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Galena Biopharma Announces NeuVax (E75) Improves Disease-Free Survival at 60-Month Median Follow-Up

-- The combined SN-33 (Node Positive) (n=97) and SN-34 (Node Negative) (n=90) Intent-to-treat (ITT) population (n=187) continued to demonstrate an excellent safety and efficacy profile.
-- Phase 2 boosted patients from SN-33 (NP) established the Phase 3 patient population. After establishing statistical significance at the 24-month Landmark Analysis (p=0.0358) and the 36-month Landmark Analysis (p=0.035), the 60-month median follow-up demonstrated a 5.6% recurrence rate with NeuVax vs 25.9% recurrence rate in the control arm--a recurrence reduction of 78.4% in the target patient population.
-- Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment) study is underway with a US FDA approved Special Protocol Assessment (SPA). To date, 35 sites are approved in four countries, over 20 sites are enrolling, and expanding to approximately 100 sites total in 2012.

 


LAKE OSWEGO, Ore., June 5, 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, updated NeuVax(TM) (E75) results at a physician panel on Monday, June 5, 2012 during the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting in Chicago, Illinois.

THE COMBINED PHASE 1/2 NEUVAX CLINICAL TRIALS, SN-33 (NODE POSITIVE,
NP) (N=97) AND SN-34 (NODE NEGATIVE, NN) (N=90), CONTINUE TO DEMONSTRATE AN EXCELLENT SAFETY AND EFFICACY PROFILE AT MEDIAN 60-MONTH FOLLOW-UP

Multiple clinical trials have shown NeuVax (E75 + GM-CSF) to be safe and effective at raising HER2 immunity. Trials SN-33 (NP) (n=97) and
SN-34 (NN) (n=90) enrolled clinically eligible patients who had completed standard of care (n=187). Treatment assignment was then based on HLA type, with HLA A2/A3 patients vaccinated and HLA-A2/A3 negative patients followed prospectively as controls for recurrence.
Disease-Free Survival (DFS) at 24 months was the primary endpoint for the Landmark Analysis. Of note, the reported results are 60-month median follow-up, and the final few patients will complete five years of therapy later this year after which the final study report will be presented.

NeuVax continues to exhibit an excellent safety and tolerability profile. The combined SN-33 (NP) (n=97) and SN-34 (NN) (n=90) Intent-to-treat (ITT) population (n=187) continue to demonstrate a durable response.


-- NeuVax is safe and effective at raising HER2 immunity. Of note, no
serious adverse events (SAEs) or cardiotoxicity has been reported.
-- 24-month Landmark Analysis: 94.3% of NeuVax patients were disease-free
versus 86.8% of patients on the control arm (p=0.08).
-- 60-month Analysis: 89.7% of NeuVax patients remain disease-free versus
79.6% of patients on the control arm--a recurrence reduction of 49.5%
among all patients at any dose.

 


PHASE 2 BOOSTED PATIENTS FROM SN-33 (NODE POSITIVE) ESTABLISHED PHASE 3 PATIENT POPULATION

The target patient population (TPP) for Galena's Phase 3 PRESENT trial is based on the SN-33 trial. SN-33 was conducted in node positive patients, and was well balanced between the two arms: Vaccine HLA-A2/A3 positive (n=53) vs Control HLA-A2/A3 negative (n=44). During the conduct of this trial, Herceptin(R) (trastuzumab; Genentech/Roche) became commercially available for HER2 IHC Positive (3+) patients, and the trial was modified accordingly to allow these patients to receive Herceptin, and exclude this patient group from future enrollment and analysis.

Below are the summary results from the SN-33 trial. This new, 60-month data analysis shows that breast cancer recurrence is greatly reduced for patients treated with NeuVax and that these results are both clinically relevant and durable over time. This five-year time point is noteworthy as it is often the mark where patients are considered cured of their disease.

SN-33 Intent-to-treat (ITT) population (n=97):


-- 24-month Landmark Analysis: 90.6% of NeuVax patients (n=53) were
disease-free versus 79.5% of patients on the control arm (n=44)
(p=0.1155).
-- 60-month Analysis: 84.5% of NeuVax patients (n=53) remain disease-free
versus 77.1% of patients on the control arm (n=44).

 


SN-33 HER2 Negative (IHC 1+,2+ and/or FISH <2.0) patients who received boosters (n=45) established the Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax(TM) Treatment) study is underway with a US FDA approved Special Protocol Assessment (SPA):


-- 24-month Landmark Analysis: 0% recurrences for patients treated with
NeuVax: statistically significant DFS for NeuVax at 100% (n=18) vs 77.8%
Control (n=27) (p=0.0358).
-- 36-month Landmark Analysis: 0% recurrences for patients treated with
NeuVax for a statistically significant DFS for NeuVax at 100% (n=18) vs
77.8% Control (n=27) (p=0.035). Of note, no patients receiving booster
inoculations had a recurrence through 36 months, which is the Phase 3
PRESENT study endpoint.
-- 60-month Analysis: 5.6% recurrence rate with NeuVax versus 25.9%
recurrence rate in the control arm.
-- DFS for NeuVax at 94.4% (n=18) vs 74.1% Control (n=27)--a recurrence
reduction of 78.4% in the target patient population.

 


"The 60-month median data analysis shows that breast cancer recurrence is greatly reduced for patients treated with NeuVax," stated Mark J.
Ahn, Ph.D., President and CEO. "NeuVax directly increases the immunologic activity of directed CD8 killer T-cells both during the initial inoculation, as well as when the booster regimen was added, to maintain the durability of immune response and clinical benefit in patients."

All new NeuVax data has been updated in the company presentation at www.galenabiopharma.com.

About NeuVax(TM) (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 that achieved its primary endpoint of disease-free survival, the Food and Drug Administration granted NeuVax a Special Protocol Assessment 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 ongoing and additional information on the study can be found at www.neuvax.com.

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% of them have breast cancer tissue that tests positive for some level of HER2 staining (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 50% of patients with tumors that stain low or intermediate for HER2 (HER2 1+ and 2+), who would not receive Herceptin after they successfully complete their surgery, adjuvant chemotherapy and radiation. This provides this large group of early stage breast cancer patients an option for a HER2-targeted adjuvant treatment 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 and prospects of Galena's NeuVax product candidate. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the risks that the anticipated benefits are not borne out in further clinical testing, as well as the risks, uncertainties and assumptions relating to the development of Galena's new product candidates 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 clinical benefits of NeuVax and results of further clinical testing 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.


CONTACT: Madeline Hatton
Toll free: +1 (855) 855-GALE (4253), ext. 109
info@galenabiopharma.com

or

Remy Bernarda
IR Sense, LLC
+1 (503) 400-6995
remy@irsense.com
 

Posted: June 2012

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