNDN), and Stemline Therapeutics Inc. (STML), among others.
Technology
The company develops cancer immunotherapies by using their autologous dendritic cell (DC) based vaccines, that not only target the tumor cells but also the cancer stem cells, triggering a powerful immune response. The cancer stem cells (CSCs) are subsets of cancer cells, with functions similar to normal stem cells, and generate tumors. These cancer stem cells are only 5% of the tumor, but are resistant to chemotherapy and radiation. Thus even after treatment these cells self-renew and are responsible for the recurrence of cancer, despite the removal of tumor. The company's DC-based vaccines target not only the multiple antigens associated with cancer, but also these CSCs, thus making it a more effective treatment. These vaccines are developed using the patient's own blood cells, processed in the laboratory to produce a number of potent mature DCs. These DCs are then processed with tumor associated antigens and inoculated back in the patient, thus activating the T-cells that destroy relevant cancer cells.
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Another round of fire has begun in the dendritic cell vaccine war. The latest casualty has been ImmunoCellular Therapeutics (IMUC). After the market closed on December 11, ImmunoCellular, the cancer immunotherapy biotech, announced the results from a Phase II study of ICT-107. The company tried to sugarcoat the news in its press release attempting to highlight what little good news there was to report and burying the bad in the second paragraph, but in the end, the treatment did not show an increase in overall survival for the intent to treat population, which was the trial's primary endpoint.
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The responses and reactions have come in a flurry, and ImmunoCellular's dendritic cell vaccine counterpart, Northwest Biotherapeutics (NWBO), has once again been dragged in to the controversy. IMUC's failure is apparently bleeding into NWBO's stock price.
When the market opened on December 12, ImmunoCellular stock had plummeted to $1.07, losing over 60 percent of its value as a result of the missed endpoint. It now sits even lower, around $0.90. Within the same time frames, NWBO plummeted from just shy of $4 a share to a little over $3.30 and now sits at $3.35. Northwest released no data, yet suffered a similar fate. Investors believe the failure of ImmunoCellular's ICT-107 equates to a similar outcome for Northwest's DCVax-L.
The latest round of discussion centers around three authors. One is Josh Ginsburg at Seeking Alpha, who defends DCVax-L by accurately differentiating it from IMUC's ICT-107. Two is Adam Feuerstein at TheStreet, who lambasts Northwest as he has been doing for some time, calling its Phase I results misleading, just as IMUC's turned out to be. Three is Larry Smith, one of NWBO's staunch, thorough, and consistent defenders. While Smith does his usual good job at covering (almost) all the bases and taking Feuerstein's attacks in stride, I feel that Smith does not go after Feuerstein's accusations and attacks directly enough. Neither does Ginsburg. Feuerstein's reasoning with regard to DCVax-L's "misleading" Phase I results is strong, and needs to be dealt with head on. In this article I will try to sort out the thorniest of the issues involved here.
Ginsburg vs. Feuerstein, Who's Right Regarding What?
I will precursor this section with a statement not intended to offend, but simply to get us, as investors, to admit something. The vast majority of us are not scientists. Even those who are will likely be unable to claim they have a deep understanding of either the technology involved with the manufacture of dendritic cell vaccine or the science involved with the immune response to a brain tumor. We can only gather whatever information is out there and use it to the best of our ability, trying to check our bias at the door as much as possible.
That said, Ginsburg correctly points out that ICT-107 and DCVax-L are NOT the same, for two crucial reasons. First, ICT-107 uses 6 synthetic antigens in priming its dendritic cells. The synthetic antigen approach has been used many a time before in attempts to overcome a myriad of diseases. It rarely works. There are hundreds of different antigens on any given pathogen, and picking a small handful (6 in IMUC's case) of these is like shooting a giant with a BB gun loaded with 6 rounds, hoping somehow you'll hit a vital system and the giant will fall. Also, as Ginsburg points out, "There is absolutely no reason to be assured that products of a synthetic nature can be effectively identified and responded to by the immune system." In other words, the BB gun may not even fire in the first place.
Second, and as Ginsburg points out, the antigens picked up by dendritic cells in DCVax-L are from the patient's actual tumor. Nobody knows - not even the inventors of DCVax-L itself - exactly what or how many antigens are being picked up by these cells during the DCVax-L manufacturing process. It's all going on under a microscope and it's all a big mystery. It is unknowable. Asking how many or which antigens dendritic cells pick up in DCVax-L is like asking how many angels can dance on the head of a pin, or in this case, on the head of a brain tumor. However, if I may humbly and hypothetically put myself in the terrible and terrifying position of a GBM sufferer, being explained the differences between the DCVax-L and ICT-107 manufacturing processes, I would take my chances with DCVax-L. At least it loads the gun with a lot more bullets, bullets that match my own tumor indigenously.
So Ginsburg is correct on this issue, and Feuerstein is wrong when he bluntly states carte blanche,
Northwest's DCVax is not different from ImmunoCellular's ICT-107. DCVax will fail just like ICT-107 failed because dendritic cancer vaccines are too weak to overcome cancer's innate ability to overpower or evade the body's immune system," Feuerstein does have a very strong point when he talks about both Northwest's and ImmunoCellular's Phase I trials.
While DCVax may yet fail, he is wrong about why, because the two are different, and neither he nor anybody else can possibly know what's going on with the DCVax-L dendritic cells dancing on the head of a tumor and if they are "too weak" just because the whole dendritic cell approach is not to his liking.
As regards his attack against the dendritic cell vaccine approach in general, another company working on a dendritic cell vaccine, Agenus (AGEN), just recently announced the results of a Phase II study involving 41 patients for Prophage. Overall survival was 11 months. There was no control group so estimations of statistical relevance are problematic when comparing to standard of care, but median overall survival was 4 weeks longer than for Avastin, which is already approved, and Prophage has a much more benign side effect profile. Agenus' approach is almost identical to Northwest's, except that the former uses heat shock proteins to aid antigen recognition. While Feuerstein seems focused on IMUC's Phase II failure to bash dendritic cell vaccines, what about Agenus' recent developments with Prophage?
That aside, Feuerstein does have a very strong point when he talks about the anomalies with regard to the "spectacular results" surrounding IMUC's Phase I trial for ICT-107. How could it be that ICT-107 showed a median overall survival of 38.4 months in Phase I, but failed to even statistically outpace standard of care at all in Phase II with median overall survival? His answer is very damning for Northwest and DCVax-L. He says that in Phase I, patients are more easily handpicked for health and probability of long survival times, and he is right. On top of that, the 16 patients involved in ICT-107's "spectacular" Phase I trial may have even been handpicked for expressing the antigens attacked by the vaccine. From the press released linked above:
According to information presented at the scientific meetings, all eight long-term survivors had tumors with at least five antigens, 75 percent had tumors with all six, and 100 percent had tumors with at least four antigens associated with cancer stem cells - cancer-originating cells that appear to enable tumors to resist radiation and chemotherapy and even regenerate after treatment.
What does this mean for DCVax-L? It means that its Phase I data is also likely based on a handpicked sample of relatively healthier patients, and therefore data is also likely skewed by some margin.
The crucial question, however, is this: By how much is it skewed?
Another round of fire has begun in the dendritic cell vaccine war. The latest casualty has been ImmunoCellular Therapeutics (IMUC). After the market closed on December 11, ImmunoCellular, the cancer immunotherapy biotech, announced the results from a Phase II study of ICT-107. The company tried to sugarcoat the news in its press release attempting to highlight what little good news there was to report and burying the bad in the second paragraph, but in the end, the treatment did not show an increase in overall survival for the intent to treat population, which was the trial's primary endpoint.
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The responses and reactions have come in a flurry, and ImmunoCellular's dendritic cell vaccine counterpart, Northwest Biotherapeutics (NWBO), has once again been dragged in to the controversy. IMUC's failure is apparently bleeding into NWBO's stock price.
When the market opened on December 12, ImmunoCellular stock had plummeted to $1.07, losing over 60 percent of its value as a result of the missed endpoint. It now sits even lower, around $0.90. Within the same time frames, NWBO plummeted from just shy of $4 a share to a little over $3.30 and now sits at $3.35. Northwest released no data, yet suffered a similar fate. Investors believe the failure of ImmunoCellular's ICT-107 equates to a similar outcome for Northwest's DCVax-L.
The latest round of discussion centers around three authors. One is Josh Ginsburg at Seeking Alpha, who defends DCVax-L by accurately differentiating it from IMUC's ICT-107. Two is Adam Feuerstein at TheStreet, who lambasts Northwest as he has been doing for some time, calling its Phase I results misleading, just as IMUC's turned out to be. Three is Larry Smith, one of NWBO's staunch, thorough, and consistent defenders. While Smith does his usual good job at covering (almost) all the bases and taking Feuerstein's attacks in stride, I feel that Smith does not go after Feuerstein's accusations and attacks directly enough. Neither does Ginsburg. Feuerstein's reasoning with regard to DCVax-L's "misleading" Phase I results is strong, and needs to be dealt with head on. In this article I will try to sort out the thorniest of the issues involved here.
Ginsburg vs. Feuerstein, Who's Right Regarding What?
I will precursor this section with a statement not intended to offend, but simply to get us, as investors, to admit something. The vast majority of us are not scientists. Even those who are will likely be unable to claim they have a deep understanding of either the technology involved with the manufacture of dendritic cell vaccine or the science involved with the immune response to a brain tumor. We can only gather whatever information is out there and use it to the best of our ability, trying to check our bias at the door as much as possible.
That said, Ginsburg correctly points out that ICT-107 and DCVax-L are NOT the same, for two crucial reasons. First, ICT-107 uses 6 synthetic antigens in priming its dendritic cells. The synthetic antigen approach has been used many a time before in attempts to overcome a myriad of diseases. It rarely works. There are hundreds of different antigens on any given pathogen, and picking a small handful (6 in IMUC's case) of these is like shooting a giant with a BB gun loaded with 6 rounds, hoping somehow you'll hit a vital system and the giant will fall. Also, as Ginsburg points out, "There is absolutely no reason to be assured that products of a synthetic nature can be effectively identified and responded to by the immune system." In other words, the BB gun may not even fire in the first place.
Second, and as Ginsburg points out, the antigens picked up by dendritic cells in DCVax-L are from the patient's actual tumor. Nobody knows - not even the inventors of DCVax-L itself - exactly what or how many antigens are being picked up by these cells during the DCVax-L manufacturing process. It's all going on under a microscope and it's all a big mystery. It is unknowable. Asking how many or which antigens dendritic cells pick up in DCVax-L is like asking how many angels can dance on the head of a pin, or in this case, on the head of a brain tumor. However, if I may humbly and hypothetically put myself in the terrible and terrifying position of a GBM sufferer, being explained the differences between the DCVax-L and ICT-107 manufacturing processes, I would take my chances with DCVax-L. At least it loads the gun with a lot more bullets, bullets that match my own tumor indigenously.
So Ginsburg is correct on this issue, and Feuerstein is wrong when he bluntly states carte blanche,
Northwest's DCVax is not different from ImmunoCellular's ICT-107. DCVax will fail just like ICT-107 failed because dendritic cancer vaccines are too weak to overcome cancer's innate ability to overpower or evade the body's immune system," Feuerstein does have a very strong point when he talks about both Northwest's and ImmunoCellular's Phase I trials.
While DCVax may yet fail, he is wrong about why, because the two are different, and neither he nor anybody else can possibly know what's going on with the DCVax-L dendritic cells dancing on the head of a tumor and if they are "too weak" just because the whole dendritic cell approach is not to his liking.
As regards his attack against the dendritic cell vaccine approach in general, another company working on a dendritic cell vaccine, Agenus (AGEN), just recently announced the results of a Phase II study involving 41 patients for Prophage. Overall survival was 11 months. There was no control group so estimations of statistical relevance are problematic when comparing to standard of care, but median overall survival was 4 weeks longer than for Avastin, which is already approved, and Prophage has a much more benign side effect profile. Agenus' approach is almost identical to Northwest's, except that the former uses heat shock proteins to aid antigen recognition. While Feuerstein seems focused on IMUC's Phase II failure to bash dendritic cell vaccines, what about Agenus' recent developments with Prophage?
That aside, Feuerstein does have a very strong point when he talks about the anomalies with regard to the "spectacular results" surrounding IMUC's Phase I trial for ICT-107. How could it be that ICT-107 showed a median overall survival of 38.4 months in Phase I, but failed to even statistically outpace standard of care at all in Phase II with median overall survival? His answer is very damning for Northwest and DCVax-L. He says that in Phase I, patients are more easily handpicked for health and probability of long survival times, and he is right. On top of that, the 16 patients involved in ICT-107's "spectacular" Phase I trial may have even been handpicked for expressing the antigens attacked by the vaccine. From the press released linked above:
According to information presented at the scientific meetings, all eight long-term survivors had tumors with at least five antigens, 75 percent had tumors with all six, and 100 percent had tumors with at least four antigens associated with cancer stem cells - cancer-originating cells that appear to enable tumors to resist radiation and chemotherapy and even regenerate after treatment.
What does this mean for DCVax-L? It means that its Phase I data is also likely based on a handpicked sample of relatively healthier patients, and therefore data is also likely skewed by some margin.
The crucial question, however, is this: By how much is it skewed?
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traduzione automatica...
ImmunoCellular ( IMUC ) è una società di sviluppo palcoscenico biotecnologia impegnata nello sviluppo di cellulari basati vaccini contro il cancro dendritiche . La società ha recentemente annunciato un deludente risultato di fase II che ha messo il gasdotto in questione . ICT- 107 è molto simile a Northwest Biotherapeutics ' ( NWBO ) DCVax -L sia come GBM destinazione e utilizzare i pazienti possiedono cellule dendritiche per generare la risposta immunitaria , e produrre vaccini basati DC . Ho già coperto Nordovest più volte è per questo che ho voluto dare i seguaci di entrambi i titoli una visione comparativa dei rispettivi candidati .
il Business
ImmunoCellular Therapeutics Limited è un'azienda biotecnologica focalizzata sullo sviluppo di terapie antitumorali a base immunitaria , in particolare per il cervello , ovarico e tumori solidi . Ha tre candidati in esso conduttura , con la più avanzata in fase II . Gli obiettivi aziendali non solo gli antigeni tumorali, ma anche le cellule staminali tumorali responsabili della crescita tumorale . Questi candidati sono stati sviluppati utilizzando cellule della società dendritiche ( DC) a base di piattaforma , che è stato concesso in licenza dalla University of Pennsylvania .
La società ha acquistato alcune licenze in tutto il mondo esclusivi tra cui certa cellulare tecnologia basata la terapia da Cedars- Sinai Medical Center , la tecnologia per mesothelin specifiche immunoterapie del cancro da The John Hopkins University , la tecnologia di brevetto per vaccini basati DC della University of Pennsylvania , e di proprietà intellettuale per EphA2 , un recettore tirosina chinasi , presso l'Università di Pittsburgh . Inoltre, l'azienda ha acquisito anche la tecnologia anticorpo monoclonale da Molecular Scoperte LLC . , Che comprende anche alcuni candidati anticorpo monoclonale in fase pre-clinica potenzialmente per polmonare a piccole cellule , dell'ovaio , del pancreas e tumori multipli mieloma .
I concorrenti della società comprendono Agenus Inc. ( AGEN ) , Northwest Biotherapeutics , Dendreon Corp. ( DNDN ) , e Stemline Therapeutics Inc. ( STML ) , tra gli altri.
tecnologia
L' azienda sviluppa immunoterapie del cancro utilizzando il loro autologo cellule dendritiche ( DC ) basato vaccini , che non solo bersaglio le cellule tumorali, ma anche le cellule staminali del cancro , innescando una risposta immunitaria potente . Le cellule staminali tumorali ( CSC ) sono sottoinsiemi di cellule tumorali , con funzioni simili alle cellule staminali normali , e generare tumori. Queste cellule staminali del cancro sono solo il 5 % del tumore , ma sono resistenti alla chemioterapia e radioterapia . Così anche dopo il trattamento queste cellule auto- rinnovano e sono responsabili per la ricorrenza di cancro , nonostante la rimozione del tumore . Vaccini basati su DC della società target non solo gli antigeni multipli associati al cancro , ma anche questi CSC , rendendo così un trattamento più efficace . Questi vaccini sono sviluppate utilizzando cellule del sangue del paziente , trasformati in laboratorio per produrre un numero di cellule dendritiche mature potenti . Questi DC vengono poi elaborati con tumore antigeni associati e inoculate nel paziente , attivando così le cellule T che distruggono le cellule tumorali pertinenti .
Un altro giro di fuoco è iniziata nel dendritiche guerra vaccino cellulare . L' ultima vittima è stata ImmunoCellular Therapeutics ( IMUC ) . Dopo il mercato chiuso il 11 dicembre, ImmunoCellular , biotech immunoterapia del cancro , ha annunciato i risultati di uno studio di Fase II di ICT- 107 . La società ha cercato di sugarcoat la notizia in un comunicato stampa il tentativo di mettere in evidenza quel poco di buona notizia che c'era da segnalare e seppellire il male nel secondo paragrafo , ma alla fine , il trattamento non ha mostrato un aumento della sopravvivenza globale per l'intento di curare la popolazione , che era endpoint primario del trial .
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Le risposte e le reazioni sono venuti in un turbinio , e dendritica controparte vaccino cella di ImmunoCellular , Northwest Biotherapeutics ( NWBO ) , è stato nuovamente trascinato alla controversia . Fallimento di IMUC è apparentemente il sanguinamento in prezzo delle azioni NWBO .
Quando il mercato si è aperto il 12 dicembre , ImmunoCellular magazzino era crollata a 1,07 dollari , perdendo oltre il 60 per cento del suo valore a causa del mancato endpoint . E ora siede ancora più basso , circa $ 0,90. Entro gli stessi tempi , NWBO scesa da poco meno di 4 dollari una quota di poco più di 3,30 dollari e si trova ora a $ 3.35. Northwest rilasciato nessun dato , ma ha subito un destino simile . Gli investitori ritengono che il fallimento di di ImmunoCellular ICT- 107 equivale a un risultato simile per Northwest DCVax -L .
L'ultimo round di discussione ruota intorno tre autori . Uno è Josh Ginsburg Asca , che difende DCVax -L differenziando accuratamente da di IMUC ICT- 107 . Due è Adam Feuerstein a Trend Online , che lambasts Northwest come ha fatto per qualche tempo , chiamando il suo Fase I risultati fuorvianti , proprio come IMUC di si rivelò essere . Tre è Larry Smith , uno degli strenui difensori , approfondite e coerenti di NWBO . Mentre Smith fa il suo solito buon lavoro a coprire (quasi) tutte le basi e tenendo gli attacchi di Feuerstein a passo , sento che Smith non andare dopo le accuse e gli attacchi di Feuerstein abbastanza direttamente . Né fa Ginsburg . Il ragionamento di Feuerstein per quanto riguarda la fase di DCVax -L " fuorviante " I risultati è forte , e deve essere affrontato con la testa su . In questo articolo cercherò di risolvere la spinosa delle questioni in gioco qui .
Ginsburg vs Feuerstein , chi ha ragione riguardo a ciò ?
Io precursore questa sezione con una dichiarazione non destinati ad offendere , ma semplicemente per noi , in quanto gli investitori , di ammettere qualcosa . La stragrande maggioranza di noi non sono scienziati. Anche coloro che saranno probabilmente in grado di rivendicazione hanno una profonda comprensione sia la tecnologia con la fabbricazione di vaccino a cellule dendritiche o la scienza coinvolta con la risposta immunitaria di un tumore al cervello . Noi possiamo solo raccogliere qualsiasi informazione è là fuori e utilizziamo al meglio delle nostre possibilità, cercando di controllare il nostro pregiudizio alla porta , per quanto possibile .
Detto questo , Ginsburg sottolinea giustamente che ICT- 107 e DCVax -L NON sono la stessa , per due motivi fondamentali . In primo luogo , ICT- 107 utilizza 6 antigeni sintetici priming sue cellule dendritiche . L'approccio antigene sintetico è stato usato molte volte prima nel tentativo di superare una miriade di malattie . E raramente funziona . Ci sono centinaia di diversi antigeni in un dato agente patogeno , e raccogliendo una piccola manciata ( 6 nel caso di IMUC ) di questi è come sparare un gigante con una pistola BB caricato con 6 turni , sperando che in qualche modo ti ha colpito un sistema vitale e il gigante cadrà . Inoltre , come sottolinea Ginsburg , "Non c'è assolutamente alcuna ragione per essere certi che i prodotti di natura sintetica possono essere efficacemente individuati e risposta da parte del sistema immunitario . " In altre parole , la pistola BB può anche non sparare in primo luogo .
In secondo luogo, e come sottolinea Ginsburg , gli antigeni raccolti dalle cellule dendritiche in DCVax - L sono da tumore effettivo del paziente . Nessuno lo sa - nemmeno gli inventori del DCVax -L in sé - esattamente che cosa o quanti antigeni vengono raccolti da queste cellule durante il processo di fabbricazione DCVax -L . E 'tutto succede sotto un microscopio ed è tutto un grande mistero . E ' inconoscibile . Chiedere quanti o quali antigeni cellule dendritiche raccolgono in DCVax -L è come chiedere quanti angeli possono danzare sulla capocchia di uno spillo , o in questo caso , sulla testa di un tumore al cervello . Comunque , se posso umilmente e ipoteticamente mi mettere in posizione terribile e terrificante di un malato GBM , essendo spiegato le differenze tra la DCVax -L e ICT - 107 processi produttivi , vorrei prendere le mie possibilità con DCVax -L . Almeno carica la pistola con molti più proiettili , proiettili che hanno il mio tumore indigeno .
Così Ginsburg è corretto su questo tema , e Feuerstein sbaglia quando afferma senza mezzi termini carta bianca ,
DCVax del nord ovest non è diverso da quello di ImmunoCellular ICT- 107 . DCVax mancherà proprio come ICT- 107 non è riuscita perché vaccini contro il cancro dendritiche sono troppo deboli per superare la capacità innata di cancro a sopraffare o eludere il sistema immunitario del corpo ", Feuerstein ha un punto molto forte quando parla sia Northwest e studi di Fase di ImmunoCellular I .
Mentre DCVax può ancora fallire , è sbagliato perché, perché i due sono diversi , e né lui né nessun altro può assolutamente sapere che cosa sta succedendo con le cellule dendritiche DCVax -L ballare sulla testa di un tumore e se sono " troppo debole " proprio perché l'intero approccio cellule dendritiche non è di suo gradimento .
Per quanto riguarda il suo attacco contro l'approccio vaccino cellule dendritiche in generale , un'altra società lavorando su un vaccino cellule dendritiche , Agenus ( AGEN ) , proprio di recente ha annunciato i risultati di uno studio di Fase II coinvolto 41 pazienti per profago . La sopravvivenza globale è stata di 11 mesi. Non c'era nessun gruppo di controllo in modo da stime di rilevanza statistica sono problematici quando si confrontano a livello di cura , ma la sopravvivenza globale mediana è stata di 4 settimane in più rispetto a Avastin , che è già stato approvato , e profago ha un profilo di effetti collaterali molto più benigna . Approccio Agenus ' è quasi identico a nord-ovest di , tranne che gli ex utilizza il calore proteine da shock per aiutare riconoscimento dell'antigene . Mentre Feuerstein sembra incentrata sulla mancanza di IMUC Fase II per colpire vaccini a cellule dendritiche , che cosa circa i recenti sviluppi Agenus ' con profago ?
A parte questo, Feuerstein ha un punto molto forte quando parla delle anomalie per quanto riguarda i "risultati spettacolari " che circonda il processo a IMUC di Fase I per ICT- 107 . Come potrebbe essere che le ICT -107 ha mostrato una sopravvivenza globale mediana di 38,4 mesi nella prima fase , ma non è riuscito a superare anche statisticamente standard di cura a tutti in Fase II con la sopravvivenza globale mediana ? La sua risposta è molto schiacciante per il nord-ovest e DCVax -L . Dice che nella fase I , i pazienti sono più facilmente raccolti a mano per la salute e la probabilità dei tempi di sopravvivenza a lungo , e ha ragione . In cima a quello , i 16 pazienti coinvolti nello studio di Fase I "spettacolare" di ICT- 107 potrebbero essere anche state raccolte a mano per esprimere gli antigeni attaccati dal vaccino . Dal comunicato rilasciato linkato sopra :
Secondo le informazioni presentate durante le riunioni scientifiche , tutte le otto sopravvissuti a lungo termine avevano tumori con almeno cinque antigeni , il 75 per cento aveva tumori con tutti e sei , e il 100 per cento avevano tumori con almeno quattro antigeni associati con le cellule staminali del cancro - cancro originario cellule che sembrano consentire tumori di resistere alle radiazioni e chemioterapia e anche rigenerarsi dopo il trattamento .
Cosa significa questo per DCVax -L ? Ciò significa che la sua dati di Fase I è probabile basa anche su un campione raccolto a mano di pazienti relativamente sani , e quindi i dati è anche probabile distorta da un certo margine .
La questione cruciale , però , è questa: Di quanto è distorta ?
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Due articoli dello stesso sito (seekingalpha.com) ma in apparente contradizione, mettono in relazione IMUC con altre e in particolare NWBO sull'utilizzo dello stesso farmaco.. ma i diversi titoli non hanno lo stesso andamento... morale: mi pare che nessuno si spieghi un crollo di tale proporzione... quindi potrebbe essere, come dici tu, isterismo
Inoltre non e' evidente che ict-107 sia stato un fallimento... ancora ci stanno discutendo
Qualcosa non mi torna...
(IMO)
maumal
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Editors' Note: This article covers a stock trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.
Shares of Immunocellular Therapeutics (IMUC) have been among the top downside movers for several days in a row since the company reported results a week ago from its placebo-controlled, double-blind, randomized phase II trial of its dendritic cell-based vaccine, ICT-107 in newly diagnosed patients with glioblastoma multiforme (GBM) following resection and chemo-radiation. After a 63% gap-down to $1.00 at market-open the day after the announcement, shares have dropped every day, hitting a low of 65c in early morning trading yesterday, December 18th, before closing the day at 74c. At its current price, shares are now off more than 80% from the all-time high of $4 that they hit just days before the announcement after both Roth and Maxim provided positive coverage based on their expectation of a positive outcome to the phase II trial.
On the day after the announcement, on December 12th, Roth and MLV & Co. lowered their price target, with Roth lowering it from $9 to $2, and MLV & Co. lowering it from $6 to $1.25. IMUC shares, however, have fallen well below both of these price targets, by between 40% and 65%. At today's closing price, at a market-cap of just $44 mill., it is as if the company has been left for dead. It is our contention that market pessimism, while justified, has been over-done to the downside, and that the shares are setting up for a quick rebound to the $1 range, before consolidating there as the market awaits more development news and new data analysis that will be coming out next year.
Results from the phase II trial demonstrated that ICT-107 had a statistically significant increase in progression-free survival (PFS) in GBM patients, with the difference in the median PFS times between ICT-107 and placebo being two months in favor of ICT-107 in the intent-to-treat population of all 124 randomized patients, and with that rising to three months in favor of ICT-107 in the per-protocol population subset of 117 GBM patients. However, PFS is a secondary end-point, with the phase II trial failing to achieve the primary endpoint of a statistically significant difference in the overall survival (OS) in both the intent-to-treat and per-protocol populations. It is this disappointment that the market reacted to severely, punishing shares in five back-to-back down sessions, and down on the sixth trading day so far today.
Shares of Immunocellular Therapeutics (IMUC) have been among the top downside movers for several days in a row since the company reported results a week ago from its placebo-controlled, double-blind, randomized phase II trial of its dendritic cell-based vaccine, ICT-107 in newly diagnosed patients with glioblastoma multiforme (GBM) following resection and chemo-radiation. After a 63% gap-down to $1.00 at market-open the day after the announcement, shares have dropped every day, hitting a low of 65c in early morning trading yesterday, December 18th, before closing the day at 74c. At its current price, shares are now off more than 80% from the all-time high of $4 that they hit just days before the announcement after both Roth and Maxim provided positive coverage based on their expectation of a positive outcome to the phase II trial.
On the day after the announcement, on December 12th, Roth and MLV & Co. lowered their price target, with Roth lowering it from $9 to $2, and MLV & Co. lowering it from $6 to $1.25. IMUC shares, however, have fallen well below both of these price targets, by between 40% and 65%. At today's closing price, at a market-cap of just $44 mill., it is as if the company has been left for dead. It is our contention that market pessimism, while justified, has been over-done to the downside, and that the shares are setting up for a quick rebound to the $1 range, before consolidating there as the market awaits more development news and new data analysis that will be coming out next year.
Results from the phase II trial demonstrated that ICT-107 had a statistically significant increase in progression-free survival (PFS) in GBM patients, with the difference in the median PFS times between ICT-107 and placebo being two months in favor of ICT-107 in the intent-to-treat population of all 124 randomized patients, and with that rising to three months in favor of ICT-107 in the per-protocol population subset of 117 GBM patients. However, PFS is a secondary end-point, with the phase II trial failing to achieve the primary endpoint of a statistically significant difference in the overall survival (OS) in both the intent-to-treat and per-protocol populations. It is this disappointment that the market reacted to severely, punishing shares in five back-to-back down sessions, and down on the sixth trading day so far today.
maumal
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Nota dell'editore : Questo articolo riguarda una compravendita di azioni a meno di 1 dollaro per azione e / o con meno di 100 milioni di dollari di capitalizzazione di mercato . Si prega di essere consapevoli dei rischi associati a tali stock.Azioni di ImmunoCellular Therapeutics ( IMUC ) sono stati tra i peggiori al ribasso migliori per diversi giorni di fila da quando la società ha riportato risultati di una settimana fa dal suo , in doppio cieco , controllato con placebo , randomizzato di fase II del suo vaccino a base di cellule dendritiche , ICT- 107 in pazienti con nuova diagnosi di glioblastoma multiforme ( GBM ) dopo la resezione e chemio-radioterapia . Dopo un gap -down a $ 1.00 al mercato aperto il giorno dopo l'annuncio del 63% , le azioni sono scesi ogni giorno , toccato un minimo di 65c nei primi scambi di ieri mattina , 18 dicembre , prima di chiudere la giornata a 74c . Al suo prezzo attuale , le azioni sono ora fuori oltre l'80 % dal massimo storico di $ 4 che hanno colpito pochi giorni prima l'annuncio dopo che sia Roth e Maxim forniti di copertura positivo basato sulla loro aspettativa di un esito positivo alla sperimentazione di fase II .
Il giorno dopo l'annuncio , il 12 dicembre , Roth e MLV & Co. hanno abbassato il loro prezzo obiettivo , con Roth abbassandolo da $ 9 a $ 2 , e MLV & Co. abbassandola da $ 6 a $ 1,25. Azioni IMUC , tuttavia , sono scesi ben al di sotto entrambi questi obiettivi da perseguire , tra il 40 % e il 65 % . Al prezzo di chiusura di oggi, in un capitalizzazione di mercato di appena $ 44 mill . , È come se la società è stato lasciato per morto . È nostra opinione che il pessimismo di mercato, mentre giustificato , è stato over -fatto al ribasso , e che le azioni si insediano per una rapida ripresa della gamma $ 1, prima di consolidare lì come il mercato attende ulteriori notizie sviluppo e nuova analisi dei dati che uscirà il prossimo anno .
I risultati dello studio di fase II ha dimostrato che le ICT -107 ha avuto un aumento statisticamente significativo della sopravvivenza libera da progressione ( PFS) in pazienti con GBM , con la differenza di PFS mediana tra ICT -107 e placebo essendo due mesi a favore di ICT- 107 nella popolazione intent- to-treat di tutti i 124 pazienti randomizzati , e che l'aumento a tre mesi a favore delle ICT- 107 nella popolazione per-protocol sottogruppo di 117 pazienti con GBM . Tuttavia, PFS è un end- point secondario , con la sperimentazione di fase II non riuscire a raggiungere l'endpoint primario di una differenza statisticamente significativa nella sopravvivenza globale ( OS) in entrambe le popolazioni intent-to- treat e per -protocol . E ' questa delusione che il mercato ha reagito a grave , punendo le azioni in cinque back-to -back verso il basso le sessioni , e giù per il sesto giorno di negoziazione finora oggi .
eli64
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è da due giorni che la guardo oggi mi sono convinto a prenderne alcune...me lo sentivo che doveva salire """
maumal
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Quello che dicevo qui sopra...
ImmunoCellular Therapeutics Ltd (IMUC): Immunocellular Shares Are Set For A Rebound - Seeking Alpha
Other factors to consider include the following:
while the FDA requires OS as the most reliable endpoint for cancer drug approval, it has acknowledged and indeed approved drugs based on tumor assessment endpoints such as PFS, such as Genentech's Avastin in breast cancer;
the European Medicines Agency (EMEA) has long used PFS as an acceptable endpoint for the approval of first-line cancer drugs, so even if ICT-107 is not approved in the U.S., if OS data continues to be non-significant in future trials, it might still find success overseas;
the company is still analyzing the results of the trial, and there might be a subset that may have promising significance data;
per the company, this is the first time that a placebo-controlled immunotherapy trial in glioblastoma has demonstrated a statistically significant improvement in a clinically relevant measure, such as progression-free survival, which may have an influence on FDA decisions;
IMUC shares may have been over-sold to the downside due to year-end tax-loss selling, setting them up for a quick rebound near year-end and next year;
Also, just as we are writing this article, IMUC's President/CEO Andrew Gengos disclosed a 27,000 share purchase at an average price of $0.7171/share that were bought just earlier yesterday, on December 18th.
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Altri fattori da considerare sono i seguenti :
mentre la FDA richiede OS come endpoint più affidabile per l' approvazione dei farmaci cancro, ha riconosciuto e farmaci effettivamente approvati sulla base di endpoint di valutazione tumorale come PFS , come Avastin di Genentech nel cancro al **** ;
l'Agenzia europea per i medicinali ( EMEA) ha utilizzato a lungo PFS come endpoint accettabile per l'approvazione dei farmaci contro il cancro di prima linea , quindi, anche se ICT- 107 non è approvato negli Stati Uniti , se i dati del sistema operativo continua ad essere non significativo in studi futuri , potrebbe ancora trovare il successo oltreoceano ;
la società sta ancora analizzando i risultati della prova , e ci potrebbe essere un sottoinsieme che potrebbe essere promettenti dati rilevanza ;
per la società , questa è la prima volta che uno studio immunoterapia controllato con placebo in glioblastoma ha dimostrato un miglioramento statisticamente significativo in misura clinicamente rilevante , come ad esempio la sopravvivenza libera da progressione , che possono avere un'influenza sulle decisioni della FDA ;
Azioni IMUC possono essere stati over -sold al ribasso a causa di fine anno selling perdite fiscali , la loro istituzione per un rapido rimbalzo nei pressi di fine anno e il prossimo anno ;
Inoltre, proprio come stiamo scrivendo questo articolo , il presidente della IMUC / CEO Andrew Gengos rivelato un acquisto 27 mila parti ad un prezzo medio di $ 0.7171/share che sono stati acquistati solo prima di ieri , 18 dicembre .
ImmunoCellular Therapeutics Ltd (IMUC): Immunocellular Shares Are Set For A Rebound - Seeking Alpha
Other factors to consider include the following:
while the FDA requires OS as the most reliable endpoint for cancer drug approval, it has acknowledged and indeed approved drugs based on tumor assessment endpoints such as PFS, such as Genentech's Avastin in breast cancer;
the European Medicines Agency (EMEA) has long used PFS as an acceptable endpoint for the approval of first-line cancer drugs, so even if ICT-107 is not approved in the U.S., if OS data continues to be non-significant in future trials, it might still find success overseas;
the company is still analyzing the results of the trial, and there might be a subset that may have promising significance data;
per the company, this is the first time that a placebo-controlled immunotherapy trial in glioblastoma has demonstrated a statistically significant improvement in a clinically relevant measure, such as progression-free survival, which may have an influence on FDA decisions;
IMUC shares may have been over-sold to the downside due to year-end tax-loss selling, setting them up for a quick rebound near year-end and next year;
Also, just as we are writing this article, IMUC's President/CEO Andrew Gengos disclosed a 27,000 share purchase at an average price of $0.7171/share that were bought just earlier yesterday, on December 18th.
-------------------------------------------------------------------------------------
Altri fattori da considerare sono i seguenti :
mentre la FDA richiede OS come endpoint più affidabile per l' approvazione dei farmaci cancro, ha riconosciuto e farmaci effettivamente approvati sulla base di endpoint di valutazione tumorale come PFS , come Avastin di Genentech nel cancro al **** ;
l'Agenzia europea per i medicinali ( EMEA) ha utilizzato a lungo PFS come endpoint accettabile per l'approvazione dei farmaci contro il cancro di prima linea , quindi, anche se ICT- 107 non è approvato negli Stati Uniti , se i dati del sistema operativo continua ad essere non significativo in studi futuri , potrebbe ancora trovare il successo oltreoceano ;
la società sta ancora analizzando i risultati della prova , e ci potrebbe essere un sottoinsieme che potrebbe essere promettenti dati rilevanza ;
per la società , questa è la prima volta che uno studio immunoterapia controllato con placebo in glioblastoma ha dimostrato un miglioramento statisticamente significativo in misura clinicamente rilevante , come ad esempio la sopravvivenza libera da progressione , che possono avere un'influenza sulle decisioni della FDA ;
Azioni IMUC possono essere stati over -sold al ribasso a causa di fine anno selling perdite fiscali , la loro istituzione per un rapido rimbalzo nei pressi di fine anno e il prossimo anno ;
Inoltre, proprio come stiamo scrivendo questo articolo , il presidente della IMUC / CEO Andrew Gengos rivelato un acquisto 27 mila parti ad un prezzo medio di $ 0.7171/share che sono stati acquistati solo prima di ieri , 18 dicembre .
visal
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E siccome il titolo e' molto volatile ne vedremo delle belle
Ecco che si sta verificando la profezia
maumal
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E siccome il titolo e' molto volatile ne vedremo delle belle
Ecco che si sta verificando la profezia
