Zavante therapeutics’ zolyd™ met primary endpoint in pivotal zeus study for treatment of complicated urinary tract infections – ktvn channel 2 – reno tahoe sparks news, weather, video

Information contained on this page is provided by an independent third-party content provider. How to lose weight no exercise Frankly and this Site make no warranties or representations in connection therewith. A healthy diet consists of If you are affiliated with this page and would like it removed please contact pressreleases@franklyinc.com

SAN DIEGO, April 6, 2017 /PRNewswire/ — Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, today announced that the company’s investigational product candidate, ZOLYD™ (fosfomycin for injection, also known as ZTI-01), met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the pivotal ZEUS™ clinical trial in patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). Weight loss workouts for men ZOLYD is a first-in-class injectable epoxide antibiotic with a differentiated mechanism of action and broad spectrum of activity against Gram-negative and Gram-positive pathogens, including multi-drug resistant (MDR) pathogens.

The ZEUS study was a multi-center, randomized, double-blind Phase 2/3 trial designed to evaluate the safety and efficacy of ZOLYD in the treatment of hospitalized adults with cUTI or AP. Low carb diet and constipation The primary endpoint of overall success, defined as clinical cure plus microbiologic eradication, was assessed in the microbiologic-modified intent-to-treat population at the test-of-cure visit (Day 19). Weight loss nutrition plan In the study, ZOLYD met the primary endpoint of statistical non-inferiority compared to piperacillin/tazobactam, with an overall success rate of 64.7% (119/184 patients) versus 54.5% (97/178 patients), respectively, a treatment difference of 10.2% (95% CI: -0.4, 20.8). Low carb diet side effects diarrhea Clinical cure rates were high and similar between treatment groups (90.8% vs. Exercise stress test cost 91.6%, respectively). Exercise science jobs atlanta Zavante plans to present the complete ZEUS study results at an upcoming infectious disease conference, and expects to submit a new drug application to the U.S. Exercise and stress Food and Drug Administration in early 2018.

“In an environment of rapidly increasing resistance, safe and effective antibiotics with activity against MDR pathogens are sorely needed,” said Keith Kaye M.D., M.P.H., Professor of Medicine, University of Michigan. Paleo chili seasoning “If approved, ZOLYD’s unique mechanism of action and broad spectrum of activity would add to the treatment armamentarium when treating seriously ill patients in the hospital.”

The ZEUS study enrolled 465 patients who were randomized to receive 6 grams ZOLYD as a one-hour intravenous infusion three times daily (18 grams total daily dose) or 4.5 grams IV piperacillin/tazobactam as a one-hour IV infusion three times daily (13.5 grams total daily dose) for seven days. Paleo alcohol recipes Oral step-down therapy was prohibited. Exercise science jobs utah Patients with concurrent bacteremia received up to 14 days of therapy.

In the ZEUS study safety population, ZOLYD was generally well tolerated. Liquid diet for weight loss recipe Treatment emergent adverse events (TEAEs) were observed in 42.1% of patients in the ZOLYD arm versus 32.0% of patients in the piperacillin/tazobactam arm. Weight loss johnson city tn Most TEAEs were mild and transient, and most events did not lead to premature discontinuation of the study drug. Can u lose weight while pregnant Serious adverse events were uncommon, occurring in five patients in the ZOLYD arm and six in the piperacillin/tazobactam arm, and there were no deaths reported during the study.

“Increasing antimicrobial resistance is significantly limiting the number of therapies available to treat infections in U.S. Paleo ground beef recipes hospitals. Healthy diet program We believe that ZOLYD is an important antibiotic with a novel mechanism of action that, if approved, will help fill the void and address the unmet need. Diet plan app iphone The strong trial results advance our goal of making ZOLYD available to U.S. Weight loss inspiration tumblr physicians and their patients,” said Evelyn J. Exercise on demand Ellis-Grosse, Ph.D., Chief Scientific Officer of Zavante Therapeutics. Diet plan 1200 calories “We are deeply grateful to the investigators and patients who participated in our global cUTI pivotal study and played an important role in potentially advancing a new medicine for life-threatening infections.”

“We believe that the results of the ZEUS study bring us one step closer to introducing ZOLYD as a foundational, broad-spectrum antibiotic in the U.S. Paleo diet shopping list and meal plan hospital market,” said Ted Schroeder, President and Chief Executive Officer of Zavante. “We recognize the urgent need for new treatment options for patients with complicated urinary tract infections caused by suspected or confirmed multi-drug resistant pathogens. A healthy diet menu We expect to file our NDA in early 2018 and, if approved, look forward to introducing ZOLYD for appropriate patients who can benefit from a new antibiotic therapy.”

ZOLYD is a first-in-class injectable epoxide antibiotic with a differentiated mechanism of action that has demonstrated a broad spectrum of bactericidal activity in vitro against both Gram-negative and Gram-positive bacteria, including activity against most contemporary MDR strains.


Low carb diet rules In vitro data have shown that ZOLYD may act synergistically with other antibiotics to improve bacterial killing.

The U.S. Lose belly fat at home Food and Drug Administration (FDA) granted Fast Track designation and Qualified Infectious Disease Product (QIDP) designation for the investigation of ZOLYD for the following indications: cUTI, hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), acute bacterial skin and skin structure infections (ABSSSI), complicated intra-abdominal infections (cIAI). Exercise induced anaphylaxis symptoms These designations make ZOLYD eligible for certain incentives available for the development of new antibiotics, including priority FDA review and an additional five years of market exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act.

ZOLYD™ is an investigational medication that has not been approved by the FDA for any indication.

Zavante Therapeutics, Inc. Healthy diet chart is a privately-held, late clinical-stage biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients. How to lose weight in college and still drink Additional information is available at www.zavante.com.

This press release contains forward-looking statements within the meaning of U.S. Paleo diet pyramid federal securities laws. How do i lose belly fat fast Words such as “plans,” “expects,” and similar expressions are intended to identify forward-looking statements. Weight loss workout plan Forward-looking statements contained in this press release include statements about the anticipated effectiveness of ZOLYD in treating serious infections in hospitalized patients, including those caused by MDR pathogens, and the company’s plans and timing for submitting an NDA for, and commercializing, ZOLYD. Healthy diets to lose weight Forward-looking statements are not historical facts or assurances of the company’s future performance, but are based on management’s current beliefs, expectations and assumptions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and may be outside of the company’s control. Paleo chili easy Because the company’s actual results and financial condition may differ materially from those indicated in the forward-looking statements, you should not rely on any such forward-looking statements. Weight loss soup Important factors that could cause our actual results to differ materially from those indicated in this release include, among others, the following: whether the results of our ZEUS clinical trial are deemed to be sufficient by FDA to support approval of an NDA for ZOLYD; unanticipated delays that may occur, or unanticipated findings that may emerge, in analyzing the data from the ZEUS clinical trial; our ability to successfully complete necessary manufacturing and related development activities for ZOLYD on time and at reasonable costs; our ability to obtain additional financing required to complete development activities and prepare for the commercialization of ZOLYD, if approved by FDA; and potential changes in the FDA’s regulatory policies that could negatively impact FDA approval of ZOLYD or the Fast-track or QIDP designations granted by FDA for ZOLYD. 6 week weight loss workout Forward-looking statements contained in this press release are based only on information currently available to the company and speak only as of the date made. Paleo chicken soup Zavante undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

ZOLYD, ZEUS and ZAVANTE are trademarks or registered trademarks of Zavante Therapeutics, Inc.

To view the original version on PR Newswire, visit: http://www.prnewswire.com/news-releases/zavante-therapeutics-zolyd-met-primary-endpoint-in-pivotal-zeus-study-for-treatment-of-complicated-urinary-tract-infections-300435655.html

If you have ever studied ballet, Bachata or ballroom dance, you know there are specific movements you need to master. Weight loss lexapro Gaining in popularity, however, is a movement that blends all genres of dance and music and there is no wrong way to do it. How to lose weight in a day yahoo What the GROOVE DANCEfloor Experience is all about in Health Watch. Exercise benefits statistics More >>

If you have ever studied ballet, Bachata or ballroom dance, you know there are specific movements you need to master. Dr g weight loss dadeland Gaining in popularity, however, is a movement that blends all genres of dance and music and there is no wrong way to do it. Exercise physiologist salary florida What the GROOVE DANCEfloor Experience is all about in Health Watch. Exercise yoga More >>

Robb Wolf, a Reno biochemist and author of the New York Times bestselling books “The Paleo Solution” and “Wired to Eat” said the widespread diet failure is largely due to a combination of genetics, community, and sleep. Weight loss eating plan for vegetarian More >>

Robb Wolf, a Reno biochemist and author of the New York Times bestselling books “The Paleo Solution” and “Wired to Eat” said the widespread diet failure is largely due to a combination of genetics, community, and sleep. Omega 3 weight loss More >>

The price of a pack of cigarettes is about to go up in California. Slow carb diet rules The state cigarette tax rises by $2 a pack on Saturday, more than doubling the current 87-cent tax. Weight loss challenge Taxes also will rise for other tobacco and vaping products. Weight loss with pcos More >>

The price of a pack of cigarettes is about to go up in California. 5 days diet plan lose 5kg The state cigarette tax rises by $2 a pack on Saturday, more than doubling the current 87-cent tax. Exercise before bed for weight loss Taxes also will rise for other tobacco and vaping products. Weight loss before and after tumblr More >>

When it comes to overall health, like how long we live and how good we feel day-to-day, Washoe County ranks at the top statewide. Paleo diet health risks But there are some economic changes in our area that could hurt that ranking. Weight loss clinic More >>

When it comes to overall health, like how long we live and how good we feel day-to-day, Washoe County ranks at the top statewide. Best diet lose weight fast But there are some economic changes in our area that could hurt that ranking. Military diet workout More >>

What do you get when a former dancer teams up with an athlete who studied nutrition and chemistry? You get a scientifically based workout that is easy on your joints, but challenging for your mind and body. Weight loss plateau on atkins The Pilates method is called seriesTHREE at Body Harmony. Healthy diet chart for adults How the creators say it’s different in Health Watch. Weight loss plans for teens More >>

What do you get when a former dancer teams up with an athlete who studied nutrition and chemistry? You get a scientifically based workout that is easy on your joints, but challenging for your mind and body. Icd 9 weight loss The Pilates method is called seriesTHREE at Body Harmony. Exercise videos on netflix instant How the creators say it’s different in Health Watch. Lose water weight in one day More >>

Leave a Reply

Your email address will not be published. Required fields are marked *