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'lizbeth · 02-28-2014, 10:07 AM

February 28, 2014

Galena Biopharma Bolsters NeuVax(TM) (nelipepimut-S) Intellectual Property With Patent Acceptance in Australia

PORTLAND, Ore., Feb. 28, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that it has received a Notice of Acceptance from the Australian Patent Office for a patent covering the use of Galena's development product candidate, NeuVax™ (nelipepimut-S), a HER2/neu peptide vaccine, for inducing protective or therapeutic immunity to breast cancer recurrence in patients having low-to-intermediate HER2 IHC ratings of 1+ or 2+ and a FISH rating of less than 2.0 ± 20% for CYP17 to HER2/neu gene expression ratio. The patent provides NeuVax the exclusivity for this indication until 2028, not including any patent term extensions.
"With our Phase 3 PRESENT trial currently ongoing in 13 countries, the continued addition of commercial partnerships, and a future clinical trial to be conducted in India, we are positioning NeuVax to be a potential treatment option for HER2 cancer patients worldwide," stated Mark J. Ahn, Ph.D., President and CEO. "This Australian patent strengthens our global intellectual property portfolio to potentially provide a tool to prevent recurrence in women with breast cancer."
NeuVax is currently in two clinical breast cancer trials, including the Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial and a Phase 2b trial in combination with Herceptin® (trastuzumab). A Phase 2 gastric cancer trial is also expected to initiate this year and will be run by Galena's partner in India, Dr. Reddy's.

02-28-2014, 10:07 AM	#1
'lizbeth Senior Member Join Date: Apr 2008 Location: Sunny San Diego Posts: 2,214	NeuVax Patent in Australia February 28, 2014 Galena Biopharma Bolsters NeuVax(TM) (nelipepimut-S) Intellectual Property With Patent Acceptance in Australia PORTLAND, Ore., Feb. 28, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that it has received a Notice of Acceptance from the Australian Patent Office for a patent covering the use of Galena's development product candidate, NeuVax™ (nelipepimut-S), a HER2/neu peptide vaccine, for inducing protective or therapeutic immunity to breast cancer recurrence in patients having low-to-intermediate HER2 IHC ratings of 1+ or 2+ and a FISH rating of less than 2.0 ± 20% for CYP17 to HER2/neu gene expression ratio. The patent provides NeuVax the exclusivity for this indication until 2028, not including any patent term extensions. "With our Phase 3 PRESENT trial currently ongoing in 13 countries, the continued addition of commercial partnerships, and a future clinical trial to be conducted in India, we are positioning NeuVax to be a potential treatment option for HER2 cancer patients worldwide," stated Mark J. Ahn, Ph.D., President and CEO. "This Australian patent strengthens our global intellectual property portfolio to potentially provide a tool to prevent recurrence in women with breast cancer." NeuVax is currently in two clinical breast cancer trials, including the Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial and a Phase 2b trial in combination with Herceptin® (trastuzumab). A Phase 2 gastric cancer trial is also expected to initiate this year and will be run by Galena's partner in India, Dr. Reddy's.