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Galena Biopharma submits SEC filing for spin-off of non-core RNAi assets.
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Galena will retain a 4% equity position, with the potential to receive up to $45 million in milestones; and 8% of the equity position in the RNAi company will be distributed to Galena shareholders after the filing is effective.
- Galena to change its NASDAQ symbol to "GALE."
LAKE OSWEGO, Ore., Oct. 25, 2011 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using targeted biotherapeutics, today reported a series of steps to further its strategy to accelerate its efforts as a focused, late-stage cancer immunotherapy company. The Company will change its NASDAQ symbol to "GALE," effective October 26, 2011 to reflect its strategic focus in targeted cancer drug development.
"Galena is now set to build value with a world class portfolio of novel, late-stage cancer immunotherapy products," said Mark J. Ahn, Ph.D., President and Chief Executive Officer. "Galena will tightly focus on its lead product, NeuVax™, a cancer immunotherapy targeted for low-to-intermediate HER2/neu oncogene expressing breast cancer patients, and is expected to initiate its pivotal Phase 3 study in the first half of 2012 under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA)."
Since the acquisition of NeuVax in April 2011, the Company has aggressively completed several operational steps towards initiating its Phase 3 PRESENT trial, including:
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Strengthened NeuVax patent portfolio. Acquired two additional patents covering worldwide rights to develop and commercialize NeuVax (E75) in combination with trastuzumab (Herceptin®; Genentech/Roche); and the use of NeuVax in low-to-intermediate HER2+ breast cancer patients not eligible for Herceptin therapy.
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Presented Phase 2 results demonstrating statistically significant increase in disease free survival (DFS) at 36 months in the NeuVax treated group vs the control group for the planned Phase 3 patient population (p=0.035). The vaccine treated group showed no recurrences of cancer (0% recurrence rate), while the control group demonstrated a 22% recurrence rate which is consistent with historical norms. The planned Phase 3 patient population as defined in the FDA approved SPA includes breast cancer patients who are node positive, have low-to-intermediate HER2 expression (HER2 1+ and 2+ by IHC), are HLA A2+ & A3+ and who are disease free following standard of care therapy.
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Initial Phase 3 site IRB approvals obtained. Obtained Institutional Review Board (IRB) approval of the NeuVax protocol for first wave of sites; at least ten key sites are targeted for approval by year-end 2011, and approximately 100 sites approved in 2012.
- Product manufacturing filings approved by FDA. Final Phase 3 clinical trial drug product has been manufactured and scheduled for distribution to clinical sites by year-end 2011.
In addition, the company has licensed a second off-the-shelf, targeted vaccine, Folate Binding Protein-E39 (FBP), which is being developed for the prevention of recurrence of ovarian, endometrial, and breast cancers. FBP has been granted Investigational New Drug (IND) approval by the U.S. Food and Drug Administration (FDA) to initiate clinical trials. IRB approval has also been received allowing Galena to initiate Phase 1 trials by year-end 2011.
Galena also announced that its new RXi Pharmaceuticals Corporation subsidiary has filed a registration statement with the Securities and Exchange Commission to register the shares of RXi common stock that will be distributed to Galena's stockholders. The plan to distribute the RXi shares was previously announced by Galena. The distribution will be made to Galena stockholders as of the record date for the distribution, which is expected to be ten days after the registration statement is declared effective by the Securities and Exchange Commission. All holders of Galena shares as of the future record date will automatically receive shares of RXi.
The permanent financing of the new RXi subsidiary and the spin-off itself, are subject to certain conditions, including the completion of the registration of the spin-off with the Securities and Exchange Commission.
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® (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:GALE) 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.
Registration Statement
A registration statement relating to the distribution of the RXi shares described in this press release has been filed with the Securities and Exchange Commission. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state in which such offer, solicitation or sale would be lawful to registration or qualification under the securities laws of any such state.
Forward-Looking Statements
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.