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Bloomington, IN, United States

ClinData Services Inc.

Bloomington, IN, United States
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PubMed | One Health Commission, Washington University in St. Louis, University of Pennsylvania, University of Missouri - Kansas City and 17 more.
Type: Journal Article | Journal: Clinical and translational medicine | Year: 2016

A1 One health advances and successes in comparative medicine and translational researchCheryl StroudA2 Dendritic cell-targeted gorilla adenoviral vector for cancer vaccination for canine melanomaIgor Dmitriev, Elena Kashentseva, Jeffrey N. Bryan, David T. CurielA3 Viroimmunotherapy for malignant melanoma in the companion dog modelJeffrey N. Bryan, David Curiel, Igor Dmitriev, Elena Kashentseva, Hans Rindt, Carol Reinero, Carolyn J. HenryA4 Of mice and men (and dogs!): development of a commercially licensed xenogeneic DNA vaccine for companion animals with malignant melanomaPhilip J. BergmanA5 Successful immunotherapy with a recombinant HER2-expressing Listeria monocytogenes in dogs with spontaneous osteosarcoma paves the way for advances in pediatric osteosarcomaNicola J. Mason, Josephine S. Gnanandarajah, Julie B. Engiles, Falon Gray, Danielle Laughlin, Anita Gaurnier-Hausser, Anu Wallecha, Margie Huebner, Yvonne PatersonA6 Human clinical development of ADXS-HER2Daniel OConnorA7 Leveraging use of data for both human and veterinary benefitLaura S. TremlA8 Biologic replacement of the knee: innovations and early clinical resultsJames P. StannardA9 Mizzou BioJoint Center: a translational success storyJames L. CookA10 University and industry translational partnership: from the lab to commercializationMarc JacobsA11 Beyond docking: an evolutionarily guided OneHealth approach to drug discoveryGerald J. Wyckoff, Lee Likins, Ubadah Sabbagh, Andrew SkaffA12 Challenges and opportunities for data applications in animal health: from precision medicine to precision husbandryAmado S. GuloyA13 A cloud-based programmable platform for healthHarlen D. HaysA14 Comparative oncology: One Health in actionAmy K. LeBlancA15 Companion animal diseases bridge the translational gap for human neurodegenerative diseaseJoan R. Coates, Martin L. Katz, Leslie A. Lyons, Gayle C. Johnson, Gary S. Johnson, Dennis P. OBrienA16 Duchenne muscular dystrophy gene therapyDongsheng DuanA17 Polycystic kidney disease: cellular mechanisms to emerging therapiesJames P. CalvetA18 The domestic cat as a large animal model for polycystic kidney diseaseLeslie A. Lyons, Barbara GandolfiA19 The support of basic and clinical research by the Polycystic Kidney Disease FoundationDavid A. BaronA20 Using naturally occurring large animal models of human disease to enable clinical translation: treatment of arthritis using autologous stromal vascular fraction in dogsMark L. WeissA21 Regulatory requirements regarding clinical use of human cells, tissues, and tissue-based productsDebra A. WebsterA22 Regenerative medicine approaches to Type 1 diabetes treatmentFrancis N. KaranuA23 The zoobiquity of canine diabetes mellitus, mans best friend is a friend indeed-islet transplantationEdward J. RobbA24 One Medicine: a development model for cellular therapy of diabetesRobert J. Harman.

PubMed | ClinData Services Inc., University of Pennsylvania, Advaxis and Drexel University
Type: Journal Article | Journal: Clinical cancer research : an official journal of the American Association for Cancer Research | Year: 2016

Recombinant Listeria vaccines induce tumor-specific T-cell responses that eliminate established tumors and prevent metastatic disease in murine cancer models. We used dogs with HER2/neu(+) appendicular osteosarcoma, a well-recognized spontaneous model for pediatric osteosarcoma, to determine whether a highly attenuated, recombinant Listeria monocytogenes expressing a chimeric human HER2/neu fusion protein (ADXS31-164) could safely induce HER2/neu-specific immunity and prevent metastatic disease.Eighteen dogs that underwent limb amputation or salvage surgery and adjuvant chemotherapy were enrolled in a phase I dose escalation clinical trial and received either 2 10(8), 5 10(8), 1 10(9), or 3.3 10(9) CFU of ADXS31-164 intravenously every 3 weeks for 3 administrations.Only low-grade, transient toxicities were observed. ADXS31-164 broke peripheral tolerance and induced antigen-specific IFN responses against the intracellular domain of HER2/neu in 15 of 18 dogs within 6 months of treatment. Furthermore, ADXS31-164 reduced the incidence of metastatic disease and significantly increased duration of survival time and 1-, 2-, and 3-year survival rates when compared with a historical control group with HER2/neu(+) appendicular osteosarcoma treated with amputation and chemotherapy alone.These findings demonstrate that ADXS31-164 administered in the setting of minimal residual disease can induce HER2/neu-specific immunity and may reduce the incidence of metastatic disease and prolong overall survival in a clinically relevant, spontaneous, large animal model of cancer. These findings, therefore, have important translational relevance for children with osteosarcoma and adults with other HER2/neu(+) cancers. Clin Cancer Res; 22(17); 4380-90. 2016 AACR.

Brouns F.,Maastricht University | Theuwissen E.,Maastricht University | Adam A.,Cargill Inc. | Bell M.,ClinData Services Inc. | And 2 more authors.
European Journal of Clinical Nutrition | Year: 2012

Background/Objectives:Viscous fibers typically reduce total cholesterol (TC) by 3-7% in humans. The cholesterol-lowering properties of the viscous fiber pectin may depend on its physico-chemical properties (viscosity, molecular weight (MW) and degree of esterification (DE)), but these are not typically described in publications, nor required by European Food Safety Authority (EFSA) with respect to its generic pectin cholesterol-lowering claim.Subjects/Methods: Here, different sources and types of well-characterized pectin were evaluated in humans. Cross-over studies were completed in mildly hyper-cholesterolemic persons receiving either 15 g/day pectin or cellulose with food for 4 weeks.Results:Relative low-density lipoprotein (LDL) cholesterol (LDL-C) lowering was as follows: citrus pectin DE-70apple pectin DE-70 (7-10% reduction versus control)>apple pectin DE-35=citrus pectin DE-35>OPF (orange pulp fiber) DE-70 and low-MW pectin DE-70>citrus DE-0. In a subsequent 3-week trial with 6 g/day pectin, citrus DE-70 and high MW pectin DE-70 reduced LDL-C 6-7% versus control (without changes in TC). In both studies, high DE and high MW were important for cholesterol lowering. Source may also be important as citrus and apple DE-70 pectin were more effective than OPF DE-70 pectin. Pectin did not affect inflammatory markers high-sensitivity C-reactive protein (hsCRP) nor plasma homocysteine.Conclusions:Pectin source and type (DE and MW) affect cholesterol lowering. The EFSA pectin cholesterol-lowering claim should require a minimum level of characterization, including DE and MW. © 2012 Macmillan Publishers Limited All rights reserved.

PubMed | ClinData Services Inc., Nexvet Australia Pty. Ltd., Ridge Biotechnology and North Carolina State University
Type: Journal Article | Journal: Journal of veterinary internal medicine | Year: 2016

Limited options are available for the treatment of pain in cats. Monoclonal antibodies (mAbs) that neutralize nerve growth factor (NGF) have demonstrated analgesic capacity in rodent models, people with osteoarthritis, and dogs with degenerative joint disease.This study describes the design and characterization of a fully felinized anti-NGF monoclonal antibody. In vitro potency, pharmacokinetics, and the ability of the antibody to treat pain in a self-resolving, acute inflammation model were investigated in cats.Thirty-eight cats at a research colony at Charles River Laboratories, Ireland.Felinized anti-NGF mAb, NV-02, was produced using a complementary DNA (cDNA)-based method (PETization). Purified NV-02 was tested for affinity, potency, and immunoreactivity in vitro, then for safety and plasma pharmacokinetic distribution in vivo, and analgesic efficacy in a model of kaolin-induced inflammatory pain.Anti-NGF mAb, NV-02 neutralized NGF with high affinity and potency and did not bind complement. NV-02-administered SC had a plasma half-life of 7-15 days and was well tolerated at dosages up to 28 mg/kg. A dosage of 2 mg/kg NV-02 SC significantly decreased signs of lameness on day 2 (P = .0027), day 3 (P = .016), day 4, (P = .0063), day 5 (P = .0085), day 6 (P = .0014), and day 7 (P = .0034) after induction of inflammation.The high affinity, long plasma half-life, safety, and analgesic efficacy of felinized anti-NGF mAb (NV-02) support further investigation of the analgesic potential of this antibody in the cat.

Dammann K.W.,Cargill Inc. | Bell M.,ClinData Services Inc | Kanter M.,Excelsior | Berger A.,Cargill Inc. | Berger A.,University of Minnesota
Nutritional Neuroscience | Year: 2013

Objectives: To evaluate whether consumption of the low-glycemic index (GI) carbohydrate sucromalt improves healthy adults' perceptions of mental and physical energy and fatigue compared to dextrose (glucose), a high GI control. Methods: In this double-blind, randomized, cross-over study, subjects (n = 44 healthy adults) consumed a standardized dinner, and following an overnight fast, ingested 75 g of either sucromalt or glucose in solution at 7:30 AM the next day. Subjects completed validated questionnaires that assessed mental and physical energy, and fatigue, hunger, and sleepiness at baseline and hourly until 12:30 PM for a total of five post-consumption time points. Within-subject differences adjusted for baseline for individual questions and composite scores (Mental Energy State, Mental Fatigue State, Physical Energy State, and Physical Fatigue State) were analyzed using repeated measures analysis of variance. Results: Mental Energy State, Physical Energy State, and Physical Fatigue State results favored sucromalt compared to glucose, with significant differences emerging particularly after 4-5 hours (P < 0.050). A trend toward a delay in Mental Fatigue State was also observed with sucromalt compared to glucose (P < 0.100). Minimal differences in ratings of hunger and sleepiness were observed between the beverages. Discussion: Sucromalt may help attenuate the perceived decline in mental and physical energy and rise in mental and physical fatigue that can occur 4-5 hours after ingestion of a high GI beverage. Trials examining effects of sucromalt on cognitive and physical performance are of future interest. © W. S. Maney & Son Ltd 2013.

Rausch-Derra L.C.,Aratana Therapeutics | Huebner M.,Clin Data Services Inc. | Rhodes L.,Aratana Therapeutics
American Journal of Veterinary Research | Year: 2015

OBJECTIVE To investigate the safety of daily oral administration of grapiprant to dogs. ANIMALS Thirty-six 9-month-old Beagles of both sexes. PROCEDURES Dogs were randomly assigned to groups that received grapiprant via oral gavage at 0, 1, 6, or 50 mg/kg (total volume, 5 mL/kg), q 24 h for 9 months. Each group contained 4 dogs of each sex (ie, 8 dogs/group), except for the 50 mg/kg group, which included 4 additional dogs that were monitored for an additional 30 days after treatment concluded (recovery period). All dogs received ophthalmologic, ECG, and laboratory evaluations before treatment began (baseline) and periodi- cally afterward. All dogs were observed daily. Dogs were euthanized at the end of the study for necropsy and histologic evaluation. RESULTS All dogs remained clinically normal during treatment, with no apparent chang- es in appetite or demeanor. Emesis and soft or mucoid feces that occasionally contained blood were observed in all groups, although these findings were more common in dogs that received grapiprant. In general, clinicopathologic findings remained within baseline ranges. Drug-related changes in serum to- tal protein and albumin concentrations were detected, but differences were small and resolved during recovery. No drug-related gross or microscopic pathological changes were detected in tissue samples except mild mucosal regeneration in the ileum of 1 dog in the 50 mg/kg group. CONCLUSIONS AND CLINICAL RELEVANCE Results suggested the safety of long-term oral administration of grapiprant to dogs. Efficacy of grapiprant in the treatment of dogs with osteoarthritis needs to be evaluated in other studies. © 2015, American Veterinary Medical Association. All rights reserved.

PubMed | ClinData Services Inc., Aratana Therapeutics, Norbrook Inc. and Independent Consultant
Type: | Journal: Journal of veterinary pharmacology and therapeutics | Year: 2016

The objective of the study was to evaluate the safety of capromorelin, a ghrelin agonist that stimulates appetite and causes increased body weight and the release of growth hormone (GH). Beagle dogs (n=32) received either oral placebo or 0.3, 7, or 40mg/kg capromorelin once daily for 12 consecutive months. Safety was evaluated by physical examinations, including ECG and ophthalmic examinations, and comprehensive clinical pathology. Serum levels of capromorelin, GH, and insulin-like growth factor 1 (IGF-1) were measured periodically. Necropsies and histopathological evaluations were performed at study termination. As expected, GH and IGF-1 levels were mildly increased in capromorelin-treated dogs. Adverse events were limited to mild emesis and loose stools in all groups and excess salivation among some dogs receiving higher capromorelin doses. Clinical pathology testing was generally normal, although blood lipids and alkaline phosphatase levels were moderately increased among dogs receiving capromorelin. Treated dogs had slightly longer post-treatment PR intervals seen on ECG, but with no changes in cardiac histopathology. Postmortem findings were normal. Drug-related increases in liver weight were linked to overall increases in body weight. Capromorelin was well tolerated in dogs at daily doses up to 40mg/kg for 12months, demonstrating a wide safety margin.

PubMed | ClinData Services Inc., Aratana Therapeutics and North Carolina State University
Type: Journal Article | Journal: BMC veterinary research | Year: 2016

Local anesthetics are an important component of perioperative pain management, but the duration of action of available products is limited. We hypothesized that a single local infiltration of a novel bupivacaine liposome injectable suspension (AT-003) would provide clinically effective analgesia over a 72-h period. In a masked, randomized, placebo-controlled, multi-center pilot field study, dogs undergoing lateral retinacular suture placement for cranial cruciate insufficiency were randomly assigned to surgical site infiltration with AT-003 (5.3mg/kg) or an equivalent volume of saline. Infiltration of the surgical site was done prior to closure. Primary outcome measure was the Glasgow Composite Measure Pain Scale (CMPS-SF) assessed prior to surgery and at 2, 4, 8, 12, 24, 30, 36, 48, 54, 60 and 72h following surgery by trained individuals. Provision for rescue analgesia was employed. Repeated measures analysis of variance were utilized to test for possible differences between treatment groups and a success/failure analysis was also employed, based on the need for rescue analgesia.Forty-six dogs were enrolled and evaluated. For CMPS-SF scores there was a significant overall treatment effect (p=0.0027) in favor of AT-003. There were significantly more successes in the AT-003 group compared to placebo over each time period (p=0.0001 for 0-24h, p=0.0349 for 0-48h, and p=0.0240 for 0-72h). No significant adverse events were seen.AT-003 (bupivacaine liposome injectable suspension) provided measurable local analgesia over a 72-h period following post-stifle surgery surgical site tissue infiltration. Further work is indicated to develop this product for clinical use.

Maki K.C.,Provident Clinical Research | Rains T.M.,Provident Clinical Research | Dicklin M.R.,Provident Clinical Research | Bell M.,ClinData Services Inc.
Diabetes Technology and Therapeutics | Year: 2010

Background: The objective of this investigation was to evaluate the test-retest repeatability of insulin sensitivity and secretion indices derived from liquid meal tolerance tests (MTTs) in subjects with normal fasting glucose (NFG) (n=20), impaired fasting glucose (IFG) (n=20), or type 2 diabetes mellitus (n=38). Methods: The Matsuda Index of insulin sensitivity and a Disposition Index (the product of the Matsuda Index and the ratio of the total areas under the curves for glucose and insulin from 0 to 120min) were assessed in two standard liquid MTTs, separated by approximately 1 week. Results: Mean±SD Matsuda Index values were 14.2±7.6, 8.8±4.7, and 6.3±4.0, and Disposition Index values were 1,009.6±355.5, 671.4±249.0, and 201.8±101.3 for NFG, IFG, and diabetes, respectively (all P<0.05 except Matsuda Index for IFG vs. diabetes, P=0.241). Differences between tests in subjects with NFG, IFG, and diabetes, respectively, were-0.2±3.6 (coefficient of variation for the method error, 17.9%), 0.2±3.2 (26.1%), and 0.1±3.0 (34.1%) for the Matsuda Index and 16.5±225.8 (16.1%), 13.3±221.6 (23.1%), and 15.2±79.4 (28.1%) for the Disposition Index. Conclusions: The Matsuda and Disposition indices derived from liquid MTTs appropriately ranked categories of fasting glucose tolerance and have repeatability profiles suggesting potential usefulness in population studies and moderately sized clinical trials requiring repeated measurements. © Copyright 2010, Mary Ann Liebert, Inc.

Frestedt J.L.,Frestedt Incorporated | Young L.R.,Frestedt Incorporated | Bell M.,ClinData Services Inc.
Current Nutrition and Food Science | Year: 2012

This open label, single arm, prospective, interventional, weight loss trial evaluated a meal replacement beverage (Right Size® Smoothie) used to replace breakfast and lunch each day for 12 weeks (7 clinic visits) as part of a calorierestricted diet in overweight and obese adults. A total of 155 individuals were screened, 55 enrolled and 28 completed this 12 week study. Subjects were obese (mean weight: 206 pounds and BMI: 32.7 kg/m2) and the mean age was 40 years including 42 (76.4%) female and 13 (23.6%) male volunteers. The modified Intent to Treat and Completer groups lost an average of 10.6 and 13.8 pounds and reduced their average BMI by 1.7 and 2.2 kg/m2 respectively during this 12 week trial. The Per Protocol group lost 15.2 pounds and 2.4 kg/m2 and the Optimal Weight Loss group lost 18.5 pounds and 2.9 kg/m2. Using the Satiety Labeled Intensity Magnitude scale (SLIM) questionnaire, subjects reported feeling relatively hungry before they consumed the beverage, then feeling relatively full 15 minutes following the beverage with the sensation of some fullness lasting more than 2 hours and then feeling relatively hungry again at 3 hours after consuming the beverage. Study subjects reported significant improvements in physical functioning, general health, vitality and mental health as well as increased cognitive restraint of eating, reduced disinhibition and reduced hunger during the trial. The study beverages were well tolerated and no Serious Adverse Events (SAE) reported. This study suggests the study beverage aids in weight loss by helping to curb hunger during a reduced calorie diet program. © 2012 Bentham Science Publishers.

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