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SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite Pharma, Inc. (Nasdaq:KITE) today announced new data presentations from multiple studies related to its lead investigational candidate, axicabtagene ciloleucel (also known as KTE-C19), at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, June 2-6, 2017. The full text for abstracts is available online through the ASCO website at http://abstracts.asco.org. “The presentations at ASCO continue to enhance our growing knowledge on the potential for cell therapy,” said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. “The translational insights from these data presentations are invaluable as we advance axicabtagene ciloleucel/KTE-C19 and seek to optimize treatment, not only in NHL, but also across a broad range of hematologic malignancies.” Clinical and biologic covariates of outcomes in ZUMA-1: a pivotal trial of axicabtagene ciloleucel (axi-cel; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (r-NHL) Updated results from ZUMA-3, a phase 1/2 study of KTE-C19 chimeric antigen receptor (CAR) T cell therapy, in adults with high-burden relapsed/refractory acute lymphoblastic leukemia (R/R ALL) Product characteristics associated with in vivo expansion of anti-CD19 CAR T cells in patients treated with axicabtagene ciloleucel (axi-cel) Characterization of anti-CD19 chimeric antigen receptor (CAR) T cell-mediated tumor microenvironment immune gene profile in a multicenter trial (ZUMA-1) with axicabtagene ciloleucel (axi-cel, KTE-C19) ZUMA-6: Phase 1-2 multicenter study evaluating safety and efficacy of axicabtagene ciloleucel (axi-cel; KTE-C19) in combination with atezolizumab in patients with refractory diffuse large B-cell lymphoma (DLBCL) Kite’s lead product candidate, axicabtagene ciloleucel, previously known as KTE-C19, is an investigational therapy in which a patient's T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma. This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to advance axicabtagene ciloleucel/KTE-C19 and optimize treatment in NHL and across a broad range of hematologic malignancies. Various factors may cause differences between Kite's expectations and actual results as discussed in greater detail in Kite's filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended March 31, 2017. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


YONKERS, NY--(Marketwired - May 25, 2017) - ContraFect Corporation ( : CFRX), a biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today announced the initiation of an international Phase 2 study evaluating its first-in-class lysin, CF-301, as a potential treatment of Staphylococcus aureus (Staph aureus) bacteremia including right sided endocarditis. Staph aureus bacteremia and endocarditis are serious life threatening infections, associated with substantial morbidity and mortality despite currently available conventional antibiotics. This multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the potential for CF-301 to be used in addition to standard-of-care (SOC) antibiotics to significantly improve clinical success rates compared to SOC antibiotics alone. Safety, tolerability, and pharmacokinetics of CF-301 will also be evaluated in the study. The company expects to announce top line results in Q4 2018. "We are very pleased to initiate the first clinical study of CF-301 in patients with S. aureus bacteremia. Based on the extensive amount of pre-clinical data generated, CF-301 has the potential to improve clinical outcomes for these patients by rapid bacterial killing, synergy with conventional antibiotics and clearance of biofilms that complicate Staph aureus infections, " said Cara Cassino, M.D., EVP of Research and Development and Chief Medical Officer at ContraFect. "We are excited about the initiation of this trial, and the promise that CF-301, and potentially other lysins in our pipeline, may offer important new advances in the treatment of bacterial infections which are a global health care threat," said Steven C. Gilman, Ph.D., Chairman of ContraFect. In the United States alone, there are approximately 120,000 cases annually of the bloodstream infection Staph aureus bacteremia, which causes approximately 30,000 deaths. Staph aureus bacteremia can be further complicated when the infection spreads into the heart muscle, heart valves or lining of the heart, causing endocarditis. Even with current SOC antibiotic therapy, the resulting damage to the heart muscle or heart valves could require surgery for definitive treatment to prevent stroke, heart failure or multi-organ system damage. Of further concern, drug-resistant strains of Staph aureus are now evolving additional resistance against SOC antibiotics, which may ultimately result in an increase in the number of cases and in mortality from Staph aureus bacteremia, including endocarditis. ContraFect plans to conduct the trial in approximately 70 sites worldwide including North America, South America, and Europe. A total of 115 patients are expected to be enrolled, randomized 3:2 to receive either a single dose of 0.25 mg/kg CF-301 administered via a 2 hour IV infusion in addition to SOC antibiotics or placebo plus SOC antibiotics. The primary endpoint of the trial is early clinical response. In addition, safety, tolerability, pharmacokinetics, and a number of exploratory clinical and health resource utilization endpoints will be evaluated. More information about the trial is available at www.clinicaltrials.gov. ContraFect is a biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. An estimated 700,000 deaths worldwide each year are attributed to antimicrobial-resistant infections. We intend to address life threatening infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect's initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (Methicillin-resistant Staphylococcus aureus) and influenza. CF-301 is a recombinant bacteriophage-derived lysin with potent bactericidal activity against Staph aureus, a major cause of blood stream infections, or bacteremia. CF-301 has the potential to be a first-in-class treatment for Staphylococcus aureus (Staph aureus) bacteremia. It has a novel, rapid, and specific mechanism of bactericidal action against Staph aureus and does not impact the body's natural bacterial flora. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. Combinations of CF-301 with standard of care antibiotics significantly increased bacterial killing and survival in animal models of disease when compared to treatment with antibiotics or CF-301 alone. In addition, in vitro and in vivo experiments have shown that CF-301 is highly active against biofilm infections. CF-301 was licensed from The Rockefeller University and is being developed at ContraFect. It is the first lysin to enter clinical studies in the U.S. This press release contains, and our officers and representatives may make from time to time, "forward-looking statements" within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," "promise" or similar references to future periods. Examples of forward-looking statements in this release include, without limitation, statements regarding our ability to discover and develop protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, including whether CF-301 has the potential to be a first-in-class lysin therapeutic for the treatment of Staph aureus bacteremia including right sided endocarditis, whether CF-301 used in addition to SOC antibiotics can significantly improve clinical success rates compared to SOC antibiotics alone, whether CF-301 can improve clinical outcomes for patients by rapid bacterial killing, synergy with conventional antibiotics and clearance of biofilms which complicate Staph aureus infections, whether CF-301 and other lysins in our pipeline will offer important new advances in the treatment of bacterial infections which are a global health care threat, our plans to conduct the trial in approximately 70 sites worldwide including North America, South America, and Europe, our ability to enroll a total of 115 patients, whether we achieve our clinical endpoints, the announcement of top line results in Q4 2018 and our ability to address life threatening infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect's current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect's control. Actual results may differ from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, among others, our ability to develop treatments for drug-resistant infectious diseases and those detailed under the caption "Risk Factors" in ContraFect's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 and its other filings with the Securities and Exchange Commission. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.


SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for axicabtagene ciloleucel. The submission follows positive data demonstrated with a single infusion of axicabtagene ciloleucel in the ZUMA-1 Phase 2 trial in patients with refractory aggressive non-Hodgkin lymphoma (NHL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2017. “Patients with refractory aggressive NHL face a dire prognosis with only a 50 percent chance of surviving six months. This underscores the urgent medical need for these patients and why every day matters, from development to manufacturing to clinical experience,” said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. “We firmly believe in the potential for axicabtagene ciloleucel to address this need and forge a new path for the future of cell therapy.” The filing acceptance is supported by data from the ZUMA-1 Phase 2 trial which met the primary endpoint of objective response rate (ORR) recorded after a single infusion of axicabtagene ciloleucel with 82 percent (p<0.0001). At a median follow-up of 8.7 months, 44 percent of patients were in ongoing response, which included 39 percent of patients in complete response (CR). The most common grade 3 or higher adverse events included anemia (43 percent), neutropenia (39 percent), decreased neutrophil count (32 percent), febrile neutropenia (31 percent), decreased white blood cell count (29 percent), thrombocytopenia (24 percent), encephalopathy (21 percent) and decreased lymphocyte count (20 percent). There were three deaths throughout the course of the registrational trial not due to disease progression, of which two events, were deemed related to axicabtagene ciloleucel. In December 2015, axicabtagene ciloleucel received Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for DLBCL, TFL, and PMBCL. The company expects to submit its Market Authorization Application (MAA) of axicabtagene ciloleucel with the European Medicines Agency (EMA) in the third quarter of 2017. ZUMA-1 is supported in part by funding from The Leukemia & Lymphoma Society (LLS) Therapy Acceleration Program®. Kite’s lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient's T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma. This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential of axicabtagene ciloleucel, and the ability and timing of submitting an MAA to the EMA for axicabtagene ciloleucel. Various factors may cause differences between Kite's expectations and actual results as discussed in greater detail in Kite's filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended March 31, 2017. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced 96-week results from two ongoing Phase 3 studies evaluating the safety and efficacy of daily Vemlidy® (tenofovir alafenamide, TAF 25mg) in immune active patients and in patients switching from Gilead’s Viread® (tenofovir disoproxil fumarate, TDF 300mg). Vemlidy is a once-daily treatment approved for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. In addition, Gilead presented data from preclinical studies of investigational compounds being studied for their potential role in HBV cure strategies. Data are being presented this week at The International Liver Congress™ 2017 in Amsterdam. Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy that is noninferior to that of Viread at Week 48 in patients with chronic HBV. Vemlidy treatment at the same time point also demonstrated a beneficial impact on renal and bone laboratory safety parameters compared to Viread. Analyses now conducted at Week 96 of treatment demonstrate continued benefits of Vemlidy including high rates of viral suppression, with no evidence of resistance, and less impact on renal and bone safety parameters as compared to Viread (#PS-042, #FRI-153). Additionally, patients switching from Viread to Vemlidy after Week 96 demonstrated maintenance of viral suppression, improvement in serum alanine aminotransferase (ALT) normalization rates, and improvement in bone and renal parameters 24 weeks after switching to Vemlidy (#PS-041: “ Hepatitis B and D: emerging treatment options”). “ The results observed in these studies reinforce Vemlidy as an important treatment option for patients living with chronic HBV infection,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “ Additionally, the preclinical data presented at this EASL meeting illustrate our scientific approach to evaluating compounds with distinct mechanisms of action aimed at curing HBV infection.” Vemlidy has a boxed warning in its U.S. product label regarding the risk of post-treatment severe acute exacerbation of hepatitis B. See below for important safety information. The two randomized, double-blinded Phase 3 studies (Studies 108 and 110) from which the data are presented evaluated the use of Vemlidy given once-daily versus Gilead’s Viread given once-daily in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic HBV infection. Results demonstrate continued advantages of treatment with Vemlidy over Viread between Week 48 and Week 96. Virologic response rates at Week 96 were 90 percent (n=257/285) and 91 percent (n=127/140) in HBeAg-negative patients (Study 108) receiving Vemlidy and Viread, respectively. In HBeAg-positive patients (Study 110), virologic response rates at Week 96 were 73 percent (n=423/581) and 75 percent (n=218/292) in the Vemlidy and Viread groups, respectively. In both studies, a greater percentage of patients taking Vemlidy achieved normalization of ALT levels relative to patients taking Viread as measured by both central laboratory criteria, and by the American Association for the Study of Liver Diseases (AASLD) criteria. Patients receiving Vemlidy also demonstrated ongoing benefits at Week 96 in bone and renal safety parameters, including smaller declines from baseline in hip and spine bone mineral density (BMD) and smaller declines from baseline in estimated creatinine clearance compared with patients taking Viread in both studies. Similar rates of adverse events and low and similar rates of adverse events leading to discontinuation were observed in both treatment arms. Viral resistance analyses showed no resistance to Vemlidy or Viread at Week 96. A post-hoc analysis evaluated a subset of 541 patients from Studies 108 and 110 who completed 96 weeks of treatment with double-blind Vemlidy or Viread and were then switched to open-label treatment with Vemlidy. Among patients switched from Viread to Vemlidy at Week 96 (n=180), virologic suppression was maintained and the rates of ALT normalization by central laboratory criteria and AASLD criteria significantly increased during the subsequent 24 weeks of Vemlidy therapy. These patients also demonstrated further improvements in hip and spine BMD and had significant improvements in estimated creatinine clearance. Longer-term data are required to confirm the benefits of switching from Viread to Vemlidy for the treatment of chronic HBV. In addition, Gilead has several ongoing research programs with the goal of achieving functional cure for HBV-infected patients. Preclinical data with some of Gilead’s novel investigational compounds are being presented at the Congress. GS-5801 is an oral liver-targeted prodrug of a small molecule inhibitor of KDM5, a histone lysine demethylase. Results from in vitro preclinical studies (#SAT-160) demonstrated activity of GS-5801 in HBV-infected primary human hepatocytes with significant declines in viral proteins and HBV RNA. In addition, in vivo data (#THU-171) demonstrated the pharmacodynamic response of GS-5801 within the liver, in animal models. GS-5801 is currently being evaluated in Phase 1 trials in healthy subjects and in patients with chronic HBV infection. GS-9688, an oral selective toll-like receptor 8 (TLR8) agonist, demonstrated in vitro and in vivo pharmacodynamic effects consistent with selective TLR8 activation, including the production of antiviral cytokines (#SAT-168). Further, in an efficacy animal model of chronic HBV infection, GS-9688 treatment demonstrated a sustained antiviral response in chronically infected woodchucks (#SAT-165). GS-9688 is currently being evaluated in Phase 1 trials in healthy subjects and in patients with chronic HBV infection. Further information about the clinical studies described above can be found at http://anzctr.org.au/. GS-5801 and GS-9688 are investigational products and have not been determined to be safe or efficacious. Most common adverse reactions (incidence ≥5%; all grades) were headache, abdominal pain, fatigue, cough, nausea and back pain. Consult the full prescribing information for Vemlidy for more information on potentially significant drug interactions, including clinical comments. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California. This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing Vemlidy for the treatment of HBV. In addition, Gilead may be unable to achieve a functional cure for HBV with any of its product candidates, including GS-5801 and GS-9688. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the quarter ended December 31, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. U.S. full Prescribing Information including BOXED WARNING for Vemlidy is available at www.gilead.com. Vemlidy and Viread are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.


News Article | May 8, 2017
Site: www.marketwired.com

YONKERS, NY--(Marketwired - May 08, 2017) - ContraFect Corporation ( : CFRX), a biotechnology company focused on the discovery and development of protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, today announced results for the first quarter ended March 31, 2017. The Company ended the first quarter with cash, cash equivalents, and marketable securities of $28.9 million. "During the quarter we made substantial progress towards the initiation of the Phase 2 study of our lead asset, CF-301, a first-in-class lysin therapeutic. This multinational, randomized, double-blind, placebo-controlled clinical study will compare the safety, tolerability, efficacy and pharmacokinetics of CF-301 used in addition to standard-of-care (SOC) antibiotics, to SOC antibiotics alone for the treatment of Staphylococcus aureus (Staph aureus) bloodstream infections including endocarditis. We now have CF-301 investigational drug product that has passed release specifications and we are completing final logistics to begin opening sites for patient enrollment in mid-2017," said Cara Cassino, M.D., EVP of Research and Development and Chief Medical Officer at ContraFect. ContraFect is a biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. An estimated 700,000 deaths worldwide each year are attributed to antimicrobial-resistant infections. We intend to address life threatening infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect's initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (Methicillin-resistant Staphylococcus aureus) and influenza. CF-301 is a recombinant bacteriophage-derived lysin with potent bactericidal activity against Staph aureus, a major cause of blood stream infections, or bacteremia. CF-301 has the potential to be a first-in-class treatment for Staphylococcus aureus (Staph aureus) bacteremia. It has a novel, rapid, and specific mechanism of bactericidal action against Staph aureus and does not impact the body's natural bacterial flora. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. Combinations of CF-301 with standard of care antibiotics significantly increased bacterial killing and survival in animal models of disease when compared to treatment with antibiotics or CF-301 alone. In addition, in vitro and in vivo experiments have shown that CF-301 is highly active against biofilm infections. CF-301 was licensed from The Rockefeller University and is being developed at ContraFect. It is the first lysin to enter clinical studies in the U.S. This press release contains, and our officers and representatives may make from time to time, "forward-looking statements" within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," "promise" or similar references to future periods. Examples of forward-looking statements in this release include, without limitation, statements regarding our ability to discover and develop protein and antibody therapeutics for life-threatening, drug-resistant infectious diseases, including whether CF-301 has the potential to be a first-in-class lysin therapeutic for the treatment of Staph aureus bacteremia, our ability to address life threatening infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses, and our ability to begin opening sites for patient enrollment in mid-2017 and to treat Staph aureus bloodstream infections including endocarditis. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect's current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect's control, including those detailed in ContraFect's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, among others, our ability to develop treatments for drug-resistant infectious diseases. Any forward-looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. The comparability of basic and diluted net loss per share and weighted average shares outstanding was impacted by the Company's registered sale of securities on July 27, 2016. The Company's financial position as of March 31, 2017 and results of operations for the three months ended March 31, 2017 and 2016 have been extracted from the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. The Company's financial position as of December 31, 2016 has been extracted from the Company's audited financial statements included in its Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 15, 2017. Certain prior period amounts have been reclassified to conform to current year presentation. You should refer to both the Company's Quarterly Report on Form 10-Q and its Annual Report on Form 10-K for a complete discussion of financial information.


PubMed | Clinical Medicine and., Research and Development and., University of Bergen, University of Oslo and National Institute of Nutrition And Seafood Research
Type: Journal Article | Journal: The Journal of nutrition | Year: 2015

Data from recent meta-analyses question an association between dietary intake of saturated fatty acids (SFAs) and risk of cardiovascular disease (CVD). Moreover, the prognostic effect of dietary SFA in patients with established CVD treated with modern conventional medication has not been extensively studied.We investigated the associations between self-reported dietary SFA intake and risk of subsequent coronary events and mortality in patients with coronary artery disease (CAD).This study included patients who participated in the Western Norway B-Vitamin Intervention Trial and completed a 169-item semiquantitative food-frequency questionnaire after coronary angiography. Quartiles of estimated daily intakes of SFA were related to risk of a primary composite endpoint of coronary events (unstable angina pectoris, nonfatal acute myocardial infarction, and coronary death) and separate secondary endpoints (total acute myocardial infarction, fatal coronary events, and all-cause death) with use of Cox-regression analyses.This study included 2412 patients (81% men, mean age: 61.7 y). After a median follow-up of 4.8 y, a total of 292 (12%) patients experienced at least one major coronary event during follow-up. High intake of SFAs was associated with a number of risk factors at baseline. However, there were no significant associations between SFA intake and risk of coronary events [age- and sex-adjusted HR (95% CI) was 0.85 (0.61, 1.18) for the upper vs. lower SFA quartile] or any secondary endpoint. Estimates were not appreciably changed after multivariate adjustments.There was no association between dietary intake of SFAs and incident coronary events or mortality in patients with established CAD.


PubMed | Abbott Laboratories, Research and Development and, Lovelace Respiratory Research Institute and Research and Development and.
Type: Journal Article | Journal: The Journal of nutrition | Year: 2016

Evidence suggests that human milk oligosaccharides (HMOs) provide multiple benefits to infants, including prebiotic effects, gut maturation, antimicrobial activities, and immune modulation. Clinical intervention studies with HMOs are required to confirm these benefits in infants.Our objective was to investigate the effects of feeding formulas supplemented with the HMO 2-fucosyllactose (2-FL) on biomarkers of immune function in healthy term infants.We performed a substudy nested within a randomized, double-blind, controlled growth and tolerance study in healthy singleton infants (birth weight 2490 g) who were enrolled by 5 d of life and exclusively formula-fed (n = 317) or breastfed (n = 107) from enrollment to 4 mo of age. Formula-fed infants were randomly assigned to receive 1 of 3 formulas, all containing 2.4 g total oligosaccharides/L [control: galacto-oligosaccharides (GOS) only; experimental formulas: GOS + 0.2 or 1.0 g 2-FL/L], and compared with a breastfed reference group. For this substudy, blood samples were drawn from infants at 6 wk of age (n = 31-42/group). Peripheral blood mononuclear cells (PBMCs) were isolated for cellular phenotyping and stimulated ex vivo with phytohemagglutinin for proliferation and cell cycle progression or respiratory syncytial virus (RSV). Cytokine concentrations were measured in plasma and in ex vivo-stimulated culture supernatants.Breastfed infants and infants fed either of the experimental formulas with 2-FL were not different but had 29-83% lower concentrations of plasma inflammatory cytokines than did infants fed the control formula [interleukin (IL) receptor antagonist (IL-1ra), IL-1, IL-1, IL-6, and tumor necrosis factor (TNF-)] (P 0.05). In ex vivo RSV-stimulated PBMC cultures, breastfed infants were not different than either of the groups fed formula with 2-FL, but they had lower concentrations of TNF- (31%) and interferon (IFN- 54%) (P 0.05) and tended to have lower IL-1ra (25%) and IL-6 (38%) (unadjusted P 0.05) and IL-1 (30%) (unadjusted P = 0.06) than did infants fed the control formula.Our data indicate that infants fed formula supplemented with 2-FL exhibit lower plasma and ex vivo inflammatory cytokine profiles, similar to those of a breastfed reference group. This trial was registered at clinicaltrials.gov as NCT01808105.

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