Immunogenicity and safety of re-exposure to recombinant human thrombin in surgical hemostasis.

Background: This Phase 4, open-label study evaluated the immunogenicity and safety of a second exposure to recombinant human thrombin (rThrombin) in adult patients with previous exposure to rThrombin.

Study Design: Topical rThrombin was applied as a hemostatic aid during a surgical procedure (day 1). Adverse events and clinical laboratory abnormalities were monitored to day 29 (study end).

Safety and pharmacokinetics of recombinant factor XIII-A2 administration in patients with congenital factor XIII deficiency.

Congenital factor XIII (FXIII) deficiency is associated with a tendency for severe bleeding, a risk for spontaneous abortion, and a high rate of spontaneous intracranial hemorrhage. This phase 1 escalating-dose study was developed to evaluate the safety and pharmacokinetics of a single administration of human recombinant FXIII-A2 (rFXIII-A2) homodimer in adults with congenital FXIII deficiency. Pharmacokinetics and activity of rXIII and changes in endogenous B subunit levels were assessed.

Safety and pharmacokinetics of recombinant factor XIII in healthy volunteers: a randomized, placebo-controlled, double-blind, multi-dose study.

Factor XIII (FXIII) is a plasma transglutaminase that covalently cross-links fibrin proteins to one another and to other proteins, increasing the mechanical strength of blood clots. Endogenous FXIII is the final enzyme in the clotting cascade and circulates as a heterotetramer comprising 2 FXIII-A subunits and 2 FXIII-B subunits. Recombinant human FXIII A2 (rFXIII) homodimer is produced in Saccharomyces cerevisiae.

Safety, pharmacokinetics, and immunogenicity of single-dose rFXIII administration to healthy volunteers.

Background: Factor XIII (FXIII) is a transglutaminase that cross-links fibrin and other proteins to improve clot strength and resistance to fibrinolysis. Both congenital and acquired FXIII deficiency may result in a bleeding diathesis, and plasma-derived FXIII has been used to treat many of these clinical conditions.

Objectives: A clinical study was designed and performed to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant FXIII (rFXIII) administration to healthy adult volunteers.

A study of therapy-related acute leukaemia after mitoxantrone therapy for multiple sclerosis.

To evaluate the incidence of therapy-related acute leukaemia (t-AL) after single-agent mitoxantrone (MITO) treatment, we reviewed medical records of patients in three studies of single-agent MITO therapy for multiple sclerosis (MS) and existing literature on MITO therapy in MS, leukaemia, and solid tumors. Of 1378 MITO recipients in the three MS studies (mean cumulative dose of 60 mg/m2 and mean follow-up of 36 months), one patient had t-AL, an observed incidence proportion of 0.07% [95% confidence interval (CI) = 0.

Cardiac adverse effects associated with mitoxantrone (Novantrone) therapy in patients with MS.

Background: Mitoxantrone (MITO) is associated with dose-related cardiotoxicity when administered concomitantly with other cytotoxic agents with or without radiotherapy for leukemia and solid tumors.

Objective: To review observed cardiotoxicity of single-agent MITO therapy for MS.

Methods: Records of 1,378 patients from three clinical trials of MITO treatment for MS were reviewed for signs and symptoms of cardiac dysfunction and left ventricular ejection fraction (LVEF) results.

Phase I study of recombinant human CD40 ligand in cancer patients.

Purpose: To determine the toxicity, maximum-tolerated dose (MTD), and pharmacokinetics of recombinant human CD40 ligand (rhuCD40L) (Avrend; Immunex Corp, Seattle, WA), suggested in preclinical studies to mediate cytotoxicity against CD40-expressing tumors and immune stimulation.

Patients And Methods: Patients with advanced solid tumors or intermediate- or high-grade non-Hodgkin's lymphoma (NHL) received rhuCD40L subcutaneously daily for 5 days in a phase I dose-escalation study. Subsequent courses were given until disease progression.

Scintigraphic evaluation of dogs with acute synovitis after treatment with glucosamine hydrochloride and chondroitin sulfate.

Objective: To evaluate the effects of orally administered glucosamine hydrochloride (GlAm)-chondroitin sulfate (CS) and GlAm-CS-S-adenosyl-L-methionine (SAMe) on chemically induced synovitis in the radiocarpal joint of dogs.

Animals: 32 adult mixed-breed dogs.

Procedure: For 21 days, all dogs received a sham capsule (3 groups) or GlAm-CS (prior treatment group) in a double-blinded study.

Evaluation of solid phase radiolabels of dog food for gastric emptying.

99mTc-Pertechnetate, 99mTc-mebrofenin, 99mTc-disofenin, 99mTc-sulfur colloid, and 99mTc-Dowex resin beads were evaluated for in vitro stability as a label for both dry extruded, and canned dog food for gastric emptying scintigraphy. A sample of each radiolabeled diet was added to water, gastric juice, intestinal juice, or gastric juice followed by intestinal juice for in vitro digestion. After a 3-hour digestion period, tubes were centrifuged and percentage solid phase retention (%SPR) was calculated.

Actin polymerization enhances Pasteurella haemolytica leukotoxicity.

Pasteurella haemolytica leukotoxin is cytotoxic to bovine leukocytes, causing increased cell membrane permeability, osmotic swelling, release of cytosolic proteins and cell lysis. These studies were designed to test if leukotoxin causes release of the cytoskeletal protein, actin, from bovine leukemia cells and if purified actin-influenced bacterial growth or leukotoxin production. Culture supernatants caused a 7-fold decrease in viability of bovine leukemia cells and increased cell permeability that was accompanied by release of beta-actin into the cell culture supernatant.

Comparison of gastric emptying times in healthy cats simultaneously evaluated with radiopaque markers and nuclear scintigraphy.

Gastric emptying in 18 healthy cats was assessed simultaneously using scintigraphy and barium-impregnated polyethylene spheres (BIPS). Canned Prescription Diet Feline c/d (Hill's Pet Nutrition, Inc., Topeka, KS) labeled with 99mTc-disofenin (Hepatolite, DuPont Merck Pharmaceutical Co.

Effect of percutaneous endoscopic gastrostomy on gastric emptying in clinically normal cats.

Objective: To assess the effect of percutaneous endoscopic gastrostomy (PEG) tube placement on gastric emptying in clinically normal cats.

Animals: 8 healthy adult 3- to 5-year-old cats.

Procedure: Cats were accommodated to the diet for 2 weeks prior to scintigraphy.

Comparison of serologic and protective responses induced by two Pasteurella vaccines.

Vaccine development for the prevention of pneumonic pasteurellosis remains a critical issue for the feedlot industry. Most currently available Pasteurella vaccines are formulated to stimulate immunity by either providing an adequate antigenic mass in the administered dose, or by relying on subsequent production of antigens by in vivo growth of live organisms. The ability of these different types of vaccines to stimulate rapid and high titres to key antigens is a key factor that will influence subsequent resistance to disease.

Scintigraphic assessment of gastric emptying of canned and dry diets in healthy cats.

Objective: To characterize factors that affect solid-phase gastric emptying in healthy cats by use of nuclear scintigraphy and to assess differences in emptying patterns of dry and canned diets.

Animals: 20 healthy cats.

Procedure: 2 groups of 10 cats each were fed dry or canned diet for at least 2 weeks before scintigraphy was done.

Population profile of stable flies (Diptera: Muscidae) caught on Alsynite traps in various feedlot habitats.

Cylindrical traps made from Alsynite fiberglass were placed in 4 habitats in a confined cattle feedlot environment from 2 May to 30 October 1996 to evaluate abundance, sex ratio, physiological age structure, and blood-fed status of trapped adult stable flies, Stomoxys calcitrans (L.). Significantly more stable flies were caught on the trap located between host cattle and trees.

Effect of stanozolol on body composition, nitrogen balance, and food consumption in castrated dogs with chronic renal failure.

Objective: To determine the effect of stanozolol on body composition, nitrogen balance, and food consumption in castrated dogs with chronic renal failure.

Design: Blinded crossover trial.

Animals: 22 castrated Beagles with experimentally induced chronic renal failure.

Evaluation of solid-phase labels for gastric emptying studies in cats.

Unlabelled: Development of appropriate radiolabeled diets for solid-phase gastric emptying studies in experimental animals is important for testing the effects of disease, drugs, surgical procedures and stress. This study evaluates the in vitro and in vivo stability of various radiolabels in commercially available dry, extruded and canned cat foods.

Methods: Dry, extruded cat food was labeled with 99mTc-pertechnetate, 99mTc-sulfur colloid or 99mTc-disofenin.

Prognosis of canine mast cell tumors: a comparison of three methods.

In this study, age, sex, recurrence, metastasis, death rate, and histologic patterns were in agreement with those of previous reports on canine mast cell tumors. Histologic grading, mitotic index, chromosome nucleolar organizer regions stained with silver (AgNORs), and anti-proliferating cell nuclear antigen (PCNA) were evaluated as indicators of prognosis. Histologic grading, AgNORs estimated in 100 cells, and PCNA-labeled fraction estimated in five high power fields (HPFs) were significantly different between recurring and nonrecurring tumors.

Vitamin E is not degraded by ruminal microorganisms: assessment with ruminal contents from a steer fed a high-concentrate diet.

Using an in vitro incubation system containing undiluted ruminal contents from a steer fed a high-concentrate, corn-based diet, we examined microbial degradation of DL-alpha-tocopherol acetate (TA). Gas production, pH, and fermentation acid profiles were done in an initial experiment to ensure conditions for reproducible, viable cultures over 24 h. The pH decreased from 5.