Celldex Therapeutics garantierte 100 % bis 06/10
Ein Plus von 50 % Überlebenswahrscheinlichkeit.
Mediane Überlebenszeit jetzt ungefähr 15 Monate, mit CDX 110 22-24 Monate! Ein Plus von 7-9 Monaten.
Beeindruckend. Provenge hat lange nicht so gute Daten zu liefern, und wird Dendreon Milliarden in die Kassen spülen.
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das Problem ist meiner Meinung nach die sehr kleine Versuchsgruppe bei Celldex in Phase II, Dendreon hatte 500 bzw. 1000 Patienten!
Celldex kann es schaffen, aber es wird evtl. noch Jahre dauern mit Rückschlägen in Form neuer Trials etc. wie bei Dendreon, die mußten auch 15 Jahre durch die Hölle um dann in den "Himmel zu kommen"!
denke weiterhin dass Cldx bei der ASCO explodieren wird
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Pfizer wird mit Celldex in Kürze Phase 3 einleiten,
läuft alles nach Plan...
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He also did an excellent job presenting CDX-011 and CDX-1307. I'm smelling a partership coming for either CDX-011 or CDX-1307 very soon! "
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He then noted in his talk and in slides that the rate of PFS (patients whose tumors have not yet returned) at 8.5 months was 70% and 80% in those studies, ie roughly the same as the preliminary results of ACTIII. The chart also showed that for the historical control group (TMZ and radiation without the vaccine) the percentage of progression free patients is only 25%.
He noted that Pfizer is in talks with the FDA and health agencies worldwide concerning the design of the Phase III trial.
He also mentioned the CDX-1307 and CDX-011 results.
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Bloomberg News
Pfizer Inc. and Celldex Therapeutics Inc. said 70 percent of patients getting their experimental brain tumor vaccine were alive without their cancer worsening about eight months after diagnosis, a study found.
Cancer typically progresses in about 50 percent of patients during that time period, said Tom Davis, Celldex's chief medical officer. The finding, involving 40 patients, is from an interim analysis of a study by the American Society for Clinical Oncology. The full results will be presented this week at the group's annual meeting in Chicago.
The treatment is designed to ramp up the body's immune response to fight off the tumor. The vaccine targets the molecule called epidermal growth factor receptor variant III, which plays a role in cell growth. The strategy could be applied to breast, ovarian and prostate cancer as well, though none of those indications are in human testing, Celldex said.
In the research, newly diagnosed patients received injections of CDX-110 along with radiation therapy and Merck & Co.'s Temodar until their tumor progressed. All patients received the experimental treatment, rather than giving the medicine to half of the participants while the other half received placebos. Final results from 65 patients enrolled in the trial should be available by year's end, Davis said.
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Celldex Therapeutics Presents Positive Results from Phase 1/2 Advanced Breast Cancer Study with CDX-011 at 46th Annual ASCO Meeting
Study Achieves Primary Endpoint
CHICAGO, Jun 05, 2010 (BUSINESS WIRE) -- Celldex Therapeutics, Inc. /quotes/comstock/15*!cldx/quotes/nls/cldx (CLDX 6.56, -0.31, -4.51%) today announced that mature results from a Phase 1/2 study evaluating CDX-011 in advanced stage breast cancer patients were presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). CDX-011 is an experimental antibody-drug conjugate (ADC) directed against glycoprotein NMB (GPNMB) and linked to a potent cancer cell-killing drug, monomethyl-auristatin E (MMAE).
Mature data from this study of CDX-011 show a progression free survival (PFS) rate at 12 weeks of 35% of patients, which is a positive outcome for a heavily treated advanced breast cancer population with very limited treatment options. "The results in triple negative disease are especially encouraging," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "A subset analysis using a newly optimized diagnostic assay for GPNMB showed that patients with strong stromal or tumor cell expression of GPNMB may be most likely to respond to CDX-011."
"A reliable and marketable assay to detect a target antigen is critical in the development of any targeted therapy," said Tom Davis, M.D., Chief Medical Officer of Celldex Therapeutics. "We are confident that we can use our GPNMB assay to identify target expression patterns and levels in breast cancer to allow appropriate patient selection in our next study. A Phase 2b trial in advanced, refractory breast cancer is planned, which will select patients on the basis of significant GPNMB expression."
The trial, planned for initiation in Q3-2010, is a Phase 2, randomized, multi-center, controlled trial that will enroll 120 patients with heavily pre-treated, advanced breast cancer who are refractory/resistant to all approved therapies and whose tumors are confirmed to express significant levels of GPNMB via a validated, centralized diagnostic assay. It is anticipated that a significant portion of the enrolled patients will be triple-negative, since GPNMB is frequently expressed in this population. Patients will be randomized (2:1) to receive either CDX-011 or single-agent "Investigator's Choice" chemotherapy. Activity endpoints will include response rate and PFS. The study will be conducted in approximately 25 academic and community sites across the U.S.
Phase 1/2 Breast Cancer Study Overall Results
In the poster entitled Correlation of GPNMB Expression with Outcome in Breast Cancer (BC) Patients Treated with the Antibody-Drug Conjugate (ADC), CDX-011 (CR011-vcMMAE), Celldex described positive results from the Phase 1/2 trial. In this multicenter, open label, Phase 1/2 study, 42 patients with heavily pre-treated (median of seven prior anticancer regimens), progressive, locally advanced or metastatic breast cancer were administered CDX-011 as a 90 minute IV infusion, once every three weeks until intolerance or progression. In the Phase 1 portion of the study, sequential cohorts of patients were treated with escalating doses of CDX-011 to the pre-defined maximum of 1.88 mg/kg once every three weeks. The Phase 2 portion of the study enrolled an expanded cohort of patients at that maximum dose. Enrolled patients were not selected for GPNMB expression. The primary endpoint for the study, PFS rate at 12 weeks for the Phase 2 study portion, has been met, with a 12-week PFS rate of 35% (9 of 26). For all patients treated at the maximum dose level, tumor shrinkage was seen in 62% (16/26) and PFS was 9.1 weeks. A subset of 10 patients had "triple negative disease," a more aggressive breast cancer subtype that carries a high risk of relapse and reduced survival as well as limited therapeutic options due to lack of over-expression of HER2/neu, estrogen and progesterone receptors. In these patients, 78% (7/9) had any tumor shrinkage, 12-week PFS rate was 70% (7/10), and median PFS was 17.9 weeks. Tumor samples from a subset of patients across all dose groups were analyzed for GPNMB expression using a newly developed, validated, centralized assay intended for use in Phase 2 studies of CDX-011 and outcomes were examined for patients with significant stromal and tumor cell expression of GPNMB. In the small subset of patients with significant stromal or tumor cell expression of GPNMB, overall response rate was 22%, median PFS was 17.3 weeks, and the 12-week PFS rate was 67%. The most common treatment-related toxicities were fatigue, rash, nausea, alopecia (hair loss), neutropenia and vomiting.
About CDX-011
CDX-011 is an antibody-drug conjugate (ADC) that consists of a fully-human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin E (MMAE). The ADC technology, comprised of MMAE and a stable linker system for attaching it to CR011, was licensed from Seattle Genetics, Inc. Following intravenous administration, CDX-011 targets and binds to GPNMB, a specific protein that is expressed in more than 40% of breast cancers as well as other tumor types, and which promotes the migration, invasion, and metastasis of breast cancer. Upon internalization into the targeted cell, CDX-011 is designed to release MMAE from CR011 to produce a cell-killing effect. CDX-011 has been shown to be safe and active, with observed objective responses, in two positive trials including the current breast cancer trial and a Phase 1/2 trial in advanced melanoma.
About Celldex Therapeutics, Inc.
Celldex Therapeutics 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 Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, antibody-targeted 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 (PF-04948568 or CDX-110), CDX-1307, CDX-011, CDX-1135 (formerly TP10), CDX-1401, CDX-1127, 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; our ability to adapt APC Targeting Technology(TM) 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; our development partners' willingness to make announcements with respect to co-developed products; the uncertainties inherent in clinical testing; our ability to manage research and development efforts for multiple products at varying stages of development; Pfizer's and our strategy and business plans concerning the continued development and commercialization of Rindopepimut (PF-04948568 or CDX-110); the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; our ability to successfully integrate the businesses, multiple technologies and programs of CuraGen and Celldex; 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, 2009, 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.
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CHICAGO, Jun 05, 2010 (BUSINESS WIRE) -- Celldex Therapeutics, Inc. /quotes/comstock/15*!cldx/quotes/nls/cldx (CLDX 6.56, -0.31, -4.51%) today announced that interim results from a Phase 2b study evaluating rindopepimut (formerly PF-04948568 or CDX-110) in newly-diagnosed glioblastoma multiforme (GBM) patients were presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). Rindopepimut, an investigational immunotherapeutic vaccine that targets the tumor-specific molecule epidermal growth factor receptor variant III (EGFRvIII), was developed by Celldex Therapeutics and is licensed to Pfizer.
"We are pleased that interim data from ACT III is consistent with data generated from our two previous clinical studies with rindopepimut in GBM," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "70 percent of ACT III patients were progression-free at 5.5 months after initiating treatment with rindopepimut, which corresponds to the 8.5 months seen in ACT II and ACTIVATE when measured from diagnosis and surgery. The earlier ACTIVATE and ACT II trials reported progression free rates at 8.5 months of 70 and 80 percent, respectively. Importantly, previous studies were conducted in just a few leading centers, whereas ACT III enrolled patients in over 25 centers in the United States. We look forward to the final ACT III data later this year, and are working with Pfizer to determine appropriate next steps in the development of rindopepimut."
Approximately 10,000 patients are diagnosed with GBM annually in the United States, and it is estimated that the EGFRvIII mutation may be expressed in approximately 25 to 30 percent of the GBM population.(1,2) Based upon historic controls from Duke/MDACC, median progression free survival for patients with EGFRvIII positive GBM is 6.3 months.
ACT III Results
-- For the planned interim analysis, 40 patients out of a total 65 were evaluated at 5.5 months for Progression Free Rate (PFR), a primary endpoint.
-- Patients were newly-diagnosed with EGFRvIII-positive GBM and had undergone successful surgery to remove the tumor. All patients received rindopepimut in combination with maintenance temozolomide (TMZ) after successful completion of standard radiation therapy and concurrent TMZ.
-- 5.5 month progression free rate (PFR) of 70 percent (28/40) while on treatment with rindopepimut is consistent with data observed in previous rindopepimut clinical studies in GBM. (The 5.5 month primary endpoint correlates with approximately 8.5 months since diagnosis/surgery.)
-- Adverse events as a result of treatment with rindopepimut were limited to injection site reactions and reversible hypersensitivity reactions. One hypersensitivity reaction was reported as a serious adverse event and required discontinuation of rindopepimut.
Study Design
The ongoing ACT III Phase 2 trial is a single-arm study that has enrolled 65 patients with newly-diagnosed EGFRvIII-positive GBM who have undergone surgical (gross total) resection followed by conformal radiation therapy and concurrent oral TMZ (75 mg/m2 per day) without tumor progression. Rindopepimut mixed with granulocyte-macrophage colony stimulating factor (GM-CSF) (142mcg) was administered intradermally. Patients received rindopepimut bi-weekly for three doses prior to starting maintenance TMZ and monthly thereafter until disease progression. The primary endpoint of the interim analysis was PFR at 5.5 months from first vaccination.
The ACT III Phase 2b trial originally included a control arm but was amended to a single arm design when 14/16 control arm patients declined further participation after notification of randomization assignment. When the patients randomized to the control arm withdrew from the study, the trial could no longer achieve the planned statistical goals.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers, including breast, lung, prostate, sarcoma, melanoma, and various hematologic cancers. Pfizer Oncology has more than 20 biologics and small molecules in clinical development and more than 100 clinical trials underway.
By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time. For more information please visit www.Pfizer.com.
About Celldex Therapeutics, Inc.
Celldex Therapeutics 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 Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, antibody-targeted 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 (PF-04948568 or CDX-110), CDX-1307, CDX-011, CDX-1135 (formerly TP10), CDX-1401, CDX-1127, 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; 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; our development partners' willingness to make announcements with respect to co-developed products; the uncertainties inherent in clinical testing; our ability to manage research and development efforts for multiple products at varying stages of development; Pfizer's and our strategy and business plans concerning the continued development and commercialization of RINDOPEPIMUT (PF-04948568 OR CDX-110) ; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; our ability to successfully integrate the businesses, multiple technologies and programs of CuraGen and Celldex; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and other factors listed in our annual report on Form 10-K for the fiscal year ended December 31, 2009, and its Forms 10-Q and 8-K.
(1) Heimberger, A.B., et al., "Prognostic effect of epidermal growth factor receptor and EGFRvIII in glioblastoma multiforme patients." Clin Cancer Res, 2005. 11(4): p. 1462-6.
(2) Pelloski, C.E., et al., "Epidermal growth factor receptor variant III status defines clinically distinct subtypes of glioblastoma." J Clin Oncol, 2007. 25(16): p. 2288-94.
SOURCE: Celldex Therapeutics, Inc.
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7:16 am ET 06/07/2010- Reuters
Following is a summary of research actions on non-S&P 500 companies reported by Reuters on Monday. Stock entries are in alphabetical order. For a summary of research on S&P 500 companies, double click on . For a summary of research on Canadian companies, double click on .
STOCK RESEARCH BY ACTION AMB Property Corp Goldman Sachs Removes from conviction sell list; keeps sell rating
ArcelorMittal HSBC Cuts price target to $48 from $58;
keeps overweight rating
ATP Oil & Gas Howard Weil Cuts target price from $20 to $15,
market perform rating
Celldex Therapeutics Roth Capital Raises price target to $15 from $11; Inc keeps buy rating
Cinemark Holdings Macquarie Ups to outperform from neutral rating Inc price target $20
Community Bank Janney Capital Raises to buy rating System Inc Markets
Digital Realty Trust UBS Raises to buy from neutral Inc
Dupont Fabros Technology UBS Raises to buy from neutral Inc
Plexus Corp S&P Equity Raises to buy from hold rating, keeps
Research target price of $42
Sterling Bancshares Baird Raises to neutral from underperform Inc
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“Both CDX-011 and CDX-1307 have demonstrated tremendous potential for the treatment of the most difficult to treat cancers,” said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. “Further development is warranted for both candidates and we look forward to reporting additional clinical data in the near future.”
CDX-011 Phase 2 Melanoma Study Results
In the poster entitled Frequent Dosing and GPNMB Expression with CDX-011 (CRO11-vcMMAE), an Antibody-Drug Conjugate (ADC), in Patients with Advanced Melanoma, Celldex described updated results from the Phase 2 portion of the multicenter, open-label Phase 1/2 study of CDX-011 in patients with unresectable Stage III/IV melanoma. A total of 34 patients were enrolled in the Phase 2 expansion and the primary activity endpoint of overall response rate (ORR) in the cohort was achieved with an ORR of 15%. Median progression free survival (PFS) was 3.9 months. CDX-011 was found to be active in advanced melanoma patients in the study.
In the Phase 2 expansion study, CDX-011 was administered at the pre-defined maximum tolerated dose (MTD) once every three weeks. A more frequent dosing schedule at MTD was evaluated in two additional, parallel dose-escalation arms in which patients received CDX-011 weekly (n=15) or twice every three weeks (n=6). The response rate was observed to be 20% and 33%, respectively.
CDX-011 consists of the potent cellular toxin MMAE conjugated to a fully-human monoclonal antibody (CR011) to GPNMB. The destruction of GPNMB-expressing cells, or transmembrane glycoprotein NMB, a novel glycoprotein expressed in over 80% of melanomas, may be involved in growth delay and reduction of a tumor’s metastatic potential. CDX-011 is designed to be stable in the bloodstream but to release MMAE upon internalization in GPNMB-expressing tumor cells, resulting in a targeted cell-killing effect. 83% (33/40) of patients with tumor sample analyzed by immunohistochemistry to date were positive for GPNMB expression. Preliminary data suggest an increase in PFS in patients with high tumoral GPNMB expression. The subset of seven patients, whose tumors were found to express high amounts of GPNMB, and who were treated at the maximum tolerated doses across all dosing schedules, demonstrated a median PFS of 4.9 months. The development of rash, which may be associated with the presence of GPNMB in the skin correlated with greater PFS. The most frequent treatment-related adverse events included rash, fatigue, alopecia (hair loss), pruritus, diarrhea and neuropathy.
CDX-1307 Bladder Cancer Study Design
In the poster entitled A Randomized Phase II Study of a Novel Antigen-Presenting Cell-Targeted hCG-β Vaccine (the CDX-1307 Regimen) in Muscle-Invasive Bladder Cancer, Celldex describes the study design for its Phase 2 trial of CDX-1307 in bladder cancer initiated in May of 2010. Recently CDX-1307 successfully completed a Phase 1 study in epithelial cancer.
In the multi-center Phase 2 controlled trial, 60 chemotherapy-naive patients with newly diagnosed, non-metastatic, resectable, muscle invasive hCG-beta positive bladder cancer will be randomized to receive either a neoadjuvant gemcitabine/cisplatin chemotherapy (GC) or CDX-1307 in combination with GC, poly-ICLC (PIC) and resiquimod (R) (the CDX-1307 regimen). The CDX-1307 dual mechanism of action shows that cytotoxic T cell responses specific to hCG-beta can directly kill tumor cells and that humoral anti-hCG-beta responses may neutralize anti-hCG-beta activity.
About CDX-011
CDX-011 is an antibody-drug conjugate (ADC) that consists of a fully-human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin E (MMAE). The ADC technology, comprised of MMAE and a stable linker system for attaching it to CR011, was licensed from Seattle Genetics, Inc. Following intravenous administration, CDX-011 targets and binds to GPNMB, a specific protein that is predominantly expressed in cancerous tumors, including melanoma, breast cancer and gliomas. Upon internalization into the targeted cell, CDX-011 is designed to release MMAE from CR011 to produce a cell-killing effect. CDX-011 has been shown to be safe and active, with observed objective responses, in two positive trials in breast cancer and advanced melanoma.
About CDX-1307
CDX-1307 is the first antibody-based cancer vaccine designed to induce robust immune responses against cells containing the beta chain of human chorionic gonadotropin (hCG-beta) which are found in several epithelial tumors. hCG-beta appears to directly facilitate cancer progression and has been shown to correlate with poor prognosis. CDX-1307 consists of a fully human monoclonal antibody with specificity for the mannose receptor on dendritic cells, genetically linked to the hCG-beta tumor antigen and combined with the adjuvants TLR-7/8 agonist (toll-like receptor) and Hiltonol™ (a TLR-3 agonist). It is in development for colorectal, pancreatic, bladder, ovarian and breast cancers. CDX-1307 is derived from Celldex’ APC Targeting Technology™ platform.
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kauf die Panik und verkaufe die Euphorie...nur hab ich zweites verpasst...
Celldex ist z.Zt. ein Schnäppchen...
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Lausche heute CNBC, jede Minute dreht sich um die Eurokrise...der perfekte Background für die Shorties
Morgen und am 9.Juni kommt noch ne Konferenz, was Celldex braucht ist ein Phase 3 announcement
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Roth Capital raised its price target after Celldex announced positive data updates. The firm reiterates a Buy rating on the stock. :theflyonthewall.com
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Celldex also reported data on its metastatic melanoma treatment and a bladder cancer treatment at the ASCO meeting. Still, shares plunged 19.7% to $5.27. Celldex declined to comment about the share movement.
Roth analyst, Joseph Pantginis, said it was likely investors were selling on the news as shares had been up 40% year-to-date before Monday's fall, last month hitting as high as $9.49. But Pantginis said the reports were very encouraging, and boosted his price target to $15.
WBB Securities analyst Stephen Brozak said investors might be unwilling to pile into such an undervalued stock because the low price makes it too easy of a takeover target. With a market capitalization falling below $200 million Monday and an impressive pipeline, a takeover could come in at a level well below the $15 Brozak and other analysts think is fair value. That would reduce the incentive of large investors, Brozak said.
"The real danger here isn't that the company will decline," Brozak said. "The real danger is the company can get taken out for a price that's way too cheap."
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