Resverlogix Announces Seventh Positive Recommendation From The Data Safety Monitoring Board For Phase 3 Study of Apabetalone
A data review by the independent Data Safety Monitoring Board resulted in a recommendation for the BETonMACE trial to continue as planned without any modification
CALGARY, Alberta,, Aug. 07, 2018 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) today announced that the independent Data and Safety Monitoring Board (DSMB) for the Company's Phase 3 BETonMACE trial in high-risk cardiovascular disease (CVD) patients has completed a seventh planned safety review and recommended that the study should continue as planned without any modifications. The DSMB reviewed available study data and noted that no safety or efficacy concerns were identified, and will conduct additional periodic reviews. Resverlogix, the clinical steering committee, and all investigators remain blinded to the trial data.
"The DSMB has now had the opportunity to review data from all of the target 2,400 patients recruited to the BETonMACE study and have not identified any safety issues. There are now sufficient patients recruited to BETonMACE to yield 250 MACE events and we look forward to study completion," stated Dr. Michael Sweeney, M.D., Senior Vice President of Clinical Development.
Apabetalone (see description below) is currently being studied in a Phase 3 trial, BETonMACE, in high-risk CVD patients with type 2 diabetes mellitus and low levels of high-density lipoprotein. The primary endpoint of the BETonMACE trial is designed to establish a relative risk reduction of Major Adverse Cardiac Events, narrowly defined as a single composite endpoint of cardiovascular death, non-fatal myocardial infarction or stroke. In BETonMACE, two additional pre-specified endpoints will be captured, the first being renal function. Approximately 11% of the participants in the study will also have Stage 3 chronic kidney disease, which is defined by an estimated glomerular filtration rate below 60 at baseline. Additionally, pre-specified analysis of cognitive function will take place in approximately 18% of the study participants aged 70 and older. Cognitive function will be assessed using the Montreal Cognitive Analysis (MoCA). This group will be tested in the following categories: those with a baseline MoCA of 26 or above, deemed cognitively normal, and those with a baseline MoCA of 25 or below, defined as those who have some form of cognitive disorder.
Resverlogix is developing apabetalone (RVX-208), a first-in-class, small molecule that is a selective BET (bromodomain and extra-terminal) inhibitor. BET bromodomain inhibition is an epigenetic mechanism that can regulate disease-causing genes. Apabetalone is a BET inhibitor selective for the second bromodomain (BD2) within the BET proteins. This selective inhibition of apabetalone on BD2 produces a specific set of biological effects with potentially important benefits for patients with high-risk cardiovascular disease, diabetes mellitus, chronic kidney disease, end-stage renal disease treated with hemodialysis, neurodegenerative disease, Fabry disease, peripheral artery disease and other orphan diseases, while maintaining a well described safety profile.
Resverlogix common shares trade on the Toronto Stock Exchange (TSX:RVX).
Follow us on Twitter: @Resverlogix_RVX
For further information please contact:
This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. In particular, this news release includes forward looking information relating to the Company's Phase 3 clinical trial and the potential role of apabetalone in the treatment of CVD, DM, chronic kidney disease, end-stage renal disease treated with hemodialysis, Alzheimer's disease, Fabry disease, and Orphan diseases. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR at www.sedar.com. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
TESARO Announces Data Presentations at ESMO 2018 Congress20.10.2018 07:30 | Pressemelding
Data presented indicate that TSR-042 (anti-PD-1 antibody) is well tolerated and has robust activity in patients with MSI-H endometrial cancer PRIMA safety data for individualized niraparib dose regimen presented Top-line results for PRIMA trial of niraparib in first-line ovarian cancer regardless of biomarker status expected in late 2019 MUNICH, Germany, Oct. 20, 2018 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today summarized updated Phase 1 GARNET data of TSR-042 (anti-PD-1 antibody) in patients with recurrent or advanced microsatellite instability high (MSI-H) endometrial cancer presented during the European Society for Medical Oncology (ESMO) Congress. Blinded, pooled interim safety data from the Phase 3 PRIMA trial of niraparib in patients with first-line ovarian cancer regardless of biomarker status were also presented in a poster discussion session and additional data from the QUADRA trial of niraparib for treatment of late-li
The Navigators Group, Inc. Announces Expiration of Hart-Scott-Rodino Waiting Period for Proposed Merger19.10.2018 22:01 | Pressemelding
STAMFORD, Conn., Oct. 19, 2018 (GLOBE NEWSWIRE) -- The Navigators Group, Inc. (NASDAQ:NAVG) (“Navigators” or the “Company”) announced today that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), in connection with its previously announced merger with a direct wholly owned subsidiary (“Merger Sub”) of The Hartford Financial Services Group, Inc. (“The Hartford”), expired at 11:59 p.m. Eastern Time on October 18, 2018. The expiration of the waiting period under the HSR Act satisfies one of the conditions to the closing of the merger, which remains subject to other closing conditions in the Agreement and Plan of Merger, dated as of August 22, 2018, by and among the Company, The Hartford and Merger Sub. About Navigators The Navigators Group, Inc. (NASDAQ: NAVG) (“Navigators” or the “Company”) is a global specialty insurance holding company. We provide customized insurance solutions designed to protect clients from the complex risk
ATTO Technology introduces the XstreamCORE® FC 7600 32Gb Fibre Channel to 12Gb SAS Hardware Accelerated Storage Controller19.10.2018 15:00 | Pressemelding
AMHERST, N.Y., Oct. 19, 2018 (GLOBE NEWSWIRE) -- ATTO Technology, Inc., a global leader of storage, network connectivity and infrastructure solutions for data-intensive computing environments for 30 years, announces availability of the ATTO XstreamCORE® FC 7600 storage controller. ATTO XstreamCORE FC 7600 is a standalone, accelerated storage controller that connects any external SAS device, such as a JBOD of HDDs or SSDs, a RAID array or external tape devices, and presents them isolated to individual hosts or shared over a Fibre Channel SAN fabric. It includes ATTO exclusive technologies, ATTO xCORE hardware acceleration processor and ATTO intelligent Bridging Architecture™, that combine to keep latency astonishingly low at three microseconds. For less than the price of a performance server, XstreamCORE FC 7600 enables up to 64 Fibre Channel connected clients to remotely access and share up to 240 SAS/SATA SSD or HDD devices via JBOD or JBOF at direct attached speeds with consistent, d
Biome Grow Introduces PEI Brand, Red Sands Craft Cannabis Co.19.10.2018 13:30 | Pressemelding
TORONTO, Oct. 19, 2018 (GLOBE NEWSWIRE) -- Biome Grow Inc. (“Biome” or the “Company”) (CSE:BIO) (FSE:6OTA) is pleased to introduce its fifth subsidiary company and brand, Red Sands Craft Cannabis Co. (“Red Sands”). Red Sands is located in Prince Edward Island (PEI) and will service both the local and tourist markets in that province with locally produced and regionally grown cannabis products. The Red Sands Craft Cannabis Co. brand reflects PEI’s iconic red sand beaches and the craft goods and services that are produced locally. Visually, it balances the vibrant, energetic colours with the calm nature that PEI is known for, setting the stage for the tailored cannabis products that Red Sands will offer. Though the smallest Canadian province both in terms of land area and population, with approximately 153,000 residents living on the Island, the province has a robust tourism industry. In 2017, the province set records with more than 1,000,000 overnight stays, by an estimated 1.56 million
CORRECTION - Elite Petro & Gas broadens financial services and signs a deal with Tabarak Investment Capital Limited18.10.2018 23:35 | Pressemelding
DUBAI, United Arab Emirates, Oct. 18, 2018 (GLOBE NEWSWIRE) -- Today the President of Elite Petro & Gas, Mr. George Matharu and the President of Tabarak Investment Capital Limited (Investment Bank), Dr. Mohamed Ahmadi announced a deal in which the two companies will use their combined resources to execute physical commodity trades, and provide banking and finance facilities for oil and gas transactions. The alliance between the two entities will also allow compliance related activities to be carried out from two major international hubs of London and Dubai. This increases the international presence of both companies. Additionally, Elite Petro & Gas (“EPG”) has recently formed relationships with the owners of a number of high profile European, South American and Chinese projects, which EPG and Tabarak can work on together. Tabarak Investment Capital Limited is a regulated investment bank by Dubai Financial Services Authority and incorporated in the Dubai International Financial Centre.
Partnership Between Zaiput Flow Technologies and ThalesNano Set to Improve Process Intensification18.10.2018 15:21 | Pressemelding
BUDAPEST, Hungary and WALTHAM, Mass., Oct. 18, 2018 (GLOBE NEWSWIRE) -- Zaiput Flow Technologies, a global leader in separation, and ThalesNano, the world leader in bench-top flow chemistry reactors, recently signed a distribution agreement and entered into a technology partnership that exploits the benefits of their combined technologies. Under the distribution Zaiput liquid-liquid phase separators and back pressure regulators are available via ThalesNano in Europe and a number of other countries on a non-exclusive basis, either separately or as part of a bundled offering with ThalesNano’s own microflow reactors. Within the framework of the technology partnership the companies will collaborate to promote adoption of the combined use of their technologies. “We are very excited to work with ThalesNano to offer better-integrated flow chemistry systems to our customers and streamline the work of both novice and experienced users in the flow chemistry space,” said Zaiput CEO, Dr. Andrea Ad
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom