On Tuesday, Shares of Bristol-Myers Squibb Co (NYSE:BMY), gained 0.82% to $69.74.
Seattle Genetics, Inc. (Nasdaq:SGEN) and Bristol-Myers Squibb (BMY), declared that the companies have initiated a phase 1/2 clinical trial of ADCETRIS (brentuximab vedotin) in combination with Opdivo (nivolumab) for patients with CD30-expressing relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas (NHL), counting diffuse large B-cell lymphoma (DLBCL), peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). This is the second of two trials being conducted under a formerly declared clinical trial partnershipagreement between Bristol-Myers Squibb Company and Seattle Genetics. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a marker expressed on Hodgkin lymphoma (HL) and several types of NHL, which combines the targeting ability of a monoclonal antibody with a highly potent cell-killing agent. Recent preclinical data suggest that ADCETRIS causes immunogenic cell death of tumor cells, providing rationale for combination with Opdivo, a human antibody that targets and inhibits the programmed death receptor-1 (PD-1), resulting in T-cell activation. Opdivo is part of a new class of cancer immunotherapy treatments known as checkpoint inhibitors, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system.
“This is the second corporate-sponsored clinical trial to evaluate ADCETRIS combined with a checkpoint inhibitor to determine if the combination can improve patient outcomes,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “This study is a part of a broad development program that comprises more than 70 ongoing clinical trials evaluating ADCETRIS in multiple lines of therapy for Hodgkin and non-Hodgkin lymphoma and as part of novel combinations that could result in improved clinical benefit with manageable safety profiles. Our aim is to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas.”
The phase 1/2 open-label, multi-center, clinical trial is designed to evaluate the safety, tolerability and antitumor activity of ADCETRIS in combination with Opdivo in patients with relapsed or refractory CD30-expressing NHL. The study will comprise of a phase 1 dose evaluation portion followed by a single-arm phase 2 portion that will expand enrollment to treat disease-specific cohorts with relapsed or refractory DLBCL, PTCL or CTCL at the recommended dose level and treatment plan. The primary endpoints are safety, tolerability and objective response rate of the combination of ADCETRIS with Opdivo. The secondary endpoints comprise duration of response, complete response rate with the combination regimen, duration of complete response, progression-free survival and overall survival. The trial is being conducted at multiple centers in the United States, Canada and Europe and is designed to enroll about 120 patients.
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. It provides chemically-synthesized drugs or small molecules, and biologics in various therapeutic areas, counting virology comprising human immunodeficiency virus infection (HIV); oncology; neuroscience; immunoscience; and cardiovascular.
Shares of FirstEnergy Corp. (NYSE:FE), declined -0.12% to $32.60, during its last trading session.
Mon Power and Potomac Edison, auxiliaries of FirstEnergy Corp. (FE), declared that the Public Service Commission (PSC) of West Virginia has approved settlement agreements allowing recovery of costs for improved tree-trimming programs and higher fuel and purchased power expenses incurred by the utilities.
The settlements were negotiated by the utilities and the PSC Staff, the Consumer Advocate Division, West Virginia Energy Users Group and the West Virginia Citizen Action Group. As a result, the monthly bill for a typical residential customer using 1,000 kilowatt-hours of electricity will rise about $9. Even with the improvement, rates for Mon Power and Potomac Edison residential customers will be about 16 percent below the national average. The new rates will be effective for the companies’ West Virginia customers starting January 1, 2016.
Since implementing the improved vegetation administration program in 2014, Mon Power and Potomac Edison circuits have practiced significantly fewer tree-related outages in areas where tree trimming has been conducted to the new standards. Tree-trimming activities have been accomplished along more than 7,000 miles of power line right-of-ways across more than 19,000 acres to date. The PSC approved the companies’ vegetation administration program in April 2014.
FirstEnergy Corp., through its auxiliaries, generates, transmits, and distributes electricity in the United States. The company operates through Regulated Distribution, Regulated Transmission, and Competitive Energy Services segments.
Finally, Seagate Technology PLC (NASDAQ:STX), ended its last trade with 1.12% gain, and closed at $37.15.
Starrex International Ltd., declares that, further to its news release dated December 9, 2015, the Company has determined to restate and re-file: (i) its first, second and third quarter unaudited interim financial statements for the periods ended March 31, June 30 and September 30, 2015 (originally filed on May 29, August 28 and November 30, 2015); (ii) the corresponding administration’s negotiations and analyses for the quarterly periods ended March 31, June 30 and September 30, 2015 (originally filed on May 29, August 28 and November 30, 2015); and (iii) the administration’s negotiation and analysis for the year ended December 31, 2014, originally filed on April 30, 2015.
The changes to the interim financial statements for 2015 arise principally out of the allocation of the valuations of the acquisitions accomplished by the Company on July 9, 2014, together with the divestitures effective May 1, 2015. The changes will comprise disclosure of the valuation process for the acquisitions, subsequent divesture allocations and the corresponding impact on the applicable financial statements and the accounting treatment therein.
The Company intends to file the amended and restated interim financial statements, the corresponding administration’s negotiations and analyses, and the administration’s negotiation and analysis for the year ended December 31, 2014, by January 22, 2016.
Seagate Technology Public Limited Company designs, manufactures, and sells electronic data storage products in the Asia Pacific, the Americas, and EMEA countries. It provides hard disk drives, solid state hybrid drives, solid state drives, PCIe cards, and serial advanced technology architecture controllers that are designed for enterprise servers and storage systems in mission critical and nearline applications; for client compute applications comprising desktop and mobile computing; and for client non-compute applications, such as digital video recorders, personal data backup systems, portable external storage systems, digital media systems, and surveillance systems.
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