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Sehouli J.,Charité - Medical University of Berlin | Pietzner K.,Charité - Medical University of Berlin | Wimberger P.,TU Dresden | Vergote I.,University Hospitals Leuven | And 14 more authors.
Medical Oncology | Year: 2014

This two-arm, randomised, multicentre, openlabel, phase IIIb study investigated the safety and efficacy of a 3-h catumaxomab infusion with/without prednisolone premedication to reduce catumaxomab-related adverse events. Patients with malignant ascites due to epithelial cancer received four 3-h intraperitoneal catumaxomab infusions with/without intravenous prednisolone (25 mg) premedication before each infusion. The primary safety endpoint was a composite safety score calculated from the incidence and intensity of the most frequent catumaxomab-related adverse events (pyrexia, nausea, vomiting and abdominal pain). Puncture-free survival (PuFS) was a coprimary endpoint. Time to next puncture (TTPu) and overall survival (OS) were secondary endpoints. Prednisolone premedication did not result in a significant reduction in the main catumaxomab-related adverse events. The mean composite safety score was comparable in both arms (catumaxomab plus prednisolone, 4.1; catumaxomab, 3.8; p = 0.383). Median PuFS (30 vs. 37 days) and TTPu (78 vs. 102 days) were shorter in the catumaxomab plus prednisolone arm than in the catumaxomab arm, but the differences were not statistically significant (p = 0.402 and 0.599, respectively). Median OS was longer in the catumaxomab plus prednisolone arm than in the catumaxomab arm (124 vs. 86 days), but the difference was not statistically significant (p = 0.186). The superiority of catumaxomab plus prednisolone versus catumaxomab alone could not be proven for the primary endpoint. Prednisolone did not result in a significant reduction in the main catumaxomab-related adverse events. The study confirms the safety and efficacy of catumaxomab administered as four 3-h intraperitoneal infusions for the treatment of malignant ascites. © Springer Science+Business Media 2014.


WiseGuyReports.Com Publish a New Market Research Report On – “Immunotherapy Drugs Market Global Potential Growth,Share,Demand and Analysis Of Key Players Research Report Forecasts to 2020”. This market research report presents a comprehensive segmentation of the global immunotherapy drugs market by type of immunotherapy (mAbs, vaccines, immune checkpoint inhibitors, non-specific immunotherapies, and others), by therapy area (oncology, infectious disease, autoimmune and inflammatory disorders, respiratory diseases, and others), and by geography (the Americas, APAC, and EMEA). Key vendors are AbbVie, Amgen, Bristol-Myers Squibb, F.Hoffmann-La Roche, Johnson & Johnson, and Merck. Overview of the global immunotherapy drugs market  The market research analyst predicts that the global immunotherapy drugs market will grow at a steady CAGR of close to 12% by 2020. During a rise in cancer and a number of autoimmune diseases, the need for immunotherapy drugs is on the rise. Furthermore, with the increasing demand for mAbs, the market for immunotherapy drugs will have a positive outlook until the end of the forecast period. mAbs have a high affinity for specific disease cells and areas that need treatment. Consequently, they can be used for therapies like radioimmunotherapy and antibody-directed enzyme prodrug therapy. The augmented usage of these antibodies in drug development will help to bolster the market’s revenue generating capacity over the course of the next four years. For more information or any query mail at [email protected] An important factor impelling the prospects for growth in this market is the emergence of biosimilars. Unlike generic drugs, which have active pharmaceutical ingredients similar to original drugs, biosimilars are almost identical to their originator biologic compounds. Since biosimilars help to make treatments more accessible to patients and are less expensive than biologics, their sale among the end users is anticipated to increase significantly over the next few years. Segmentation by type of immunotherapy and analysis of the immunotherapy drugs market  - mAbs  - Vaccines  - Immune checkpoint inhibitors  - Non-specific immunotherapies During 2015, the mAbs segment dominated this market and accounted for an impressive market share of nearly 61%. The development of new drugs and the entry of new molecules like zanolimumab, elotuzumab, obinutuzumab, and onartuzumab into the market will aid in the growth of this market segment during the forecast period. Geographical segmentation and analysis of the immunotherapy drugs market  - Americas  - APAC  - EMEA The Americas dominated the global market with over 50% market share in 2015. The market is flourishing in this region due to the higher incidences of cancer, infectious diseases, and autoimmune diseases in the US. Additionally, factors such as the high affordability of therapies due to the presence of well-structured reimbursement plans will also spur the prospects for market growth until 2020. Competitive landscape and key vendors  The global market for immunotherapy drugs is highly competitive due to the presence of a number of large and small vendors. Many of these vendors have a huge global presence and enter into strategic alliances to aid in the manufacture and marketing of essential drugs. Safety and effectiveness of drugs are key factors, which will give vendors an edge in the marketplace. Key vendors in this market are - AbbVie  Amgen  Bristol-Myers Squibb  F.Hoffmann-La Roche  Johnson & Johnson  Merck  Other prominent vendors are AB Science. Ablynx, Acorda Therapeutics, ADC Therapeutics, Aduro Biotech, Advantagene, Advaxis, Agensys, Agenus, Alder Biopharmaceuticals, AlphaVax, Altor BioScience, Antares Pharma, Antigen Express, Argos Therapeutics, Astellas Pharma, AstraZeneca, AVAX Technologies, Bavarian Nordic, Baxter, Bayer, Biogen, Biotech Pharmaceutical, Biothera, Boehringer Ingelheim, Can-Fite BioPharma, Celgene, Celldex Therapeutics, Celltrion, Cel-Sci, ChemoCentryx, Chugai Pharmaceutical, Coherus BioSciences, CTI BioPharma, CureVac, Daiichi Sankyo, Eisai, Eli Lilly, Fortress Biotech, Galena Biopharma, Genexine, Genmab, Gilead Sciences, GSK, GlobeImmune, Gradalis, Heat Biologics, Hospira, Idera, Inmatics, ImmunoCellular Therapeutics, Immunomedics, ImmuPharma, Immutep, Incyte, Inovio Pharmaceuticals, Intas Pharmaceuticals, Invion, ISA Pharmaceuticals, Janssen Biotech, Juvaris Biotherapeutics, KaloBios Pharmaceuticals, Kyowa Hakko Kirin, Lexicon Pharmaceuticals, MedImmune, Morphotek, Neovii Biotech, Northwest Biotherapeutics, Novartis, NovaRx, Novo Nordisk, OncoMed Pharmaceuticals, Oncothyreon, Oncovir, Opexa Therapeutics, Oxford BioMedica, Pfizer, Prima BioMed, Principia, Progenics, Provectus Biopharmaceuticals, Regeneron, Sandoz, Sanofi, Santarus, Seattle Genetics, Sotio, Spectrum Pharmaceuticals, Takeda, TG Therapeutics, Transgene, UbiVac, UCB, Vaccinex, Vaccinogen, Vaxon Biotech, Vertex Pharmaceuticals, Vical, Vitae Pharmaceuticals, and XBiotech. Key questions answered in the report include  - What will the market size and the growth rate be in 2020?  - What are the key factors driving the global immunotherapy drugs market?  - What are the key market trends impacting the growth of the global immunotherapy drugs market?  - What are the challenges to market growth for immunotherapy drugs?  - Who are the key vendors in the global immunotherapy drugs market?  - What are the market opportunities and threats faced by the vendors in the immunotherapy drugs market?  - Trending factors influencing the market shares of the Americas, APAC, and EMEA.  - What are the key outcomes of the five forces analysis of the global immunotherapy drugs market? For more information or any query mail at [email protected] Wise Guy Reports is part of the Wise Guy Consultants Pvt. Ltd. and offers premium progressive statistical surveying, market research reports, analysis & forecast data for industries and governments around the globe. Wise Guy Reports features an exhaustive list of market research reports from hundreds of publishers worldwide. We boast a database spanning virtually every market category and an even more comprehensive collection of market research reports under these categories and sub-categories.


Pietzner K.,Charité - Medical University of Berlin | Vergote I.,University Hospitals Leuven and Leuven Cancer Institute | Santoro A.,Instituto Clinico Humanitas | Chekerov R.,Charité - Medical University of Berlin | And 5 more authors.
Medical Oncology | Year: 2014

Malignant ascites is a common phenomenon in cancer patients. It poses a great challenge to the clinician, because of limited treatment options and strong impairment of the quality of life of the often palliative patients. The SECIMAS study investigated the feasibility of a re-challenge with four catumaxomab intraperitoneal infusions in patients who had already received a first cycle of four infusions in the phase III CASIMAS study, which compared catumaxomab with and without prednisolone premedication. The primary endpoint was the proportion of patients who received at least three catumaxomab infusions. Secondary endpoints included a composite safety score (CSS) summarising the worst grades for the main catumaxomab-related adverse events (pyrexia, nausea, vomiting and abdominal pain), safety, efficacy and the occurrence of anti-drug antibodies (ADAs). Eight of nine screened patients received a second catumaxomab cycle. Compliance with a catumaxomab re-challenge was high: all eight patients (100 %) received all four infusions. The median CSS was 3.0 versus 3.4 in CASIMAS. The tolerability profile of the second catumaxomab cycle was comparable to that of the first cycle. Median puncture-free survival (48 days) and overall survival (407 days) were longer than in CASIMAS (35 and 103 days, respectively), although median time to next puncture was shorter (60 vs. 97 days). Of six patients sampled, all were ADA positive at screening and remained ADA positive until the end of the study. The presence of ADAs did not affect catumaxomab’s safety or efficacy. The CSS and tolerability profile for catumaxomab in SECIMAS were comparable to those in CASIMAS. The majority of patients benefitted from a second cycle of catumaxomab. A re-challenge seems to be feasible and safe for selected patients with recurrent malignant ascites due to carcinoma after a first cycle of catumaxomab. © 2014, Springer Science+Business Media New York.


Werner I.,Goethe University Frankfurt | Seitz-Merwald I.,Neovii Biotech GmbH | Kiessling A.H.,Goethe University Frankfurt | Kur F.,Ludwig Maximilians University of Munich | Beiras-Fernandez A.,Goethe University Frankfurt
Transplantation Proceedings | Year: 2014

Introduction: Antithymocyte globulin (ATG)-Fresenius (Neovii-Biotech, Graefelfing, Germany), a highly purified rabbit polyclonal antihuman T-lymphocyte immunoglobulin resulting from immunization of rabbits with the Jurkat T-lymphoblast cell line, is currently used for the prevention of acute rejection in patients receiving solid organ transplants. Our aim was to investigate the in vitro activity of ATG-Fresenius regarding the proliferation of peripheral blood mononuclear cells (PBMCs), an important mechanism of rejection after solid organ transplantation. Methods: PBMCs were isolated from 6 healthy donors. Proliferation was assayed using [3H] thymidine incorporation. For analysis of mitogen-stimulated proliferation, the PBMCs were incubated at 37°C with various concentrations of ATG-Fresenius in the absence/presence of 40 μg/mL phytohemagglutinin. For analysis of the mixed lymphocyte reaction, PBMCs were incubated at 37°C with various concentrations of ATG-Fresenius for 3 days. On day 3, PBMCs (stimulator cells) from allogeneic donors were incubated with 25 μg/mL mitomycin C. The responder cells (preincubated with ATG-Fresenius) were then cultured at 37°C with the stimulator cells for 6 days. Groups were compared using ANOVA and the Tukey-Kramer multiple comparison test. Results: Preincubation of PBMCs with ATG results in concentration-dependent inhibition of phytohemagglutinin-stimulated proliferation. The effect was more pronounced after 2 and 3 days of treatment with ATG compared with 1 day. There was a concentration-dependent decrease in the mixed lymphocyte reaction-induced proliferation (up to 80%) at ATG-Fresenius concentrations as low as 0.05 to 0.5 μg/mL. No further effect on proliferation at ATG-Fresenius concentrations of 0.5 to 50 μg/mL was seen, and higher concentrations (>100 μg/mL) totally inhibited proliferation. Conclusions: Our in vitro results provide more evidence of the beneficial effect of ATGs in the early phase of solid organ transplantation, by reducing effector cell proliferation. © 2014 by Elsevier Inc. All rights reserved.


Mau-Sorensen M.,Rigshospitalet | Dittrich C.,Ludwig Boltzmann Research Institute | Dienstmann R.,Vall dHebron Hospital | Lassen U.,Rigshospitalet | And 3 more authors.
Cancer Chemotherapy and Pharmacology | Year: 2015

Purpose: The aim of the study was to evaluate the safety and determine the maximum tolerated dose (MTD) of intravenous catumaxomab, a trifunctional bispecific antibody that binds to EpCAM on epithelial cancer cells and CD3 on T cells. Methods: The trial was a dose-escalation study with a 3 + 3 design in epithelial cancers with known EpCAM expression. The dose-limiting toxicity (DLT) period consisted of 4 weeks, with weekly intravenous administration of catumaxomab. Key DLTs were ≥grade 3 optimally treated non-hematological toxicity; ≥grade 3 infusion-related reactions refractory to supportive care; ≥grade 3 increase in liver enzymes and/or bilirubin not resolving to grade 2. Results: Sixteen patients were enrolled receiving doses of 2 (n = 5), 4 (n = 3), 7 (n = 7) and 10 μg catumaxomab (n = 1). The most common treatment-emergent adverse events (TEAEs) were chills (93.8 %) and pyrexia (87.5 %). The most common TEAE of grade ≥3 was transient dose-dependent increases in aspartate aminotransferase (56.3 %). The intensity of toxicities decreased with the number of infusions. Also, serum IL-6 increased in a dose-dependent manner and reverted to low or undetectable levels after four infusions. A reversible decrease in liver function test (prothrombin time) at the 7-μg dose level was considered a DLT. The first patient at 10 μg experienced a fatal hepatic failure related to catumaxomab that led to the termination of the study. Conclusions: The MTD of weekly intravenous catumaxomab was 7 μg. Major toxicities were cytokine release-related symptoms and hepatotoxicity. © 2015 Springer-Verlag Berlin Heidelberg.


PubMed | Ludwig Maximilians University of Munich, Neovii Biotech GmbH and Goethe University Frankfurt
Type: Evaluation Studies | Journal: Transplantation proceedings | Year: 2014

Antithymocyte globulin (ATG)-Fresenius (Neovii-Biotech, Graefelfing, Germany), a highly purified rabbit polyclonal antihuman T-lymphocyte immunoglobulin resulting from immunization of rabbits with the Jurkat T-lymphoblast cell line, is currently used for the prevention of acute rejection in patients receiving solid organ transplants. Our aim was to investigate the in vitro activity of ATG-Fresenius regarding the proliferation of peripheral blood mononuclear cells (PBMCs), an important mechanism of rejection after solid organ transplantation.PBMCs were isolated from 6 healthy donors. Proliferation was assayed using [(3)H] thymidine incorporation. For analysis of mitogen-stimulated proliferation, the PBMCs were incubated at 37C with various concentrations of ATG-Fresenius in the absence/presence of 40 g/mL phytohemagglutinin. For analysis of the mixed lymphocyte reaction, PBMCs were incubated at 37C with various concentrations of ATG-Fresenius for 3 days. On day 3, PBMCs (stimulator cells) from allogeneic donors were incubated with 25 g/mL mitomycin C. The responder cells (preincubated with ATG-Fresenius) were then cultured at 37C with the stimulator cells for 6 days. Groups were compared using ANOVA and the Tukey-Kramer multiple comparison test.Preincubation of PBMCs with ATG results in concentration-dependent inhibition of phytohemagglutinin-stimulated proliferation. The effect was more pronounced after 2 and 3 days of treatment with ATG compared with 1 day. There was a concentration-dependent decrease in the mixed lymphocyte reaction-induced proliferation (up to 80%) at ATG-Fresenius concentrations as low as 0.05 to 0.5 g/mL. No further effect on proliferation at ATG-Fresenius concentrations of 0.5 to 50 g/mL was seen, and higher concentrations (>100 g/mL) totally inhibited proliferation.Our in vitro results provide more evidence of the beneficial effect of ATGs in the early phase of solid organ transplantation, by reducing effector cell proliferation.

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