Zwischen 4,8 und 6 Dollar vorbörslich, gibt anscheinend unterschiedliche Meinungen. Wie immer an der Börse hängt halt viel von den allwissenden Anal-lysten ab. Hauptsach wir schliessen heut über 5 Dollar.
Ich will dir ja nicht in die suppe spucken,Andreano,aber Celldex,das wird imho nix mehr,jährlich halbiert sich die aktie mindestens ! Die haben auch überhaupt keine blockbuster anwendung,nichts,deshlab geb ich dir den Tipp dir mal Opexa Therapeutics anzuschauen,aktuell nur 1/4 wert im Vergleich zu Celldex mit Megapotential (Phase-3 Zelltherapie zu MS startet noch in 2011) !
NEEDHAM, Mass.--(BUSINESS WIRE)-- Celldex Therapeutics, Inc. (NASDAQ: CLDX - News) today announced that it has launched a pivotal, randomized, double-blind, controlled Phase 3 trial of rindopepimut in patients with surgically resected epidermal growth factor variant III (EGFRvIII)-positive glioblastoma, the “ACT IV Study.” US investigators have started screening patients for inclusion in the trial that is expected to enroll up to 440 patients internationally to recruit 374 patients with Gross Total Resection (GTR) for the primary analysis. Rindopepimut is a therapeutic cancer vaccine candidate that targets the tumor-specific oncogene EGFRvIII, which confers an enhanced capacity for unregulated tumor growth and which is present in many cancer cell types, but not present at significant levels in normal cells. Expression of EGFRvIII is linked to poor long term survival regardless of other factors such as extent of resection and age. EGFRvIII has been shown by polymerase chain reaction (PCR) analysis to be expressed in approximately 31% of glioblastoma tumors.
“Rindopepimut has demonstrated significant potential to offer a new treatment option to patients suffering from glioblastoma, a disease with an extremely poor prognosis and few treatment options,” commented Thomas Davis, M.D., Chief Medical Officer of Celldex. “Celldex has worked diligently with both US and European regulatory authorities to design the ACT IV trial to rigorously evaluate the addition of rindopepimut to standard of care in EGFRvIII-positive glioblastoma patients. This international Phase 3 study will be conducted in a blinded fashion, comparing rindopepimut against a control arm receiving only a low-dose of keyhole limpet hemocyanin (KLH). KLH is a component of rindopepimut and was selected due to its ability to generate a similar injection site reaction to that observed with the rindopepimut vaccine,” added Dr. Davis.
“Given the consistent encouraging clinical data from multiple previous trials of rindopepimut showing clear improvements in median Overall Survival and median Progression Free Survival to both matched historical controls and historical data with the standard of care treatment, we look forward to expanding on this body of evidence in the pivotal ACT IV study,” said Anthony Marucci, President and CEO of Celldex. “The initiation of ACT IV is an important milestone for Celldex and we expect to make substantial progress in this trial throughout 2012. We are also planning to further expand on the clinical development program for rindopepimut in 2011 by initiating the Phase 2 ReACT study of rindopepimut in combination with Avastin® in patients with recurrent or refractory glioblastoma.”
About the ACT IV Study
The ACT IV study is a randomized, double-blind, controlled study of rindopepimut plus GM-CSF added to standard of care temozolomide in patients with newly diagnosed, surgically resected, EGFRvIII-positive glioblastoma. Patients will be randomized after the completion of surgery and standard chemoradiation. The treatment regime includes a vaccine priming phase post-radiation followed by an adjuvant temozolomide phase and a vaccine maintenance therapy phase. Patients will be treated until disease progression or intolerance to therapy. The primary objective of the study is to determine whether rindopepimut plus GM-CSF improves the overall survival of patients with newly diagnosed EGFRvIII positive glioblastoma after GTR when compared to treatment with the current standard of care, temozolomide. A total of approximately 440 patients will be enrolled at over 150 centers worldwide to recruit 374 patients with GTR to be included in the primary analysis. Secondary endpoints include: progression free survival; safety and tolerability of rindopepimut and GM-CSF in combination with temozolomide; neurologic status and quality of life. Patients will be stratified based upon geographic region, RPA class prognostic factors and MGMT methylation status.
Clinical Data Supporting Rindopepimut in Glioblastoma
Rindopepimut has been evaluated in three successful clinical studies of patients with EGFRvIII-positive glioblastoma to date: the ACTIVATE, ACT II and ACT III studies. Notably, rindopepimut demonstrated consistent and statistically significant increased survival rates across all three studies. In ACTIVATE, ACT II and ACT III, median progression free survival (PFS) from diagnosis was 14.2, 15.3 and 12.3 months, while median overall survival (OS) from diagnosis was 24.6, 24.4 and 24.6 months, respectively. The results were not statistically different between these studies. Mature data from the ACT III study were presented at the Society for Neuro-Oncology conference, indicating that 52% of the patients were alive at two years, while 50% of the enrolled patients in both earlier studies were alive at two years from diagnosis. These data compare favorably to a cohort of patients (historical controls) treated at M.D. Anderson Cancer Center and matched for eligibility including having glioblastoma expressing the EGFRvIII oncogene, where median PFS was 6.4 months and median OS was 15.2 months, with less than 6% of patients alive after 2 years. In addition, the four-year survival rate for ACTIVATE is 22%, while follow-up in ACT II and ACT III is ongoing.
In ACT III, the results for the predefined primary endpoint, 66% Progression Free Rate (PFR) at approximately 8.5 months post-diagnosis, show a statistically significant improvement (p=0.0168) over a predetermined estimate of 53%, which is beyond the range of expected progression-free survival for glioblastoma patients receiving standard of care (SOC). Published results for SOC and from matched historical controls are 45% and 29%, respectively, for PFR at 8.5 months post-diagnosis.
In all clinical trials to date, rindopepimut has been generally well tolerated with injection site reaction being the most frequently observed side effect.
Rindopepimut is an investigational immunotherapeutic vaccine that targets the tumor-specific molecule epidermal growth factor receptor variant III (EGFRvIII). EGFRvIII is a mutated form of the epidermal growth factor receptor (EGFR) that is only expressed in cancer cells and not in normal tissue and is a transforming oncogene that can directly contribute to cancer cell growth. Expression of EGFRvIII is linked to poor long term survival regardless of other factors such as extent of resection and age. EGFRvIII has been shown by polymerase chain reaction (PCR) analysis to be expressed in approximately 31% of glioblastoma tumors
...hat ja nicht gehalten, was er versprach. Dennoch habe ich einige interessante Beiträge gefunden:
Biotech Celldex Therapeutics is another one counting on positive outcomes to generate future gains. It applies its Precision Targeted Immunotherapy platform to create a pipeline of candidates to treat cancer and other difficult-to-treat diseases, but the loss of Pfizer (NYSE: PFE ) last year as a partner has affected revenues. Product sales, which arose out of the agreement with the pharmaceutical, are virtually eliminated. General and administrative expenses now far exceed its revenues, making for a pretty dicey outlook.
While the stock plummeted after it released its second-quarter report, it has been struggling to regain the lost momentum. It was at least able to report some positive data for CDX-1135, a treatment for pediatric kidney disease. All-Star CAPS members might not be as bullish as the broader community, but 89% still see it beating the Street.
Hi bierro,ja ,da hast du Recht,es ist zumindest für 2012 mal eine aktie ,die man kaufen könnte ! Übrigens sehe ich das bei Exelixis (Nasdaq:EXEL) genauso,nur die sind mir aktuell noch zu teuer,aber wenn die noch 50% fallen,bin ich auch da dabei .....
Damit hat sich Celldex für mich erst mal erledigt:
NEW YORK (AP) -- Shares of Celldex Therapeutics Inc. added to its recent gains Friday after an analyst predicted success for the company's brain cancer treatment rindopepimut, although he said it will be years until Celldex has late-state trial data supporting the drug.
THE SPARK: Jefferies & Co. analyst Biren Amin started coverage with a "Buy" rating and a price target of $4 per share. He said Celldex has a series of promising drug candidates, and the stock should trade higher over the next year to 18 months as the company reports data from a series of clinical trials. He said the company has a broad pipeline of products, as it is also studying drugs that treat breast cancers, lymphoma, solid tumors, and kidney disease.
THE BIG PICTURE: Rindopepimut is designed to stimulate the immune system to fight cancer. It targets a growth factor found only in cancer cells. Celldex is studying the drug as a treatment for glioblastoma, which is the most aggressive type of brain cancer. In late November, Celldex said patients who were treated with rindopepimut had median survival of 24.6 months. The company said that similar patients who were treated with other methods had median survival time of 15.2 months.
Celldex started a late-stage clinical trial of the drug on Thursday. Amin said he doesn't expect initial data from that trial until late 2016, but he thinks the drug is promising and said U.S. sales could grow to $465 million per year by 2026.
SHARE ACTION: Celldex shares rose 5.6 percent Thursday after the company said it started the late-stage trial, and in Friday afternoon trading, the stock picked up 22 cents, or 8 percent, to $3.03. Shares of Celldex have fallen about 26 percent in 2011 and they are down 36 percent from the stock's 52-week high of $4.70, which it reached in early April.
<< Back Celldex Therapeutics Announces Initiation of Phase 1 Clinical Trial of CDX-301 NEEDHAM, Mass.--(BUSINESS WIRE)--Jan. 17, 2012-- Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced that dosing has initiated in a Phase 1 study of its hematopoietic growth factor, CDX-301, in healthy subjects. The study is being conducted in collaboration with Rockefeller University. CDX-301 is soluble, recombinant human FMS-like tyrosine kinase 3 ligand (Flt3L) and previous experience has shown that it increases the numbers and activity of blood stem cells and immune cells. CDX-301 is a potent stem cell mobilizer and dendritic cell growth factor. While there are multiple possible indications for CDX-301, Celldex’s first priority is to develop this molecule for hematopoietic stem cell transplant, where it has demonstrated improvement of blood cell reconstitution in preclinical in vivo models.
The Phase 1 study of CDX-301 is a dose-escalating clinical trial aimed at determining the appropriate dose for further development based on safety, tolerability and biological activity. The trial will evaluate seven different dosing regimens of CDX-301 and will accrue approximately 30 healthy subjects at Rockefeller University.
“This clinical trial represents the first step in the continued clinical development of this biologically active molecule,” said Thomas Davis, M.D., Chief Medical Officer of Celldex Therapeutics. “In particular, we believe that CDX-301 has significant potential to be developed in a number of indications in cancer, inflammatory and infectious diseases.”
About CDX-301 (Flt3L)
CDX-301 or Flt3L is a potent hematopoietic cytokine that stimulates the expansion and differentiation of hematopoietic progenitor and stem cells. Flt3L has demonstrated a unique capacity to increase the number of circulating dendritic cells in both laboratory and clinical studies. In addition, Flt3L has shown impressive results in models of cancer, infectious diseases and inflammatory/autoimmune diseases. Celldex believes this ligand may hold significant opportunity for synergistic development in combination with other proprietary molecules in the Company’s portfolio.
About Celldex Therapeutics, Inc.
Celldex is the first antibody-based combination immunotherapy company. Celldex has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy (PTI) Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, vaccines and immunomodulators used in optimal combinations to create novel disease-specific drug candidates. For more information, please visit http://www.celldextherapeutics.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the Company’s strategic focus and the future development and commercialization (by Celldex and others) of rindopepimut (CDX-110), CDX-011, CDX-1135 (formerly TP10), CDX-1401, CDX-1127, CDX-301, Belinostat and other products. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we plan to initiate in 2011; our ability to adapt APC Targeting TechnologyTM to develop new, safe and effective vaccines against oncology and infectious disease indications; our ability to successfully complete product research and further development of our programs; the uncertainties inherent in clinical testing; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage research and development efforts for multiple products at varying stages of development; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our limited cash reserves and our ability to obtain additional capital on acceptable terms, or at all; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the Company's Form 10-K for the fiscal year ended December 31, 2010, and its Forms 10-Q and 8-K.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Celldex Therapeutics, Inc. Celldex Therapeutics, Inc. Anthony S. Marucci, 781-433-0771 President and CEO or Avery W. Catlin, 781-433-0771 Chief Financial Officer IR@celldextherapeutics.com or BMC Communications Brad Miles, 212-477-9007 x17 email@example.com