Galena Biopharma positive data from Phase 2

Galena Biopharma (WKN: A1JLGN)

 

Galena  Biopharma Presents Positive NeuVax(TM) Clinical Results at the 26th  Annual Meeting of the Society for Immunotherapy of Cancer

       

 

LAKE OSWEGO, Ore., Nov. 4, 2011 (GLOBE NEWSWIRE) -- Galena Biopharma (Nasdaq:GALE),  a biotechnology company focused on developing innovative, targeted  oncology treatments that address major unmet medical needs to advance  cancer care, announced that positive data from Phase 2 clinical trials  of NeuVax™ was presented today at the 26th Annual Meeting of the Society  for the Immunotherapy of Cancer. The event is being held November 4-6,  2011 at the Bethesda North Marriott Hotel & Conference Center in  North Bethesda, Maryland. 

     

The abstract entitled: "Vaccination with the HER2-derived E75 peptide  vaccine in breast cancer patients may confer greater benefit to patients  with less aggressive disease," was presented by Alan K. Sears, MD et  al. The Phase 2 trials evaluated the NeuVax (the HER2-derived E75  peptide) vaccine in breast cancer patients in the adjuvant setting. The  results suggested that patients with less aggressive disease traits may  derive greater clinical benefit from vaccination and have lower rates of  breast cancer recurrence. These included vaccinated patients with node  negative disease, lower levels of HER2 expression, lower grade tumors,  hormone receptor positivity, or lower Adjuvant! Online scores.  This  analysis is part of the continued focus on the targeting of active  cancer immunotherapies to patients with a lower bioburden of  disease. This strategy is the cornerstone of the development strategy  for NeuVax, and represents a potent pathway for the development of the  next generation of cancer vaccines.

     

A total of 187 patients were enrolled in the combined trials  (vaccine=108, control=79). Patients enrolled in the trial were node  positive or high-risk node negative breast cancer patients with any  level of HER2 expression (IHC 1+, 2+, or 3+), and rendered disease-free  after standard adjuvant therapies. With 60 months median follow-up, the  vaccine group experienced a 10.6% recurrence rate compared to 20.3% in  the control group (48% risk reduction, p=0.098). Recurrence rates for  vaccine and control patients with different disease features (nodal  status, HER2 expression, tumor grade, and hormone receptor status) were  also analyzed. 

     

"The results presented today show additional evidence that NeuVax may  provide a meaningful clinical benefit in patients with less aggressive  forms of breast cancer, and potentially keep them free of their disease,  a clear unmet medical need," said Mark J. Ahn, PhD, President and  CEO. "It is important to note that this study included an expanded  population from the patients we are targeting for our Phase 3  trial. Even with this larger and more diverse group of patients, NeuVax  continued to show almost a 50 percent improvement over the control  group."

     

Phase 2 trials were conducted giving the HER2-derived E75 peptide  vaccine to breast cancer patients in the adjuvant setting. E75  (HER2:p369-377) is an immunogenic HLA-A2/A3-restricted peptide from the  extracellular domain of the HER2 protein, and was combined with GM-CSF  (immunoadjuvant) for the trial.  HLA-A2/A3+ patients were vaccinated  with E75+GM-CSF while HLA-A2/A3- patients served as controls. The  vaccine was given as 4-6 monthly intradermal inoculations, and the  primary endpoint of the trial was disease-free survival. 

     

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.

     

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 benefits of the transactions recently announced by Galena  and the timing of the proposed partial spin-off of its RXi subsidiary,  as well as statements about expectations, plans and prospects of the  development of Galena's 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.

CONTACT: Madeline Hatton          Toll free: +1 (855) 855-GALE (4253), ext. 109          info@galenabiopharma.com           or           Remy BernardaIR Sense, LLC          +1 (503) 400-6995          remy@irsense.com

                             

Source: Galena Biopharma

 

 

http://pdf.reuters.com/htmlnews/...ml:reuters.com:20140214:nGNXUZVGHa

 

http://www.prnewswire.com/news-releases/...-inc---gale-245577261.html

p.s. Die Kanzlei dürfte u.a. Ariad-Shareholdern (und nichts nur denen) bestens bekannt sein...

 

http://wallstcheatsheet.com/business/stock-news/...s-a-good-buy.html/

p.s. Schätze aber, durch die Pomerantz-Geschichte könnte es kurzfristig weiter gen Süden gehen. Nur meine Meinung und keine Empfehlung... ;-)

 

Danke für den Hinweis. Das ist die Stellungnahme vom CEO Mark Ahn, die m.E. schon viel früher hätte kommen müssen...  

Ja, aber 1. hätte man das mit der "Stock Promotion" ein wenig ausführlicher "erklären" sollen und 2. kennst Du als Ariad-Aktionär sicherlich auch die Pomerantz-"Maschinerie", denn der Stock Alert dürfte noch heute Abend um die ganze Welt gehen. Werde am WE noch einmal alles überdenken, ein weiterer Rücksetzer durch die Pomerantz-Geschichte  wäre für mich durchaus interessant, um evtl. wieder mit einer Trading Posi einzusteigen...  

So ist es. War ja auch nur eine Frage der Zeit, bis die erste Anwaltskanzlei mit dem Versuch eine Sammelklage aufzustellen, an die Öffentlichkeit geht. Aber ohne mich....-:).
Wegen des Feiertages "Washington´s Birthday" am Montag, bleiben die Börsen in den USA geschlossen. Mal sehen, was nachhaltig passiert  

inwiefern werden die Amerikaner auf den Zug von Fred und Jim aufsteigen? Die Psychologie ist jedenfalls grad ein Feind von Galena. biotech  

über die Klagen diskutiert wird.

Ist fast bei jeder Ami Aktie so, dass nach großen Kursanstiegen und entsprechenden Rücksetzern Klagen kommen, wenn es auch nur gewisse Hinweise auf Insideraktionen gibt.

Da sind die Amis völlig bekloppt btw. die oben eingestiegenene schlechte Verlierer.

Werde Montag eine Position aufbauen, das gröbste ist überstanden und der Anstieg hatte ja entsprechende Spekulationen als Grundlage.

Lasst mal das lange WE in Amerika vorbei sein, tippe Dienstag auf eine deutliche Kurserholung und dann wird wieder alles rosarot gesehen.

Intraday ist am Freitag doch schon die Talsohle durchschritten worden.

Mien Tipp Ende: Ende der Woche steht der Kurs zwischen 4,5-5 Dollar !  

http://seekingalpha.com/article/...l_rt_article_readmore&uprof=51

p.s. Vielleicht könnte VanZant zu den inhaltlichen Aspekten etwas schreiben... ;-)

 

Ich möchte hier einmal auf mein Posting vom 7.2. verweisen. Offenbar haben die Galena-Direktoren ein "gutes Näschen" für Investments, denn Kindred Biopharma befindet sich seit dem Einstieg im Höhenflug... ;-)  

Werde mir den Artikel genauer durchlesen. Möchte die Patientendaten zu der rezidivfreien Zeit ganz gerne mit unseren Patientendaten (unabhängig davon, ob die Patientinnen an einer klinischen Studie teilgenommen haben oder nicht) vergleichen. Melde mich noch mal ausführlicher dazu....  

Danke. Hast Du Dir evtl. mal diese Kindred-Firma angeschaut? Heute schon wieder fast 5 Prozent im Plus. Schon seltsam das Ganze...  

Wer bei Kindred investiert, muß ein wirklicher Tierliebhaber sein.... Ehrliche Antwort von mir: nicht so mein Ding. Aber auch ich habe mich bei einem "wow" ertappt, der Kurs hebt wirklich ab....  

http://seekingalpha.com/article/...l_rt_article_readmore&uprof=51

 

... da muß ich nicht mal meine Datenbank filtern um zu erkennen, daß die Erkrankungsfreie Überlebenszeit in den beiden Gruppen keinen signifikanten Unterschied macht..  Das ist halt das Problem bei klinischen Studien, wenn man sich Endpunkte über einen begrenzten Zeitraum setzt. Viel wichtiger sind m.E. langjährige Follow up Beobachtungen der Patienten, um einen Aussagekräften Beweis zu erhalten, ob NeuVax anderen Therapieformen wirklich überlegen ist... (das soll ja mit der Phase 3 Studie untersucht werden...).  

Unabhängig davon, wie die Sammelklagen im Einzelnen zu bewerten sind: der Aktienkurs rauscht weiter gegen Süden... . Neuvax betreffend kommt Mark Ahn, GALENA immer mehr in Erklärungsnot. Bleibt nur noch zu hoffen, das mit der Marktexpansion für Abstral sublingual die Verkaufserlöse gesteigert werden können.
Ich habe vor einigen Wochen hier in diesem Thread Galena Biopharma eine ähnliche Erfolgsgeschichte wie Insys Therapeutics zugetraut. Davon ist Galena Biopharma meilenweit entfernt....  

http://online.barrons.com/article/...od=rss_barrons_most_emailed_week

Und als Zuschlag, falls noch nicht bekannt:
Get your opiates for free: Capitalism meets the zombie apocalypse
http://brontecapital.blogspot.de/2014/02/...-for-free-capitalism.html  

Pardon, jetzt mit richtiger Linkszuordnung:

An Insider's Tale of a Stock Promotion Plan
http://online.barrons.com/article/...od=rss_barrons_most_emailed_week

Behind The Scenes With Dream Team, CytRx And Galena
http://seekingalpha.com/article/...s-with-dream-team-cytrx-and-galena

Get your opiates for free: Capitalism meets the zombie apocalypse
http://brontecapital.blogspot.de/2014/02/...-for-free-capitalism.html  

Source: sec.gov, 17-MAR-2017, after hours

http://www.sec.gov/Archives/edgar/data/1390478/...e-20131231ex991.htm  

Jul 1, 2014

Galena Biopharma Receives Notice of Allowance of Broad U.S. Patent for NeuVax(TM) (nelipepimut-S)
Allowed Claims Cover the Use of NeuVax Alone or in Combination to Prevent Recurrence of Any Her2/neu Expressing Tumor Having a FISH Rating of Less Than About 2.0

PORTLAND, Ore., July 1, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (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 notice of allowance of a U.S. Patent for NeuVax? (nelipepimut-S) covering the use of NeuVax alone or in combination to prevent recurrence of any HER2/neu expressing tumor having a fluorescence in situ hybridization (FISH) rating of less than about 2.0. NeuVax is a peptide immunotherapy for the prevention of cancer recurrence and is Galena's lead development agent in multiple ongoing and planned clinical trials. Once issued, the patent will expire in 2028, not including any patent term extensions.

FISH is a diagnostic test used to identify patients with high levels of HER2 gene expression, or FISH greater than 2.0. These patients are eligible for existing approved HER2-directed treatments. Currently there are no approved HER2-directed therapies for patients who express lower levels of HER2, or less than 2.0 by the FISH testing scale.

The patent will cover the use of NeuVax in patients with a FISH of less then about 2.0, as a stand-alone therapy or in combination with an adjuvant and/or other agents (e.g. other drugs such as Herceptin® (trastuzumab; Genentech/Roche)). Importantly, this NeuVax patent provides Galena with coverage for any tumor expressing low-to-intermediate levels of HER2.

"This allowance further strengthens our broad patent estate for NeuVax, covering all tumor types expressing low-to-intermediate levels of HER2 both as a monotherapy and in combination with other agents," said Mark J. Ahn, Ph.D., President and Chief Executive Officer. "Our clinical development program with NeuVax continues to grow with ongoing and planned clinical trials in breast and gastric cancers. We look forward to completing enrollment in our Phase 3 PRESENT trial this year and advancing NeuVax in other programs to prevent cancer recurrence for patients."

About NeuVax? (nelipepimut-S)

NeuVax? (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-S 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® (trastuzumab; Genentech/Roche).

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 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 development of Galena's NeuVax product candidate,  as well as statements about our expectations, 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, 2013 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements.  

Jul 22, 2014
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Galena Biopharma Enters Into Definitive Agreement to License U.S. Rights for Zuplenz(R) (ondansetron) Oral Soluble Film

   Novel, rapidly dissolving oral PharmFilm® enables faster absorption, increased convenience and better compliance for patients.
   Planned launch in multiple indications?chemotherapy-, radiation- and post operative-induced nausea and vomiting?in early 2015.
   FDA-Approved product to be added to Galena's established oncology commercial team.

PORTLAND, Ore., July 22, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced it has entered into a definitive agreement to license the U.S. rights for the commercial product Zuplenz® (ondansetron) oral soluble film. The asset was licensed from MonoSol Rx, LLC, the developer of the oral soluble film technology, PharmFilm®, and manufacturer of the product.

Zuplenz was approved in 2010 by the U.S. Food and Drug Administration (FDA) in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV).  Zuplenz is also approved in pediatric patients for moderately emetogenic CINV. Nausea and vomiting are two of the most common side-effects experienced by post-surgery patients and patients receiving chemotherapy or radiation. It is estimated that up to 90% of chemotherapy and up to 80% of radiotherapy patients will experience CINV and RINV respectively.

The active pharmaceutical ingredient in Zuplenz, ondansetron, is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron belongs to a class of medications called serotonin 5-HT3 receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.  According to data from Wolters Kluwer, the oral 5-HT3 market exceeds $1 billion in the U.S.

Zuplenz utilizes MonoSol Rx's proprietary PharmFilm® technology, an oral soluble film that dissolves on the tongue in less than thirty seconds. This rapidly dissolving, oral soluble film eliminates the burden of swallowing pills during periods of emesis and in cases of oral irritation, therefore increasing patient adherence and reducing emergency room visits and hospitalization due to a lack of patient compliance or the patient's inability to keep the medication down without vomiting. Zuplenz is supplied in both 4 mg and 8 mg ondansetron doses with a safety profile equivalent to other products in the class.

"We believe the innovative product benefits of Zuplenz, combined with our experienced oncology sales team, will create significant acceleration and leverage to our commercial product portfolio," said Mark J. Ahn, Ph.D., President and Chief Executive Officer of Galena Biopharma. "Our commercial franchise was established last year with the acquisition of Abstral® for the treatment of breakthrough cancer pain. Adding Zuplenz to our commercial portfolio enhances our offering of supportive care products that are simple to take and provide reliable dosing to improve the quality of life for patients suffering from cancer or recovering from surgery and the associated side-effects."

Galena has entered into an exclusive license and supply agreement with MonoSol Rx, the effectiveness of which is subject to the court approval of a settlement that MonoSol Rx has reached with a former licensee of Zuplenz.  Under the terms of the license agreement, upon effectiveness of the license and transfer to Galena of the New Drug Application (NDA) for Zuplenz, Galena will pay MonoSol Rx a total of $5,000,000 in cash and stock. The license agreement also provides for fixed double-digit royalties on net sales and pre-specified, one-time sales milestones. Zuplenz has issued and pending U.S. patent applications with an anticipated expiration date of 2029. Galena expects to launch Zuplenz in early 2015.

"MonoSol Rx has established our proprietary PharmFilm technology in multiple approved and pipeline products, including Zuplenz and Suboxone®. We believe Galena's established, oncology focused commercial team understands the advantages of our PharmFilm technology and can successfully commercialize Zuplenz in all three indications," concluded, A. Mark Schobel, Co-President and CEO of MonoSol Rx.

About Zuplenz® (ondansetron) Oral Soluble Film

Zuplenz® (ondansetron) Oral Soluble Film is approved by the U.S. Food and Drug Administration (FDA).  Zuplenz is approved in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved in pediatric patients for moderately emetogenic CINV. Nausea and vomiting are two of the most common side-effects experienced by post-surgery patients and patients receiving chemotherapy or radiation.

Zuplenz utilizes the proprietary PharmFilm® technology as an oral soluble film that dissolves on the tongue in under 30 seconds.   This rapidly dissolving film eliminates the burden of swallowing pills during periods of emesis and in cases of oral irritation, therefore increasing patient adherence and reducing emergency visits and hospitalization due to a lack of patient compliance or the patient's inability to keep their treatment down without vomiting.  Zuplenz is supplied in both 4 mg and 8 mg ondansetron doses with a safety profile equivalent to other products in the class.

About Chemotherapy-, Radiation- and Post Operative-Induced Nausea and Vomiting

It is estimated that up to 90% of patients receiving chemotherapy experience CINV and up to 80% of patients undergoing radiotherapy will experience RINV. For patients, CINV/RINV is among the most feared and distressing side effects, and uncontrolled or poorly controlled CINV/RINV can cause patients to be malnourished or dehydrated, have electrolyte imbalances, or experience physical and mental deterioration. In extreme cases, patients may choose to discontinue beneficial therapy because of this side effect.

Postoperative nausea and vomiting (PONV) is one of the most commonly occurring complications as a result of anesthesia and/or the pain medications given during surgery. PONV results in high levels of patient discomfort and dissatisfaction, and can result in increased recovery room time, expanded nursing care, and potential hospital admission?all factors that may increase total health care costs.

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to develop products which address the unmet needs of patients. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs.  The Company's leadership in film drug delivery is supported by strong intellectual property, a pipeline of prescription formulations based on PharmFilm® technology, and two FDA approvals - Zuplenz®, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® sublingual film, the first sublingual film product for the treatment of opioid dependence. For press releases and other company information visit www.monosolrx.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 visit www.galenabiopharma.com.  

Jul 29, 2014
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Galena Biopharma to Report Second Quarter 2014 Financial Results on Monday, August 11, 2014

PORTLAND, Ore., July 29, 2014 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (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 the Company will report its second quarter financial results on Monday, August 11, 2014 after the close of the financial markets. The company will host a conference call following the announcement at 2:00 p.m. P.T./5:00 pm E.T. to discuss financial and business results.

The conference call can be accessed by dialing (844) 825-4413 toll-free in the United States, or (973) 638-3403 for participants outside the U.S. The Conference ID number is: 78727492. The conference call will also be webcast live and available under the Investors section/Events and Presentations on the Company's website at www.galenabiopharma.com. The archived webcast replay will be available on the Company's website for 90 days.  

http://www.thestreet.com/story/12852344/1/...-promotions-scandal.html

Feuersteins Vermutung, dass das im Zusammenhang mit der "stock promotion" steht, liegt natürlich sehr nah. Mal sehen, wie der Kurs heute reagiert...

 

...über die aktuelle finanzielle Lage von Galena:

http://www.fool.com/investing/general/2014/10/20/...out-of-money.aspx

Dazu dann auch der aktuelle Quartalsbericht:

http://investors.galenabiopharma.com/...sedetail.cfm?ReleaseID=880023