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Galena Biopharma, Inc.

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Mark W. Schwartz Ph.D., President & Chief Executive Officer, gave guidance for the interim analysis for the PRESENT trial. He stated, "The NeuVax PRESENT trials is our most advanced program and by far the primary value driver of our development pipeline with three trials ongoing and two plan to initiate this year. 2016 is poised to be a very important for NeuVax, as we will reach two critical milestones in the PRESENT trial. Most importantly, we are still on track for the readout of our interim analysis in the second quarter, which is predicated on reaching the 70th event in the trial. Once we reach the 70th event we will prepare the data for a review by our Independent Data Monitoring Committee or the IDMC, and the IDMC will then conduct an interim safety and futility analysis. While we anticipated that the 70th event will be identified by March the final adjudication of the event will come in the end of this month or next month. Regardless to the exact timing around the 70th event, we still expect to announce results of the interim analysis at the end of the second quarter."
Source: Q4 2015 earnings conference call, 3/10/16.

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Galena Biopharma Phase 3 PRESENT Clinical Trial with NeuVax™ (nelipepimut-S) Achieves 70th Qualifying Disease Free Survival Event

Mar 29, 2016
Interim analysis results expected by the end of the second quarter
SAN RAMON, Calif., March 29, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced that the 70th qualifying disease free survival (DFS) event has been achieved in the NeuVax™ (nelipepimut-S) Phase 3, PRESENT (Prevention of Recurrence in Early-Stage, Node Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. NeuVax is a peptide immunotherapy vaccine currently being evaluated for the prevention of cancer recurrence and is Galena’s lead development agent in multiple ongoing and planned clinical trials.

Based on clinical and radiological data, seventy qualifying DFS events have been confirmed by the trial’s independent Endpoint Adjudication Committee (EAC), comprised of two oncologists and one radiologist with expertise in the conduct of clinical trials in breast cancer. In the ensuing months, Galena will compile and submit the clinical data to the trial’s Independent Data Monitoring Committee (IDMC) to perform the Interim Analysis. The Interim Analysis is a pre-specified futility and overall safety analysis to evaluate the likelihood of the study to achieve its primary objectives. Upon completion of this prospective analysis, the IDMC will provide a recommendation to the Company regarding further continuation of the trial.

“We are pleased that we have achieved this important milestone in the PRESENT trial and that the rate of recurrences are in line with the original assumptions that led to the study design,” stated Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. “Reaching the 70th qualifying DFS event triggers the pre-planned Interim Analysis. We will now prepare the data package for the IDMC in order for the committee to evaluate the safety of NeuVax for all patients enrolled, perform a futility analysis, and provide its recommendation on continuing the trial. We anticipate reaching this next milestone in the PRESENT trial at the end of the second quarter.”

Dr. Nejadnik continued, “The 70th event also represents a significant maturation of the program and is a meaningful time point as it brings us halfway to the full number of 141 events required for the primary endpoint analysis in conjunction with three years minimum follow-up. I am grateful to our clinical team, our committee’s physician experts, and our trial sites, as they have been instrumental in achieving this milestone. With this point of progress in the trial, we are assembling our internal teams responsible for drafting our Biologics License Application.”

For the PRESENT trial, a qualifying DFS event is defined as: a recurrence of the primary breast cancer, either locally in the breast, regionally in the lymph nodes, or distantly as metastatic disease; an occurrence of another cancer; or, death from any cause. All qualifying DFS events are confirmed by the EAC. The IDMC is comprised of two medical oncologists, one cardiologist, and one statistician and will perform the Interim Analysis.
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Source: press release, 3/29/16. http://investors.galenabiopharma.com/investors/press-releases/press-rele...

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Galena Biopharma Announces Independent Data Safety Monitoring Committee Recommends Reduction of Cardiac Toxicity Monitoring for NeuVax(TM) PRESENT Trial

PORTLAND, Ore., Aug. 24, 2015 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced that the Independent Data Monitoring Committee (IDMC) has recommended to the Company that it can reduce the cardiac toxicity monitoring for patients in its NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) clinical trial. The trial is being run under a Special Protocol Assessment (SPA) approved by the U.S. Food and Drug Administration (FDA).

Following its most recent IDMC meeting in June 2015, the IDMC recommended routine cardiac monitoring could be reduced in the PRESENT trial and that such a reduction is justified and consistent with the pre-specified Cardiac Toxicity Monitoring Stopping Rules defined in the study protocol. The IDMC concluded that cardiac toxicity monitoring by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans could be reduced. The IDMC had no other suggestions and recommended the trial continue as planned.

Mark W. Schwartz, Ph.D., President and Chief Executive Officer, stated, "We are pleased to see that cardiac events have not appeared as a safety issue thus far in the study, relative to published reports of cardiac toxicity associated with other HER2 directed therapies. Importantly, the recommendation by the IDMC to reduce the frequency of cardiac assessments, per the protocol, facilitates the ongoing compliance and patient retention on trial."

Per the PRESENT protocol, the IDMC was established and is made up of a group of physicians including medical oncologists, a cardiologist, and an independent statistician with pertinent expertise to evaluate accumulated data from the trial. The IDMC meets periodically and advises Galena regarding the continuing safety of trial patients, efficacy, as well as the continuing validity, integrity, and the overall conduct of the trial.
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Source: press release, 8/24/15. http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=928520

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Apr 14, 2015

Galena Biopharma Completes Over-Enrollment of NeuVax(TM) (nelipepimut-S) Phase 3 PRESENT Clinical Trial

PRESENT Clinical Trial Milestone Achieved With 758 Patients Enrolled

PORTLAND, Ore., April 14, 2015 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced the completion of enrollment in the NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) clinical trial. NeuVax™ is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting.

As anticipated, Galena over-enrolled the trial by 7.7% with a total of 758 patients now in the intent-to-treat (ITT) population. The protocol for the PRESENT trial, being conducted under an FDA approved Special Protocol Assessment (SPA), called for 700 patients; and, the Company expects this higher number of ITT patients will increase the confidence in both the timing and quality of the statistics and the final outcome of the trial. The primary endpoint is currently expected to be reached in 2018, after the last patient dosed reaches her 36th month of treatment, or a total of 141 events (recurrence or death) occur, whichever comes later.

"Completion of enrollment in our Phase 3 PRESENT trial is a landmark event for Galena and for breast cancer patients worldwide," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "As we look forward to reaching our interim analysis by the end of this year or in Q1, 2016, it is important to note the significant medical need that Galena aims to address with NeuVax. Despite advances in the diagnosis and treatment of breast cancer, approximately 25% of node positive patients have a recurrence within three years after achieving no evidence of disease. NeuVax is designed to prevent these often fatal recurrences, and we anticipate that data from the PRESENT study, as well as our ongoing combination studies of NeuVax in breast cancer, will demonstrate this capability."

"The women in the PRESENT trial are part of the approximately fifty percent of breast cancer patients who have tumors that are HER2 1+ or 2+, and currently have no available treatment options to maintain their disease-free status after their standard of care therapy. Based on our early work with NeuVax, we believe this agent can have a meaningful impact for these women. I am grateful to the hundreds of women who participated in this study and for all of the sites and investigators who devoted their time to help us accomplish this milestone," added Elizabeth A. Mittendorf, M.D., Ph.D., Associate Professor, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center and the Principal Investigator of the PRESENT trial.

PRESENT is a randomized, double blind, placebo controlled, international, Phase 3 trial and is the most advanced study in Galena's pipeline. The trial is being run in 13 countries at more than 140 sites. The PRESENT trial targets the approximately 50%-60% of women with breast cancer who have low to intermediate (immunohistochemistry [IHC] 1+/2+ or fluorescence in situ hybridization [FISH] < 2.0) HER2 expression and achieved no evidence of disease following current standard of care treatment (surgery, chemotherapy, and radiation therapy). Patients enrolled must be lymph node positive, haplotype (HLA) A2 or A3 positive, and have Stage IIa-IIIa breast cancer. Once patients completed their current standard of care treatment, they are administered an injection once a month for six months (Primary Vaccine Series), then receive five booster injections once every six months for a total of eleven injections over a three year period. Currently there are no other treatment options for these patients to maintain their disease-free status.
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Source: press release, 4/14/15. http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=906375

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Feb 9, 2015

Galena Biopharma Enrolls 700th Patient in NeuVax(TM) (nelipepimut-S) Phase 3 PRESENT Clinical Trial

Key PRESENT trial enrollment milestone achieved
Over-enrollment planned with expected completion near the end of Q1
PORTLAND, Ore., Feb. 9, 2015 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced enrollment of the 700th patient in the NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVaxTreatment) clinical trial. NeuVax™ is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. There are currently no available, targeted treatment options to maintain the disease-free status for these women.

Seven hundred is the patient enrollment target as defined by the PRESENT Phase 3 clinical trial protocol. A Special Protocol Assessment (SPA) was granted by the U.S. Food and Drug Administration (FDA) on the PRESENT trial, certifying the agreement with the FDA regarding the study endpoints, study design and statistical assumptions of the clinical trial. As previously mentioned by the Company, Galena is continuing to enroll those identified patients who are completing their standard of care and have passed their initial qualifications for potential enrollment in the trial. The Company expects over-enrollment will increase the confidence in both the timing and quality of the statistics and the final outcome of the trial. Completion of final enrollment in the trial is expected near the end of the first quarter of 2015.

"Reaching enrollment of our 700th patient is a significant milestone for the PRESENT trial and for our NeuVax cancer immunotherapy franchise," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "We are grateful to all the women who volunteered to participate in our study, and we now look forward to completing enrollment near the end of this quarter and reaching our event-driven, interim analysis, which we anticipate occurring at the end of 2015/early 2016 timeframe. Next year, we also expect several key milestones from our portfolio of NeuVax trials, including our ongoing Phase 2b trial with NeuVax in combination with Herceptin®."

PRESENT is a randomized, double blind, placebo controlled, international, Phase 3 trial and the leading study in Galena's pipeline. The trial is currently running in 13 countries at more than 140 sites. The PRESENT trial targets the approximately 50%-60% of women with breast cancer who are low to intermediate (immunohistochemistry [IHC] 1+/2+ or fluorescence in situ hybridization [FISH] < 2.0) HER2 expression and achieved no evidence of disease with current standard of care treatment (surgery, chemotherapy, and radiation therapy). Patients must be lymph node positive, haplotype (HLA) A2 or A3 positive, and have Stage IIa-IIIa breast cancer. Once patients have completed their current standard of care treatment, with no available HER2-targeted adjuvant treatment options to maintain their disease-free status, patients are administered an injection once a month for six months (Primary Vaccine Series), then receive five booster injections once every six months for a total of eleven injections over a three year period. The final endpoint is currently expected to be reached in 2018, after the last patient dosed reaches her 36th month of treatment, or 141 events (recurrence or death), whichever comes later.
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Source: press release, 2/09/15. http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=895318

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Mark J. Ahn, Ph.D., President & Chief Executive Officer, commented on the phase-III program for NeuVax in breast cancer. He stated, "Once we are finished enrollment which we are hoping to wrap up this summer, we hit the interim analysis at 70 events, seven zero, this is an indepenndent data safety monitoring board will assess the the data at that point, make a determination, kind of go-no-go decision, sort of a white smoke-black smoke kind of event. Then at the end of 36 months we find out the final read-out based on disease free survival."
Source: 13th Annual Needham Healthcare Conference, 4/08/14.

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Mark J. Ahn, Ph.D., President & Chief Executive Officer, commented on the interim analysis for the PRESENT study, NeuVax for breast cancer. He stated, "We are hoping to finish up our enrollment in the first half of 2014 and get this so-called interim analysis at the end of the year. The interim analysis is event driven, 70 events and the independent data safety monitoring board will assess safety and futility at that time. Then the end-point is 36 months the same as the Herceptin HERA trial if you are familiar with that program."
Source: Oppenheimer 24th Annual Healthcare Conference, 12/10/13.

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Mark J. Ahn, Ph.D., President & Chief Executive Officer, commented on the Neuvax programs. He stated, "We finished our phase-II, got a special protocol assessment and plunged into a phase-III that we hope to finish enrollment on by year end. Get through interim analysis next year on route to a 3 year disease free survival endpoint with our lead asset Neuvax in adjuvant breast cancer. Secondly, we are collaborating with Genentech/Roche on a combination study with Neuvax in combination with Herceptin and that is a phase-IIb study in 300 patients that will read-out in about the same time, in 24 months end-point in disease free survival."
Source: Rodman & Renshaw Annual Global Investment Conference, 9/09/13.

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NeuVax is the first adjuvant breast cancer vaccine to enter pivotal Phase 3 clinical trials. Galena is currently enrolling its randomized, multi-national Phase 3 trial entitled PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment). The study is being conducted under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA), and is currently enrolling in over 125 clinical sites worldwide.
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Source: press release, 5/09/13. http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=763666

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Mark J. Ahn, Ph.D., President & Chief Executive Officer, gave guidance for the timing of the interim analysis of the PRESENT study. He stated, "Today, we are up at Cornell and 26 other hospitals in the United States. We will be at 38 by the end of next month and we are going to 100 sites world wide by the end of this summer in 12 countries. This is enrolling quite nicely. We will hit an interim analysis we believe by the end of next year. Basically that is event driven so as those patients start to have 70 events of recurrences in either arm, the combination when it hits 70 will trigger an interim analysis. If you saw at ASCO this year, Immunogen and Genentec reported out the so called EMELIA study with TDM-1 that had an interim analysis, we are hoping to do that at the end of next year."
Source: 2012 Marcum Microcap Conference, 6/20/12.

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June 5, 2012
Galena Biopharma Announces NeuVax(TM) (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™ (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.
Source: press release, 6/05/12. http://investors.galenabiopharma.com/releasedetail.cfm?ReleaseID=680008

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Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax(TM) Treatment
Estimated Enrollment: 700
Study Start Date: November 2011
Estimated Study Completion Date: April 2025
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01479244?term=NeuVax&rank=1

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
NeuVax (nelipepimut-S or E75) NP Breast CancerOncologyBreast CancerVaccine anti-cancerHER2/neu-expressing tumor cell

Mechanism of action: NeuVax (E75 peptide plus GM-CSF vaccine) is a cancer peptide vaccine comprised of a human leukocyte antigen (HLA) A2/A3 restricted HER2/neu (ERBB2) peptide (amino acids 366 to 379) from the extracellular domain of the HER2 protein (E75 peptide) and combined with the immunoadjuvant granulocyte-macrophage colony-stimulating factor (GM-CSF), with potential immunomodulating and antineoplastic activity. Upon intradermal injection, the E75 peptide plus GM-CSF vaccine may induce a specific cytotoxic T-lymphocyte (CTL) response against HER2/neu-expressing tumor cell types. HER2/neu, a tumor-associated antigen and a member of the epidermal growth factor receptor family of tyrosine kinases, is overexpressed in various tumor cell types. GM-CSF potentiates the antitumor immune response.

Phase of Development: III

Event Type: Data: Phase III trial results (interim)

Dates: 2016-06-01 - 2016-07-31

Results:

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Galena Biopharma Discontinues NeuVax™ (nelipepimut-S) Phase 3, PRESENT Interim Analysis based on Independent Data Monitoring Committee Recommendation

Jun 29, 2016
SAN RAMON, Calif., June 29, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the recommendation from the Independent Data Monitoring Committee (IDMC) on the interim analysis for Galena’s NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. On June 27, 2016, the IDMC recommended that the PRESENT trial be stopped due to futility. The letter is attached to the Form 8-K filed today and available on the Company’s website. This planned safety and futility interim analysis was triggered after 70 qualifying disease free survival (DFS) events were reached, and a total of 71 events were reviewed by the IDMC.

“We are extremely disappointed with the outcome of the PRESENT futility analysis,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “On behalf of our entire company, I would like to thank all of the courageous patients and their families, investigators, study staff and independent committees who participated in the PRESENT study. To date, the trial has not been un-blinded other than by the IDMC, and we need to evaluate the data. We expect to host a conference call next week to provide a preliminary review of the PRESENT trial and an update on all of our immunotherapy and hematology clinical development programs.”
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Source: press release, 6/29/16. http://investors.galenabiopharma.com/investors/press-releases/press-rele...

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