Galena Biopharma, Inc.
Dec 9, 2011

Galena Biopharma Presents Phase 2 Trial Design for NeuVax(TM) (E75 + GM-CSF) Combined With Herceptin(R) (Trastuzumab) at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium

LAKE OSWEGO, Ore., Dec. 9, 2011 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, today presented the trial design for the upcoming Phase 2 combination trial with NeuVax™ (E75 plus GM-CSF) and Herceptin® (trastuzumab; Genentech/Roche) at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium. The event is being held December 6-10, 2011 at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

A presentation entitled, "Combination immunotherapy with trastuzumab and the HER2 vaccine E75 in low and intermediate HER2-expressing breast cancer patients to prevent recurrence," was presented today during the Ongoing Trials 3 Poster Session. The poster summarizes previously reported data and outlines the details of the planned Phase 2 clinical trial evaluating NeuVax™ in combination with trastuzumab.

The previously reported pilot Phase 2 trial investigated sequential therapy with trastuzumab followed by HER2 vaccination in the adjuvant setting. Of 62 patients who received standard-of-care trastuzumab, the 32 who received no vaccine experienced a 12.5% breast cancer recurrence rate (4/32), comparable with reported rates of similarly staged and treated patients. In contrast, of the 30 patients who were vaccinated with vaccine following trastuzumab therapy, the recurrence rate was 0% (0/30) (p=0.065). The median follow-up for this cohort is 48 months.

Based on this data, it is hypothesized that combination adjuvant immunotherapy with NeuVax and trastuzumab will result in a greater reduction in breast cancer recurrence than trastuzumab therapy alone. The multi-center, prospective, randomized, single-blinded Phase 2 trial will evaluate the efficacy of this immunotherapy combination in breast cancer patients with HER2 low- and intermediate-expressing tumors (HER2 1+, 2+) in the adjuvant setting. Disease-free patients at risk for recurrence will be randomized to receive trastuzumab + NeuVax versus trastuzumab + GM-CSF alone. The primary endpoint will compare disease-free survival at 24 months between the treatment arms. Secondary endpoints include disease-free survival at 36 months, immunologic responses to vaccination, and safety.

"Our data to date showing no recurrence with NeuVax in combination with Herceptin provides the rationale for a randomized Phase 2 trial to offer this combination to breast cancer patients expressing low-to-intermediate levels of HER2+ and who are currently not eligible to receive Herceptin therapy," said COL George E. Peoples, MD, FACS, Director, Cancer Vaccine Development Program; Deputy Director, United States Military Cancer Institute; Professor (adjunct), Surgical Oncology, M.D. Anderson Cancer Center; Professor, Surgery, Uniformed Services University; Chief, Surgical Oncology, Brooke Army Medical Center (BAMC). "We expect to initiate this trial in 1H 2012 and follow each of the patients for three years, with a primary endpoint assessment at 24 months."

The trial will be conducted at 20 sites worldwide under the direction of Dr. Peoples. The collaborative trial is being co-sponsored by Galena Biopharma and Genentech/Roche through the Henry M. Jackson Foundation. Each company will provide their respective drugs for the 300 patient trial and support approximately half of the trial costs.  

"We are excited about collaborating on this study to evaluate the potential efficacy of NeuVax in combination with Herceptin, thus potentially expanding the clinical utility of both products," added Mark J. Ahn, Ph.D., President and CEO of Galena Biopharma.

Phase 2 Trial Design:

The study will be a multi-center, prospective, randomized, single-blinded Phase 2 trial evaluating NeuVax + trastuzumab (vaccine) vs. trastuzumab + GM-CSF (control) alone in the adjuvant setting in breast cancer patients. HLA-A2/A3+ node positive (or node negative if also negative for both ER and PR) breast cancer patients with HER2 1+ or 2+ expressing tumors who are disease-free after completing standard adjuvant therapies will be enrolled and randomized. Patients must have adequate cardiac function for enrollment (LVEF > 50%), and randomization will be further stratified based on HER2 status (1+ or 2+) and nodal status (N0, N1, N2, or N3). 

Trastuzumab will be given to all enrolled patients every three weeks as monotherapy for one year, initiated upon completion of standard-of-care chemotherapy/radiotherapy. Patients in the study will then receive either NeuVax or GM-CSF intradermally every 3 weeks for a total of 6 vaccinations, 30-120 minutes after completion of trastuzumab infusion. Upon completion of the vaccination series, booster inoculations (same dose and route) will be administered every six months for a total of four boosters. Patient blinding will be maintained throughout the study. 

From previously published experience with trastuzumab, a recurrence rate of 15% is expected in trastuzumab (plus GM-CSF) treated patients, and it is anticipated that the combination of trastuzumab with NeuVax will reduce this recurrence rate to 5%. In order to show a statistical difference between these recurrence rates, 150 patients will be enrolled per treatment arm (300 total) with a type 1 error rate of 5% and 80% power to detect the primary endpoint.

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.

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.

The Galena Biopharma, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=10647

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 clinical benefits, expectations, plans and prospects of the development of NeuVax and Galena's other 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.

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