- Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment) study now enrolling under an FDA approved Special Protocol Assessment (SPA).
- NeuVax demonstrated statistical significance in 3-year Disease Free Survival (DFS) in adjuvant breast cancer, with 0% recurrence in the treated group versus 22.2% in the untreated group. NeuVax continues to demonstrate an excellent safety and tolerability profile.
- NeuVax.com provides background information on NeuVax™ (E75 plus GM-CSF) as an immunotherapy treatment, key data, and enrollment information on the study.
LAKE OSWEGO, Ore., Feb. 9, 2012 (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 announced the launch of a new patient website: www.NeuVax.com. The website will offer patients and investigators information about NeuVax™ (E75 plus GM-CSF) and patient enrollment for the Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment) clinical trial. Patients can access the website for treatment information, eligibility criteria, information on the screening process and access other breast cancer advocacy resources. Patients and investigators can also find additional information for the clinical study, including contact information for enrolling sites, at: ClinicalTrials.gov (identifier: NCT01479244).
"NeuVax is the first breast cancer vaccine to initiate Phase 3 clinical trials and it is important for patients to have informational resources," stated Rosemary Mazanet, M.D., Ph.D., Chief Medical Officer. "Promising Phase 2 results has led to increasing levels of awareness in the oncology community about NeuVax. We're excited about working with investigators and the breast cancer advocacy community to raise awareness for new, emerging immunotherapy approaches to reducing recurrence rates in breast cancer patients."
On January 20, 2012, Galena initiated the PRESENT trial for the NeuVax™ vaccine in low-to-intermediate HER2 breast cancer patients (often referred to as HER2-negative, not eligible for Herceptin) in the adjuvant setting to prevent recurrence. The PRESENT study is a randomized, multicenter, multinational clinical trial that will enroll approximately 700 breast cancer patients. The trial design has been updated to include current National Comprehensive Cancer Network (NCCN) guidelines and has received Special Protocol Assessment (SPA) concurrence from the U.S. Food and Drug Administration (FDA)."
Based on a previous Phase 2 trial of NeuVax that achieved its primary endpoint of disease-free survival (DFS), the FDA has agreed in the SPA that the design and planned analysis of the Phase 3 PRESENT study is adequately designed to provide the necessary data that, depending upon the outcome, could support a regulatory submission for marketing approval. In 2011, the company presented Phase 2 results at the American Society of Clinical Oncology and in the journal Cancer, published by the American Cancer Society (http://onlinelibrary.wiley.com/doi/10.1002/cncr.26574/abstract). Key highlights from the Phase 2 trial include:
- Statistically significant increase in DFS at 36 months in the NeuVax treated group versus 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 SPA includes breast cancer patients who are node positive, have low-to-intermediate HER2 expression, are HLA A2+/A3+ and who are disease free following standard of care therapy.
- An excellent safety profile, with no serious adverse events (SAE's) related to drug reported to date. All adverse events (AE's) reported were minor and resolved within 24 -72 hours.
- In the intent-to-treat population who received all ranges of doses and schedules, the low-to-intermediate HER2 expressors continued to show significant activity in improvement of DFS (p=0.045), with the vaccine group demonstrating a reduction of 66% in relative risk for recurrence. This data demonstrates strong support for targeting of low-to-intermediate HER2 expressors, a group for which there is currently no HER2 directed therapies.
- The optimally dosed (1 milligram of E75 plus 250 micrograms of GM-CSF) group continues to demonstrate superior efficacy compared to sub-optimal doses (varying doses from 100 – 500 micrograms E75 plus 125 – 500 micrograms GM-CSF), with a recurrence rate of 3% for the optimally dosed group versus 12% for the sub-optimally dosed group and 14% for the control group.
"Ultimately, our goal is to expand access so that everyone who may benefit from NeuVax treatment can obtain it. We are excited about the promise of NeuVax and the opportunity to make it available to investigators and patients," added Mark Ahn, Ph.D., President and CEO. "While we are grateful to our investigators, we also know that our progress is dependent upon the courage and commitment of breast cancer patients and their families."
About NeuVax™
NeuVax™ is a peptide-based immunotherapy intended to reduce the recurrence of breast cancer in low-to-intermediate HER2-positive breast cancer patients not eligible for trastuzumab (Herceptin®; Genentech/Roche). NeuVax is an immunotherapy that stimulates the immune system to actively seek out and selectively kill cancer cells. NeuVax directs "killer" T-cells to target and destroy cancer cells that express HER2/neu, a protein associated with epithelial tumors in breast, ovarian, pancreatic, colon, bladder and prostate cancers. NeuVax has been shown to be most effective in patients with low-to-intermediate HER2/neu expressors with HLA type A2+ or A3+. We believe that approximately 25,000-40,000 of the approximately 200,000 women diagnosed with breast cancer in the United States each year meet these criteria.
NeuVax is comprised of two components: a HER2/neu-derived peptide called E75 and the immune adjuvant GM-CSF. E75 is a nine‑amino acid sequence that is immunogenic (produces an immune response) and GM-CSF is a commercially available protein that acts to stimulate and activate components of the immune system such as macrophages and dendritic cells.
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). NeuVax targets the remaining 50% of the low-to-intermediate HER2 breast cancer patients (often referred to as HER2-negative, not eligible for Herceptin) 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.