Tetraphase Pharmaceuticals Announces Submission and Validation of IV Eravacycline Marketing Authorization Application by European Medicines Agency
WATERTOWN, Mass., Aug. 17, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical-stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug- resistant (MDR) infections, today announced that the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA). Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens. The MAA filing is based on data from the phase 3 IGNITE1 clinical trial in which eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the test-of-cure (TOC) visit.
"The MAA filing represents a significant milestone for Tetraphase as it is our first regulatory application for marketing authorization and a major step toward making eravacycline available as a new antibiotic treatment option for patients with serious hospital infections," said Guy Macdonald, President and Chief Executive Officer of Tetraphase. "I am proud of the dedicated team at Tetraphase who made this happen and who support our commitment to develop novel antibiotics to treat drug-resistant infections. We look forward to working with the EMA during their review of this application and to focusing on the submission of the New Drug Application to the U.S. Food and Drug Administration in the first quarter of 2018."
Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens that have been highlighted as urgent public health threats by both the World Health Organization and the U.S. Centers for Disease Control (CDC). Eravacycline has demonstrated potent activity against multidrug-resistant (MDR) pathogens, including carbapenem-resistant enterobacteriaceae (CRE), Acinetobacter baumannii, and colistin-resistant bacteria carrying the mcr-1 gene. Eravacycline is in phase 3 clinical development for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
Eravacycline is currently being investigated in the Company's phase 3 IGNITE (Investigating Gram-negative Infections Treated with Eravacycline) program. To date, eravacycline has been administered to over 1,500 patients and in two completed phase 3 trials in cIAI. In IGNITE1, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem, was well tolerated, and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates. The IGNITE1 data is serving as the basis of the MAA for IV eravacycline for the treatment of patients with cIAI now under review by the EMA. In IGNITE4, a second phase 3 clinical trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem, was well tolerated, and achieved high cure rates. The Company plans to use the results from IGNITE1 and IGNITE4 to support an NDA submission for IV eravacycline in cIAI. Tetraphase is also currently conducting IGNITE3, an additional phase 3 trial evaluating once-daily IV eravacycline in patients with cUTI and, assuming a positive outcome, the Company plans to use the results from IGNITE3 to support a supplemental NDA submission for eravacycline in cUTI. In parallel, Tetraphase is continuing its efforts to develop an oral dose formulation of eravacycline. A phase 1 clinical program is ongoing which is designed to evaluate and optimize the oral dosing regimen for eravacycline.
About Complicated Intra-abdominal Infections (cIAI)
Intra-abdominal infection (IAI) is a common problem in clinical practice and comprises a wide variety of disease processes. IAI is classified as uncomplicated or complicated based on the extent of the infection. Complicated intra-abdominal infection extends beyond the source organ into the peritoneal space (the space between the two membranes that separate the organs in the abdominal cavity from the abdominal wall) as a result of perforation or other damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. Different bacterial pathogens are responsible for cIAI, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. IAI is an important cause of morbidity and mortality and is the second most common cause of infectious mortality in the intensive care unit. Early detection, containment and appropriate antimicrobial treatment are essential to the successful treatment of IAI. This is even more critical with increasing rates of infections caused by drug-resistant bacteria, which limit the effectiveness of currently available antibiotics.
About Tetraphase Pharmaceuticals, Inc.
Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening bacterial infections, including those caused by many of the multidrug-resistant (MDR) bacteria highlighted as urgent public health threats by the CDC. Tetraphase has created more than 3,000 novel tetracycline analogs using its proprietary technology platform. Tetraphase's pipeline includes three antibiotic clinical candidates: eravacycline, which is in phase 3 clinical trials, and TP-271 and TP-6076, which are in phase 1 clinical trials. Please visit www.tphase.com for more company information.
Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "anticipates," "believes," "expects," "plans," "will" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward- looking statements as a result of various important factors, including: whether results obtained in previous clinical trials will be indicative of results obtained in future clinical trials; whether eravacycline or any other clinical candidate will advance through the clinical trial process on a timely basis or at all; whether the results of the Company's development efforts will warrant regulatory submission and whether any such submissions will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if any clinical candidate obtains approval, it will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q, filed with the Securities and Exchange Commission on August 2, 2017. In addition, the forward-looking statements included in this press release represent our views as of August 17, 2017. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so.
Sam Brown Inc.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Tetraphase Pharmaceuticals via Globenewswire
Följ NASDAQ OMX
Abonnera på våra pressmeddelanden.
Senaste pressmeddelandena från NASDAQ OMX
Nitinat Provides Progress Report on Carscallen and Jasper Properties23.4.2018 22:38 | Pressmeddelande
TORONTO, April 23, 2018 (GLOBE NEWSWIRE) -- Nitinat Minerals Corp. (the "Company") (TSXV:NZZ) (Frankfurt:04U1) is pleased to announce that the work on its 100% owned Carscallen Property is underway and is going as planned. The Corporation will be providing details on an ongoing basis as the work progresses and details become available. The Corporations is also pleased to announce the initiation of a work program on its 100% owned Jasper Property which is located inland from the western shore of Vancouver Island, B.C., roughly 80 kilometers Northwest of Victoria, lying in the area of Nitinat Creek and Lake and is accessed by logging roads coming in from the North. The Jasper Property consists of the Jas 3 legacy mineral claim and eight unnamed cell mineral claims that together comprise nine contiguous claims that cover 3978 hectares. The Jasper Property is 100% owned and operated by the Company. The Highly Visible mineralized showings on the Jasper claims lie in a rugged forested area a
Atico Reports Consolidated Financial Results for 201723.4.2018 22:30 | Pressmeddelande
(All amounts expressed in US dollars, unless otherwise stated) VANCOUVER, British Columbia, April 23, 2018 (GLOBE NEWSWIRE) -- Atico Mining Corporation (the "Company" or "Atico") (TSX-V:ATY) (OTC:ATCMF) today announced its financial results for the year ended December 31, 2017, posting income from mining operations of $15.32 million and a net income of $4.04 million. Production for the year at Atico's El Roble mine totaled 20.6 million pounds ("lbs") of copper and 10,923 ounces ("oz") of gold in concentrates at a cash cost(1) of $1.45 per payable pound of copper produced(2). Fernando E. Ganoza, CEO and Director, commented, "We are pleased to report our strongest year to date both operationally and financially, as the Company concluded 2017 exceeding nearly all set objectives for the year. Operationally, we delivered above our higher end guidance while further increasing operational standards at El Roble. Financially, we have delivered a record year in most metrics while significantly s
Luxoft Develops 'Blockchain Adapter' for a Business Process Management Tool on Appian's Platform23.4.2018 21:58 | Pressmeddelande
Luxoft to unveil healthcare use case for blockchain adapter at Appian World in Miami, April 23-25 (Booth 16) Zug, SWITZERLAND and Reston, VA -- 24 April, 2018 - Luxoft Holding Inc. (NYSE:LXFT), a global IT service provider, today announces it has built a blockchain adapter for Appian's (NASDAQ:APPN) rapid application development platform. It is now available exclusively to businesses using Appian's Business Process Management (BPM) tool and will allow its users to integrate a blockchain network into their day-to-day business processes, creating a secure, digital environment that facilitates data sharing. "The launch of this adapter is about helping businesses realise the potential of blockchain by making it easier to use," said Vasiliy Suvorov, Vice President of Technology Strategy at Luxoft. "Problems integrating blockchain into existing in-house systems are often the biggest obstacles to its adoption. Now, by integrating blockchain into a BPM, a business can leverage the benefits of
Mitratech Acquires ThinkSmart LLC to Create Industry-First, End-to-End Legal Operations Platform23.4.2018 17:00 | Pressmeddelande
Integration of ThinkSmart's agile workflow software into Mitratech's TeamConnect platform sets a new global standard for legal and compliance innovation and excellence LAS VEGAS, April 23, 2018 (GLOBE NEWSWIRE) -- Today, Mitratech a leading provider of legal and compliance software, announced the acquisition of ThinkSmart LLC, creating an end-to-end platform designed to transform legal operations into a center of innovation and excellence. With the addition of ThinkSmart and the ThinkSmart Automation Platform (TAP), Mitratech's TeamConnect platform can now bring people, processes and information together like never before, by leveraging TAP's easy-to-use workflow automation engine to extend TeamConnect's reach across the entire enterprise. In today's rapidly evolving legal landscape, there is a need for a truly evolutionary Enterprise Legal Management (ELM) platform. ELM systems have delivered on the operational efficiencies, centralized view of information, security and data integrity
Vricon unveils new solution at GEOINT 2018: Vricon Precision 3D Registration (P3DR)23.4.2018 16:20 | Pressmeddelande
Precise, accurate, georegistered GEOINT data for analytics and visualization-at a global scale McLean, Virginia, April 23, 2018 (GLOBE NEWSWIRE) -- Vricon is pleased to announce that it is unveiling the next in a series of GEOINT solutions - Vricon Precision 3D Registration (P3DR) - at this year's GEOINT 2018 Symposiumin Tampa, Fla. Vricon P3DR is a software suite designed to automatically georegister imagery, regardless of collection platform, against the most accurate 3D geospatial foundation available, The Globe in 3D. P3DR can be implemented as a real-time processing workflow for imagery feeds without the need for GPS location, heading information, or ground control points. "While we've always been able to perform georegistration of individual data sets using our 3D models as an accurate foundation, Vricon P3DR takes this capability to a whole new level," said Magnus Brege, Vricon CEO. "Our users now have multiple options for where and when they can automatically georegister their
Abeona Announces FDA Grants RMAT Designation to ABO-102 Gene Therapy in MPS IIIA23.4.2018 14:15 | Pressmeddelande
First Gene Therapy Using AAV Approach Granted Regenerative Medicine Advanced Therapy Designation NEW YORK and CLEVELAND, April 23, 2018 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, announced today that the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ABO-102, the Company's AAV-mediated gene therapy for the treatment of Sanfilippo syndrome Type A (MPS IIIA), a rare autosomal-recessive lysosomal storage disease. "We are encouraged to have received the first gene therapy RMAT designation in MPS IIIA and look forward to further collaborating with the FDA to determine next steps in the development pathway for ABO-102," said Carsten Thiel, Ph.D., CEO of Abeona Therapeutics. "This action further reinforces the clinical significance in the data observed in the ongoing P
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum