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Posted by BooDog on :
 
I'll try and get more info in on this soon.

http://finance.yahoo.com/news/galena-biopharma-poster-presentation-american-1105 00437.html

Galena Biopharma Poster Presentation at the American Pain Society 32nd Annual Scientific Meeting

http://www.americanpainsociety.org/meeting/content/conferencehome.html
 
Posted by BooDog on :
 
10Q
http://www.sec.gov/Archives/edgar/data/1390478/000119312513211191/0001193125-13- 211191-index.htm

NeuVax
A video accompanying this release is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=18614
 
Posted by BooDog on :
 
dip in AH yesterday. Probably dip today too.
 
Posted by BooDog on :
 
Recovered nicely.
 
Posted by Lockman on :
 
http://stockcharts.com/h-sc/ui?s=GALE&p=D&b=5&g=0&id=p25065885888

Looking for bottom
 
Posted by Lockman on :
 
http://stockcharts.com/h-sc/ui?s=GALE&p=D&b=5&g=0&id=p25065885888

Nice move

waiting for new entry point
 
Posted by BooDog on :
 
Still a gap around $2 but I like the move it's been making. [Were Up]
 
Posted by BooDog on :
 
Galena Biopharma Launches Abstral(R) (fentanyl) Sublingual Tablets for the Treatment of Breakthrough Cancer Pain

First Commercial Product for Galena Biopharma Available Nationwide
GlobeNewswirePress Release: Galena Biopharma – 30 minutes ago..

PORTLAND, Ore., Oct. 3, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced the official product launch of Abstral(R) (fentanyl) Sublingual Tablets in the United States. Abstral is a sublingual (under the tongue) fentanyl tablet indicated for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. Galena acquired Abstral in March 2013 and since that time has scaled its field commercial team, manufactured the drug for commercial sale, secured broad access and reimbursement support from commercial and federal health insurance entities, implemented a robust patient assistance program, and developed a broad product distribution network. Abstral can be prescribed by healthcare professionals and is available to patients at all retail pharmacies nationwide.

"As an oncology company dedicated to improving patients' lives, we are thrilled to introduce Abstral as our first commercial product and offer cancer patients relief from their breakthrough pain," said Mark J. Ahn, President and Chief Executive Officer. "We believe Abstral delivers best in class performance because it is simple to carry, simple to use, and requires no speacial handling or disposal. We have a commercial team of highly dedicated, patient-focused professionals with experience in both pain and oncology who have helped us reach this tremendous milestone for Galena. I look forward to reporting our continued progress later this year."

Breakthrough cancer pain is defined as a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain. Breakthrough cancer pain occurs in the majority of patients who are already receiving chronic, long-acting opioid pain management and yet have episodes of severe tumor- and treatment-related cancer pain. Breakthrough pain occurs frequently in these patients, particularly as they try to conduct normal daily activities, with a mean number of episodes of 4 per day (range of 1-14 per day) and a median duration of 30 minutes (range of 1-240 minutes). The wide range of time to relief of these severe pain episodes leads to high levels of distress and impaired quality of life experienced by patients.

About Abstral(R) (fentanyl) Sublingual Tablets

Abstral(R) (fentanyl) Sublingual Tablets are an important treatment option for inadequately controlled breakthrough cancer pain which impact 40%-80% of cancer patients. Abstral is approved by the U.S. Food and Drug Administration, and is a sublingual (under the tongue) fentanyl tablet indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. The innovative Abstral formulation delivers the analgesic power and increased bioavailability of micronized fentanyl in a more convenient sublingual tablet which rapidly dissolves under the tongue in seconds, provides rapid relief of breakthrough pain in minutes, and matches the duration of the entire pain episode.

Important Abstral Safety Information
• There is a risk of respiratory depression, medication errors, and abuse potential with the use of Abstral. See full prescribing information for important complete black-box warning.
• Due to the risk of fatal respiratory depression, ABSTRAL is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.
• Keep out of reach of children.
• Use with CYP3A4 inhibitors may cause fatal respiratory depression.
• When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to ABSTRAL.
• When dispensing, do not substitute with any other fentanyl products.
• Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.
• ABSTRAL is available only through a restricted program called the TIRF (Transmucosal Immediate Release Fentanyl) REMS (Risk Evaluation and Mitigation Strategy) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.

About Galena Biopharma

Galena Biopharma, Inc. (GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information visit www.galenabiopharma.com.

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 progress of the commercialization of Abstral(R) and development of Galena's product candidates, including patient enrollment in our clinical trials, as well as statements about our expectations for our commercial success, plans and prospects. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2012 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2013 filed 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 press release.
 
Posted by BooDog on :
 
Galena Biopharma to Present at the 12th Annual BIO Investor Forum
GlobeNewswirePress Release: Galena Biopharma – 34 minutes ago..

GALE 2.39
PORTLAND, Ore., Oct. 4, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Mark W. Schwartz, Ph.D., Executive Vice President and Chief Operating Officer will present a corporate update at the 12th Annual BIO Investor Forum. The presentation will take place on Wednesday, October 9, 2013 at 9:00 a.m. PT at The Palace Hotel in San Francisco, CA.

About Galena Biopharma

Galena Biopharma, Inc. (GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit http://www.galenabiopharma.com.

http://www.bio.org/events/conferences/12th-annual-bio-investor-forum

http://www.bio.org/node/18766
 
Posted by Lockman on :
 
http://stockcharts.com/h-sc/ui?s=GALE&p=D&b=5&g=0&id=p25065885888

Nice Call from 2.00
chart resetting should be lots of money made here.
 
Posted by BooDog on :
 
quote:
Originally posted by Lockman:
http://stockcharts.com/h-sc/ui?s=GALE&p=D&b=5&g=0&id=p25065885888

Nice Call from 2.00
chart resetting should be lots of money made here.

Thanks!

ATM machine lock. [Were Up]

Back in yesterday, well, flipped some out on the run so added back in. Thought for sure it would go under $2 but it held on. We'll see. I like the ascending triangle on the 3 month chart anyway so it was worth the risk. The stochastic family says i'm wrong though. [Eek!] But I can live with a bit more of a dip if I am.
 
Posted by BooDog on :
 
So far so good!
 
Posted by BooDog on :
 
http://seekingalpha.com/article/1746212-will-lost-patents-force-roche-into-acqui sition-mode?source=yahoo

Will Lost Patents Force Roche Into Acquisition Mode?

Interesting article playing on Roche's patents and Galena potential.
 
Posted by BooDog on :
 
ABSTRAL
(NDA # 022510)
011 FENTANYL CITRATE GALENA BIOPHARMA Manufacturing Change or Addition 10/02/2013

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Repor ts.Supplements

Supplements to New Drug Applications (NDAs and BLAs) by Month
Supplemental approvals to NDAs and BLAs

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Searc h.DrugDetails
Drug Details

Drug Name(s) ABSTRAL
FDA Application No. (NDA) 022510
Active Ingredient(s) FENTANYL CITRATE
Company GALENA BIOPHARMA
Original Approval or Tentative Approval Date January 7, 2011
Chemical Type 3 New formulation

Review Classification S Standard review drug
 
Posted by BooDog on :
 
got a wierd pop up coming in here today lol.
diverted me. usually just get a pop up in a new window.

Anywayz, need to tell scottie GALE needs more power to hold the 50dma!
 
Posted by BooDog on :
 
Interesting AH. Thought for sure this would break support but it didn't.

[Good Luck]
 
Posted by BooDog on :
 
http://www.sec.gov/Archives/edgar/data/1390478/000139047813000031/gale-20130930x 10q.htm

Abstral showing revs early.
Galena Biopharma Reports Third Quarter 2013 Results
GlobeNewswirePress Release: Galena Biopharma – 16 minutes ago..
.
PORTLAND, Ore., Nov. 6, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (GALE), a biopharmaceutical company commercializing and developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today reported its financial results for the three and nine months ended September 30, 2013 and provided a business update.

"Our commercial success to date with Abstral(R) has been very encouraging and we are excited to report initial revenues ahead of schedule. With our sales force and commercial organization fully deployed, we continue to make significant strides with physicians, payors and patients—and expect continuing strength with the launch," said Mark J. Ahn, Ph.D., President and Chief Executive Officer. "We are also making steady progress in advancing our NeuVax(TM) and FBP cancer immunotherapy pipeline."

Third Quarter 2013 Financial Highlights

Net revenue was $1.2 million for the three months ended September 30, 2013, the first quarter of Abstral(R) (fentanyl) sublingual tablet sales, ahead of our official launch and commencement of promotional efforts in the fourth quarter. Cost of revenue and gross profit for the three months ended September 30, 2013 were $0.3 and $0.9 million, respectively.

Operating loss for the three months ended September 30, 2013 was $6.9 million, including $0.5 million in stock-based compensation charges, compared with an operating loss of $5.5 million for the three months ended September 30, 2012, which includes $0.4 million in stock-based compensation charges. For the nine months ended September 30, 2013, operating loss from continuing operations was $21.5 million compared with $15.6 million for the nine months ended September 30, 2012.

Galena Biopharma also incurred income or expense due to non-cash charges related to changes in the fair value estimates of the Company's warrant liabilities and contingent purchase price liability, as well as the realized gain from the sale of marketable securities, which is included in other income and expense. The non-cash expenses related to the changes in values of our warrant and contingent purchase price liabilities for the three months ended September 30, 2013 were $1.8 million versus $0.7 million for the three months ended September 30, 2012. These expenses for the nine months ended September 30, 2013 were $7.7 million versus $13.9 million for the nine months ended September 30, 2012. Other income from the realized gain on the sale of marketable securities was $0.8 million and $1.4 million for the three and nine months ended September 30, 2013, respectively.

Net loss for the three months ended September 30, 2013 was $9.3 million, or $0.11 per basic and diluted share, versus a net loss of $6.3 million, or $0.09 per basic and diluted share, for the three months ended September 30, 2012. Net loss for the nine months ended September 30, 2013 was $28.2 million, or $0.34 per basic and diluted share, versus a net loss (including both continued operations and discontinued operations) of $31.2 million, or $0.52 per basic and diluted share, for the nine months ended September 30, 2012.

As of September 30, 2013, Galena had cash, cash equivalents, marketable securities and net accounts receivable of $55.8 million, compared with $35.6 million as of December 31, 2012. Our marketable securities consisted of approximately 0.8 million shares of common stock in RXi Pharmaceuticals (RXII) with a market value of approximately $2.8 million as of September 30, 2013 and 33.5 million (1.1 million post reverse-stock split) shares of common stock of RXi with a market value of approximately $2.7 million as of December 31, 2012.

On May 8, 2013 Galena completed a debt financing of $15 million to fund the purchase and launch of Abstral, of which $10 million was drawn immediately and $5 million remains available.

Third Quarter and Recent Highlights
• Launched First Commercial Product: Abstral(R) (fentanyl) Sublingual Tablets for the Treatment of Breakthrough Cancer Pain. Galena acquired Abstral in March 2013 and formally launched the product in the U.S. in October. Abstral is a sublingual (under the tongue) fentanyl tablet indicated for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. Abstral can be prescribed by Risk Evaluation and Mitigation Strategy (REMS) certified healthcare professionals and is available to patients at all retail pharmacies nationwide.

• Initiated RELIEF Patient Registry for Abstral and Debuted Marketing Campaign at PAINWeek. RELIEF: Rapid Evaluation of Lifestyle, Independence, and Elimination of breakthrough cancer pain with Freedom from oral discomfort through the use of Abstral(R) (fentanyl) Sublingual Tablets. RELIEF is a post-marketing, multicenter trial to assess Abstral for breakthrough cancer pain (BTcP) in opioid-tolerant cancer patients. RELIEF is an observational registry study to be completed by enrolled patients over a thirty-day period while using Abstral for treatment of their BTcP. Approximately 2,500 patients are expected to enroll in the program.

• Strengthened leadership team with appointment of Dr. Brian Hamilton, M.D., Ph.D. to serve as Galena's Executive Vice President and Chief Medical Officer. Dr. Hamilton has extensive academic and pharmaceutical experience in immunology, hematopoietic stem cell transplantation, and oncology. Having worked in both large pharmaceutical companies such as AstraZeneca and Wyeth, as well as biotech companies such as BioVex, Soligenix, and Onyx, he has experience with drug development across multiple therapeutic indications and platforms, including small molecules, biologics, oncolytic viruses, and vaccines. He has been a partner and Vice President of Biopharm Solutions, a private consulting firm in the life sciences industry, since 2001. Dr. Hamilton received his M.D. and Ph.D. from the University of Washington School of Medicine with extensive specialty training to include Pediatrics at the Children's Medical Center in Dallas, Texas, Immunology at the Children's Hospital Medical Center and Sidney Farber Cancer Center, and Allergy at the University of California-San Francisco. He has held academic appointments at the University of Washington and the University of Miami. Dr. Hamilton will replace Rosemary Mazanet M.D., Ph.D., whose employment with Galena will conclude November 7, 2013.

• Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax(TM) Treatment) trial, under an SPA, continues to enroll at approximately 130 sites globally. Galena has partnered with Leica Biosystems to develop a reliable and reproducible HER2 companion diagnostic test to assure a uniform determination of patients' HER2 status. The diagnostic will enable HER2 0, 1+, 2+ and 3+ differentiation to ensure Galena is enrolling the appropriate patients with low to intermediate HER2 expression into the PRESENT trial, and ultimately for treatment with the NeuVax vaccine. Leica's Bond Oracle(TM) HER2 IHC System is a state-of-the-art diagnostic testing system that provides added assurance the patients enrolled in the trial have the appropriate HER2 expression level.

• Phase 2b NeuVax plus Herceptin(R) (trastuzumab; Genentech/Roche) 300 patient randomized, combination trial is enrolling at 9 sites in the US.

• Results from the Phase 1 portion of the Folate Binding Protein (FBP) trial will be presented at the Society for Immunotherapy of Cancer (SITC) conference taking place this weekend, November 7-10, 2013.

• Expanded NeuVax(TM) Intellectual Property With European Allowance. This Pharmaceutical Use Patent for NeuVax(TM) (nelipepimut-S) covers the use of NeuVax as a vaccine for the prevention of relapse in breast cancer patients with an immunochemistry (IHC) rating of 1+ or 2+ for HER2/neu protein expression and a fluorescence in situ hybridization (FISH) rating of less than 2.0 for HER2/neu gene expression. The intention to grant the patent was received in August 2013, with the official Decision to Grant received in October 2013. The patent affords protection in all of the European countries and will expire in April 2028.

• NeuVax Oral presentation at the American College of Surgeons Clinical Congress. NeuVax shown to induce a full immune response in treated patients and create an immune memory to target residual cancer cells. Additionally, the Phase 3 PRESENT HER2 1+/2+ patients confirmed as optimal treatment population.

• Completed $40 Million financing to significantly strengthen our balance sheet.

About NeuVax(TM) (nelipepimut-S)

NeuVax(TM) (nelipepimut-S) is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the U.S. 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 PRESENT trial is ongoing and additional information on the study can be found at www.neuvax.com. A randomized, multicenter investigator sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin(R) (trastuzumab; Genentech/Roche).

According to the National Cancer Institute, over 230,000 women in the U.S. are diagnosed with breast cancer annually. Of these women, only about 25% are HER2 positive (IHC 3+). NeuVax targets the approximately 50%-60% of these women who are HER2 low to intermediate (IHC 1+/2+ or FISH

About Folate Binding Protein (FBP)

Folate Binding Protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is a well-validated therapeutic target. FBP is the source of immunogenic peptides like E39 that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy preclinical FBP-expressing cancer cells. The FBP vaccine consists of the FBP peptide(s) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). Galena's FBP vaccine, E39, is currently in Phase 1/2 trial in two gynecological cancers; ovarian and endometrial adenocarinomas.

About Abstral(R) (fentanyl) Sublingual Tablets

Abstral(R) (fentanyl) Sublingual Tablets are an important treatment option for inadequately controlled breakthrough cancer pain which impacts 40%-80% of cancer patients. Abstral is approved by the U.S. Food and Drug Administration, and is a sublingual (under the tongue) fentanyl tablet indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. The innovative Abstral formulation delivers the analgesic power and increased bioavailability of micronized fentanyl in a more convenient sublingual tablet which rapidly dissolves under the tongue in seconds, provides rapid relief of breakthrough pain in minutes, and matches the duration of the entire pain episode. See full prescribing information at www.abstral.com.

About Galena Biopharma

Galena Biopharma, Inc. (GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information, visit www.galenabiopharma.com.
 
Posted by quickpicker on :
 
November 6, 2013
Galena Biopharma Reports Third Quarter 2013 Results

PORTLAND, Ore., Nov. 6, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company commercializing and developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today reported its financial results for the three and nine months ended September 30, 2013 and provided a business update.

"Our commercial success to date with Abstral® has been very encouraging and we are excited to report initial revenues ahead of schedule. With our sales force and commercial organization fully deployed, we continue to make significant strides with physicians, payors and patients—and expect continuing strength with the launch," said Mark J. Ahn, Ph.D., President and Chief Executive Officer. "We are also making steady progress in advancing our NeuVax™ and FBP cancer immunotherapy pipeline."

Third Quarter 2013 Financial Highlights

http://investors.galenabiopharma.com/releases.cfm
 
Posted by quickpicker on :
 
November 6, 2013
Galena Biopharma Reports Third Quarter 2013 Results

PORTLAND, Ore., Nov. 6, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company commercializing and developing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today reported its financial results for the three and nine months ended September 30, 2013 and provided a business update.

"Our commercial success to date with Abstral® has been very encouraging and we are excited to report initial revenues ahead of schedule. With our sales force and commercial organization fully deployed, we continue to make significant strides with physicians, payors and patients—and expect continuing strength with the launch," said Mark J. Ahn, Ph.D., President and Chief Executive Officer. "We are also making steady progress in advancing our NeuVax™ and FBP cancer immunotherapy pipeline."

Third Quarter 2013 Financial Highlights

http://investors.galenabiopharma.com/releases.cfm
 
Posted by quickpicker on :
 
Sorry for the double post .
 
Posted by BooDog on :
 
quote:
Originally posted by quickpicker:
Sorry for the double post .

Cool, looking for a double in the pps by January.

[Were Up] [Were Up] [Cool]
 
Posted by quickpicker on :
 
[/qb][/QUOTE]Cool, looking for a double in the pps by January.

[Were Up] [Were Up] [Cool] [/QB][/QUOTE]

You could be right. On the move again this am.
 
Posted by quickpicker on :
 
November 11, 2013
Galena Biopharma Announces Initial Results From the Folate Binding Protein Vaccine Phase 1 Trial at the Society for Immunotherapy of Cancer Conference

Folate Binding Protein (FBP) shown to be safe and immunogenic in its Phase 1 trial
Phase 2a trial expected to initiate by year end
PORTLAND, Ore., Nov. 11, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced a poster presentation at the Society for Immunotherapy of Cancer (SITC) Conference 2013 on November 7-10, 2013, in National Harbor, Maryland. The data presented are the results of the Phase 1 portion of the trial for the Folate Binding Protein (FBP) vaccine. FBP is a folate receptor alpha-derived, peptide-based cancer immunotherapy administered to HLA A2 positive patients in combination with granulocyte macrophage-colony stimulating factor (GM-CSF) as an adjuvant treatment to prevent recurrences in high-risk, endometrial and ovarian cancer patients rendered disease-free after completing standard of care therapy.

The poster presentation entitled "Phase 1 Trial Results of a Folate Receptor Alpha-directed Cancer Vaccine (E39) in Ovarian and Endometrial Cancer Patients to Prevent Recurrence," showed that the FBP vaccine is both safe and immunogenic. The primary outcome of the Phase 1 trial was to determine safety and the optimal dose, with a secondary outcome to look for an initial efficacy signal and immunological response. The optimal dose was determined to be 500 mcg peptide combined with 250 mcg GM-CSF. FBP proved to be well tolerated, with largely Grade 1 toxicities, primarily consisting of injection site reactions. After a median follow-up of six months, there have been 2 recurrences (13.3%; n=15) in the vaccine group vs. 4 recurrences (25%, n=16) in the control group, although the trial was not powered for any efficacy measurements.

"New approaches are needed for ovarian and endometrial cancer patients who face a high risk of disease recurrence. The initial results from the Phase 1 trial show that the FBP vaccine may be a potential cancer immunotherapy treatment to prevent recurrence in these high risk patient populations," concluded Dr. Erika J. Schneble, San Antonio Military Medical Center, San Antonio, TX who presented the results at the SITC conference.

The Phase 1 component was a 3x3, dose-escalation, safety trial enrolling disease-free endometrial and ovarian cancer, HLA-A2 positive patients into the vaccine group, while HLA-A2 negative patients were being followed prospectively as an untreated control group. Six monthly intradermal inoculations of either 100mcg, 500mcg, or 1000mcg of peptide vaccine + 250 mcg GM-CSF immunoadjuvant were administered during the primary vaccine series. Immunologic responses were assessed by both local reaction after each inoculation and by delayed-type hypersensitivity (DTH) reaction measured pre-vaccination and after the primary vaccine series. Recurrences are determined clinically. Thirty-one patients were enrolled in the Phase 1 trial: 15 in the vaccine group and 16 in the active control group. There were no significant differences in age, grade, stage, or nodal status between groups. Overall, the vaccine was well tolerated with the majority of local and systemic toxicities Grade 1 (maximum local toxicity: 93% Grade 1; maximum systemic toxicity: 60% Grade 1). Local skin reactions increased from the first to the third injections, and then plateaued for the remainder of therapy.

"We are encouraged by the initial results of our Phase 1 trial with the FBP vaccine, showing that it is well-tolerated and demonstrated promising immune responses in high risk gynecological cancers," said Mark J. Ahn, President and Chief Executive Officer of Galena Biopharma. "As a result, we are moving forward with the Phase 2a component which will be initiated by year end and will include the enrollment of additional patients at the optimal dose as well implementing a booster regimen."

About Folate Binding Protein (FBP)

Folate Binding Protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is a well-validated therapeutic target. FBP is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy presenting FBP-expressing cancer cells. The FBP vaccine consists of the FBP peptide(s) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF). Galena's FBP vaccine is currently in a Phase 1/2 trial in two gynecological cancers: ovarian and endometrial adenocarcinomas.

About Ovarian/Endometrial Cancers

Ovarian cancer occurs in over 22,000 patients per year in the U.S. and is the most lethal gynecologic cancer. Despite the incidence of ovarian cancer being only approximately 20% of that of breast cancer, the number of patients that die from ovarian cancer is nearly 50% of that of breast cancer. Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease. These patients have their tumors routinely surgically debulked to minimal residual disease, and then are treated with platinum- and/or taxane-based chemotherapy. While most patients respond to this treatment regimen 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.

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. There are two basic types of endometrial cancer: endometriod and papillary serous. The latter has a much more aggressive clinical course and the majority of these patients will die of this form of the disease.

About Galena Biopharma

Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit: www.galenabiopharma.com.

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 preliminary results Galena's clinical trials and planned additional trials. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2012 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 filed 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 press release.

CONTACT: Remy Bernarda

Senior Director, Communications

(503) 405-8258

rbernarda@galenabiopharma.com
 
Posted by a surfer on :
 
quote:
Originally posted by BooDog:
quote:
Originally posted by quickpicker:
Sorry for the double post .

Cool, looking for a double in the pps by January.

[Were Up] [Were Up] [Cool]

Way to go Boo!!
 
Posted by Lockman on :
 
http://stockcharts.com/h-sc/ui?s=GALE&p=D&b=5&g=0&id=p55004897676

Nice chart
 
Posted by BooDog on :
 
Thanks Surf! Good to see you!


Galena Biopharma, Inc. After Hours Trading


GALE
$2.74
*
0.06

2.24%

Read more: http://www.nasdaq.com/symbol/gale/after-hours#ixzz2kUEKn6vD


Believe it or not, Bob did say that allstocks is getting over 10k hits per day. I am about 2 - 5 of those. AND, now I have to wait until around 4 to be able to post on forums because of my work. At least for a short time.
So, there are plenty that still visit and don't post ~ certainly above what's going on in the OFF Topic threads! Just sayin, be nice to see more active on the stocks than getting hung up on the real bs that's going on in the world. [Big Grin]


Cheers.

I hope everyone fairs well going into the holiday season.

And thanks to all my fellow vets, past and present. An extra toast of malt to all of you.
 
Posted by BooDog on :
 
Nice day for GALE, good time to take some off the table.

Pushing into the power zone too.

IMO
 
Posted by BooDog on :
 
quote:
Originally posted by BooDog:
Nice day for GALE, good time to take some off the table.

Pushing into the power zone too.

IMO

Did take some off yesterday over $3 [Were Up]

Now to pick them back up before it really takes off. I like to see the runners get back inside the bollingers and maybe even fill their gaps.
Gap @ 2.70 and back in the bollingers @ 2.81.
Pre market starts @ 6am.
[Cool]

[Good Luck]
 
Posted by BooDog on :
 
A LOT of FUN today, and yes, pocketed some nice green for Christmas shopping!

[Were Up] [Were Up] [Were Up]

HOD 4.1642

arca accumulated big time trying to build a short (I'm just guessing) for a pull back Monday.

Nice break out though and I'll keep a few freebies to see what happens. The higher it goes the further out I take the chart for resistance targets. Out to a 5 year chart now.

Good luck!

http://app.quotemedia.com/quotetools/chartcache/71614.png
 
Posted by quickpicker on :
 
November 26, 2013
Galena Biopharma to Present at the 25th Annual Piper Jaffray Healthcare Conference

PORTLAND, Ore., Nov. 26, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Mark J. Ahn, Ph.D., President and Chief Executive Officer will present a corporate update at the 25th Annual Piper Jaffray Healthcare Conference. The presentation will take place on Tuesday, December 3, 2013 at 8:10 a.m. ET at The New York Palace Hotel in New York, NY.

The presentation will be webcast and available on the Investors section of the Company's website at www.galenabiopharma.com.

About Galena Biopharma

Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit: www.galenabiopharma.com.

CONTACT: Remy Bernarda

Senior Director, Communications

(503) 405-8258

rbernarda@galenabiopharma.com
 
Posted by quickpicker on :
 
December 4, 2013
Galena Biopharma to Present at the Oppenheimer 24th Annual Healthcare Conference

PORTLAND, Ore., Dec. 4, 2013 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Mark J. Ahn, Ph.D., President and Chief Executive Officer, will present a corporate update at the Oppenheimer 24th Annual Healthcare Conference. The presentation will take place on Tuesday, December 10, 2013 at 10:55 a.m. ET at the Crowne Plaza Hotel in New York, NY.

The presentation will be webcast and available on the Investors section of the Company's website at www.galenabiopharma.com.

About Galena Biopharma

Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit: www.galenabiopharma.com.

CONTACT: Remy Bernarda

Vice President, Marketing & Communications

(503) 405-8258

rbernarda@galenabiopharma.com

Close window | Back to top
 
Posted by BooDog on :
 
Hey quickpicker. lol

Guess I have a case of CRS (can't remember ....)

I'm riding free on GALE for now, waiting to see if it tests better support. Recovered pretty well today. Still watching to see if it dips closer to $4 or even a touch under.
 
Posted by BooDog on :
 
Here's the dip my alerts were going off one after another lol 3.86's filled, should have tried for some lower.
We'll see how it holds up.
 
Posted by quickpicker on :
 
Watching this closely today as well.
 
Posted by BooDog on :
 
Not a bad day really. If todays lod of 3.78 hold and this goes sideways a bit I think it'll be good to go waiting on the story to pan out going into January.

I keep typing 1.whatever.... not use to posting on stocks over the $. lmao I keep correcting before posting though at least.
 
Posted by BooDog on :
 
AH trading. Almost $15mln @ 17:21 in one trade.
http://www.nasdaq.com/symbol/gale/after-hours

Dec. 19, 2013 Market Close: $ 4.03
 
Posted by Lockman on :
 
http://stockcharts.com/h-sc/ui?s=GALE&p=D&b=5&g=0&id=p53251543269

Looks like it's ready to turn up soon, 4.00 entry
4.50 exit...
 
Posted by BooDog on :
 
GALE entering the power zone.

[Were Up] [Cool]
 
Posted by BooDog on :
 
took some $$$ off gale 5.09 - 5.15 keeping some
[Were Up] [Were Up]
 
Posted by BooDog on :
 
Last

Change / % Change

Dividend Yield

Volume

Avg Volume (10 day)

S&P Capital IQ Ranking


6.24 0.88 16.42% 0.00% 25,428,843 6.2M No Ranking


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Latest News Headlines for Galena Biopharma Inc


Galena Biopharma Enrolls First Patient In GALE-301 (Folate Binding Protein (FBP)) Cancer Immunotherapy Phase 2 Clinical Trial In Ovarian Cancer1 days 11 hours 39 minutes ago - Dow Jones News
Dow Jones News has only provided a headline at this time.

Galena Biopharma Enrolls First Patient in GALE-301 (Folate Binding Protein (FBP)) Cancer Immunotherapy Phase 2 Clinical Trial in Ovarian Cancer1 days 11 hours 39 minutes ago - GlobeNewsWire via Dow Jones News
Galena Biopharma Enrolls First Patient in GALE-301 (Folate Binding Protein (FBP)) Cancer Immunotherapy Phase 2 Clinical Trial in Ovarian Cancer PORTLAND, Ore., Jan. 7, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced the first patient has been enrolled in the Phase 2 trial for GALE-301 (Folate Binding Protein (FBP) vaccine). GALE-301 is a folate receptor alpha-derived, peptide-based cancer immunotherapy administered to HLA-A2 positive patients in combination with granulocyte macrophage-colony stimulating factor (GM-CSF) as an adjuvant treatment to prevent recurrences in high-risk, endometrial and ovarian cancer patients rendered disease-free after completing standard of care therapy.
View more recent headlines


Latest Annual and Quarterly SEC Filings
More Filings

10-KMarch 12, 2013
This report contains detailed information about the company's business finances and management.

10-QNovember 6, 2013
Quarterly reports contain financial statement, a discussion from management and a list of company events (stock splits, acquisitions, etc.)


Company Background

Galena Biopharma, Inc. (Galena), formerly RXi Pharmaceuticals Corporation, is a biotechnology company focused on discovering, developing and commercializing therapies addressing unmet medical needs using targeted biotherapeutics. The Company is pursuing the development of cancer therapeutics using peptide-based immunotherapy products, including its main product candidate, NeuVaxTM (E75), for the treatment of breast cancer and other tumors. 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). The Company's Phase 2 trial of NeuVax achieved its primary endpoint of disease-free survival (DFS). On April 13, 2011, the Company completed its acquisition of Apthera, Inc.,(Apthera).

http://www.galenabiopharma.com/


Bid/Size

Ask/Size


6.26 / 100 6.28 / 700


Price Open

Previous Close


5.52 5.36


Day High

Day Low


6.84 5.50
 
Posted by BooDog on :
 
Galena Biopharma, Inc. After Hours Trading


GALE
$6.38
*
0.34
negative
5.63%

Read more: http://www.nasdaq.com/symbol/gale/after-hours#ixzz2pxEHy1CC

rockin and rollin.
 
Posted by BooDog on :
 
GALE pre market gone wild. Low 2.50.
 


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