On Wednesday, XOMA Corporation (NASDAQ:XOMA)’s shares gained 4.18%, and closed at $3.74, as on April 1, a leader in the discovery and development of therapeutic antibodies, declared gevokizumab will be tested in a Phase 2 study in patients with Type 2 diabetes and diabetic kidney disease, clinically referred to as diabetic nephropathy. The international, multicenter, randomized, double-blind, parallel-group, placebo-controlled study is predictable to enroll 370 patients who will be randomized to receive gevokizumab or placebo for 52 weeks. The primary objective of this study is to detect the existence of an overall dose-response relationship of subcutaneously dosed gevokizumab on the measured glomerular filtration rate (mGFR), an accurate measure of kidney function, at Week 52. The study also will determine gevokizumab’s effect on a number of biological biomarkers assessing kidney function. Servier will fully sponsor the study’s execution and cost.
Inflammatory kidney disease is a cause of morbidity and mortality in diabetic patients. There is an increasing amount of evidence that interleukin-1 beta (IL-1 beta), is one of the cytokines involved in the pathogenesis of diabetic nephropathy. A mouse model study of renal inflammation showed gevokizumab significantly reduced proteinuria, a ordinarily seen abnormality in diabetic nephropathy, and several other renal function biomarkers contrast to placebo. Gevokizumab also reduced inflammatory cytokine responses in blood and kidney cortex extracts, in addition to reduced development of fibrosis, the scarring of tissues that is central to the reduction of kidney function.
XOMA Corporation discovers and develops antibody-based therapeutics in the United States, Europe, and the Asia Pacific. The corporation’s lead product candidate comprises gevokizumab, a proprietary humanized allosteric-modulating monoclonal antibody that binds to the inflammatory cytokine interleukin-1 beta, which is in Phase III clinical trial for NIU and Behçet’s disease uveitis, pyoderma gangrenosum, active non-infectious anterior scleritis, autoimmune inner ear disease, and cardiovascular diseases, in addition to diseases under the neutrophilic dermatoses designation, Schnitzler syndrome, and other diseases; and various proof-of-concept studies comprising polymyositis/dermatomyositis, Schnitzler syndrome, and giant cell arteritis.
Gulfmark Offshore, Inc. (NYSE:GLF)’s shares jumped 4.17%, and settled at $15, during the last trading session on Wednesday, after offshore marine support and transportation services provider, declared that its first quarter 2015 earnings conference call is planned for Tuesday, April 21, 2015, at 9:00 a.m. eastern daylight time. The call will be hosted by Quintin Kneen, President and Chief Executive Officer; Jay Mitchell, Executive Vice President and Chief Financial Officer; and David Rosenwasser, Senior Executive Vice President and Chief Operating Officer. The Corporation will issue earnings results for the first quarter the evening before the planned call.
To take part in the teleconference, investors in the U.S. should dial 1-888-317-6003 at least 10 minutes before the start time and when prompted, enter the passcode 1335944. Canada-based callers should dial 1-866-284-3684, and international callers outside of North America should dial +1 412-317-6061.
GulfMark Offshore, Inc. provides offshore marine support and transportation services primarily to the companies involved in the offshore exploration and production of oil and natural gas. The corporation’s vessels offer various services supporting the construction, positioning, and ongoing operation of offshore oil and natural gas drilling rigs and platforms, and related infrastructure.
At the end of Wednesday’s trade, Alkermes plc (NASDAQ:ALKS)’s shares climbed 4.08%, and closed at $63.20, after an integrated biopharmaceutical corporation, declared positive topline results from the complete, six-month, randomized, dose-ranging phase 2 study of ALKS 3831, an investigational, novel, oral atypical antipsychotic drug candidate designed to be a broad-spectrum treatment for schizophrenia. The study was designed in two stages: for the initial three months, patients were randomized to receive olanzapine or one of three doses of ALKS 3831, and antipsychotic efficacy and weight gain were assessed. Positive topline data from this stage were declared in January 2015, showing that ALKS 3831 met the study’s primary endpoint, demonstrating antipsychotic efficacy equivalent to olanzapine, in addition to key secondary endpoints showing ALKS 3831’s favorable effects on weight gain contrast to olanzapine. For the second three months, all patients who received ALKS 3831 during the initial three months continued to receive ALKS 3831, and patients who had received olanzapine were switched to ALKS 3831. Data from the accomplished study support and extend the initial positive results showing ALKS 3831’s favorable efficacy and mean weight gain profile and show for the first time that switching patients from olanzapine to ALKS 3831 resulted in a cessation of mean weight gain.
Patients who received olanzapine in the initial three-month stage were transitioned to receive ALKS 3831 for the second three-month stage. For these patients, efficacy as evaluated by PANSS scores was maintained (change in PANSS total score from Week 12 to Week 24 was -1.3 points, 95% CI: (-3.3, 0.7)). During the initial three-month stage, this patient population practiced noteworthy weight gain, consistent with formerly stated studies of olanzapine (mean percent change in body weight from baseline was 4.3%, 95% CI: (2.4%, 6.2%)). When these patients were transitioned to ALKS 3831 in the second three-month stage, overall no further weight gain was observed (mean percent change in body weight from Week 12 to Week 24 was 0.1%, 95% CI: (-1.0%, 1.2%)).
ALKS 3831 was generally well tolerated in the six-month study. For the initial three-month, active-controlled stage of the study, the most ordinary adverse events in the ALKS 3831 treatment groups relative to olanzapine were somnolence, sedation and dizziness. Alkermes will present comprehensive safety and efficacy data from the phase 2 study at an forthcoming medical meeting and submit the results for publication in a peer-reviewed journal. Alkermes plans to meet with the U.S. Food and Drug Administration (FDA) for an End-of-Phase 2 meeting and advance ALKS 3831 into a pivotal development program in 2015.
Alkermes Public Limited Corporation, an integrated biopharmaceutical corporation, engages in the research, development, and commercialization of pharmaceutical products to address unmet medical needs of patients in various therapeutic areas.
Raptor Pharmaceuticals Corp. (NASDAQ:RPTP), ended its Wednesday’s trading session with 4.07% gain, and closed at $10.75, after a biopharmaceutical corporation, declared that Krishna Polu, M.D., Chief Medical Officer, will be a speaker at the following conference:
Inaugural Neurology Innovation Conference on Sunday, April 19, 2015, at 2:05pm ET in Washington, D.C. Dr. Polu plans to talk about the mechanism of action for RP103 and its utility as a potential treatment for Huntington’s disease.
Raptor Pharmaceutical Corp., a biopharmaceutical corporation, focuses on developing and commercializing life-altering therapeutics that treat debilitating and often fatal diseases. The corporation offers PROCYSBI, a delayed-release capsule, which is used for the administration of nephropathic cystinosis in adults, in addition to in six years and older children in the United States, in the 28 member states of the European Union, Norway, Liechtenstein, and Iceland.
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