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Frassetto L.A.,University of California at San Francisco | Tan-Tam C.C.,University of California at San Francisco | Barin B.,EMMES | Browne M.,University of California at San Francisco | And 4 more authors.
Transplantation | Year: 2014

BACKGROUND: Interactions between antiretrovirals (ARVs) and transplant immunosuppressant agents (IS) among HIV-infected transplant recipients may lead to lack of efficacy or toxicity. In transplant recipients not infected with HIV, tacrolimus (TAC) trough levels (C0) or cyclosporine (CsA) drawn at C0 or 2 hours after dosing (C2) correlate with drug exposure (area under the curve [AUC]/dose) and outcomes. Because of ARV-IS interactions in HIV-infected individuals, and the high rate of rejection in these subjects, this study investigated the correlations between IS concentrations and exposure to determine the best method to monitor immunosuppressant levels. METHODS: This study prospectively studied 50 HIV-infected transplant recipients undergoing kidney or liver transplantation evaluating the pharmacokinetics of the IS in 150 studies over time after transplantation (weeks 2 to 4, 12, 28, 52, and 104). IS levels were measured with liquid chromatography-tandem mass spectrometry and AUC calculated using WinNonlin 9.0. Correlation analyses were run on SAS 9.2. RESULTS: CsA concentration at C4 correlated better with AUC than C0 or C2, and over time TAC concentration correlated better at C0 or C2. CONCLUSIONS: It is suggested that C0 is acceptable for TAC monitoring, but poor predictability will occur at C0 with CsA. The low correlation of C0 with CsA AUC could be responsible for the higher rejection rates on CsA that has been reported in these subjects. © 2014 by Lippincott Williams & Wilkins.


News Article | November 17, 2016
Site: www.marketwired.com

SAN DIEGO, CA--(Marketwired - November 17, 2016) - EMMES Realty Services of California LLC announced a multiple floor lease today with a high-tech tenant who will be relocating and expanding to its 1 Columbia Place property in downtown San Diego. The tenant, highly respected video game development studio Psyonix, will be expanding within the downtown EMMES portfolio from a 9,000 square-foot office space at 707 Broadway to a 40,000 square-foot office at 1 Columbia Place. Psyonix, which was represented by Jordan Williams of Strom Commercial for its new lease, will occupy two contiguous floors in the high-rise section of the 27-story building. Psyonix's expansion highlights both the flexibility within the downtown EMMES portfolio to accommodate significant tenant growth and downtown San Diego's continued attractiveness to growing, innovative companies, which are capitalizing on the area's rich amenity base and deep talent pool. "We are thrilled for Psyonix's success and for its continued growth within the downtown EMMES portfolio," said Jordan Johnson, vice president of EMMES Realty Services of California LLC. "Downtown San Diego has arrived as a dynamic hub for innovation-oriented companies and EMMES is working hard to design, upgrade and improve our buildings to fit today's innovation companies' cultures and needs." Johnson added that this includes superior technology infrastructure such as enhanced Wi-Fi coupled with a Building-Wide Fiber Optic Network, as well as amenities such as expansive terraces with hotel-style lounge seating, in-building retail shops and restaurants, banking, multiple state-of-the-art building conference/meeting rooms, an indoor cycling studio, secure tenant bike storage, as well as shower and locker facilities. Psyonix -- best known for the commercial success of its video game, Rocket League®, which has sold more than 8 million copies to date -- relocated from North Carolina to San Diego in 2009 and has grown exponentially ever since. "We have experienced tremendous growth since the launch of Rocket League® in July of 2015. The game's huge success with more than 22 million players is a big reason why we're moving into the new office space," said Dave Hagewood, Psyonix founder, CEO and studio director. "We needed a fantastic modern location like 1 Columbia Place that could better accommodate our increasing team size and loftier goals." Hagewood added that the game studio's prime location downtown will also attract more creative talent to Psyonix. "The spectacular views, proximity to quality restaurants, and beautiful architecture at 1 Columbia Place are all amazing values for us," Hagewood said. "San Diego is also an excellent alternative to other large cities in general because of its close proximity to great beaches and family entertainment. There's definitely a beach vibe all over town, which is perfect for our company culture and mindset." EMMES Realty Services of California LLC is a member of The EMMES Group of Companies. Founded in 1992, with offices in New York and California, The EMMES Group of Companies and its affiliates are engaged in principal real estate investments, funds management and real estate services. The downtown San Diego EMMES portfolio is comprised of four high-rise office properties: 1 Columbia Place, 2 Columbia Place, 701 B Street, and 707 Broadway, along with a large parking and retail facility, which was recently rebranded to 6th & A Parking. For more information, visit www.emmesco.com. Based in San Diego, CA, Psyonix is a critically-acclaimed independent video game developer and leading expert in Unreal Engine technology. For more than a decade, the studio has been a driving force behind some of the most successful games in the industry, including Gears of War, Mass Effect 3, XCOM: Enemy Unknown, Bulletstorm, Unreal Tournament III, Unreal Tournament 2004, and the award-winning Sports-Action hit, Rocket League®. For more information, visit www.psyonix.com.


Treanor J.J.,University of Rochester | Atmar R.L.,Baylor College of Medicine | Frey S.E.,Saint Louis University | Gormley R.,Naval Medical Research Center | And 6 more authors.
Journal of Infectious Diseases | Year: 2014

Background. Noroviruses are the most important viral causes of gastroenteritis-related morbidity and mortality. A randomized, double-blind, placebo-controlled study evaluated an adjuvanted bivalent intramuscular norovirus virus-like particle (VLP) vaccine. Methods. Forty-eight adults aged 18-49 years received either 2 doses containing genotype GI.1 VLP and a consensus GII.4 VLP or 2 doses of placebo. Doses (5 μg, 15 μg, 50 μg, or 150 μg of each VLP) were administered 4 weeks apart in the first stage. Subsequently, 54 adults, aged 18-49 (n = 16), 50-64 (n = 19), and 65-85 (n = 19) years, received 2 doses of vaccine containing 50 μg of each VLP. Total and class-specific antibody responses, as well as histoblood group antigen (HBGA) blocking antibody responses, were measured before and after each dose. Results. Local reactions were mainly injection site pain/tenderness, with no reported fever or vaccine-related serious adverse events. One dose of vaccine containing 50 μg of each VLP increased GI.1 geometric mean titers (GMTs) by 118-fold, 83-fold, and 24-fold and increased GII.4 GMTs by 49-fold, 25-fold, and 9-fold in subjects aged 18-49, 50-64, and 65-83 years, respectively. Serum antibody responses peaked at day 7 after the first dose, with no evidence of boosting following a second dose. Most subjects achieved HBGA-blocking antibody titers of ≥200. Conclusions. The vaccine was well tolerated and immunogenic. Rapid immune response to a single dose may be particularly useful in military personnel and travelers and in the control of outbreaks. Clinical Trials Registration. NCT01168401. © The Author 2014.


PubMed | University of Maryland Baltimore County, Baylor College of Medicine, University of Missouri-St. Louis, University of Rochester and 3 more.
Type: Clinical Trial, Phase I | Journal: The Journal of infectious diseases | Year: 2014

Noroviruses are the most important viral causes of gastroenteritis-related morbidity and mortality. A randomized, double-blind, placebo-controlled study evaluated an adjuvanted bivalent intramuscular norovirus virus-like particle (VLP) vaccine.Forty-eight adults aged 18-49 years received either 2 doses containing genotype GI.1 VLP and a consensus GII.4 VLP or 2 doses of placebo. Doses (5 g, 15 g, 50 g, or 150 g of each VLP) were administered 4 weeks apart in the first stage. Subsequently, 54 adults, aged 18-49 (n=16), 50-64 (n=19), and 65-85 (n=19) years, received 2 doses of vaccine containing 50 g of each VLP. Total and class-specific antibody responses, as well as histoblood group antigen (HBGA) blocking antibody responses, were measured before and after each dose.Local reactions were mainly injection site pain/tenderness, with no reported fever or vaccine-related serious adverse events. One dose of vaccine containing 50 g of each VLP increased GI.1 geometric mean titers (GMTs) by 118-fold, 83-fold, and 24-fold and increased GII.4 GMTs by 49-fold, 25-fold, and 9-fold in subjects aged 18-49, 50-64, and 65-83 years, respectively. Serum antibody responses peaked at day 7 after the first dose, with no evidence of boosting following a second dose. Most subjects achieved HBGA-blocking antibody titers of 200.The vaccine was well tolerated and immunogenic. Rapid immune response to a single dose may be particularly useful in military personnel and travelers and in the control of outbreaks. Clinical Trials Registration.NCT01168401.


Meador K.J.,Emory University | Baker G.A.,University of Liverpool | Browning N.,EMMES | Cohen M.J.,University of Georgia | And 8 more authors.
The Lancet Neurology | Year: 2013

Background: Many women of childbearing potential take antiepileptic drugs, but the cognitive effects of fetal exposure are uncertain. We aimed to assess effects of commonly used antiepileptic drugs on cognitive outcomes in children up to 6 years of age. Methods: In this prospective, observational, assessor-masked, multicentre study, we enrolled pregnant women with epilepsy on antiepileptic drug monotherapy (carbamazepine, lamotrigine, phenytoin, or valproate) between October, 1999, and February, 2004, at 25 epilepsy centres in the UK and the USA. Our primary outcome was intelligence quotient (IQ) at 6 years of age (age-6 IQ) in all children, assessed with linear regression adjusted for maternal IQ, antiepileptic drug type, standardised dose, gestational birth age, and use of periconceptional folate. We also assessed multiple cognitive domains and compared findings with outcomes at younger ages. This study is registered with ClinicalTrials.gov, number NCT00021866. Findings: We included 305 mothers and 311 children (six twin pairs) in the primary analysis. 224 children completed 6 years of follow-up (6-year-completer sample). Multivariate analysis of all children showed that age-6 IQ was lower after exposure to valproate (mean 97, 95% CI 94-101) than to carbamazepine (105, 102-108; p=0·0015), lamotrigine (108, 105-110; p=0·0003), or phenytoin (108, 104-112; p=0·0006). Children exposed to valproate did poorly on measures of verbal and memory abilities compared with those exposed to the other antiepileptic drugs and on non-verbal and executive functions compared with lamotrigine (but not carbamazepine or phenytoin). High doses of valproate were negatively associated with IQ ( r=-0·56, p<0·0001), verbal ability ( r=-0·40, p=0·0045), non-verbal ability ( r=-0·42, p=0·0028), memory ( r=-0·30, p=0·0434), and executive function ( r=-0·42, p=0·0004), but other antiepileptic drugs were not. Age-6 IQ correlated with IQs at younger ages, and IQ improved with age for infants exposed to any antiepileptic drug. Compared with a normative sample (173 [93%] of 187 children), right-handedness was less frequent in children in our study overall (185 [86%] of 215; p=0·0404) and in the lamotrigine (59 [83%] of 71; p=0·0287) and valproate (38 [79%] of 40; p=0·0089) groups. Verbal abilities were worse than non-verbal abilities in children in our study overall and in the lamotrigine and valproate groups. Mean IQs were higher in children exposed to periconceptional folate (108, 95% CI 106-111) than they were in unexposed children (101, 98-104; p=0·0009). Interpretation: Fetal valproate exposure has dose-dependent associations with reduced cognitive abilities across a range of domains at 6 years of age. Reduced right-handedness and verbal ( vs non-verbal) abilities might be attributable to changes in cerebral lateralisation induced by exposure to antiepileptic drugs. The positive association of periconceptional folate with IQ is consistent with other recent studies. Funding: US National Institutes of Health, UK Epilepsy Research Foundation. © 2013 Elsevier Ltd.


Atmar R.L.,Baylor College of Medicine | Bernstein D.I.,University of Cincinnati | Harro C.D.,Johns Hopkins University | Al-Ibrahim M.S.,Shin Nippon Biomedical Laboratories Clinical Pharmacology Center | And 7 more authors.
New England Journal of Medicine | Year: 2011

BACKGROUND: Noroviruses cause epidemic and sporadic acute gastroenteritis. No vaccine is available to prevent norovirus illness or infection. METHODS: We conducted a randomized, double-blind, placebo-controlled, multicenter trial to assess the safety, immunogenicity, and efficacy of an investigational, intranasally delivered norovirus viruslike particle (VLP) vaccine (with chitosan and monophosphoryl lipid A as adjuvants) to prevent acute viral gastroenteritis after challenge with a homologous viral strain, Norwalk virus (genotype GI.1). Healthy adults 18 to 50 years of age received two doses of either vaccine or placebo and were subsequently inoculated with Norwalk virus and monitored for infection and gastroenteritis symptoms. RESULTS: Ninety-eight persons were enrolled and randomly assigned to receive vaccine (50 participants) or placebo (48 participants), and 90 received both doses (47 participants in the vaccine group and 43 in the placebo group). The most commonly reported symptoms after vaccination were nasal stuffiness, nasal discharge, and sneezing. Adverse events occurred with similar frequency among vaccine and placebo recipients. A Norwalk virus-specific IgA seroresponse (defined as an increase by a factor of 4 in serum antibody levels) was detected in 70% of vaccine recipients. Seventy-seven of 84 participants inoculated with Norwalk virus were included in the per-protocol analysis. Vaccination significantly reduced the frequencies of Norwalk virus gastroenteritis (occurring in 69% of placebo recipients vs. 37% of vaccine recipients, P = 0.006) and Norwalk virus infection (82% of placebo recipients vs. 61% of vaccine recipients, P = 0.05). CONCLUSIONS: This norovirus VLP vaccine provides protection against illness and infection after challenge with a homologous virus. (Funded by LigoCyte Pharmaceuticals and the National Institutes of Health; ClinicalTrials.gov number, NCT00973284.) Copyright © 2011 Massachusetts Medical Society.


Thera M.A.,University of Bamako | Doumbo O.K.,University of Bamako | Coulibaly D.,University of Bamako | Laurens M.B.,Howard Hughes Medical Institute | And 33 more authors.
New England Journal of Medicine | Year: 2011

BACKGROUND: Blood-stage malaria vaccines are intended to prevent clinical disease. The malaria vaccine FMP2.1/AS02a, a recombinant protein based on apical membrane antigen 1 (AMA1) from the 3D7 strain of Plasmodium falciparum, has previously been shown to have immunogenicity and acceptable safety in Malian adults and children. METHODS: In a double-blind, randomized trial, we immunized 400 Malian children with either the malaria vaccine or a control (rabies) vaccine and followed them for 6 months. The primary end point was clinical malaria, defined as fever and at least 2500 parasites per cubic millimeter of blood. A secondary end point was clinical malaria caused by parasites with the AMA1 DNA sequence found in the vaccine strain. RESULTS: The cumulative incidence of the primary end point was 48.4% in the malaria-vaccine group and 54.4% in the control group; efficacy against the primary end point was 17.4% (hazard ratio for the primary end point, 0.83; 95% confidence interval [CI], 0.63 to 1.09; P = 0.18). Efficacy against the first and subsequent episodes of clinical malaria, as defined on the basis of various parasite-density thresholds, was approximately 20%. Efficacy against clinical malaria caused by parasites with AMA1 corresponding to that of the vaccine strain was 64.3% (hazard ratio, 0.36; 95% CI, 0.08 to 0.86; P = 0.03). Local reactions and fever after vaccination were more frequent with the malaria vaccine. CONCLUSIONS: On the basis of the primary end point, the malaria vaccine did not provide significant protection against clinical malaria, but on the basis of secondary results, it may have strain-specific efficacy. If this finding is confirmed, AMA1 might be useful in a multicomponent malaria vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT00460525.) Copyright © 2011 Massachusetts Medical Society. All rights reserved.


Burks A.W.,Duke University | Jones S.M.,University of Arkansas for Medical Sciences | Wood R.A.,Johns Hopkins University | Fleischer D.M.,National Jewish Health | And 10 more authors.
New England Journal of Medicine | Year: 2012

BACKGROUND: For egg allergy, dietary avoidance is the only currently approved treatment. We evaluated oral immunotherapy using egg-white powder for the treatment of children with egg allergy.METHODS: In this double-blind, randomized, placebo-controlled study, 55 children, 5 to 11 years of age, with egg allergy received oral immunotherapy (40 children) or placebo (15). Initial dose-escalation, build-up, and maintenance phases were followed by an oral food challenge with egg-white powder at 10 months and at 22 months. Children who successfully passed the challenge at 22 months discontinued oral immunotherapy and avoided all egg consumption for 4 to 6 weeks. At 24 months, these children underwent an oral food challenge with egg-white powder and a cooked egg to test for sustained unresponsiveness. Children who passed this challenge at 24 months were placed on a diet with ad libitum egg consumption and were evaluated for continuation of sustained unresponsiveness at 30 months and 36 months.RESULTS: After 10 months of therapy, none of the children who received placebo and 55% of those who received oral immunotherapy passed the oral food challenge and were considered to be desensitized; after 22 months, 75% of children in the oral-immunotherapy group were desensitized. In the oral-immunotherapy group, 28% (11 of 40 children) passed the oral food challenge at 24 months and were considered to have sustained unresponsiveness. At 30 months and 36 months, all children who had passed the oral food challenge at 24 months were consuming egg. Of the immune markers measured, small wheal diameters on skin-prick testing and increases in egg-specific IgG4 antibody levels were associated with passing the oral food challenge at 24 months.CONCLUSIONS: These results show that oral immunotherapy can desensitize a high proportion of children with egg allergy and induce sustained unresponsiveness in a clinically significant subset. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00461097.) Copyright © 2012 Massachusetts Medical Society.


ROCKVILLE, Md., Nov. 14, 2016 /PRNewswire-USNewswire/ -- The Emmes Corporation today announced that a large team of scientists and health professionals including those from the company, LDS Hospital in Salt Lake City, Utah, Lovelace Biomedical Environmental Research Institute in...


Lindblad R.,Emmes | El Fiky A.,Emmes | Zajdowicz T.,Emmes
Journal of Allergy and Clinical Immunology | Year: 2015

The ongoing epidemic of Ebola virus in West Africa and attendant cases described in other parts of the world has focused attention on this heretofore rare disease. In this brief opinion article, we provide a short primer on the epidemiology, pathogenesis, clinical manifestations, US-based hospital preparedness, vaccine and therapy development, and control of Ebola virus disease for noninfectious disease physicians. © 2014 American Academy of Allergy, Asthma & Immunology.

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