Sellas Life Sciences Group (ehemals Galena Biopharma) (Seite 146)
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ISIN: US81642T2096 · WKN: A2PU3T · Symbol: SLS
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Antwort auf Beitrag Nr.: 50.629.247 von Growth2012 am 15.09.15 14:49:12Wenn die Insider jetzt auch noch kaufen würden, dann wäre uns allen gewiss, dass hier was großes im Busch ist 
Ich bin letzte Woche schon mal vorsorglich eingestiegen
Das FDA Meeting würde ich aber nicht gerade als Kurstreiber bezeichnen. Das findet ja erst zum Ende des Jahres statt.
Ich denke, wir sollten eher unser Augenmerk auf Gale-301 und die ESMO werfen.
Ich bin letzte Woche schon mal vorsorglich eingestiegen
Das FDA Meeting würde ich aber nicht gerade als Kurstreiber bezeichnen. Das findet ja erst zum Ende des Jahres statt.
Ich denke, wir sollten eher unser Augenmerk auf Gale-301 und die ESMO werfen.
Bin zurzeit sehr überzeugt vom Gale's Behmühungen Richtung Zulassung mit NeuVax, hier zwei postings stateside die diese Überzeügung "leicht unterstützten"...
Dr. Schwartz Dropped a BOMB on the Shorts - FDA Meeting for FBP
He also stated that 50% of Ovo/Endo patients suffer a recurrence in the FIRST 12 MONTHS -- This is very short time line - This Trial data is NOT BLIND - He sees the results and says he is "excited, very excited", add that up along with a significant unmet need + a Meeting with the FDA -- Do the math. GALE PPS Is on the way UP. Less
LOL James. The response of the share price to your post reminds me of the saying you can lead a cow to the water but you cannot make her drink. I have been jumping in and out of GALE for a few times in the past but I always keep 1 share in my portfolio to help me monitor it. When the G 301 result came out I could not believe what I saw. Even more amazing was the share price at that time. I jumped back in with both feet and hands. I have been buying non stop, even today. You cannot ask for more of an opportunity. A 1/15 vg vs 11/22 cg with a p=.035 in 9.8 months and a share price of 1.5. Are you kidding ? You don't need to be a medical scientist to understand it.
The only thing even more amazing is some people go short on GALE. Must be the lead in their drinking water. Less
http://finance.yahoo.com/mbview/threadview/?&bn=12a6b315-348…
The question for me is Partnership, or go it alone
Schwartz wäre nie so euphorisch wenn er keine vertiefte kenntnisse hätte (The Dream Team "Übertreibung days "lassen wieder Grüßen
This Trial data is NOT BLIND - He sees the results and says he is "excited, very excited", add that up along with a significant unmet need + a Meeting with the FDA
Dr. Schwartz Dropped a BOMB on the Shorts - FDA Meeting for FBP
He also stated that 50% of Ovo/Endo patients suffer a recurrence in the FIRST 12 MONTHS -- This is very short time line - This Trial data is NOT BLIND - He sees the results and says he is "excited, very excited", add that up along with a significant unmet need + a Meeting with the FDA -- Do the math. GALE PPS Is on the way UP. Less
LOL James. The response of the share price to your post reminds me of the saying you can lead a cow to the water but you cannot make her drink. I have been jumping in and out of GALE for a few times in the past but I always keep 1 share in my portfolio to help me monitor it. When the G 301 result came out I could not believe what I saw. Even more amazing was the share price at that time. I jumped back in with both feet and hands. I have been buying non stop, even today. You cannot ask for more of an opportunity. A 1/15 vg vs 11/22 cg with a p=.035 in 9.8 months and a share price of 1.5. Are you kidding ? You don't need to be a medical scientist to understand it.
The only thing even more amazing is some people go short on GALE. Must be the lead in their drinking water. Less
http://finance.yahoo.com/mbview/threadview/?&bn=12a6b315-348…
The question for me is Partnership, or go it alone
Schwartz wäre nie so euphorisch wenn er keine vertiefte kenntnisse hätte (The Dream Team "Übertreibung days "lassen wieder Grüßen
This Trial data is NOT BLIND - He sees the results and says he is "excited, very excited", add that up along with a significant unmet need + a Meeting with the FDA
The 2 year DFS estimate is 24.8% (CG) v 91.7% (1000 mcg pts) (p=0.02). OUTSTANDING RESULTS!!
Preliminary results of the phase I/IIa dose finding trial of a folate binding protein vaccine (E39+GM-CSF) in ovarian and endometrial cancer patients to prevent recurrence
Session title: Gynaecological Cancer
Session type: Poster Session
Track: Gynaecological Cancer
Abstract number: 2764
Abstract title:
Preliminary results of the phase I/IIa dose finding trial of a folate binding protein vaccine (E39+GM-CSF) in ovarian and endometrial cancer patients to prevent recurrence
J.M. Greene(1), E.J. Schneble(1), J.S. Berry(1), A.F. Trappey(1), G.T. Clifton(2), K. Darcy(3), J.C. Elkas(4), C.A. Hamilton(5), G.L. Maxwell(6), G.E. Peoples(7)
(1)San Antonio Military Medical Center, General Surgery, San Antonio, TX, USA
(2)MD Anderson Cancer Center, Surgical Oncology, Houston, TX, USA
(3)Department of Defense Gynecologic Cancer Center of Excellence Women's Health Integrated Research Center at Inova Health System/Inova Fairfax Hospital, Gynecologic Oncology, Annandale, VA, USA
(4)Mid-Atlantic Gynecologic Oncology and Pelvic Surgical Associates, Gynecologic Oncology, Annandale, VA, USA
(5)Department of Defense Gynecologic Cancer Center of Excellence Women's Health Integrated Research Center at Inova Health System/Inova Fairfax Hospital, Gynecologic Oncology, Bethesda, MD, USA
(6)Department of Defense Gynecologic Cancer Center of Excellence Women's Health Integrated Research Center at Inova Health System/Inova Fairfax Hospital, Gynecologic Oncology, Falls Church, VA, USA
(7)Cancer Vaccine Development Program/Cancer Insight/Galena Consultant, Surgical Oncology, Bethesda, MD/San Antonio, TX, USA
Background: Folate Binding Protein (FBP) (aka Folate Receptor-a) is an immunogenic protein over-expressed in endometrial (EC) and ovarian cancer (OC). We are conducting a phase I/IIa trial with E39, an HLA-A2-restricted, FBP-derived peptide + GM-CSF vaccine. E39 is given adjuvantly to prevent clinical recurrences (CR) in disease-free high-risk, EC and OC patients (pts) after standard-of-care therapy (SOC). Here, we summarize toxicity, in vivo immunologic responses, and disease-free survival (DFS) in this dose-finding trial.
Materials and Methods: This trial began as a 3×3, dose-escalation (100, 500, 1000 mcg of E39), safety phase I trial and transitioned to a phase IIa comparing expanded dose cohorts. Disease-free EC and OC pts were enrolled after SOC. HLA-A2+ pts were vaccinated (VG), and HLA-A2- pts followed prospectively as a control group (CG). 6 monthly intradermal inoculations of E39 + 250 mcg GM-CSF are administered followed by 2 boosters every 6 months. Demographic, safety, immunologic, and CR data are being collected. In vivo immunologic response is measured by the orthogonal mean of a delayed type hypersensitivity reaction (DTH) to the E39 peptide without GM-CSF placed remote from the primary vaccination site. DFS is compared by Kaplan-Meir and logrank tests. Continuous variables are compared with analysis of variance and proportions with Fisher's exact test.
Results: 51 pts were enrolled; 29 in the VG (15 pts 1000mcg v 14 pts <1000mcg) and 22 in the CG. There are no differences in age, grade, stage, or histology between groups (all p=0.1). E39 is well-tolerated and safe with no >grade 3 toxicities and no differences in toxicities based on dose. DTH increased pre- to post-vaccination (5.9mm+1.5 v 11.7mm+3.2, p=0.08). DTH increase was larger in 1000 mcg pts (3.8mm v 17.8mm, p=0.06) v <1000 mcg pts (8mm v 11mm, p=0.56). With 9.3 months median follow-up, CR rate is 38% (VG) v 50% (CG), p=0.41. Among 1000 mcg pts, there is only one CR (6.7% v 50% CG, p=0.01). The 2 year DFS estimate is 24.8% (CG) v 91.7% (1000 mcg pts) (p=0.02).
Conclusions: This phase I/IIa trial reveals that E39 + GM-CSF is well-tolerated and elicits a strong and dose-dependent in vivo immune response. Early efficacy results are promising in the 1000 mcg dose cohort. This dose-finding study proves the safety and establishes the dose of E39 for a prospective, randomized, GM-CSF controlled, late stage trial in HLA-A2+ EC and OC patients to prevent recurrence.
Trial Number: NCT01580696
Conflict of interest: Other Substantive Relationships: George Peoples is a consultant to and stockholder of Galena. He holds partial patent rights and royalties to E39.
http://investorshub.advfn.com/boards/read_msg.aspx?message_i…
Preliminary results of the phase I/IIa dose finding trial of a folate binding protein vaccine (E39+GM-CSF) in ovarian and endometrial cancer patients to prevent recurrence
Session title: Gynaecological Cancer
Session type: Poster Session
Track: Gynaecological Cancer
Abstract number: 2764
Abstract title:
Preliminary results of the phase I/IIa dose finding trial of a folate binding protein vaccine (E39+GM-CSF) in ovarian and endometrial cancer patients to prevent recurrence
J.M. Greene(1), E.J. Schneble(1), J.S. Berry(1), A.F. Trappey(1), G.T. Clifton(2), K. Darcy(3), J.C. Elkas(4), C.A. Hamilton(5), G.L. Maxwell(6), G.E. Peoples(7)
(1)San Antonio Military Medical Center, General Surgery, San Antonio, TX, USA
(2)MD Anderson Cancer Center, Surgical Oncology, Houston, TX, USA
(3)Department of Defense Gynecologic Cancer Center of Excellence Women's Health Integrated Research Center at Inova Health System/Inova Fairfax Hospital, Gynecologic Oncology, Annandale, VA, USA
(4)Mid-Atlantic Gynecologic Oncology and Pelvic Surgical Associates, Gynecologic Oncology, Annandale, VA, USA
(5)Department of Defense Gynecologic Cancer Center of Excellence Women's Health Integrated Research Center at Inova Health System/Inova Fairfax Hospital, Gynecologic Oncology, Bethesda, MD, USA
(6)Department of Defense Gynecologic Cancer Center of Excellence Women's Health Integrated Research Center at Inova Health System/Inova Fairfax Hospital, Gynecologic Oncology, Falls Church, VA, USA
(7)Cancer Vaccine Development Program/Cancer Insight/Galena Consultant, Surgical Oncology, Bethesda, MD/San Antonio, TX, USA
Background: Folate Binding Protein (FBP) (aka Folate Receptor-a) is an immunogenic protein over-expressed in endometrial (EC) and ovarian cancer (OC). We are conducting a phase I/IIa trial with E39, an HLA-A2-restricted, FBP-derived peptide + GM-CSF vaccine. E39 is given adjuvantly to prevent clinical recurrences (CR) in disease-free high-risk, EC and OC patients (pts) after standard-of-care therapy (SOC). Here, we summarize toxicity, in vivo immunologic responses, and disease-free survival (DFS) in this dose-finding trial.
Materials and Methods: This trial began as a 3×3, dose-escalation (100, 500, 1000 mcg of E39), safety phase I trial and transitioned to a phase IIa comparing expanded dose cohorts. Disease-free EC and OC pts were enrolled after SOC. HLA-A2+ pts were vaccinated (VG), and HLA-A2- pts followed prospectively as a control group (CG). 6 monthly intradermal inoculations of E39 + 250 mcg GM-CSF are administered followed by 2 boosters every 6 months. Demographic, safety, immunologic, and CR data are being collected. In vivo immunologic response is measured by the orthogonal mean of a delayed type hypersensitivity reaction (DTH) to the E39 peptide without GM-CSF placed remote from the primary vaccination site. DFS is compared by Kaplan-Meir and logrank tests. Continuous variables are compared with analysis of variance and proportions with Fisher's exact test.
Results: 51 pts were enrolled; 29 in the VG (15 pts 1000mcg v 14 pts <1000mcg) and 22 in the CG. There are no differences in age, grade, stage, or histology between groups (all p=0.1). E39 is well-tolerated and safe with no >grade 3 toxicities and no differences in toxicities based on dose. DTH increased pre- to post-vaccination (5.9mm+1.5 v 11.7mm+3.2, p=0.08). DTH increase was larger in 1000 mcg pts (3.8mm v 17.8mm, p=0.06) v <1000 mcg pts (8mm v 11mm, p=0.56). With 9.3 months median follow-up, CR rate is 38% (VG) v 50% (CG), p=0.41. Among 1000 mcg pts, there is only one CR (6.7% v 50% CG, p=0.01). The 2 year DFS estimate is 24.8% (CG) v 91.7% (1000 mcg pts) (p=0.02).
Conclusions: This phase I/IIa trial reveals that E39 + GM-CSF is well-tolerated and elicits a strong and dose-dependent in vivo immune response. Early efficacy results are promising in the 1000 mcg dose cohort. This dose-finding study proves the safety and establishes the dose of E39 for a prospective, randomized, GM-CSF controlled, late stage trial in HLA-A2+ EC and OC patients to prevent recurrence.
Trial Number: NCT01580696
Conflict of interest: Other Substantive Relationships: George Peoples is a consultant to and stockholder of Galena. He holds partial patent rights and royalties to E39.
http://investorshub.advfn.com/boards/read_msg.aspx?message_i…
Hoffe sehr das GALE ein wesentliche Beitrag hiebei leisten wird....
http://www.breastcancerdeadline2020.org/about-the-deadline/
http://www.breastcancerdeadline2020.org/about-the-deadline/
Trading Spotlight
Quickly closing in an E75's Endspurt....
...und 'falls' dieses vom Erfolg gekrönt wird, folgen die weiteren "Indikationen" im verlinkte Testbereiche (siehe Chart) fast vom selbst.
Bin ja gespannt wie der Markt-mit etwas vertiefte schutzenhilfe durch Beth Mittendorff- dann wohl reagieren mag?!?
...und 'falls' dieses vom Erfolg gekrönt wird, folgen die weiteren "Indikationen" im verlinkte Testbereiche (siehe Chart) fast vom selbst.
Bin ja gespannt wie der Markt-mit etwas vertiefte schutzenhilfe durch Beth Mittendorff- dann wohl reagieren mag?!?
From Rocketjock & Cyntiques100 over at Yahoo, Lesenswert -(der dortige thread Any updates on this morning's presentation ?- meiner Meinung nach ....
Well, my model estimates the 70th event would occur on September 11th (This Friday) if Neuvax recurrence reduction is 30% from the CA (CA @22.2% recurrence). I have pondered how long it might take from time of the 70th event to notification of shareholders and haven't found anything concrete on which to base an estimate. We know that it took two months for the company to let us know that the Cardiac Toxicity monitoring had been reduced by the IDMC. Being that the 70th event is a much more material event than cardiac toxicity, my hope is the information will be disseminated with days of it becoming known. Maybe, 7 days for attending physician to verify cancer recurrence plus 1 day for data transmittal to IDMC plus 5 days for data compilation/assessment and report issuance plus 2 days for Galena to approve and make a news release for a total of 15 days from model recurrence date.
Yes, I thought Schwartz did an excellent job, considering he only had less than 25 minutes. He covered a lot of ground. Visual presentation was comprehensive, yet concise and focused to hit on critical investor interests. IMO, the key take out from this presentation was his verbal confirmation that there "will be" additional data from GALE-301 P1/2a trial presented at ESMO later this month.
http://finance.yahoo.com/mbview/threadview/;_ylt=Ai2JW6q3hgX…
...eins ist jedenfalls klar, wir sind erheblich näher dran als je zuvor in GALE's historie- this is (shoulld be) our season!
Well, my model estimates the 70th event would occur on September 11th (This Friday) if Neuvax recurrence reduction is 30% from the CA (CA @22.2% recurrence). I have pondered how long it might take from time of the 70th event to notification of shareholders and haven't found anything concrete on which to base an estimate. We know that it took two months for the company to let us know that the Cardiac Toxicity monitoring had been reduced by the IDMC. Being that the 70th event is a much more material event than cardiac toxicity, my hope is the information will be disseminated with days of it becoming known. Maybe, 7 days for attending physician to verify cancer recurrence plus 1 day for data transmittal to IDMC plus 5 days for data compilation/assessment and report issuance plus 2 days for Galena to approve and make a news release for a total of 15 days from model recurrence date.
Yes, I thought Schwartz did an excellent job, considering he only had less than 25 minutes. He covered a lot of ground. Visual presentation was comprehensive, yet concise and focused to hit on critical investor interests. IMO, the key take out from this presentation was his verbal confirmation that there "will be" additional data from GALE-301 P1/2a trial presented at ESMO later this month.
http://finance.yahoo.com/mbview/threadview/;_ylt=Ai2JW6q3hgX…
...eins ist jedenfalls klar, wir sind erheblich näher dran als je zuvor in GALE's historie- this is (shoulld be) our season!
Antwort auf Beitrag Nr.: 50.601.227 von alfarr27 am 11.09.15 05:34:49Wie jetzt "nur" 3$ ?!?...der ist entweder Schotte, oder Witzbold (aber zweimal überlegt, evtl. sogar beides 
)
)
Antwort auf Beitrag Nr.: 50.594.054 von Growth2012 am 10.09.15 09:41:37Und noch eins...
Galena Biopharma Now Covered by Analysts at Raymond James (GALE)
Raymond James assumed coverage on shares of Galena Biopharma (NASDAQ:GALE) in a research note issued to investors on Wednesday morning, The Fly reports. The firm issued an outperform rating and a $3.00 price objective on the biotechnology company’s stock.
http://sleekmoney.com/galena-biopharma-now-covered-by-analys…
Galena Biopharma Now Covered by Analysts at Raymond James (GALE)
Raymond James assumed coverage on shares of Galena Biopharma (NASDAQ:GALE) in a research note issued to investors on Wednesday morning, The Fly reports. The firm issued an outperform rating and a $3.00 price objective on the biotechnology company’s stock.
http://sleekmoney.com/galena-biopharma-now-covered-by-analys…
Moin, moin, zwar vom ende August, aber war dieses schon bekannt?
Analysts Set Galena Biopharma Target Price at >>>$5.17<<< (NASDAQ:GALE)
http://sleekmoney.com/analysts-set-galena-biopharma-target-p…
Analysts Set Galena Biopharma Target Price at >>>$5.17<<< (NASDAQ:GALE)
http://sleekmoney.com/analysts-set-galena-biopharma-target-p…
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