$GALE: Galena Biopharma to Provide Corporate and C
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Posted On: 01/06/2017 10:09:40 AM
$GALE: Galena Biopharma to Provide Corporate and Clinical Update and 2017 Outlook During Presentation at Biotech Showcase 2017
GlobeNewswire•
SAN RAMON, Calif., Jan. 05, 2017 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, today provided a corporate and clinical outlook for 2017 and announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will give a company presentation at the Biotech Showcase 2017. The presentation will take place on Wednesday, January 11, 2017 at 10:30 a.m. PT at the Hilton San Francisco Union Square. The presentation will be webcast and available on the Investors section of the Company's website at http://investors.galenabiopharma.com/events.cfm.
“2017 looks to be promising for Galena Biopharma as we prepare to initiate our Phase 3 clinical trial in patients with essential thrombocythemia (ET) with GALE-401, our controlled release version of anagrelide,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “After a productive meeting with the U.S. Food and Drug Administration (FDA) last month, we were pleased to confirm that the GALE-401 development program is appropriate for a New Drug Application (NDA) filing using the 505(b)(2) regulatory pathway in patients who are intolerant to or failed to achieve an optimal response with hydroxyurea. In the U.S., ET has a prevalence of approximately 150,000 people and we estimate up to 25% of those patients who receive initial treatment with hydroxyurea may be candidates for the GALE-401 trial. We expect to finalize the details of the Phase 3 clinical trial protocol including the trial size, endpoints, and dosing this quarter and initiate the trial in the second quarter of 2017.”
Dr. Schwartz continued, “We were also excited to announce last month that the Phase 2 clinical trial with NeuVax™ (nelipepimut-S) in Ductal Carcinoma in Situ (DCIS) resumed enrollment. In 2017, we expect enrollment to be completed in both of our NeuVax and trastuzumab combination trials. These investigator-sponsored trials (ISTs) are relatively low cost and allow us to leverage our resources to validate NeuVax as a potential treatment option whether as a stand-alone therapy or in combination with other agents. We believe there is substantial interest in the potential efficacy of NeuVax in a number of breast cancer indications and other malignancies such as gastric cancer, and ISTs such as these allow us to expand the utility of the agent. Similarly, with our folate binding protein (FBP) programs, GALE-301 and GALE-302, our investigators provided a wealth of data in 2016 at various medical conferences including a November publication in Oncotarget on the GALE-301 interim analysis. These data on dosing and treatment schedules are extremely valuable as they highlight the potential utility of the vaccine in different cancer indications.”
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GlobeNewswire•
SAN RAMON, Calif., Jan. 05, 2017 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, today provided a corporate and clinical outlook for 2017 and announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will give a company presentation at the Biotech Showcase 2017. The presentation will take place on Wednesday, January 11, 2017 at 10:30 a.m. PT at the Hilton San Francisco Union Square. The presentation will be webcast and available on the Investors section of the Company's website at http://investors.galenabiopharma.com/events.cfm.
“2017 looks to be promising for Galena Biopharma as we prepare to initiate our Phase 3 clinical trial in patients with essential thrombocythemia (ET) with GALE-401, our controlled release version of anagrelide,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “After a productive meeting with the U.S. Food and Drug Administration (FDA) last month, we were pleased to confirm that the GALE-401 development program is appropriate for a New Drug Application (NDA) filing using the 505(b)(2) regulatory pathway in patients who are intolerant to or failed to achieve an optimal response with hydroxyurea. In the U.S., ET has a prevalence of approximately 150,000 people and we estimate up to 25% of those patients who receive initial treatment with hydroxyurea may be candidates for the GALE-401 trial. We expect to finalize the details of the Phase 3 clinical trial protocol including the trial size, endpoints, and dosing this quarter and initiate the trial in the second quarter of 2017.”
Dr. Schwartz continued, “We were also excited to announce last month that the Phase 2 clinical trial with NeuVax™ (nelipepimut-S) in Ductal Carcinoma in Situ (DCIS) resumed enrollment. In 2017, we expect enrollment to be completed in both of our NeuVax and trastuzumab combination trials. These investigator-sponsored trials (ISTs) are relatively low cost and allow us to leverage our resources to validate NeuVax as a potential treatment option whether as a stand-alone therapy or in combination with other agents. We believe there is substantial interest in the potential efficacy of NeuVax in a number of breast cancer indications and other malignancies such as gastric cancer, and ISTs such as these allow us to expand the utility of the agent. Similarly, with our folate binding protein (FBP) programs, GALE-301 and GALE-302, our investigators provided a wealth of data in 2016 at various medical conferences including a November publication in Oncotarget on the GALE-301 interim analysis. These data on dosing and treatment schedules are extremely valuable as they highlight the potential utility of the vaccine in different cancer indications.”
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