AI
Wednesday, February 25, 2009 4:18:01 PM
Nice GNTA reversal...
The CEO of Genta has clearly stated on several occasions that Genasense in Melanoma continues to be their #1 priority, the AGENDA Clinical Trial.
In 2007, the EMEA (European Medicines Agency ) asked Genta for an additional clinical study on the effectiveness of Genasense in Melanoma in order for approval.
"In its review, the EMEA rapporteurs indicated that positive
findings observed in the Phase 3 trial of Genasense should be confirmed in
an additional study."
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/07-19-2007/0004629263&EDATE=
In the same link above it goes on to say:
"Genta has previously announced its intent to conduct this study, known as AGENDA, which is expected to initiate in the near future."
So Genta says, "That's fine...not only are we going to give you an additional clinical study, we're going to give you a world-wide (self explanatory), double-blind (the patient doesn't know what they're receiving and the administor of the drug doesn't know what they're giving), placebo-controlled(I'm assuming you know what a placebo is), completely randomized, parallel-group (A trial that compares two groups of people, one of which receives the intervention of interest and one of which is a control group)study...and not only that, we're going to let an outside group do our analytical data to remove any kind of bias with respect to how the results are calculated. Sound like a plan? Good."
As we all know, it's now 2009. The Agenda trial is well underway and is expecting to complete enrollment by the end of March, 2009. The company released preliminary data from the Agenda trial in January, 2009.
Here are the interim results from the study released in January, 2009.
That is a 188.88% increase in overall response compared to chemotherapy alone (DTIC). If you think that's not significant action, then there is something wrong with you. 188.88% increase in overall response, people. EMEA asked for confirmatory evidence, with a second trial, and this is MORE than confirmatory. It's the FDA's Golden Standard with respect to how clinical trials are conducted. Completely unbiased and now Genasense has been administered to well over 2,000 patients showing similar results.
I'd say this gives everyone something to be excited about, if they are a Genta shareholder. As spoken by the CEO of Genta, the Agenda trial is producing "overwhelming" results and will easily confirm the prior results submitted to the EMEA.
Not only this, but Genta has a pending FDA appeal and should hear on it within the next 30 days. Data the FDA was requesting on the long term survival was submitted in the appeal after Genta leadership met with the FDA on their requirements...the data is positive.
Genta has met all of the requests from the FDA in order to receive approval of Genasense for the treatment of CLL, as specified by the FDA.
Please read slides 18 and 19 from the following link to get yourself up to speed on why the appeal was submitted by Genta leadership:
http://webcastingplayer.corporate-ir.net/player/LrgPlayer.aspx?EventId=2079510&StreamId=1260249&TIK={8CEC9688-9089-484E-ABC1-DBB417AFD647}&RGS=1&override=lrg
The CEO of Genta has clearly stated on several occasions that Genasense in Melanoma continues to be their #1 priority, the AGENDA Clinical Trial.
In 2007, the EMEA (European Medicines Agency ) asked Genta for an additional clinical study on the effectiveness of Genasense in Melanoma in order for approval.
"In its review, the EMEA rapporteurs indicated that positive
findings observed in the Phase 3 trial of Genasense should be confirmed in
an additional study."
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/07-19-2007/0004629263&EDATE=
In the same link above it goes on to say:
"Genta has previously announced its intent to conduct this study, known as AGENDA, which is expected to initiate in the near future."
So Genta says, "That's fine...not only are we going to give you an additional clinical study, we're going to give you a world-wide (self explanatory), double-blind (the patient doesn't know what they're receiving and the administor of the drug doesn't know what they're giving), placebo-controlled(I'm assuming you know what a placebo is), completely randomized, parallel-group (A trial that compares two groups of people, one of which receives the intervention of interest and one of which is a control group)study...and not only that, we're going to let an outside group do our analytical data to remove any kind of bias with respect to how the results are calculated. Sound like a plan? Good."
As we all know, it's now 2009. The Agenda trial is well underway and is expecting to complete enrollment by the end of March, 2009. The company released preliminary data from the Agenda trial in January, 2009.
Here are the interim results from the study released in January, 2009.
That is a 188.88% increase in overall response compared to chemotherapy alone (DTIC). If you think that's not significant action, then there is something wrong with you. 188.88% increase in overall response, people. EMEA asked for confirmatory evidence, with a second trial, and this is MORE than confirmatory. It's the FDA's Golden Standard with respect to how clinical trials are conducted. Completely unbiased and now Genasense has been administered to well over 2,000 patients showing similar results.
I'd say this gives everyone something to be excited about, if they are a Genta shareholder. As spoken by the CEO of Genta, the Agenda trial is producing "overwhelming" results and will easily confirm the prior results submitted to the EMEA.
Not only this, but Genta has a pending FDA appeal and should hear on it within the next 30 days. Data the FDA was requesting on the long term survival was submitted in the appeal after Genta leadership met with the FDA on their requirements...the data is positive.
Genta has met all of the requests from the FDA in order to receive approval of Genasense for the treatment of CLL, as specified by the FDA.
Please read slides 18 and 19 from the following link to get yourself up to speed on why the appeal was submitted by Genta leadership:
http://webcastingplayer.corporate-ir.net/player/LrgPlayer.aspx?EventId=2079510&StreamId=1260249&TIK={8CEC9688-9089-484E-ABC1-DBB417AFD647}&RGS=1&override=lrg
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