Healthcare Industry News: trastuzumab
News Release - October 4, 2011
Galena Biopharma Hires Hana B. Moran as Vice President, Regulatory Affairs and ComplianceLAKE OSWEGO, Ore., Oct. 4, 2011 -- (Healthcare Sales & Marketing Network) -- Galena Biopharma, Inc. (Nasdaq:RXII ), a biotechnology company focused on developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that it has hired Hana B. Moran, Ph.D. as Vice President, Regulatory Affairs and Compliance, effective immediately.
"Dr. Moran's high energy and outstanding accomplishments in the biopharmaceutical industry, including multiple NDAs, will significantly strengthen our management team," stated Mark Ahn, Ph.D., President and CEO. "We look forward to her contributions and leadership, particularly as we advance into late-stage clinical development with NeuVax(TM)."
Dr. Moran has more than 25 years of pharmaceutical industry experience in research, regulatory affairs, and quality assurance in start-up and high-growth companies including SangStat, Scios, Athena Neurosciences, Intarcia, and Hana Biosciences. She has a long and varied experience in development of pharmaceuticals, including oncology products and led marketing approval activities for nine pharmaceutical products, among them drugs, biologics, medical devices and in-vitro diagnostics globally. Dr. Moran earned an MSc in Chemical Engineering from Slovak Technical University, Bratislava, Slovakia and a Ph.D. in Organic Chemistry from the Weizmann Institute of Science, Rehovoth, Israel.
About NeuVax (E75)
NeuVax consists of the E75 peptide derived from human epidermal growth factor receptor 2 (HER2) combined with the immune adjuvant granulocyte macrophage colony-stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to target cells expressing any level of HER2. NeuVax is given as an intradermal injection once a month for six months, followed by a booster injection once every six months. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The Phase 3 trial is expected to commence in the first half of 2012.
According to the National Cancer Institute, over 200,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, about 75% test positive for HER2 (IHC 1+, 2+ or 3+). Only 25% of all breast cancer patients, those with HER2 3+ disease, are eligible for Herceptin(R) (trastuzumab; Roche-Genentech), which had revenues of over $5 billion in 2010. NeuVax targets the remaining 50% of HER2-positive patients (HER2 1+ and 2+) who achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.
Folate Binding Protein (FBP)-E39
Folate Binding Protein-E39 (FBP) is a targeted vaccine aimed at preventing the recurrence of ovarian, endometrial, and breast cancers. The FBP vaccine consists of the E39 peptide derived from the folate binding protein combined with the immune adjuvant granulocyte macrophage colony stimulating factor (GM-CSF). FBP is over-expressed (20-80 fold) in more than 90% of ovarian and endometrial cancers, as well as 20-50% of breast, lung, colorectal, and renal cell carcinomas. FBP has very limited tissue distribution and expression in non-malignant tissue, making it an ideal immunotherapy target. A Phase 1/2 trial is expected to commence by year end 2011.
Ovarian cancer occurs in over 22,000 patients per year in the U.S. and is the most lethal gynecologic cancer. Although the incidence of ovarian cancer is only approximately 20% of that of breast cancer, the number of patients that die from ovarian cancer is nearly 50% greater than the percentage of breast cancer patients who die from this disease. Endometrial cancer is the most common gynecologic cancer and occurs in over 46,000 women, with over 8,000 deaths, in the U.S. annually. While many patients respond to initial treatment and become clinically free of disease, the majority of these patients will relapse, and, once the disease recurs, the treatment options and successes drop dramatically.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:RXII ) is a Portland, Oregon-based biopharmaceutical company that develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit us at www.galenabiopharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the possible benefits of the transactions recently announced by Galena and the timing of the proposed partial spin-off of its RXi subsidiary, as well as statements about expectations, plans and prospects of the development of Galena's new product candidates. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the risks that the anticipated benefits of the announced transactions are not achieved and that the proposed spin-off is delayed or is never completed, as well as the risks, uncertainties and assumptions relating to the development of Galena's new product candidates, including those identified under "Risk Factors" in Galena's most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings Galena periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.
Source: Galena Biopharma
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