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Koola M.M.,Clinical Research Program | Tsapakis E.M.,Kings College London | Wright P.,Takeda Bio Development Center | Smith S.,Kings College London | And 3 more authors.
Journal of Psychopharmacology | Year: 2014

Background: The aim of this study was to examine whether there was an association between tardive dyskinesia (TD) and number of functional CYP2D6 genes. Methods: A Caucasian sample of 70 patients was recruited in 1996-1997 from South London and Maudsley National Health Service (NHS) Foundation Trust, UK. Subjects had a DSM-IIIR diagnosis of schizophrenia and were treated with typical antipsychotics at doses equivalent to at least 100 mg chlorpromazine daily for at least 12 months prior to assessment. All patients were genotyped for CYP2D6 alleles*3-5, *41, and for amplifications of the gene. Results: There were 13 patients with TD. The mean (standard deviation (SD)) years of duration of antipsychotic treatment in TD-positive was 15.8 (7.9) vs TD-negative 11.1 (7.4) (p=0.04). Increased odds of experiencing TD were associated with increased ability to metabolize CYP2D6, as measured by genotypic category (odds ratio (OR)=4.2), increasing duration in treatment (OR=1.0), and having drug-induced Parkinsonism (OR=9.7). Discussion: We found a significant association between CYP2D6 genotypic category and TD with the direction of effect being an increase in the number of functional CYP2D6 genes being associated with an increased risk of TD. This is the first study to examine the association between TD and CYP2D6 in Caucasians with this number of genotypic categories. In the future, metabolomics may be utilized in the discovery of biomarkers and novel drug targets. © The Author(s) 2014. Source

Erdmann E.,University of Cologne | Harding S.,Takeda Bio Development Center | Lam H.,Takeda Development Center Americas Inc. | Perez A.,Takeda Development Center Americas Inc.
Diabetes, Obesity and Metabolism | Year: 2016

Aims: To conduct a 10-year, observational follow-up of patients completing PROactive to investigate whether trends of cardiovascular benefit with pioglitazone and imbalances in specific malignancies persisted over time. Methods: Macrovascular endpoints and malignancies were compared based on original randomization to pioglitazone or placebo and 'any' versus 'no' pioglitazone use for bladder and prostate cancer. Results: Of 4873 patients completing the PROactive trial, 74% entered the follow-up. During follow-up (mean 7.8years), there were no statistically significant differences in the primary [all-cause mortality, myocardial infarction (MI), cardiac intervention, stroke, major leg amputation, leg revascularization] or main secondary (death, MI, stroke) endpoints for subjects originally randomized to pioglitazone and placebo, except for leg amputations during follow-up [4.1% pioglitazone, 5.6% placebo; hazard ratio 0.74, 95% confidence interval (CI) 0.55-0.99; p=0.046]. During follow-up, the incidence of total malignancies was similar between groups; bladder cancer was reported in 0.8% of patients (n=14) in the pioglitazone versus 1.2% (n=21) in the placebo group [relative risk (RR) 0.65, 95% CI 0.33-1.28], and prostate cancer was reported in 44 men (3.7%) in the pioglitazone versus 29 men (2.5%) in the placebo group (RR 1.47, 95% CI 0.93-2.34). Conclusions: The trends of macrovascular benefits of pioglitazone compared with placebo during PROactive did not persist in the absence of continued pioglitazone during this 10-year follow-up. Trends of decreased bladder cancer and increased prostate cancer were observed in the pioglitazone group during follow-up; however, these imbalances should be interpreted with caution because of the limitations of the observational study design. © 2016 John Wiley & Sons Ltd. Source

Peng X.V.,Takeda Bio Development Center
Drugs of the Future | Year: 2013

Elagolix sodium is an oral non-peptide gonadotropin-releasing hormone (GnRH) antagonist that was discovered by Neurocrine Biosciences and is currently in phase III clinical development at the company and AbbVie in patients with endometriosis. Endometriosis is an estrogendependent disorder associated with various symptoms, including dysmenorrhea, dyspareunia, chronic pelvic pain, infertility, menorrhagia, etc. The current treatment strategy for endometriosis targets inhibiting estrogen production by the ovary and other sites of production, and/or directly on the endometriotic lesions by surgical and/or hormonal therapies, all of which have undesirable or even serious side effects. The potential availability of an oral treatment lacking the side effect profile of the currently available peptide GnRH agonists or antagonists may be a desirable alternative pharmaceutical therapy. Publicly accessible preclinical and clinical data indicate that elagolix sodium may be a drug with such promise. Copyright © 2013 Prous Science, S.A.U. or its licensors. All rights reserved. Source

Osaka Japan, August 1, 2013 --- Takeda Pharmaceutical Company Limited (“Takeda”) announced today its decision to transfer the current business of Takeda Bio Development Center Limited (“Takeda Bio”) to Takeda under the agreement concluded between both parties. Dedicated oncology therapeutic area expertise will be maintained within Japan, with direct accountability to the Global Oncology Therapeutic Area Unit. The clinical development of Takeda’s oncology products pipeline in Japan for which Takeda Bio has been responsible will be handled by Takeda’s Pharmaceutical Development Division, and after the completion of the transfer scheduled in April 2014, Takeda Bio will be dissolved. Takeda Bio has demonstrated track record of success including the regulatory approval in Japan of Vectibix® (generic name: panitumumab), a treatment for unresectable, advanced or recurrent colorectal cancer with wild-type KRAS, and also an NDA submission of brentuximab vedotin for the treatment of malignant lymphoma. Takeda Bio is currently conducting Phase 3 clinical trials of trebananib for ovarian cancer, orteronel for prostate cancer, and motesanib diphosphate for advanced non-squamous non-small cell lung cancer, among other trials. All the clinical trials will continue as currently planned under the responsibility and coordination of Takeda's Pharmaceutical Development Division. With the transfer of the business of Takeda Bio, Takeda’s development operations for both oncology and non-oncology pipelines in Japan will be fully integrated, supporting increased efficiencies and enhanced decision-making.  These actions are part of Takeda’s global initiatives to enhance its robust and efficient operating model. Note: Takeda Bio with renewed name in April 2008 restarted as Takeda’s wholly owned subsidiary, and prior to that, it had been wholly owned subsidiary of Amgen Inc. (Thousand Oaks, Calif.) in Japan. The launch of Takeda Bio was based on the agreement between Amgen Inc. and Takeda in February 2008, when both parties also agreed that Takeda licensed development pipeline from Amgen. (1)    Company name: Takeda Bio Development Center Limited (2)    Location: Marunouchi Eiraku Building, 1-4-1, Marunouchi, Chiyoda-ku, Tokyo, Japan (3)    Legal Representative: Haruo Kitado (4)    Business: Development of pharmaceutical products (5)    Established: March 26, 1992 (6)    Capital stock: 975 million yen (7)    Shares: Non-listed (8)    Shareholders of Takeda Bio: wholly owned subsidiary of Takeda Pharmaceutical Company Limited (9)    Number of employees: 108 (as of July 1, 2013)

Tahara M.,National Cancer Center Hospital East | Onozawa Y.,Shizuoka Cancer Center | Fujii H.,Jichi Medical University | Monden N.,National Hospital Organization Shikoku Cancer Center | And 3 more authors.
Japanese Journal of Clinical Oncology | Year: 2014

Objective: In Japan, cisplatin/5-fluorouracil 80/800 (cisplatin 80 mg/m2, 5-fluorouracil 800 mg/m2) is widely used to treat recurrent/metastatic squamous cell carcinoma of the head and neck, whereas cisplatin/5-fluorouracil 100/1000 (1000 mg/m2/24 h by continuous intravenous infusion on Days 1-4 plus cisplatin 100 mg/m2 on Day 1 in 3-week cycles) is the standard treatment in Europe and North America. Methods: We prospectively evaluated the feasibility of cisplatin/5-fluorouracil 100/1000 in Japanese patients enrolled in the global Phase 3 study of panitumumab 9 mg/kg combined with cisplatin/5-fluorouracil 100/1000 (Arm 1) versus cisplatin/5-fluorouracil 100/1000 alone (Arm 2). Results: Twenty Japanese patients were enrolled and received treatment (Arm 1, n 1/4 13; Arm 2, n 1/4 7). Grade 3/4 adverse events included neutropenia, hypomagnesemia, stomatitis, hyponatremia, paronychia, febrile neutropenia, decreased appetite and hypokalemia. There were no fatal adverse events. Median overall survival was not estimable in Arm 1 and 15.4 months in Arm 2. Median progression-free survival was 6.9 months in Arm 1 and 5.7 months in Arm 2. The median number of infusions (cycles) of cisplatin was 5 in Arm 1 and 4 in Arm 2; the median number of infusions (cycles) of 5-fluorouracil was 6 in both arms. The mean administered dose for cisplatin was 93.6 mg/m2 in Arm 1 and 97.2 mg/m2 in Arm 2, and 3732.6 and 3880 mg/m2 in Arm 1 and Arm 2, respectively, for 5-fluorouracil. Conclusions: These results suggested that cisplatin/5-fluorouracil 100/1000 was feasible for the recurrent/metastatic squamous cell carcinoma of the head and neck in Japanese patients. © The Author 2014. Published by Oxford University Press. Source

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