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
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www.streetinsider.com/Press+Releases/...herapy+of+Cancer/6914680.html
Additional clinical study expands potential uses for NeuVax(TM) in combination treatments.
LAKE OSWEGO, Ore., Nov. 28, 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, today announced a clinical development collaboration with Genentech/Roche and The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) to develop NeuVax(TM) (E75) in combination with Herceptin(R) (trastuzumab; Genentech/Roche) in adjuvant breast cancer patients currently not eligible for Herceptin therapy.
Under the terms of the collaboration, Genentech and Galena will sponsor a randomized, blinded multicenter Phase 2 clinical study in adjuvant breast cancer in approximately 300 patients, scheduled to be initiated in the first half of 2012. Clinical studies presented by Galena Biopharma at the American Society of Clinical Oncology meeting in June 2011 demonstrated promising results of NeuVax in combination with Herceptin in preventing breast cancer recurrences.
"Trastuzumab has been a breakthrough treatment for breast cancer patients and has clinically validated the HER2 target, yet only addresses 25% of HER2 positive breast cancer patients," stated COL George E. Peoples, MD, FACS, Director, Cancer Vaccine Development Program; Deputy Director, United States Military Cancer Institute; Professor (adjunct), Surgical Oncology, M.D. Anderson Cancer Center; Professor, Surgery, Uniformed Services University; Chief, Surgical Oncology, Brooke Army Medical Center (BAMC). "The combination use of NeuVax with Herceptin may expand the use of both products to the remaining 75% of low-to-intermediate HER2+ patients currently not eligible to receive Herceptin therapy. Furthermore, this trial may provide confirmation data of a synergistic effect of the combination that may also extend to those patients already eligible for Herceptin."
"We are excited about collaborating with Genentech/Roche and The Henry M. Jackson Foundation to explore the combination of NeuVax and Herceptin," commented Mark J. Ahn, PhD, President and CEO of Galena Biopharma. "The potential to expand on our upcoming Phase 3 program, as well as the validation of NeuVax by a leading biopharmaceutical company, continues to build value for patients and shareholders."
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(R) (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.
MFG
Chali
The presentation will be webcast and available on the Investors section of the Company's website at www.galenabiopharma.com.
MFG
Chali
Galena’s lead product candidate for cancer immunotherapy is NeuVax, which is a peptide-based immunotherapy to reduce the recurrence of breast cancer in node-positive, low-to-intermediate HER2-positive breast cancer patients not eligible for Herceptin.
Galena Biopharma recently licensed worldwide rights to develop and commercialize a Folate Binding Protein-E39 (FBP) targeted vaccine to prevent recurrence in gynecological cancers such as ovarian and endometrial adenocarcinomas. The FBP vaccine was licensed from The University of Texas M D Anderson Cancer Center and Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF).
Pivotal Phase III Trial will be Initiated in 1H2012 for NeuVax
On September 12, 2011, Galena announced a clinical trial update on its lead program, NeuVax (E75 peptide vaccine with GM-CSF adjuvant), a cancer immunotherapy targeted for low-to-intermediate HER2 expressing breast cancer patients not eligible for trastuzamab (Herceptin).
Galena received official notification from the U.S. Food and Drug Administration (FDA) that the Chemistry, Manufacturing, and Controls (CMC) partial clinical hold has been lifted. Galena has satisfied all requirements specified by the FDA and has initiated a clinical trial material manufacturing plan to remain on schedule to meet the planned trial start date.
The CMC partial clinical hold has been lifted by the FDA, allowing the pivotal Phase 3 trial to commence.
Galena has assigned a principal investigator and initial IRB approvals received--going to 100 trial sites in the US, Canada, and Europe.
CRO Aptiv Solutions has been engaged and international trial operations are underway for the initiation of the Phase 3 PRESENT study in the first half of 2012.
Along with the clinical trial hold lift, Galena has made other significant developments in preparation for the Phase III trial initiation:
Dr. Beth Mittendorf, Assistant Professor, Department of Surgical Oncology, University of Texas M. D. Anderson Cancer Center, has been selected as a principal investigator for the trial.
Conditional Institutional Review Board (IRB) approval from two key trial sites has been received to allow for initiation of the trial, with additional worldwide sites expected to open shortly. It is anticipated that the trial will encompass approximately 100 trial sites in the U.S., Canada, and Europe.
Galena has engaged the Clinical Research Organization (CRO) Aptiv Solutions to manage the trial and clinical operations are on track for PRESENT to commence in the first half of next year.
Galena plans to initiate Phase III PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study in the first half of 2012 under a Special Protocol Assessment (SPA).
Positive NeuVax Phase II Results Reported After 36 Months of Follow-Up
On June 6, 2011, Galena Biopharma announced updated data from its Phase II clinical trial of NeuVax™ at the American Society of Clinical Oncology (ASCO) annual meeting.
Galena is developing NeuVax for the adjuvant treatment of low to intermediate HER2 expressing breast cancer. The NeuVax Phase II trials enrolled 182 patients, including node positive and node negative, HER2 1+, 2+ and 3+ patients. All patients received standard of care (SoC) therapy and were confirmed to be disease-free prior to enrollment. Following enrollment, eligible patients were administered the NeuVax vaccine once a month for six months, followed by booster shots one every 6 months thereafter. The efficacy endpoint for the trial was disease free survival (DFS).
Key highlights from the Phase II trial include:
Statistically significant increase in disease free survival at 36 months in the NeuVax treated group vs. the control group for the planned Phase III patient population (p=0.035). The vaccine treated group showed no recurrences of cancer (0% recurrence rate), while the control group demonstrated a 22% recurrence rate which is consistent with historical norms. The planned Phase III patient population as defined in the FDA approved Special Protocol Assessment includes breast cancer patients who are node positive, have low to intermediate HER2 expression (HER2 1+ and 2+ by IHC), are HLA A2+ & A3+ and who are disease free following standard of care therapy.
An excellent safety profile, with no serious adverse events related to drug reported to date. All adverse events reported were minor and resolved within 24 hours.
In the ITT (intent to treat) population who received all ranges of doses and schedules, the low to intermediate HER2 expressers continued to show significant activity in improvement of DFS (p=0.045), with the vaccine group demonstrating a reduction of 66% in relative risk for recurrence. This data demonstrates strong support for targeting of low to intermediate HER2 expressers, a group for which there is currently no HER2 directed therapies.
The optimally dosed (1 milligram of E75 plus 250 micrograms of GM-CSF) group continues to demonstrate superior efficacy compared to sub-optimal doses (varying doses from 100 – 500 micrograms E75 plus 125 – 500 micrograms GM-CSF), with a recurrence rate of 3% for the optimally dosed group vs. 12% for the sub-optimally dosed group and 14% for the control group.
The above 36-monthy follow-up data are very encouraging, which underscore the potential for cancer immunotherapy to develop into potent and well tolerated targeted therapies. The positive results are the basis for the planned Phase III PRESENT trial.
Positive Results from Combination of NeuVax and Trastuzumab May Expand NeuVax Indication
On June 8, 2011, Galena presented Phase II efficacy results for NeuVax™ in combination with trastuzumab (Herceptin®; Genentech/Roche) at the ASCO annual meeting.
Data from two combination Phase II breast cancer trials were analyzed. One combination trial is NeuVax (E75) + Tz (trastuzumab); another combination trial is Vaccine X + Tz. Vaccine X is also a HER2-derived vaccine. A total of 283 patients have enrolled in the two trials (E75=187, Vaccine X=96). Overall median length of follow-up is 48 months (E75=57 months, Vaccine X=19 months).
Of 187 patients enrolled in the E75 trial, 108 patients were vaccinated with E75 + GM-CSF; 79 patients were in the control arm. Of the 187 total patients, 15 (8%) received adjuvant Tz therapy (the E75 trial was primarily conducted prior to the widespread acceptance of Tz as standard of care adjuvant therapy for HER2-overexpressing breast cancer).
In the Vaccine X trial, 41 patients were vaccinated with Vaccine X + GM-CSF while 55 patients were given GM-CSF alone (control arm). Of these 96 patients, 47 (49%) received adjuvant Tz therapy.
Of the patients who received adjuvant Tz treatment, 32 received no vaccine, and their recurrence rate is 12.5% (4/32)—comparable with reported rates of similarly staged and treated patients. In contrast, 30 patients received either E75 + GM-CSF (12) or Vaccine X + GM-CSF (18) after completing adjuvant Tz, with a recurrence rate of 0% (0/30) (p=0.064).
(Click to enlarge)
These preliminary results indicate the potential for NeuVax combined with Tz therapy for the improved treatment for HER2 3+ breast cancer patients. The data may provide another indication for NeuVax in the treatment of HER2 3+ breast cancer patients. Combination of NeuVax and trastuzumab represents a potential expansion of the market for NeuVax to HER2 3+ breast cancer patients in the adjuvant setting.
A Phase II Combination Trial is Planned in 1H12
Based on the preliminary positive results, GALE plans to initiate a Phase II trial in the 1H2012. The FDA has approved the trial in January 2012.
The planned Phase II trial is being funded by Galena Biopharma and Genentech/Roche through the Henry M. Jackson Foundation. Each company will provide their respective drugs for the 300 patient trial and approximately half of the funding necessary to complete the trial. The trial will be conducted at twenty sites worldwide and is expected to commence in the first half of 2012.
This trial will enroll 300 breast cancer patients with HER2 low-expressing tumors in order to establish the benefit of the combination versus trastuzumab alone in the adjuvant setting.
The study will be a multi-center, prospective, randomized, single-blinded Phase II trial evaluating NeuVax + trastuzumab (vaccine) vs. trastuzumab + GM-CSF (control) alone in the adjuvant setting in breast cancer patients. HLA-A2/A3+ node positive (or node negative if also negative for both ER and PR) breast cancer patients with HER2 1+ or 2+ expressing tumors who are disease-free after completing standard adjuvant therapies will be enrolled and randomized. Patients must have adequate cardiac function for enrollment (LVEF >50%), and randomization will be further stratified based on HER2 status (1+ or 2+) and nodal status (N0, N1, N2, or N3).
Galena Licenses Novel, Targeted Cancer Vaccine for Gynecological Cancers
Galena Biopharma recently licensed worldwide rights to develop and commercialize a Folate Binding Protein-E39 targeted vaccine to prevent recurrence in gynecological cancers such as ovarian and endometrial adenocarcinomas. The FBP vaccine was licensed from The University of Texas M D Anderson Cancer Center and Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF).
FBP has been granted Investigational New Drug (IND) by the FDA to enter clinical trials. Institutional Review Board approval has also been received. Galena plans to initiate Phase I trials by the end of 2011.
The FBP vaccine consists of the E39 peptide combined with the immune adjuvant granulocyte macrophage colony stimulating factor (GM-CSF). FBP is over-expressed (20-80 fold) in more than 90% of ovarian and aggressive endometrial cancers, as well as 20-50% of breast, lung, colorectal, and renal cell carcinomas. FBP has very limited tissue distribution and expression in non-malignant tissue and has many years of validation as an ideal immunotherapy target.
The broad overexpression of FBP in a wide variety of cancers indicates that FBP vaccine has a potential targeting multiple cancer indications.
The market for FBP vaccine is huge. Ovarian cancer occurs in over 22,000 patients per year in the U.S. alone and is the most lethal gynecologic cancer. Endometrial cancer is the most common gynecologic cancer and occurs in over 43,000 women in the U.S. annually. If developed successfully, FBP vaccine could be an important option for physicians to target ovarian and endometrial cancers.
We think the acquisition is positive to Galena. The license of FBP vaccine further enhance Galena's oncology pipeline.
What do All These Mean for GALE?
Apparently, Galena has made great progress in the past few months for its clinical programs while balance sheet has been boosted. The company has become stronger than ever now than before with more focused cancer programs and less cash burn for its operations.
Galena’s cancer program NeuVax and FBP provide significant leverage in cancer immunotherapy generally, as well as in "off the shelf" vaccines.
The company recently enhanced the NeuVax patent portfolio by acquiring patent rights covering the use of NeuVax in combination with trastuzumab (Herceptin); and use in low-to-intermediate HER2+ breast cancer patients not eligible for Herceptin therapy. The company also removed the CMC hold for NeuVax. NeuVax Phase I/II clinical trial results was cited in the journal Cancer, published by the American Cancer Society. Positive data from the Phase II NeuVax clinical trials was presented at the 26th Annual Meeting of the Society for the Immunotherapy of Cancer, which demonstrated that patients with less aggressive disease traits may derive greater clinical benefit from vaccination and have lower rates of breast cancer recurrence. The addition of FBP further expanded the company’s focused cancer pipeline.
We are certainly impressed by the progress Galena has made recently which has demonstrated the company’s commitment to maximizing shareholder value. Gale is moving in the right direction. The company is poised for long term growth and creating shareholder value in my view.
MFG
Chali
•Phase 3 trial being conducted under FDA-approved Special Protocol Assessment; initiated ahead of schedule
LAKE OSWEGO, Jan. 20, 2012 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (Nasdaq:GALE - News), a biotechnology company focused on developing innovative, targeted oncology treatments, today announced the initiation of its Phase 3 PRESENT trial for NeuVax(TM) (E75 peptide plus GM-CSF) vaccine in HER2 1+ and 2+ breast cancer patients (often referred to as HER2 negative) in the adjuvant setting to prevent recurrence.
"Approximately fifty percent of breast cancer patients have tumors that are HER2 1+ or 2+. These patients are successfully rendered disease-free following treatment with current standards of care, and then are sent home to watch and wait with the hope their cancer never returns. Our encouraging findings from the previous Phase 1/2 clinical trial show that NeuVax may provide a significant benefit to maintain disease-free survival in these patients who have no other [adjuvant therapy/treatment] options," added Beth Mittendorf, M.D., Assistant Professor, Department of Surgical Oncology, University of Texas MD Anderson Cancer Center and principal investigator for the PRESENT Phase 3 study.
The PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study is a randomized, multicenter, multinational clinical trial that will enroll approximately 700 breast cancer patients. The trial design has been updated to include current National Comprehensive Cancer Network guidelines and recently received Special Protocol Assessment (SPA) concurrence from the U.S. Food and Drug Administration (FDA). Based on a successful Phase 2 trial, which achieved its primary endpoint of disease-free survival (DFS), the FDA has agreed that the design and planned analysis of the Phase 3 study adequately address the objectives necessary to support an acceptable regulatory submission for marketing approval.
"NeuVax addresses a critical unmet medical need, well-recognized by investigators, and the interest from potential patients is very high," said Rosemary Mazanet, M.D., Ph.D., Chief Medical Officer. "We are grateful to our investigators and our clinical trial sites for their ongoing feedback and support in reaching this crucial first step of enrolling patients ahead of schedule."
The NeuVax Phase 3 trial will be conducted in adjuvant breast cancer patients who are node positive, have an HLA status of A2/A3+, and have low or intermediate HER2 expression (IHC 1+, 2+, sometimes referred to as HER2 negative). These patients are not eligible to receive Herceptin(R) (trastuzumab, marketed by Roche-Genentech) therapy that is currently approved only for patients with high HER2, or 3+ expression.
Once qualified patients have achieved a complete response from current standard-of-care treatment (surgery, radiation and/or chemotherapy), they will be randomized and dosed with either NeuVax or control (placebo plus GM-CSF). Patients will receive one intradermal injection every month for six months, followed by a booster inoculation every six months thereafter. The primary endpoint is disease-free survival at three years or 139 events (recurrence of cancer). A data safety monitoring board will conduct an interim analysis for safety and futility after 70 events. Galena is currently on track for the initiation of approximately 100 investigator sites in the U.S. and abroad.
About NeuVax(TM) (E75)
NeuVax consists of the E75 peptide derived from human epidermal growth factor receptor 2 (HER2) combined with the immune adjuvant granulocyte macrophage colony-stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in a highly specific manner to target cells expressing any level of HER2.
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 percent test positive for HER2 (IHC 1+, 2+ or 3+). Only 25 percent of all breast cancer patients, those with HER2 3+ disease, are eligible for Herceptin(R) (trastuzumab; marketed by Roche-Genentech), which had revenues of over $5 billion in 2010. NeuVax targets the remaining 50 percent 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.
MFG
Chali
http://seekingalpha.com/article/...r-immunotherapy-drugs?source=yahoo
Galena Biopharmaceuticals ( GALE ) kürzlich initiierte eine Studie der Phase III für NeuVax bei der Behandlung von Patientinnen mit Brustkrebs. Wie Dendreon-und ImmunoCellular Therapeutics 'Impfstoffen gegen Krebs, NeuVax richtet sich auch an den HER2/neu Antigen. Der Vorteil in ImmunoCellular IKT-107 ist aufgrund seines Orphan Drug Status für GBM zusammen mit seinem Potenzial für mehrere Indikationen wahrscheinlich kommen. Allerdings hat der Galena NeuVax Indikation Brustkrebs einen riesigen Kopf direkt aus dem Tor mit der potentielle Markt, ein Anzeichen, in denen fast 300.000 neue Fälle diagnostiziert werden jedes Jahr. Eine 53 Patienten-Untergruppe in der NeuVax Phase II-Studie, die eine Auffrischungsimpfung alle sechs Monate nach der ersten Behandlung Protokoll empfangen ergab einen dramatischen Anstieg der Wirksamkeit als offensichtlich zu einer statistisch signifikanten krankheitsfreie Überlebensrate von 95,9% versus 79,7% in der Kontrollgruppe Gruppe (p = 0,016). Die Phase III-Studie basiert auf der gleichen Art von Booster-Zeitplan basiert, und das Unternehmen ist zuversichtlich, dass diese zentrale Ergebnisse vergleichbar sein. Ihr zweiter Impfstoff gegen Krebs, FBP, die in Phase-I-Entwicklung ist, Folat Ziele bindende Protein (FBP). FBP ist auf 90% der Eierstock-und Gebärmutterschleimhautkrebs sowie 20-50% der Lungen-, Brust-, Darm-, Nieren-und Krebserkrankungen gefunden. Galena Investment Potenzial ist aufgrund eines frühen riesige Marketing-Indikation sein mit mehreren anderen Indikationen kommen über NeuVax und FBP möglich. Die bevorstehenden Prozess und regulatorischen Updates sollte Galena Investoren mehrere Katalysatoren in den kommenden Monaten.
http://seekingalpha.com/article/...g-can-big-pharma-wait?source=yahoo
Darstellende Due Diligence bei dem Versuch, festzustellen, ob und welche Art von Position, um in einer Biotech-Aktie zu öffnen erfordert oft eine Menge Zeit und Mühe. Studiendaten, Marktgröße für bestimmte Indikationen, Neigung zur Verdünnung und Insider-Kauf / Verkauf alles geben objektiven Mittel, durch das fundierte Entscheidungen treffen zu. Allerdings Biotech-Investoren verlassen sich auch auf etwas tiefer als die objektiven Tatsachen, dass die Unternehmen berichten an ihre Aktionäre oder den Staat wissenschaftlichen Zeitschriften über Studienergebnisse. Oft beruhen sie auf dem "was wenn" und das Potenzial für eine Aktie über "Wenn das passiert" oder "wenn Ergebnisse bestätigen frühere Wirksamkeit" und so weiter. Mit ein wenig methodische Überlegungen, die Verbindung der Punkte und das Lesen zwischen den Zeilen kann sprichwörtliche erhöhen eigenen Chancen auf eine gute Entscheidung, wie das berühmte Zitat "Der Zufall begünstigt den vorbereiteten Geist" gibt.
Ein Update März 2012 Unternehmen von Galena Biopharma ( GALE ) zur Verfügung gestellt Aktionäre mit nur einer solchen Gelegenheit, Einblick in die Möglichkeiten für ihn und seine bahnbrechenden NeuVax Immuntherapie Medikament zur Behandlung von HER2 1/2 (niedrige und mittlere HER2-Expression) Brustkrebs. Das Unternehmen Update war typisch für Investoren, was wäre mit einer Zusammenfassung der Ereignisse 2011 und Pläne für das kommende Jahr erwarten. Er erwähnte die Fortschritte auf ihrem Hauptprodukt, NeuVax, jetzt in einer frühen Phase III-Studie (benannt der vorliegenden Studie) als Adjuvans zum Standard der Behandlung Strahlentherapie, Chemotherapie und / oder Resektion. NeuVax wird über intradermale Injektionen einmal pro Monat verabreicht werden, die sechs aufeinanderfolgende Monate. Danach werden Auffrischungsimpfungen alle sechs Monate für die nächsten fünf Dosen gegeben werden, damit die Immunantwort stark wie die Phase II-Studie zeigte, dass die Immunantwort auf ohne Booster-Injektionen gegeben schwinden begann. Sie gingen auf die FBP-Phase 1/2 Studie, die im Februar 2012 initiiert zu erwähnen. FBP enthält die E39-Peptid, ein Antigen, das stark in über mehr als 90% von Eierstock-und Gebärmutterschleimhautkrebs ausgedrückt wird. Für eine finanzielle Update, erwähnt das Unternehmen seine gesamte Finanzierungen von über 18.000.000 $ im Jahr 2011 und einem weiteren 10 Millionen Dollar im Februar 2012 zusammen mit seinen liquiden Mitteln von 11,4 Mio. zum 31. Dezember 2011. Schließlich sprach er von Veränderungen in der Gesellschaft Führungsteam mit wichtigen Mitarbeitern aufgenommen und dann ein wenig Informationen über das Unternehmen Abspaltung von RXi Pharmaceuticals Aktie und Verteilung wie im Zusammenhang mit, dass.
Möglicherweise durch viele Leser über-sah sich das Unternehmen Update ist ein wichtiger Unternehmens-Update mit potentiell hohen langfristigen Auswirkungen als in Bezug auf die Zukunft des Unternehmens. Der Auszug heißt es:
"Phase II studieren, um in Kombination NeuVax erkunden mit Herceptin ® (Trastuzumab, Genentech / Roche). auf einem vielversprechenden Pilotprojekt, um eine randomisierte, multizentrische Phase-II-Studie bei 300 Patienten im Jahr 2012 einleiten wird und werden von der Henry M ausgeführt werden Basierend . Jackson Stiftung zur Förderung von Military Medicine (HJF) und von Genentech / Roche kofinanziert wird. "
http://finance.yahoo.com/news/...a-takes-final-actions-110500973.html
- One-for-one RXi Pharmaceuticals Aktiendividende zu Galena Aktionäre wie der Zahlung Datum der 26. April bezahlt werden, 2012
- Galena zu behalten Minderheitsbeteiligung in RXi, mit Potenzial, erhalten bis zu $ 45 Millionen in den Meilensteinen
Beaverton, Oregon, 26. April 2012 (GLOBE NEWSWIRE) - Galena Biopharma, Inc. ( GALE - Nachrichten ), ein Biotechnologie-Unternehmen auf die Entwicklung von innovativen, zielgerichteten Therapien der Onkologie konzentriert, gab heute bekannt, dass sie die letzten Schritte eingeleitet, um abzuschließen die bereits angekündigte Spin-off der RXi Pharmaceuticals Corporation, Galena die hundertprozentige Tochtergesellschaft. Um die Spin-off zu bewirken, wird Galena eine Dividende von einer Aktie der RXi Pharmaceuticals Stammaktien für jede ausstehende Aktie von Galena Stammaktien. Die Dividende wird an die zum Geschäftsschluss am 26. April 2012 um Galena Aktionäre, die Aktien der Galena-Stammaktien zum Zeitpunkt Geschäftsschluss Besitz am 23. April 2012, dem Stichtag für die Dividende gezahlt. Galena erwartet, dass seine Stammaktien werden am Ex-Dividenden-Grundlage mit Beginn am 27. April 2012 zu handeln.
RXi Pharmaceuticals wird als eigenständiges, börsennotiertes Unternehmen auf die Entdeckung, Entwicklung und Vermarktung innovativer Therapien auf dem eigenen, Next-Generation-RNAi-Plattform konzentriert arbeiten. RXi Pharmaceuticals Stammaktien zum Handel wird voraussichtlich unter dem Symbol "RXII" auf dem OTC Bulletin Board in den nächsten ein bis zwei Wochen beginnen.
"Diese Transaktion stellt die letzte Stufe der Transformation von einem unserer prä-klinischen Plattform in einer späten klinischen Stadium, zielgerichtete Krebstherapeutika spezialisiertes Unternehmen begannen wir vor einem Jahr. Galena wird auch weiterhin die Fokussierung auf unsere Entwicklungs-Stadium, gezielte Onkologie-Pipeline, durch geführt NeuVax ( TM), die vor kurzem eine zentrale, klinischen Phase-3-Studie für niedrigen bis mittleren HER2-Brustkrebs-Patientinnen ", sagte Mark J. Ahn, Ph.D., Präsident und Chief Executive Officer von Galena. "Beide Unternehmen haben jetzt eine größere Flexibilität auf das konzentrieren, und verfolgen ihre jeweiligen Wachstumsstrategien, während potenziell bietet den Aktionären mehr Wert auf längere Sicht. RXi wird auf die Entwicklung neuartiger RNAi-basierten Wirkstoffkandidaten zu konzentrieren, mit einem anfänglichen Fokus auf RXI-109, seine Leitsubstanz entworfen, um CTGF (Bindegewebe-Wachstumsfaktor) für Anti-Narben Indikationen zum Schweigen zu bringen. "
Der beabsichtigte Spin-Off-Transaktion wurde bereits im September 2011 angekündigt, und die Dividendenzahlung wird in Anwendung des Registration Statement, dass RXi Pharmaceuticals bei der Securities and Exchange Commission, die für wirksam erklärt am 14. Februar 2012 eingereicht wurde.
Über Galena Biopharma
Galena Biopharma, Inc. ( GALE - Nachrichten ) ist ein Portland, Oregon-basiertes, biopharmazeutisches Unternehmen, das innovative, zielgerichtete Onkologie Behandlungen, die wichtigsten bislang ungedeckten medizinischen Bedarf zu fördern Krebsbehandlung entwickelt. Für weitere Informationen, besuchen Sie uns auf www.galenabiopharma.com .
Die Galena Biopharma, Inc. logo abrufbar http://www.globenewswire.com/newsroom/prs/?pkgid=10647
Über RXi Pharmaceuticals
RXi Pharmaceuticals ist ein Biotechnologieunternehmen, das auf die Entdeckung, Entwicklung und Vermarktung innovativer Therapien auf dem eigenen, Next-Generation-RNAi-Plattform konzentriert. Therapeutika, die RNA-Interferenz, oder verwenden Sie "RNAi", haben große Verheißung wegen ihrer Fähigkeit, "zum Schweigen zu bringen," oder unten zu regulieren die Expression eines bestimmten Gens, das in einem Krankheitszustand überexprimiert werden kann. Aufbauend auf der Pionierarbeit der wissenschaftlichen Gründer und Nobelpreisträger Dr. Craig Mello, RXi ersten RNAi-Produkt, RXI-109, die CTGF (Bindegewebe-Wachstumsfaktor) zielt, soll klinischen Studien am Menschen in der Anti-Narben im Jahr 2012 beginnen.
Kontakt:
Galena Biopharma Kontakte:
Madeline Hatton
Gebührenfrei: +1 (855) 855-Gale (4253), ext. 109
info@galenabiopharma.com
Remy Bernarda
IR Sense, LLC
+1 (503) 400-6995
remy@irsense.com
RXi Pharmaceuticals Kontakt:
Tamara McGrillen
RXi Pharmaceuticals Corporation
+1 (508) 929-3615
tmcgrillen@rxipharma.com
gibt es news?
Galena Biopharma scheint ja ein ganz heisses Eisen zu sein:
- Immuinotherapie bei Brustkrebspatientinnen
- Markt > 5 Milliarden USD
- man befindet sich bereits inn der Phase III bei sehr überzeugenden Phase II Ergebnissen
- Grund für die niedrge Bewertung: Galena hat das Produkt nach Meinung mancher Experten zu günstig (ca. 10 Mio USD von Anthera Pharmaceuticals) eingekauft. Anthera ist aber eine kleine Biotechfirma ohne Produkte mit nur 50 Mio Euro Marktkapitalisierung, d.h. denen hat die 10 Mio USD geholfen, denn die brauchten Cash.
Meines Erachtens ist Galena eine Spekulation wert!
Galena Biopharma (GALE), in my opinion, presents the greatest investment opportunity with the most upside potential. The company's lead candidate, NeuVax, showed a 50% reduction in breast cancer recurrence in a 200 patient Phase II trial. In its Phase III trial, it will be testing 700-1,000 patients, but the trial will only test for the indication in which NeuVax has already been proven to be effective. As a result, there is a great likelihood of success, as it's only targeting patients with low to intermediate levels of HER2, which represents a very significant share of total breast cancer patients. The reason I believe it presents the most upside is because it is a $110 million company, with a vaccine proven effective on its targeted subgroup, which has sales potential similar to Herceptin, a drug that returned $6 billion in 2011. With this being said, GALE presents a great opportunity in the immunotherapy space, with a candidate that effectively treats a large unmet medical need. Success in the phase II trial and the large targeted treatment group are most likely why the stock has increased in value by nearly 250% in 2012, making it one of the most promising immunotherapies in development. (SeekingAlpha, 4.Sept.2012)
Galena Biopharma, Inc. (GALE) (Seekingalpha, 3.September 2012)
The next interesting speculative biotech that deserves some attention is Galena. GALE is a Portland, Oregon-based biopharmaceutical company that develops innovative targeted oncology treatments that address major unmet medical needs to advance cancer care. GALE actually has a couple potential products in its pipeline, but the one that is most interesting is NeuVax, and its use with breast cancer patients.
Needless to say, investing in biotech can get into some pretty complicated science and biology. When it comes to NeuVax and how it works, it gets really involved. In layman's terms, the best way to describe this treatment is that NeuVax stimulates T cells in a highly specific manner to target cells expressing any level of Human Epidermal Growth Factor Receptor 2 (HER2). HER2 is an established tumor-associated antigen found at various types of human cancer cells. Basically, this treatment gets the body's immunity system to combat cancers.
The Phase II trials for the company seem to have gone rather well for GALE. So much so, that the Food and Drug Administration [FDA] granted NeuVax a Special Protocol Assessment for a Phase III clinical trial.
The question now is why should a potential investor bother with a company like GALE? Much like ACTC, GALE is in a unique position with its therapy. Consider this; 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 Human Epidermal growth factor Receptor 2. Of that number, only 25% of all breast cancer patients, those with HER2 3+ disease, are eligible for a drug named Herceptin. This is a drug that is marketed by the Roche-Genentech team. Looking at their 2010 revenues, one can see that it reached over $5 billion in sales. NeuVax's target is the remaining 50% of low-to-intermediate (also known as HER2-Negative) patients who are not eligible for Herceptin. These patients would be the ones who achieve remission with current standard of care, but have no available treatment options to maintain their disease free status.
Now the picture should be a bit clearer. There is lots of cash to be made if this treatment is to prove successful. Like ACTC though, nothing is without risk. Turning our attention to GALE's second quarter financial statements highlights some of these risks. As of June 30, 2012, Galena had cash and cash equivalents of $19.2 million, compared with cash and cash equivalents of $11.4 million as of December 31, 2011. The cash burn for the six months ending June 30, 2012 was around $9.1 million. That amount was made up of $6.09 million of research and development expense, while $3.04 million was general and administrative in nature. GALE believes that their existing cash and cash equivalents should be sufficient to fund operations through at least the second quarter of 2013. After that the company will face liquidity problems.
So here is where the speculation aspect comes into play. GALE's funds are limited, and they have to spend quite a bit of cash to ramp up of their Phase 3 "PRESENT" clinical trial. With funds running out by 2013, the question is what will be the source of the new funding. Will GALE further dilute shareholders with the sale of more equity, or might they find the funds with a partnership or collaborative agreements? Time will tell.
Finally, there is also a concern dealing with interruptions in the supply of NeuVax. Gale does not have the facilities or expertise to manufacture any of the potential products for their clinical trials. That means that they will be dependent upon contract manufacturers to complete the work. Obviously, this has many risks. For example, NeuVax is administered in combination with a product called Leukine. This product comes in both liquid and lyopholyzed (freeze dried) forms, and is available exclusively from Genzyme, which is a subsidiary of Sanofi-Aventis (SNY). In June 2012, Genzyme recalled all liquid Leukine without explanation. As a result, GALE began to incorporating lyopholyzed Leukine as another option in clinical testing for their Phase 3 PRESENT study. The company believes that their current supply of lyopholyzed product should be adequate for the completion of our trial.
Much like our friends at ACTC, GALE has its own unique set of challenges and risks. Following this company and their potential should be a rather exciting prospect as they make their way closer to the finish line.
gale.png (verkleinert auf 32%)
http://seekingalpha.com/article/...-biotech-ready-to-fly?source=yahoo
Die steigende Vertrauen der Anleger in Biotech ist ein positives Zeichen insgesamt für den Sektor Investitionspotenzial. Meiner Meinung nach sollten Anleger zuordnen eine kleine Position ihrer Beteiligungen an viel versprechenden Biotech-Firmen. Große Pharmafirmen gerne restock Drogen Pipelines sind daran interessiert, verschlang kleinere Firmen zu höheren Preisen.
Auf der Suche nach dem nächsten Juwel, das explodieren könnte, ist nicht einfach, aber suche Alpha und einige andere Websites sind große Quellen zu interessanten Kandidaten, die es wert zu berücksichtigen sind finden. Ich glaube, ich habe ein interessantes Unternehmen, die sehen, erneutes Interesse für die Zukunft könnte.
Therapeutische Impfstoffe
Eine neuartige Krebstherapie Impfstoff wurde traditionell als "Heiliger Gral" der Biopharma gesehen worden. Die 2010 Zulassung von Dendreon ist ( DNDN ) Provenge bei metastasierendem Prostatakrebs erwies sich die Unternehmen und die Technologie, um die wahren Schnäppchen sein. Ein weiterer vielversprechender therapeutischer Krebsimpfstoff Kandidat NeuVax für HER2-positiven Brustkrebs. Diese Therapie wird von Galena Biopharma, Inc (entwickelt GALE ), ein Portland, Oregon biopharmazeutische Unternehmen entwickelt innovative, zielgerichtete Onkologie Behandlungen.
Nachfolgend finden Sie das Unternehmen die aktuelle Produkt-Pipeline.
(Zum Vergrößern anklicken)
Quelle: Website des Unternehmens
Die Website des Unternehmens bietet eine gute Beschreibung der Galena beiden wichtigsten Produkte:
NeuVax ™ (nelipepimut-S)
NeuVax besteht aus dem Peptid von E75 Human Epidermal Growth Factor Receptor 2 (HER2) mit dem Immunadjuvans Granulozyten-Makrophagen-Kolonie-stimulierenden Faktor (GM-CSF) kombiniert abgeleitet. Die Behandlung mit NeuVax regt zytotoxischen (CD8 +) T-Zellen in einer sehr spezifischen Weise auf Krebszellen, die jede Ebene der HER2 Ziel. NeuVax als intradermale Injektion einmal im Monat für sechs Monate, durch einen Booster-Injektion, gefolgt einmal alle sechs Monate des Körpers Immunantwort gegen HER2 stark zu halten gegeben. Basierend auf einer erfolgreichen Phase-II-Studie, die ihren primären Endpunkt des krankheitsfreien Überlebens erreicht, die Food and Drug Administration (FDA) erteilte NeuVax ein Special Protocol ABSCHÄTZU nt (( SPA )) für eine Phase-III-Studie in der adjuvanten Therapie von Frauen mit niedrigen bis mittleren HER2-Expression Brustkrebs.
Nach dem National Cancer Institute werden über 230.000 Frauen in den USA mit Brustkrebs diagnostiziert jährlich. Von diesen Frauen, etwa 75% Test positiv für HER2 (IHC 1 +, 2 + oder 3 +). Nur 25% aller Patientinnen mit Brustkrebs, die mit HER2 3 + Krankheit, kommen für den Standard der Behandlung mit Herceptin ® (Trastuzumab; Roche-Genentech), die einen Umsatz von über 5 Mrd. $ im Jahr 2010 hatte. NeuVax zielt auf die restlichen 50% der low-to-intermediate (auch als HER2-negativ, nicht für Herceptin bekannt) HER2-Expression Brustkrebspatientinnen, die eine Remission zu erreichen mit den aktuellen Standard der Behandlung, haben aber keine verfügbaren HER2 adjuvanten Behandlungsmöglichkeiten zu erhalten ihren Seuchenfreiheitsstatus.
Folat-Bindungsprotein-E39
Folat-Bindungsprotein-E39 ist eine gezielte Impfung zur Verhinderung des Wiederauftretens von Eierstockkrebs, Endometrium-und Brustkrebs abzielen. Das FBP Impfstoff besteht aus dem Peptid von dem E39 Folat bindendes Protein mit der Immun-Adjuvans Granulozyten-Makrophagen-Kolonie stimulatingfactor (GM-CSF) kombiniert abgeleitet. FBP überexprimiert (20-80 fach) bei mehr als 90% von Eierstock-und Endometriumkarzinomen, sowie 20-50% der Brust-, Lungen-, Dickdarm-und Nierenzellkarzinome. FBP hat nur sehr begrenzte Verteilung im Gewebe und Expression in nicht-malignem Gewebe, so dass es ein idealer Immuntherapie Ziel, theoretisch kaum eine Chance Autoimmunreaktion.
Eierstockkrebs tritt in über 22.000 Patienten pro Jahr in den USA und ist die tödlichste gynäkologischen Krebserkrankungen. Trotz der Tatsache, dass die Häufigkeit von Eierstockkrebs nur ungefähr 20% von jener von Brustkrebs ist, ist die Anzahl der Patienten sterben an Eierstockkrebs fast 50% der Anzahl an Brustkrebs Todesfälle. Dies ist auf den Mangel an spezifischen Symptome für Eierstockkrebs, werden die meisten Patientinnen mit Ovarialkarzinom in späteren Stadien der Krankheit diagnostiziert wird, erschwert eine Behandlung mit einer schlechten Prognose. Diese Patienten sind routinemäßig chirurgisch verdichteten (Tumor chirurgisch entfernt wird teilweise) bis minimal residual disease, und anschließend mit Platin-und / oder Taxan-haltige Chemotherapie behandelt. Während die meisten Patienten auf diese Behandlung Regimes zu reagieren und sich klinisch frei von Krankheiten, die Mehrheit dieser Patienten einen Rückfall wird, und sobald die Krankheit erneut auftritt, fallen die Behandlungsmöglichkeiten und Erfolge dramatisch.
Endometriumkarzinom ist das häufigste gynäkologische Krebs und tritt in über 46.000 Frauen, mit über 8.000 Todesfälle, in den USA jährlich. Es gibt zwei grundlegende Arten von Endometriumkarzinom: endometriod und papillären serösen. Letzteres hat eine viel aggressivere klinischen Verlauf und die Mehrheit dieser Patienten werden von dieser Form der Krankheit sterben. Wenn FBP Clinicals was positive Zwischenbilanz zu beginnen, könnte die Therapie nehmen einige der Scheinwerfer ausgeschaltet NeuVax aber würde Aktionäre an dem Gewinn eines weiteren viel versprechenden Therapie und minimieren die Risiken im Zusammenhang mit der Diversifizierung. Mit anderen möglichen Kandidaten mit Katalysatoren in Kürze wird Galena nicht als "one trick pony" wie viele Entwicklungs-Phasen-Unternehmen werden, wodurch ihre Investitionen Potenzial und vielleicht Verankerung ein bisschen größere Pharmaunternehmen Interesse Ereignisse entfalten.
Partnerschaften
Im letzten Quartal Galena Biopharma wurde besetzt, Partnerschaften. Im Dezember das Unternehmen unterzeichneten einen Pakt mit Teva Pharmaceuticals ( TEVA ) an die Biotech-führendes Produkt, NeuVax, in Israel zu vermarkten. Mindestens vier Standorten der Phase-III-Studie wird in Israel sein, eine Tatsache, die in der Veröffentlichung über Galena Deal mit Teva beachten. Die Vereinbarung fordert Teva, die machen einen Push in weitere neuartige Entwicklung von Medikamenten, nachdem er der weltweit größte Generika Pharmakonzern, um Zulassungsantrag anzugehen und Unterstützung der lokalen Entwicklung der NeuVax.
"Diese Vereinbarung ist das erste Stück unserer globalen Vermarktungsstrategie," Mark Ahn, Galena CEO, erklärte. "Teva ist ein Weltklasse-pharmazeutischen Unternehmen und ein großes Pharmaunternehmen in Israel. Wir freuen uns auf ihre wertvollen finanzielle Unterstützung für unsere Entwicklungsziele in Israel sowie die Marktführerschaft für NeuVax Vermarktung in der Region."
Es ist zweite Partner Deal bekannt letzten Quartal war mit britischen Leica Biosystems. Leica unterstützt die Entwicklung eines begleitenden Diagnostik um das Vorhandensein von HER2 um auszuwählen, welche Patienten mit Galena der NeuVax behandelt werden sollten messen. Unter ein bisschen Rätselraten bei der Auswahl der Kandidaten und die Bereitstellung Regulierungsbehörden mit objektiver mittels Auswahl der Patienten sollte Galena Fortschritte durch die regulatorischen Prozess zu helfen, wenn Phase-III-Daten würdig eine New Drug Application (NDA) sind.
Abschließender Hinweis
Galena der NeuVax, die in der späten Entwicklungsphase ist für Verhinderung des Wiederauftretens bei Frauen mit Brustkrebs, die Lymphknoten infiltriert hat und hat geringe oder mittlere HER2-Expression, konnte der heilige Gral für Investoren und der Gesellschaft sein.
Galena Biopharma hat ein Patent gewährt seinem Brustkrebs-Impfstoff Exklusivität bis 2028 erhalten.
Big Pharma zahlen Aufmerksamkeit. Firmen wie Novartis ( NVS ), Pfizer ( PFE ) und Roche ( RHHBY.OB ) machen sich mit potenziell sehr großen Profite, um diese Technologien zu erwerben, in der Hoffnung, Offset Patent-und Umsatzverluste zu helfen.
Ich sehe eine potenzielle Übernahme von Galena Zukunft, aber vor, dass ich denke, wir werden einen schönen Rebound zu den $ 3 Ebenen zu sehen. Viele Analysten sind positiv, so bin ich Als die NeuVax und FBP Studien Fortschritte und Zwischenergebnisse präsentiert werden, werden die Investoren und Big Pharma genau beobachten. Weder Gruppe will etwas, das nicht zurückkehren werden Belohnungen auf ihre Investitionen, während weder will das Boot verpasst haben und auf Aktien (oder das Unternehmen) an den Premium-Preise, die erforderlich sein würde kaufen, wenn entweder Therapie erweist sich als sicher kaufen, effektive und marktfähig. Mit einem aktuellen $ 123.000.000 Marktkapitalisierung könnte Aktienkurs und Marktkapitalisierung Preise jeweils schnell zu bewegen. Sorgfältige Risiko / Rendite-Bewertung sollte von Big Pharma und private Investoren gleichermaßen durchgeführt werden.
(Zum Vergrößern anklicken)
...könnt was werden. charttechnisch siehts gut aus
http://marketplayground.com/2013/02/08/...er-vaccine-offers-new-hope/
http://m.seekingalpha.com/article/1202711
braucht nur noch steigen - theoretisch .-)
gute trades
http://finance.yahoo.com/news/...ma-present-7th-annual-120500446.html