MiamiGent
2 years ago
AMGEN INC is having a great day!
The price per share $294.845 +$17.82 (+6.43%)
Volume 3,390,182
https://stockcharts.com/h-sc/ui?s=AMGN
Amgen's Olpasiran Reduced Cholesterol Levels In 95% Of Patients In Mid-Stage Study
By Benzinga — 10:01 AM ET 11/07/22
Amgen Inc (NASDAQ:AMGN) presented end-of-treatment data from its Phase 2 OCEAN(a)-DOSE study of olpasiran (formerly AMG 890) in adults with elevated lipoprotein levels and a history of atherosclerotic cardiovascular disease (ASCVD).
These data were presented during the Nov. 6 Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions.
Patients who received 75 mg or higher every 12 weeks had a 95% or greater reduction in lipoprotein levels compared to placebo at week 36.
Related: Amgen Reports Q3 Higher Profit, Despite Slight Fall In Topline Growth.
At these doses (75 mg or higher), more than 98% of patients achieved a lipoprotein level of 125 nmol/L or less at week 36.
Overall, the rates of adverse events were similar in the olpasiran and placebo arms. The most common treatment-related adverse events were injection site reactions, primarily pain.
At week 36, lipoprotein levels increased by a mean of 3.6% in the placebo arm, whereas there were substantial reductions of Lp(a) levels in all of the olpasiran arms.
Placebo-adjusted mean percent reductions were 70.5% for 10 mg every 12 weeks, 97.4% for 75 mg every 12 weeks, 101.1% for 225 mg every 12 weeks, and 100.5% for 225 mg every 24 weeks.
Price Action: AMGN shares are up 0.90% at $271.47 on the last check Monday.
north40000
5 years ago
Next week at ACC:
https://www.sciencedaily.com/releases/2020/03/200325131536.htm
"Researchers from the University of California, Irvine have conducted a statistical analysis that predicts more than 70,000 heart attacks, strokes and other adverse cardiovascular events could be prevented each year in the U.S. through the use of a highly purified fish oil therapy.
Led by Nathan D. Wong, PhD, professor and director of the Heart Disease Prevention Program in the Division of Cardiology at the UCI School of Medicine, the abstract of the statistical analysis was accepted by the American College of Cardiology and is slated to be presented at the upcoming ACC.20/World Congress of Cardiology virtual conference taking place March 28-30. The analysis utilizes data from the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey (NHANES), and inclusion criteria from a multinational clinical trial led by investigators from Harvard University called REDUCE-IT, which was published in the New England Journal of Medicine in January of 2019.
The REDUCE-IT trial showed patients with known cardiovascular disease or diabetes and multiple risk factors who have elevated triglyceride levels and are at increased risk for ischemic events benefitted substantially from icosapent ethyl, a highly purified fish oil therapy, which lowered cardiovascular events, including heart attacks and strokes, by 25 percent. Positive results were not found in other trials, possibly due to mixtures with other omega-3 fatty acids such as DHA, or inadequate dosages according to Wong.
"Our analysis extends the findings of the REDUCE-IT trial by estimating its potential impact on the U.S. population," said Wong. "By using inclusion criteria and cardiovascular disease event rates from the REDUCE-IT trial and applying it to data on US adults from NHANES, we were able to estimate the beneficial impact icosapent ethyl could have on preventing initial and total cardiovascular events in eligible U.S. adults with cardiovascular disease or diabetes and multiple risk factors."
Wong's analysis is the first to project the findings of REDUCE-IT to the overall U.S. population.
"When you consider that for every 21 patients treated with icosapent ethyl you can spare a cardiovascular event, you begin to see the implications of our results," said Wong.
Icosapent ethyl is a purified stable eicosapentaenoic acid (EPA) which was recently approved by the Federal Drug Administration (FDA) in conjunction with maximally tolerated statin therapy to reduce the risk of cardiovascular events in certain adults with elevated triglyceride levels. The only drug of its kind to show such an effect, icosapent ethyl, is currently marketed under the name Vascepa® by Amarin Pharma. The EPA therapy has also gained the support of several major societies, which have incorporated it in various guidelines, scientific statements and advisories, including the American Diabetes Association, American Heart Association, National Lipid Association, and the European Society of Cardiology/European Atherosclerosis Society."
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crudeoil24
6 years ago
Amgen Sun. Highlighted New Data From Phase 1 Studies On BiTE Molecules Presented At ASCO
9:57 am ET June 3, 2019 (Benzinga) Print
Amgen (NASDAQ:AMGN) today announced new data from Phase 1 studies evaluating investigational bispecific T cell engager (BiTE®) molecules were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Data presented included updated investigational AMG 420 safety and efficacy results in patients with relapsed and/or refractory multiple myeloma (R/R MM), as well as initial results from the investigational AMG 212 (pasotuxizumab) first-in-human trial in patients with metastatic castration-resistant prostate cancer (mCRPC). BiTE technology is a targeted immuno-oncology platform that is designed to engage patients' own T cells to a tumor-specific antigen, activating the cytotoxic potential of T cells.
"Our BiTE immuno-oncology platform offers unique versatility, with the potential to treat various tumors through targeting tumor-associated antigens," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "As a leader in the development of targeted immuno-oncology therapies, we continue to investigate and advance more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors. These data at the ASCO Annual Meeting reinforce the potential of BiTE technology for patients with difficult-to-treat cancers like multiple myeloma and prostate cancer."
ASCO Annual Meeting Abstract #8007: Evaluation of AMG 420, An Anti-BCMA Bispecific T Cell Engager (BiTE) Immunotherapy, In R/R Multiple Myeloma (MM) Patients: Updated Results of a First-in-Human (FIH) Phase 1 Dose-Escalation Study
Updated results from a Phase 1, first-in-human dose-escalation trial of investigational AMG 420, a B-cell maturation antigen (BCMA)-targeting BiTE molecule, in patients with R/R MM were shared during an oral presentation at the ASCO Annual Meeting. This abstract was also selected for inclusion in the Best of ASCO® educational program. The objectives of the study included assessment of the safety, tolerability and anti-tumor activity of AMG 420 per International Myeloma Working Group 2006 Uniform Response Criteria for Multiple Myeloma. In the study, 42 patients with R/R MM who had progression after at least two prior lines of treatment (including a proteasome inhibitor and an immunomodulatory imide drug) received AMG 420 at varying doses [0.2 to 800 µg/day (d)]. Of the doses tested in this study, 400 µg/d was the maximum tolerated dose (MTD).
As of the latest readout, AMG 420 induced clinical responses in 13 of 42 patients across the dosing cohorts. Of the six patients that achieved a minimal residual disease (MRD)-negative complete response (CR), five were treated at the 400 µg/d dose. In addition, at the 400 µg/d dose, one patient achieved a very good partial response, and one achieved a partial response. The overall response rate at 400 µg/d was 70 percent (7/10). The median duration of response was nine months (range 5.8-13.6 months). Median time to response was one month, with 11 of 13 patients responding in the first cycle.
Serious adverse events (AEs) were reported in 19 patients (45 percent). Sixteen required hospitalization and four had prolonged hospitalization. No grade 3 or 4 central nervous system toxicities were observed. Serious AEs occurring in more than one patient included infections (n=13) and peripheral polyneuropathy (n=2). Treatment-related serious AEs included polyneuropathy (n=2, both grade 3) and edema (n=1, grade 3). Grade 3 cytokine release syndrome (CRS) was seen in one patient. Two patients died during the study from AEs not considered treatment-related: one patient died from acute respiratory distress due to concurrent flu and aspergillosis, and the second patient died from liver failure secondary to a viral infection during the course of treatment.
"These updated results presented at the ASCO Annual Meeting showed that AMG 420 at the 400 µg/d dose was efficacious with no new safety concerns in heavily pre-treated patients with relapsed and/or refractory multiple myeloma," said Max S. Topp, M.D., professor, University Hospital of Wuerzburg, Germany, and AMG 420 clinical study investigator. "Based on these results, we recommend AMG 420 at the 400 µg/d dose for further investigation."
ASCO 2019 Abstract #5034: Phase 1 Study of Pasotuxizumab (BAY 2010112), a PSMA-targeting BiTE (Bispecific T Cell Engager) Immunotherapy for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Initial results from a Phase 1 dose-escalation study of investigational AMG 212 (pasotuxizumab, formerly known as BAY 2010112), in patients with mCRPC who are refractory to standard therapy were presented in a poster at the ASCO Annual Meeting. AMG 212 is an investigational BiTE molecule which is designed to target prostate-specific membrane antigen (PSMA), a promising target in mCRPC. In the trial, 16 patients with mCRPC were enrolled into five dosing cohorts, with a target dose range of 5 to 80 µg/d delivered by continuous intravenous infusion. The primary objective was to determine safety and MTD and secondary objectives included pharmacokinetics (PK), biomarkers and tumor response. Antitumor activity as indicated by decline in serum level of prostate-specific antigen (PSA) was dose dependent. PSA decreases of = 50 percent occurred in three patients (n=1 each in 20 µg/d, 40 µg/d and 80 µg/d cohorts). One long-term responder was treated for 14 months (40 µg/d) and one for 19.4 months (80 µg/d). The latter patient showed a complete regression of soft-tissue metastases and marked regression of bone metastases, as well as a significant and durable improvement in disease-related symptoms. Recruitment in the trial was stopped before MTD was reached to facilitate initiation of a new study sponsored by Amgen.
"Metastatic castrate-resistant prostate cancer is considered a heterogenous disease and despite advances made over the last few years, the majority of patients face a poor outlook1," said Horst-Dieter Hummel, M.D., University Hospital of Wuerzburg, Germany, and AMG 212 clinical study investigator. "In the first clinical study investigating the potential of a BiTE molecule in solid tumors, AMG 212 showed clinical activity, including two long-term responders. We look forward to studying AMG 212 further in this patient population."
The most common drug-related AEs were fever (94 percent, n=15) and chills (69 percent, n=11). A drug-related serious AE (fatigue) was reported in one patient. CRS was reported for three patients (19 percent); two were grade 2 and one was grade 3. No grade 5 AEs occurred.
Additional Updates on Amgen's BiTE Immuno-Oncology Platform at ASCO 2019
Amgen continues to investigate the BiTE immuno-oncology platform across a broad range of solid and hematologic malignancies with the goal of enhancing patient experience and therapeutic potential. Amgen is investigating more than a dozen BiTE molecules across a range of solid and hematologic malignancies, with an additional two trials-in-progress being presented at the ASCO Annual Meeting.
During poster sessions, researchers shared information on the studies of AMG 596, an investigational BiTE molecule targeting epidermal growth factor receptor variant III (EGFRvIII) in glioblastoma (GBM), and AMG 757, an investigational BiTE molecule targeting delta-like ligand 3 (DLL3) in small-cell lung cancer (SCLC). GBM and SCLC are both aggressive and difficult-to-treat forms of cancer where there is a significant unmet medical need for patients.
Forty-three percent of GBM tumors test positive for amplification or mutation of the EGFR, the most common of which is the EGFRvIII gain-of-function mutation.2 A Phase 1, first-in-human, open-label, sequential dose-escalation and dose-expansion study is ongoing for investigational AMG 596, evaluating its safety, tolerability, and PK and pharmacodynamics in patients with EGFRvIII-postive glioblastoma. The study is expected to enroll 82 patients in two groups: one with recurrent GBM and a second in newly diagnosed patients in the maintenance treatment phase following standard of care treatment.
DLL3 is an inhibitory ligand of notch receptors that is expressed in most SCLC tumors but minimally expressed in normal tissues.3 An ongoing open-label, ascending, multiple-dose, Phase 1 study is evaluating investigational AMG 757 in adult patients with SCLC which has progressed or recurred after at least one platinum-based chemotherapy regimen. Primary objectives are to evaluate safety and tolerability and to determine the MTD or recommended Phase 2 dose. Secondary objectives are to characterize PK and evaluate preliminary anti-tumor activity.
For more information on these and other ongoing clinical trials, visit www.AmgenTrials.com.
© 2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
TFMG
6 years ago
Good results might not be good enough. Cautious.
Despite FDA approval for Amgen's new Enrel drug last week we see the bounce as the formation of a bear flag heading into earnings . Sentiment is so poor in the sector we fear that regardless of results the stock will eventually continue to drop . Amgen is very cheap at 14 P/E ratio with an average rating of HOLD among 25 analysts covering the name.
Amgen , Inc. is a biotechnology company, which engages in the discovery, development, manufacture and marketing of human therapeutics. Its products include the following brands: Aranesp, BLINCYTO, Corlanor, ENBREL, EPOGEN, IMLYGIC, KYPROLIS, Neulasta, NEUPOGEN, Nplate and Parsabiv.
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