A trial of radiolabeled antibody yttrium-90-FF-21101 for the treatment of advanced ovarian and other cancers.

Background: Yttrium-90 FF-21101 (Y-FF-21101) is a radiopharmaceutical that targets P-cadherin as a therapy against solid tumors. A previously reported, first-in-human study determined that a dose of 25 mCi/m was safe, and a patient with clear cell carcinoma of the ovary achieved a complete response. In this article, the authors report the results of Y-FF-21101 treatment in an ovarian carcinoma expansion cohort and in patients with selected solid tumors who had known high P-cadherin expression.

A phase 1/2a safety, pharmacokinetics, and efficacy study of the novel nucleoside analog FF-10502-01 for the treatment of advanced solid tumors.

Background: The nucleoside FF-10502-01, structurally similar to but with different biologic effects than gemcitabine, shows promising activity both alone and combined with cisplatin in preclinical gemcitabine-resistant tumor models. We conducted an open-label, single-arm, 3 + 3 first-in-human trial to explore the safety, tolerability, and antitumor activity of FF-10502-01 in patients with solid tumors.

Methods: Patients with inoperable metastatic tumors refractory to standard therapies were enrolled.

Non-reciprocal acoustics in a viscous environment.

It is demonstrated that acoustic transmission through a phononic crystal with anisotropic solid scatterers becomes non-reciprocal if the background fluid is viscous. In an ideal (inviscid) fluid, the transmission along the direction of broken symmetry is asymmetric. This asymmetry is compatible with reciprocity since time-reversal symmetry ( symmetry) holds.

Phase I Study of P-cadherin-targeted Radioimmunotherapy with Y-FF-21101 Monoclonal Antibody in Solid Tumors.

Purpose: Y-FF-21101 is an Yttrium-90-conjugated, chimeric mAb that is highly specific for binding to human placental (P)-cadherin, a cell-to-cell adhesion molecule overexpressed and associated with cancer invasion and metastatic dissemination in many cancer types. We report the clinical activity of Y-FF-21101 in a first-in-human phase I study in patients with advanced solid tumors.

Patients And Methods: The safety and efficacy of Y-FF-21101 were evaluated in a phase I 3+3 dose-escalation study in patients with advanced solid tumors ( = 15) over a dose range of 5-25 mCi/m.

Antitumor activity and safety of combination therapy with the Toll-like receptor 9 agonist IMO-2055, erlotinib, and bevacizumab in advanced or metastatic non-small cell lung cancer patients who have progressed following chemotherapy.

Background: IMO-2055 is a Toll-like receptor 9 (TLR9) agonist that potentially enhances the efficacy of antitumor agents through immune stimulation. The objective of this phase Ib dose-escalation trial (3 + 3 design) was to determine the recommended phase II dose (RP2D) of IMO-2055 when combined with erlotinib and bevacizumab in patients with advanced non-small cell lung cancer (NSCLC).

Methods: Patients with stage 3/4 NSCLC and progressive disease (PD) following chemotherapy received IMO-2055 0.

INSPIRE: A phase III study of the BLP25 liposome vaccine (L-BLP25) in Asian patients with unresectable stage III non-small cell lung cancer.

Background: Previous research suggests the therapeutic cancer vaccine L-BLP25 potentially provides a survival benefit in patients with locally advanced unresectable stage III non-small cell lung carcinoma (NSCLC). These promising findings prompted the phase III study, INSPIRE, in patients of East-Asian ethnicity. East-Asian ethnicity is an independent favourable prognostic factor for survival in NSCLC.

Disseminated Aspergillus flavus infection in broiler breeder pullets.

Increased morbidity and mortality occurred in a 5-wk-old broiler breeder replacement pullet flock. The affected broiler pullet flock was housed on the first floor of a two-story confinement building. Mortality increased to 0.

Viability of red cells prepared with S-303 pathogen inactivation treatment.

Background: A nucleic acid-targeted pathogen inactivation process with S-303 was developed to treat red blood cells (RBCs).

Study Design And Methods: Three studies in healthy subjects investigated posttransfusion recovery, life span, and immunogenic potential of autologous RBCs treated with S-303 and stored for 35 days. A two-arm trial in 42 subjects (1A) examined recovery of 35-day-old S-303 RBCs after a single transfusion.

Photochemically treated fresh frozen plasma for transfusion of patients with acquired coagulopathy of liver disease.

An ex vivo photochemical treatment (PCT) process was developed to inactivate pathogens in fresh frozen plasma (PCT-FFP). A prospective, controlled, double-blinded, randomized study was conducted to evaluate the efficacy and safety of PCT-FFP compared with conventional FFP (C-FFP). Patients (n = 121) with acquired coagulopathy, largely due to liver disease, including hepatic transplantation, were transfused with either PCT-FFP or C-FFP for up to 7 days.

Therapeutic efficacy and safety of red blood cells treated with a chemical process (S-303) for pathogen inactivation: a Phase III clinical trial in cardiac surgery patients.

Background: A randomized, double-blind trial is reported of the clinical efficacy of red blood cells (RBCs) treated for pathogen inactivation with S-303, a synthetic labile alkylating agent.

Study Design And Methods: Patients undergoing complex cardiac surgeries were randomly assigned to receive either S-303-treated (test) or conventional (control) RBC transfusion during surgery and for 6 days thereafter. Efficacy was evaluated by comparing the occurrence of a composite primary endpoint of treatment-related morbidity (myocardial infarction and renal failure) and mortality.

Fresh frozen plasma prepared with amotosalen HCl (S-59) photochemical pathogen inactivation: transfusion of patients with congenital coagulation factor deficiencies.

Background: Photochemical treatment (PCT) with amotosalen HCl (S-59) was developed to inactivate pathogens and white blood cells in plasma (PCT-FFP) used for transfusion support.

Study Design And Methods: An open-label, multicenter trial was conducted in patients with congenital coagulation factor deficiencies (factors [F]I, FII, FV, FVII, FX, FXI, and FXIII and protein C) to measure the kinetics of specific coagulation factors, hemostatic efficacy, and safety of PCT-FFP. Posttransfusion prothrombin time (PT), partial thromboplastin time (PTT), and clinical hemostasis were evaluated before and after PCT-FFP transfusions.

Optimizing independent finger flexion with zone V flexor repairs using the Massachusetts General Hospital flexor tenorrhaphy and early protected active motion.

Purpose: Independent FDS action has been cited to be problematic with repair of multiple tendons in zone V owing to adhesion formation between the flexor digitorum superficialis (FDS) and the flexor digitorum profundus (FDP) tendons. Of the several described flexor repair techniques the ideal tendon repair should be strong enough to allow for early active motion to minimize adhesion formation and maximize tendon healing. Biomechanical studies have proven the Massachusetts General Hospital (MGH) repair to be strong enough to allow for early active motion.

Free omental tissue transfer for extremity coverage and revascularization.

Microvascular transfer of the omentum has several unique advantages for the reconstruction and revascularization of extremity wounds. The omentum provides well-vascularized, malleable tissue for reconstruction of extensive soft-tissue defects and has a long vascular pedicle (35 to 40 cm) with sizable vessels, which reduces some of the potential technical challenges of microsurgery. It can also be used for flow-through revascularization of ischemic distal extremities.

Pharmacokinetic study of FFP photochemically treated with amotosalen (S-59) and UV light compared to FFP in healthy volunteers anticoagulated with warfarin.

Background: To date, no clinical trials have characterized FFP infusion efficacy, and infusion still carries infectious risk. This single-blinded crossover study compared postinfusion kinetics of FVII in photochemically treated FFP to standard FFP.

Study Design And Methods: Subjects donated plasma by apheresis.

Botulism in chickens associated with elevated iron levels.

Clostridium botulinum type C toxicosis was diagnosed by the mouse inoculation test in two outbreaks of botulism in commercial broiler and roaster chickens. One case involved 7-wk-old commercial roaster chickens, and the other involved 15-day-old commercial broiler chickens. A definitive point source for preformed C.

Prevention of transfusion-associated graft-versus-host disease by photochemical treatment.

Photochemical treatment (PCT) with the psoralen S-59 and long wavelength ultraviolet light (UVA) inactivates high titers of contaminating viruses, bacteria, and leukocytes in human platelet concentrates. The present study evaluated the efficacy of PCT to prevent transfusion-associated graft-versus-host disease (TA-GVHD) in vivo using a well-characterized parent to F1 murine transfusion model. Recipient mice in four treatment groups were transfused with 10(8) splenic leukocytes.

Structural characterization and functional effects of a circulating heparan sulfate in a patient with hepatocellular carcinoma.

A circulating anticoagulant was isolated from the plasma of a 42-year-old man with cirrhosis and hepatocellular carcinoma who had an unusual coagulation test profile. The patient developed a fatal coagulopathy, unresponsive to protamine therapy or plasma exchange following liver biopsy. However, at presentation, routine hemostasis assays were normal.

Histopathology and epidemiology of condemnations due to squamous cell carcinoma in broiler chickens in North Carolina.

Squamous cell carcinoma (SCC) lesions were confirmed by histopathology in 94% of 176 carcasses condemned for SCC during 8-hour shifts at four different processing plants. Lesions in the remaining carcasses were diagnosed as focal ulcerative dermatitis. SCC lesions were confined to the skin; no metastasis or invasion of underlying muscle was present.

Coccidioides immitis presenting as a hyphal form in a ventriculoperitoneal shunt.

We report a case of meningitis in a 31-year-old man caused by Coccidioides immitis, where the organism was observed growing in the cerebrospinal fluid exclusively as hyphae. This unusual morphology was seen in fluid obtained from a ventriculoperitoneal shunt. Only C immitis was cultured.

Salt toxicosis in commercial turkeys.

Salt toxicosis was confirmed in a flock of 20,000 thirteen-week-old tom turkeys experiencing an increase in mortality. Clinical signs included polydipsia, diarrhea, ataxia, incoordination, tremors that progressed to depression, sternal and lateral recumbency accompanied by torticollis, and death. Mortality over a 5-day period was 6.

Decreased egg production in turkeys experimentally infected with eastern equine encephalitis virus or Highlands J virus.

Turkey breeder hens were experimentally infected with strains of eastern equine encephalitis (EEE) virus or Highlands J (HJ) virus previously isolated from turkey hens experiencing decreased egg production. Depression and inappetance were observed on day 1 postexposure (PE) in hens inoculated with either EEE virus or HJ virus, and egg production fell in each virus-inoculated group from approximately 75% to less than 20% within 2-3 days PE. Egg production remained depressed (less than 20%) for 15 days in EEE-virus-inoculated hens and for 7 days in HJ-virus-inoculated hens.

Egg-production drop in turkeys associated with alphaviruses: eastern equine encephalitis virus and Highlands J virus.

Alphaviruses were isolated from tracheas of turkey breeders in two North Carolina flocks experiencing a severe drop in egg production. Highlands J virus was isolated from one of the breeder flocks, in which production decreased by as much as 72.6% in selected houses over a 48-to-96-hour period.