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LAKEWOOD, NJ, United States

Hendler D.,Institute of Oncology | Rizel S.,Institute of Oncology | Yerushalmi R.,Institute of Oncology | Neiman V.,Institute of Oncology | And 6 more authors.
American Journal of Clinical Oncology: Cancer Clinical Trials

Purpose: This prospective, nonrandomized study evaluates 4 schedules of granulocyte colony-stimulating factor (G-CSF) for patients with breast cancer receiving adjuvant dose-dense chemotherapy regarding febrile neutropenia, treatment delays, and costs. Patients and Methods: Two hundred and thirty-one patients were enrolled to receive adjuvant dose-dense chemotherapy with 4 G-CSF schedules: filgrastim (300 mcg) days 3 to 10 [n = 84 (36.4%) group A]; days 3 to 7 [n = 26 (11.3%) group B]; days 5, 7, 9, and 11 [n = 64 (27.7%) group C], or pegfilgrastim (6 mg) on day 2 [n=57 (24.6%) group D]. Results: Thirteen patients were hospitalized due to 14 episodes of febrile neutropenia; 3 in group A, 3 in group B, 1 in group C, and 6 in group D. No statistically significant difference was observed among the 4 groups. Fewer febrile neutropenic events were observed in group C than in group D (P=0.041). No statistically significant differences were observed in treatment delays or other hematological toxicities. Average overall G-CSF cost per patient in groups A and D was $8500 versus $4400 in groups B and C. Conclusions: We found a trend in favor of the shorter G-CSF schedule. A larger, prospective randomized trial should be carried out to evaluate shorter versus standard filgrastim and pegfilgrastim schedules with regard to clinical outcomes, hematological and nonhematological toxicities, and impact in costs. Copyright © 2011 by Lippincott Williams & Wilkins. Source

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 983.97K | Year: 2016

DESCRIPTION provided by applicant Neonatal hyperbilirubinemia occurs in almost all newborns and may be benign if its progression to extreme hyperbilirubinemia is recognized monitored and prevented or managed in a timely manner Neonatal jaundice carries the risk of neurotoxicity due to the deposition of bilirubin in the central nervous system Most of the bilirubin in plasma is bound to plasma proteins mainly serum albumin Bilirubin binding capacity BBC defines the dynamic relationship between an infantandapos s level of unbound or andquot freeandquot bilirubin and his her ability to andquot tolerateandquot increasing bilirubin loads BBC is not synonymous with albumin Alb levels because Alb binding of bilirubin is confounded by a variety of molecular biologic and metabolic factors While various methods exist to measure BBC none have been successfully commercialized Of these hematofluorometry holds the greatest promise of a device that can be used at the point of care and give rapid and accurate BBC measurements A SBIR Phase I grant demonstrated that such a device is possible A Phase II grant delivered improved devices to neonatal hospitals Published clinical studies with these devices not only collaborated prior knowledge but suggested ways in which BBC measurements may improve existing neonatal care The aims of this project are to transform the modernized hematofluorometers developed in Phases I and II into a final product suitable for operation in a point of care environment in the newborn nursery NICU and neonatal outpatient clinic In year one Avivandapos s goals are to develop and evaluate a andquot singleandquot position hematofluorometer in terms of increased accuracy over prior designs develop and evaluate kit designs that increase the ease of use improve the use of the internal reference develop primary standards for calibration develop validation checks Beginning in year and continuing into year Aviv will perform shelf life tests determine environmental limits of operation integrate a bar code reader and laboratory information management software support internal quality checks into the device and software investigate potential interferences to measurements and incorporate guidance for use into documentation and software During year Aviv will have a commercializable embodiment develop methods and documentation identify partners for manufacturing marketing sales and distribution Concurrent with these activities Stanford Universityandapos s Lucile Packard Childrenandapos s Hospital will conduct clinical studies to evaluate the usefulness of BBC measurements in a clinical setting Experienced consultants in the fields of neonatal care management clinical lab directors and those with hands on experience neonatal intensive care units and clinical labs will be consulted on the suitability of the device and reagent kit The goal is to obtain expert recommendations for the use of the BBC assay to inform additional clinically useful modifications of the hematofluorometer system PUBLIC HEALTH RELEVANCE Management of newborns with elevated unconjugated bilirubin levels in order to prevent bilirubin induced neurological dysfunction BIND and kernicterus remains problematical especially for premature infants The bilirubin binding capacity of albumin BBC is a determinative measure of a neonateandapos s ability to cope with an excessive bilirubin burden This proposal aims to complete the development of a bilirubin hematofluorometer that easily measures BCC at the points of care and initiate its commercialization

Aviv Biomedical, Inc. | Date: 2014-01-14

A reagent kit for detecting bilirubin in a fluid sample. The reagent kit includes a body defining at least one fluid receiving well and an optical window positioned over each at least one fluid receiving well. Each window is formed of a material having a fluorescence intensity that is of a lower magnitude than the fluorescence to be detected from the bilirubin. A hematofluorometer configured to utilize the reagent kit is also disclosed.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 170.16K | Year: 2010

DESCRIPTION (provided by applicant): Human serum albumin is capable of binding bilirubin with high affinity, thus sequestering it and mitigat- ing its harmful neurological effects in jaundiced newborns. Despite considerable work indicating that the level of bilirubin in the blood relative to the level of albumin binding sites is a key factor in assessing risk for bilirubin associated brain damage, management of neonatal jaundice remains based upon proxies, such as gestational age and birth weight along with the bilirubin level. A number of methods for assaying the bilirubin level now ex- ist. The common approaches determine the total serum bilirubin by wet chemical methods. Methods to assay reserve albumin binding capacity and unbound (mobilized) bilirubin levels in serum have been developed over the years but none have achieved routine use because they remain cumbersome laboratory tests. The pro- posed work is to develop a point-of-care system (a small fluorometer and disposables) that makes use of bili- rubin's natural fluorescence. Bilirubin bound to albumin produces a fluorescence signal that can be detected in raw blood. Assayed by fluorescence this albumin-bound bilirubin level equates to the total serum bilirubin by standard methods since the unbound bilirubin level is always much smaller until albumin binding approaches saturation. The reserve binding capacity for bilirubin can be measured by adding excess bilirubin to the blood, with the increase in fluorescence being due to the newly bound bilirubin. This approach measures the actual binding capacity and naturally takes into account factors such as albumin levels, competing binding by other solutes and weakened binding sites. The basic studies leading to this fluorometric approach were reported more than thirty years ago and prototype laboratory-bound instruments were devised and tested in clinical settings. At that time new manage- ment guidelines in the absence of binding data coupled with wide use of phototherapy obviated their use. With the current practice of very early release of apparently healthy newborns and susbsequent development of jaundice at home, management has become complicated. Interviews with pediatricians on the ground have indicated that an inexpensive and easy to use point-of-care system that requires only a heel stick quantity of blood and essentially no manipulation of the specimen, would provide for better management from the ability to provide a stat bilirubin level alone, and binding data would additionally provide guidance in management that may be more efficient and less costly. Use at crib-side should also benefit the management of the jaundiced hospitalized low-birth-weight and sick neonate. While apparently feasible with modern optoelectronic technology, several design and practical chal- lenges exist for the development of such a small point-of-care system. The proposed work will confront and overcome these challenges. PUBLIC HEALTH RELEVANCE: Kernicterus is a preventable brain injury in neonates, and it is reemerging in the USA (1-5). Present-day methods of assaying bilirubin do not take into account a child's ability to safely sequester bilirubin and must be interpreted in terms of gestational age, age, weight and other factors (6). The proposed hematofluorometer directly measures bilirubin binding and reserve bilirubin binding capacity, and has the potentials to be faster, less expensive and available at the point of care.

Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 99.97K | Year: 2005

DESCRIPTION (provided by applicant): The purpose of this STTR is to produce a commercially available rapid-scan absorbance optical detection system for XLA/I analytical ultracentrifuges. The currently available absorbance optical system provided by the analytical ultracentrifuge manufacturer is not optimized for sedimentation velocity analysis, the most commonly used analytical ultracentrifugation (AUC) experimental method in biomedical research. AUC is becoming the method of choice for: 1) the analysis of interacting complex systems, 2) QA/QC of biopharmaceutical products, 3) the characterization of vaccines, 4) the characterization of particle size distributions of virus solutions, and 5) the development of drug formulations. The federal Food and Drug Administration increasingly recommends that protein biologics be characterized by sedimentation velocity. It is essential that the data acquisition and manipulation software be modernized to minimize the potential for serious errors in the analysis and interpretation of data. The current absorbance system is too slow, particularly compromising data analysis for viral and vaccine samples. Current software is unable to index the thousands of data files generated, and does not record experimental setup or protocol, operator identification, or changes in the instrument conditions during an experiment, all of which can lead to confusion and errors when analyzing the results. Overcoming these limitations will allow ultracentrifugation to be used for analysis of larger particles and more complicated interacting systems. A prototype rapid-scan absorbance system has been developed that addresses these issues with a retrofit for existing instruments and vastly improved data acquisition and manipulation software. Work funded by this proposal would bring the prototype to commercial grade and integrate the hardware and software with the recently released fluorescence detection optical system. This work has the support of the base instrument manufacturer, academic researchers and pharmaceutical scientists.

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