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News Breaks
June 2, 2014
07:14 EDTGALEGalena presents GALE-301 Phase 1 data
Galena announced that data from the company's Phase 1 study with GALE-301, or Folate Binding Protein, was presented at the American Society of Clinical Oncology 50th Annual Meeting. The poster entitled, "Comparison of recurrent and nonrecurrent ovarian and uterine cancer patients undergoing adjuvant folate receptor vaccine therapy," was presented during the Gynecologic Cancer General Poster Session. Overall, 30 patients were enrolled in the Phase 1 trial. Of 14 control patients, 50% have recurred. Of 16 vaccinated patients, 25% have recurred after completing the primary vaccine series and 12.5% recurred prior to completing the PVS, and one patient withdrew. Of note, no recurrences have been seen in the optimal dose cohort of 1000 mcg E39. The vR patients displayed lower mean delayed type hypersensitivity reactions as well as lower local reactions at every measured time point. The company said, "These promising initial results demonstrate the vaccine is dose responsive with the immune system and we are encouraged about the potential for this compound to prevent recurrence in women suffering from high risk gynecological cancers where current treatment options are limited. The data from this study served as the basis for advancing GALE-301 into its ongoing Phase 2 trial that includes a booster regimen. We expect enrollment in this trial to complete shortly, ahead of schedule."
News For GALE From The Last 14 Days
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November 18, 2014
07:37 EDTGALEStifel to hold a conference
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07:09 EDTGALEGalena completes enrollment in GALE-401 Phase 2 clinical trial
Galena Biopharma announced the completion of enrollment in the GALE-401, or Anagrelide Controlled Release, Phase 2 Clinical Trial. The Phase 2, clinical proof-of-concept study is treating 18 patients with elevated platelet counts in myeloproliferative neoplasms, or MPNs, including Essential Thrombocythemia, or ET, Polycythemia Vera, or PV, and Primary Myelofibrosis, or PMF. The Phase 2 trial is an open-label, single-arm, multicenter study designed to confirm the platelet-lowering activity of GALE-401 in patients with MPNs, to assess safety and tolerability, and to measure plasma concentrations of anagrelide. The platelet lowering ability of GALE-401 will be measured by the proportion of patients that achieve a complete or partial platelet response for at least four weeks during 24 weeks of treatment. With enrollment complete, patients will now be followed for platelet response while they continue study treatment.
November 11, 2014
09:17 EDTGALEOn The Fly: Pre-market Movers
UP AFTER EARNINGS: FMSA Holdings (FMSA), up 4.7% following third quarter results. ALSO HIGHER: AVEO Pharmaceuticals (AVEO), up 7.6% after entering agreement with Ophthotech (OPHT) to license tivozanib... Ophthotech is 2.1% higher in pre-market trading... Galena Biopharma (GALE), up 3.6% after first patient dosed in NeuVax and Herceptin combination Phase 2 trial... Yamana Gold (AUY), up 3% after being upgraded to Overweight from Neutral at HSBC... Ambac Financial (AMBC), up 3.1% after being upgraded to Neutral from Sell at MKM Partners... China Finance (JRJC), up 12.4% after announcing a new partnership with Great Wall Securities... Zynga (ZNGA), up 5.7% after being upgraded on mobile business growth at Jefferies... Fiat Chrysler (FCAU), up 2.2% after being initiated with a Conviction Buy at Goldman. DOWN AFTER EARNINGS: Applied Optoelectronics (AAOI), down 10.7%... Ekso Bionics (EKSO), down 2.2%. ALSO LOWER: Alibaba Group (BABA), down 1.6% following comments made by vice chairman Joseph Tsai in an interview.
07:06 EDTGALEGalena doses first patient in NeuVax, Herceptin combination Phase 2 trial
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November 10, 2014
13:18 EDTGALEGalena terminates Brian Hamilton as Chief Medical Officer
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November 7, 2014
07:14 EDTGALEGalena presents GALE-301 Phase 1/2a clinical trial data
Galena Biopharma announced that data from the company's Phase 1/2a trial of GALE-301, a Folate Binding Protein, or FBP,-derived immunotherapy, will be presented at the upcoming Society for Immunotherapy of Cancer Annual Meeting. Preliminary data shows a 31% recurrence rate in the vaccine group compared to 50% in the control group at a median follow up of 13 months, a 38% reduction in relative risk of recurrence. GALE-301 plus GM-CSF is well tolerated and elicits a strong in vivo immune response with primarily Grade 1 and Grade 2 toxicities. Top-line data to be presented mid-year 2015.

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