US biotek firma Genta (GETA) har et par produkter i forskellige faser af den kliniske udvikling inden for oncology. Selskabets foerende produkt er Genasense som er blevet undersoegt i mere end 2300 patienter mod forskellige tumor typer. Desvaerre hidtil uden success.
Inden Q4 2009 (formentlig inden for den naeste maaned...) skulle resultaterne komme af det seneste fase 3 forsoeg med Genasense, kaldet the AGENDA Trail.
AGENDA er det anden randomiseret fase 3-forsoeg inden for avanceret modermaerkekraeft (stort marked!!!) for Genasense. Det foerste fejlede paa grund af virkning (p=007, ikke store safety problemer). Men baseret paa det foerste forsoeg har man nu optimeret designet for AGENDA ved hjaelp af LDH biomarker.
Det er meget vanskeligt at sige, hvad sandsynligheden for success er. Men med et positivt resultat af AGENDA, saa er der vel 100-500% stigning. Saafremt forsoeget fejler, ja saa gaar den sikkert meget hurtigt mod 0. De par penge indtil Q1 2010, saa meget risky.
Jeg har koebt lidt fra kurs 0.8 til kurs 0.69 og haaber paa af julemanden kommer tidligt I aar....
Vh
Saadan
---
Links:
http://www.genta.com/clinical_development/agendatrial.php?v=6
http://www.wsw.com/webcast/rrshq15/register.aspx?conf=rrshq15&page=gnta&url=http%3A//www.wsw.com/webcast/rrshq15/gnta/
http://www.google.com/finance?q=OTC:GETA
Inden Q4 2009 (formentlig inden for den naeste maaned...) skulle resultaterne komme af det seneste fase 3 forsoeg med Genasense, kaldet the AGENDA Trail.
AGENDA er det anden randomiseret fase 3-forsoeg inden for avanceret modermaerkekraeft (stort marked!!!) for Genasense. Det foerste fejlede paa grund af virkning (p=007, ikke store safety problemer). Men baseret paa det foerste forsoeg har man nu optimeret designet for AGENDA ved hjaelp af LDH biomarker.
Det er meget vanskeligt at sige, hvad sandsynligheden for success er. Men med et positivt resultat af AGENDA, saa er der vel 100-500% stigning. Saafremt forsoeget fejler, ja saa gaar den sikkert meget hurtigt mod 0. De par penge indtil Q1 2010, saa meget risky.
Jeg har koebt lidt fra kurs 0.8 til kurs 0.69 og haaber paa af julemanden kommer tidligt I aar....
Vh
Saadan
---
Links:
http://www.genta.com/clinical_development/agendatrial.php?v=6
http://www.wsw.com/webcast/rrshq15/register.aspx?conf=rrshq15&page=gnta&url=http%3A//www.wsw.com/webcast/rrshq15/gnta/
http://www.google.com/finance?q=OTC:GETA
Hej Saadan,
Tak for dette indlæg. Onkologi er et kæmpe marked, så hvis de lykkedes skal der nok gå "DNDN" i den.
Held og lykke, og keep us posted please.
Tak for dette indlæg. Onkologi er et kæmpe marked, så hvis de lykkedes skal der nok gå "DNDN" i den.
Held og lykke, og keep us posted please.
29/10 2009 00:23 fillandkill 0
21061 Incorporated - Genta Incorporated Announces Conference Call to Review Top-Line Results of AGENDA Phase 3 Trial of Genasense® in Patients with Advanced Melanoma
28.10.09 | 22:23 Uhr
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Immer passend, immer günstig: privater Schutz mit DKV BestMed ab ? 158,41 mtl.!
Genta Incorporated (OTCBB: GETA) announced that the Company will host a conference call and live audio webcast to review top-line results of its Phase 3 trial of Genasense® in patients with advanced melanoma The call will take place on Thursday October 29, 2009 at 8:00 AM ET.Participants can access the live call by dialing (877) 634-8606 (U.S and Canada) or (973) 200-3973 (International) The access code for the live call is Genta Incorporated.
Genta Incorporated (OTCBB: GETA) announced that the Company will host a conference call and live audio webcast to review top-line results of its Phase 3 trial of Genasense® in patients with advanced melanoma. The call will take place on Thursday October 29, 2009 at 8:00 AM ET.
Participants can access the live call by dialing (877) 634-8606 (U.S. and Canada) or (973) 200-3973 (International). The access code for the live call is Genta Incorporated. The call will also be webcast live at http://www.genta.com/investorrelation/events.html.
For investors unable to participate in the live call, a replay will be available approximately two hours after the completion of the call, and will be archived for 30 days. Access numbers for this replay are: (800) 642-1687 (U.S. and Canada) and (706) 645-9291 (International); conference ID number is: 38149996.
About Genta
29/10 2009 16:05 Saadan 021093 Sörens ogsaa. Tror det er R.I.P. for Genta.
/Saadan
---
Genta Incorporated (OTCBB: GETA) today announced top-line results from
AGENDA, the Company's Phase 3 trial of Genasense(R) (oblimersen
sodium) Injection in patients with advanced melanoma. AGENDA is a
randomized, double-blind, placebo-controlled trial of dacarbazine
administered with or without Genasense(R) in patients who have not
previously received chemotherapy. As defined in a prior randomized
trial, AGENDA uses a biomarker to define patients who might maximally
benefit from treatment.
AGENDA did not show a statistically significant benefit for its co-
primary endpoint of progression-free survival. Secondary endpoints of
overall response rate and disease control rate (which includes
complete and partial responses, plus stable disease greater-than or
equal to 3 months duration) also did not show a statistically
significant benefit. According to the prespecified analysis plan, the
statistical significance of durable response -- a secondary endpoint
that measures the proportion of patients who achieved a complete or
partial response that lasts greater-than or equal to 6 months -- is
too early to evaluate. The observed differences in progression-free
survival, overall response, disease control and durable response all
numerically favored the group that received Genasense(R).
Overall survival -- the other co-primary endpoint in AGENDA -- is too
early to evaluate, as prospectively specified. An analysis for
futility, which was defined as greater-than or equal to 50%
conditional power to observe a statistically significant benefit of
Genasense under the prospectively assumed hazard ratio of 0.69, has
been conducted for the co-primary endpoint of overall survival. AGENDA
has passed this futility analysis. The prospectively specified
analyses for both overall survival and durable response will be
conducted when the data are mature. The safety profile of Genasense in
AGENDA was consistent with prior studies.
Quantitative details of the today's announced results will be
presented at the international conference, "Molecular Targets and
Cancer Therapeutics", that will be held November 15-19, 2009 in
Boston, MA. The AGENDA results will be featured in an oral session on
Monday November 15, 2009 at 5:00 PM ET. The "Targets Meeting" is
jointly sponsored by the American Association for Cancer Research
(AACR), the U.S. National Cancer Institute (NCI), and the European
Organization for Research and Treatment of Cancer (EORTC)
"At this time, we cannot predict whether more mature data will reveal
a benefit in either overall survival or durable response," said Dr.
Raymond P. Warrell., Jr., Genta's Chief Executive Officer. "However,
the immediate failure to confirm a significant improvement in
progression-free survival will preclude our submission of a regulatory
application this year. Management and the Board are currently
assessing the impact of these data on the Company's strategic
direction. The Company plans to provide further updates in the near
future. Genta is very grateful for the tireless dedication of our
employees and for the contributions of the many physicians, patients,
and families who have worked to advance Genasense for the treatment of
melanoma."
Conference Call
Genta management will host a conference call and live audio webcast to
discuss results of the AGENDA trial on Thursday October 29, 2009 at
8:00 AM ET.
Participants can access the live call by dialing (877) 634-8606 (U.S.
and Canada) or (973) 200-3973 (International). The access code for the
live call is Genta Incorporated. The call will also be webcast live at
http://www.genta.com/investorrelation/events.html
For investors unable to participate in the live call, a replay will be
available approximately two hours after the completion of the call,
and will be archived for 30 days. Access numbers for this replay are:
(800) 642-1687 (U.S. and Canada) and (706) 645-9291 (International);
conference ID number is: 38149996.
/Saadan
---
Genta Incorporated (OTCBB: GETA) today announced top-line results from
AGENDA, the Company's Phase 3 trial of Genasense(R) (oblimersen
sodium) Injection in patients with advanced melanoma. AGENDA is a
randomized, double-blind, placebo-controlled trial of dacarbazine
administered with or without Genasense(R) in patients who have not
previously received chemotherapy. As defined in a prior randomized
trial, AGENDA uses a biomarker to define patients who might maximally
benefit from treatment.
AGENDA did not show a statistically significant benefit for its co-
primary endpoint of progression-free survival. Secondary endpoints of
overall response rate and disease control rate (which includes
complete and partial responses, plus stable disease greater-than or
equal to 3 months duration) also did not show a statistically
significant benefit. According to the prespecified analysis plan, the
statistical significance of durable response -- a secondary endpoint
that measures the proportion of patients who achieved a complete or
partial response that lasts greater-than or equal to 6 months -- is
too early to evaluate. The observed differences in progression-free
survival, overall response, disease control and durable response all
numerically favored the group that received Genasense(R).
Overall survival -- the other co-primary endpoint in AGENDA -- is too
early to evaluate, as prospectively specified. An analysis for
futility, which was defined as greater-than or equal to 50%
conditional power to observe a statistically significant benefit of
Genasense under the prospectively assumed hazard ratio of 0.69, has
been conducted for the co-primary endpoint of overall survival. AGENDA
has passed this futility analysis. The prospectively specified
analyses for both overall survival and durable response will be
conducted when the data are mature. The safety profile of Genasense in
AGENDA was consistent with prior studies.
Quantitative details of the today's announced results will be
presented at the international conference, "Molecular Targets and
Cancer Therapeutics", that will be held November 15-19, 2009 in
Boston, MA. The AGENDA results will be featured in an oral session on
Monday November 15, 2009 at 5:00 PM ET. The "Targets Meeting" is
jointly sponsored by the American Association for Cancer Research
(AACR), the U.S. National Cancer Institute (NCI), and the European
Organization for Research and Treatment of Cancer (EORTC)
"At this time, we cannot predict whether more mature data will reveal
a benefit in either overall survival or durable response," said Dr.
Raymond P. Warrell., Jr., Genta's Chief Executive Officer. "However,
the immediate failure to confirm a significant improvement in
progression-free survival will preclude our submission of a regulatory
application this year. Management and the Board are currently
assessing the impact of these data on the Company's strategic
direction. The Company plans to provide further updates in the near
future. Genta is very grateful for the tireless dedication of our
employees and for the contributions of the many physicians, patients,
and families who have worked to advance Genasense for the treatment of
melanoma."
Conference Call
Genta management will host a conference call and live audio webcast to
discuss results of the AGENDA trial on Thursday October 29, 2009 at
8:00 AM ET.
Participants can access the live call by dialing (877) 634-8606 (U.S.
and Canada) or (973) 200-3973 (International). The access code for the
live call is Genta Incorporated. The call will also be webcast live at
http://www.genta.com/investorrelation/events.html
For investors unable to participate in the live call, a replay will be
available approximately two hours after the completion of the call,
and will be archived for 30 days. Access numbers for this replay are:
(800) 642-1687 (U.S. and Canada) and (706) 645-9291 (International);
conference ID number is: 38149996.
Jeg er med på en lille portion, købt i 0.4 for et halvt års tid siden... Valgte dog at sælge det halve fra da den kom op i 1.1 , men har netop købt godt ind igen. Min begrundelse for dette frasalg er ganske enkelt firmaets MarketCap som pt. er omkring de 100mill. dollars. Dem der håber på en 10, 20 eller 50 dobling glemmer dette faktum.
Min plan er også ganske simpel at sælge alt selvsamme dag en evt. godkendelse kommer... Altså ren lotto, og også med det i baghovedet at Genta vel er et af de biotek selskaber der har skuffet mest :(
Min plan er også ganske simpel at sælge alt selvsamme dag en evt. godkendelse kommer... Altså ren lotto, og også med det i baghovedet at Genta vel er et af de biotek selskaber der har skuffet mest :(
