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16 Diseases |  |
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13 Trials |  |
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- sotatercept (MK-7962) / BMS, Merck (MSD)
Sotatercept for the Treatment of Pulmonary Arterial Hypertension: Restoring Balance Between Activin and BMP Pathways (Room 7-8 (South Building, Exhibition Level), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_3870;
There is no abstract associated with this presentation.
- sotatercept (MK-7962) / BMS, Merck (MSD)
PULSAR Open-Label Extension: Long-Term Efficacy and Safety of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) (Room 3020/3022/3024 (West Building, Level 3), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_1927;
P2
Safety was consistent with previous reports in PAH and other patient populations. These results demonstrate the potential long-term durability of clinical benefit of sotatercept in participants with this progressive disease.
- ||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Enrollment closed: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR) (clinicaltrials.gov) - Feb 9, 2022
P3, N=284, Active, not recruiting, Sponsor: Acceleron Pharma Inc.
These results demonstrate the potential long-term durability of clinical benefit of sotatercept in participants with this progressive disease. Recruiting --> Active, not recruiting
- ||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Trial completion date: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR) (clinicaltrials.gov) - Feb 3, 2022
P3, N=284, Recruiting, Sponsor: Acceleron Pharma Inc.
Recruiting --> Active, not recruiting Trial completion date: Dec 2022 --> Apr 2023
- sotatercept (ACE-011) / BMS, Merck (MSD)
PULSAR: Sotatercept, The Best New Kid on The Block (Room 147A) - Jan 28, 2022 - Abstract #ACC2022ACC_3017;
Trial completion date: Dec 2022 --> Apr 2023 There is no abstract associated with this presentation.
- || Adempas (riociguat) / Bayer, sotatercept (ACE-011) / Acceleron, BMS
Review, Journal: Pulmonology 2021: year in review (Pubmed Central) - Jan 27, 2022
Sotatercept, a promising new class of drug for treatment of group 1 PAH will soon be available. Finally, the use of transbronchial cryobiopsies as a valid alternative to surgical lung biopsy for the diagnosis of diffuse interstitial lung diseases will also be discussed in this review.
- ||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Enrollment open: CADENCE: A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) (clinicaltrials.gov) - Jan 19, 2022
P2, N=180, Recruiting, Sponsor: Acceleron Pharma Inc.
Finally, the use of transbronchial cryobiopsies as a valid alternative to surgical lung biopsy for the diagnosis of diffuse interstitial lung diseases will also be discussed in this review. Active, not recruiting --> Recruiting
- | Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Trial completion date, Trial termination, Trial primary completion date: Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia (clinicaltrials.gov) - Dec 21, 2021
P1/2, N=19, Terminated, Sponsor: Northwell Health
Active, not recruiting --> Recruiting Trial completion date: May 2022 --> Apr 2021 | Recruiting --> Terminated | Trial primary completion date: Mar 2022 --> Apr 2021; Supporter terminated the study due to no active patients (secondary to travel restrictions due to COVID).
- | Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Enrollment closed, Trial primary completion date: Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia (clinicaltrials.gov) - Dec 17, 2021
P2, N=63, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: May 2022 --> Apr 2021 | Recruiting --> Terminated | Trial primary completion date: Mar 2022 --> Apr 2021; Supporter terminated the study due to no active patients (secondary to travel restrictions due to COVID). Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2021 --> Feb 2022
- || Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Enrollment closed, Trial completion date: CADENCE: A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) (clinicaltrials.gov) - Dec 13, 2021
P2, N=180, Active, not recruiting, Sponsor: Acceleron Pharma Inc.
Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2021 --> Feb 2022 Not yet recruiting --> Active, not recruiting | Trial completion date: Mar 2025 --> Jun 2025
- ||||| sotatercept (ACE-011) / Acceleron, BMS
Clinical: Our Dr. Prithviraj Bose sharing the final results of a Phase II clinical trial of sotatercept (ACE-011) for anemia of MPN-associated myelofibrosis. Read the results: https://t.co/E8MtQEhW5U #ASH21 @bose_prithviraj #EndCancer (Twitter) - Dec 11, 2021
- ||||| sotatercept (ACE-011) / Acceleron, BMS
Clinical, Monotherapy: And @bose_prithviraj on Ph II study of sotatercept in MF with anemia #mpnsm #ASH21 -primary endpt transfusion independence or Hgb incr of 1.5; median Hgb at entry was 7.4 -ORR in monotherapy and combo cohort ~30% -HTN and limb pain seen in pts (Twitter) - Dec 11, 2021
- |||||| sotatercept (ACE-011) / Acceleron, BMS
Clinical, P2 data: Congress| #ASH21| @bose_prithviraj, @MDAndersonNews, shows final results of a phase II study of sotatercept, a first-in-class, activin receptor type IIA ligand trap, for anemia of MPN-associated MF. Overall response was 30% & 32% when used alone, or in conjunction with Rux #MPNsm (Twitter) - Dec 11, 2021
- ||||| sotatercept (ACE-011) / Acceleron, BMS
Clinical, P2 data: Fantastic presentations on the #MDS session on non-JAKi therapies for #Myelofibrosis @bose_prithviraj closes the session with the final results of a Phase II trial of sotatercept for #anemia of MPN-associated myelofibrosis #ASH21 #HemOnc #MDSsm (Twitter) - Dec 11, 2021
- || Novel drugs for PAH: -Sotatercept -Imatinib -Seralutinib -Rodatristat: we are in a trial-rich era in PAH! #CVCT2021 #CVCTForum @FaiezZANNAD (Twitter) - Dec 4, 2021
- || azacitidine / Generic mfg.
Clinical, Review, Journal: Increasing recognition and emerging therapies argue for dedicated clinical trials in chronic myelomonocytic leukemia. (Pubmed Central) - Nov 21, 2021
To date, approved drugs for CMML treatment are HMA, including azacitidine, decitabine, and more recently the oral combination of decitabine and cedazuridine...Several novel agents, such as sotatercept, ruxolitinib, lenzilumab, and tagraxofusp have shown promising clinical efficacy in CMML...This review focuses on recent therapeutic advances and innovative treatment strategies in CMML, including global and molecularly targeted approaches. We also discuss what may help to make progress in the design of rationally derived and disease-modifying therapies for CMML.
- ||| sotatercept (ACE-011) / Acceleron, BMS
Preclinical: Sotatercept analog RAP-011 from @AcceleronPharma improves pulmonary hypertension and reduces RV hypertrophy in PH-HFpEF rats. #AHA21 (Twitter) - Nov 14, 2021
- || Jakafi oral (ruxolitinib) / Novartis, Incyte, sotatercept (ACE-011) / Acceleron, BMS, Reblozyl (luspatercept-aamt) / Acceleron, BMS
Review, Journal: Improving Ineffective Erythropoiesis in Thalassemia: A Hope on the Horizon. (Pubmed Central) - Nov 12, 2021
Relevant titles and abstracts were screened to choose relevant articles. Further, the full-text articles were retrieved and relevant cross-references were scanned to collect information for the present review.
- sotatercept (ACE-011) / Acceleron, BMS
Final Results of a Phase 2 Study of Sotatercept (ACE-011) for Anemia of MPN-Associated Myelofibrosis (GWCC - A411-A412, Level 4) - Nov 5, 2021 - Abstract #ASH2021ASH_1425;
P2
Current therapies for anemia of MF (erythropoietin and analogs, danazol, IMiDs®) are unsatisfactory...All responses in the rux cohort occurred in non-TD pts. The trial (NCT01712308) has been closed to new pt enrollment.
- |||| sotatercept (MK-7962) / BMS, Merck (MSD)
Enrollment open: A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) (clinicaltrials.gov) - Oct 31, 2021
P3, N=166, Recruiting, Sponsor: Acceleron Pharma Inc.
The trial (NCT01712308) has been closed to new pt enrollment. Not yet recruiting --> Recruiting
- | Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Trial completion date, Trial primary completion date, Combination therapy: Sotatercept (ACE-011) With Lenalidomide or Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Oct 29, 2021
P1, N=33, Active, not recruiting, Sponsor: Massachusetts General Hospital
Not yet recruiting --> Recruiting Trial completion date: Mar 2020 --> Jun 2022 | Trial primary completion date: May 2018 --> Jun 2022
- | sotatercept (ACE-011) / Acceleron, BMS
Just a coincidence that this occurs while $XLRN / $MRK are gearing up to launch sotatercept in PAH? (Twitter) - Oct 1, 2021
- sotatercept (ACE-011) / Acceleron, BMS
[VIRTUAL] Sotatercept for the Treatment of Pulmonary Arterial Hypertension: The PULSAR Trial (OnDemand) - Sep 24, 2021 - Abstract #AHA2021AHA_6676;
- sotatercept (ACE-011) / Acceleron, BMS
[VIRTUAL] Sotatercept Phase 3 Program Design and Rationale: A Novel Treatment for Pulmonary Arterial Hypertension (ePosters) - Sep 24, 2021 - Abstract #AHA2021AHA_4225;
P3
Trial completion date: Mar 2020 --> Jun 2022 | Trial primary completion date: May 2018 --> Jun 2022 The robust Phase 3 clinical program has the potential to further characterize the efficacy and safety of sotatercept across a broad spectrum of patients with PAH and provide a novel treatment option.
- sotatercept (ACE-011) / Acceleron, BMS
[VIRTUAL] Sotatercept Analog RAP-011 is More Effective Than Sildenafil in Improving Pulmonary Hypertension and Reducing Right Ventricular Hypertrophy in a ZSF1 Rat Model of Heart Failure With Preserved Ejection Fraction (ePosters) - Sep 24, 2021 - Abstract #AHA2021AHA_2426;
Therapeutic treatment with the sotatercept analog RAP-011 exerted beneficial cardiopulmonary effects in a ZSF1 rat model of PH-HFpEF that were significantly greater than those produced by sildenafil, fully normalizing PH and RV hypertrophy and improving RV function. These findings support evaluation of sotatercept in patients with PH-HFpEF (Group 2 PH).
- | sotatercept (ACE-011) / Acceleron, BMS
Journal: Sotatercept therapy for PAH. (Pubmed Central) - Sep 22, 2021
These findings support evaluation of sotatercept in patients with PH-HFpEF (Group 2 PH). No abstract available
- |||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Enrollment open: HYPERION: Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) (clinicaltrials.gov) - Aug 12, 2021
P3, N=662, Recruiting, Sponsor: Acceleron Pharma Inc.
No abstract available Not yet recruiting --> Recruiting
- sotatercept (ACE-011) / Acceleron, BMS
[VIRTUAL] PULSAR open-label extension: interim results from a phase 2 study of the efficacy and safety of sotatercept when added to standard of care for the treatment of pulmonary arterial hypertension (PAH) (Channel 6) - Jul 29, 2021 - Abstract #ERS2021ERS_1306;
Importantly, placebo assignment did not affect the ability to respond after 24 wks. Safety was consistent with previous reports in PAH and other pt populations.
- | sotatercept (ACE-011) / Acceleron, BMS
Journal: Sotatercept for Pulmonary Arterial Hypertension. (Pubmed Central) - Jul 8, 2021
Safety was consistent with previous reports in PAH and other pt populations. No abstract available
- |||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
New P2 trial: CADENCE: A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16) (clinicaltrials.gov) - Jun 30, 2021
P2, N=180, Not yet recruiting, Sponsor: Acceleron Pharma Inc.
- |||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Enrollment open: SOTERIA: A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12) (clinicaltrials.gov) - Jun 2, 2021
P3, N=700, Recruiting, Sponsor: Acceleron Pharma Inc.
No abstract available Not yet recruiting --> Recruiting
- |||||||| sotatercept (MK-7962) / BMS, Merck (MSD)
New P3 trial: A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH) (clinicaltrials.gov) - May 20, 2021
P3, N=166, Not yet recruiting, Sponsor: Acceleron Pharma Inc.
- ||| sotatercept (ACE-011) / Acceleron, BMS
Clinical: That was from the D003 Session this morning, title: https://t.co/1CcBx6VnCj "PULSAR Study Open-Label Extension: Interim Results from a Phase 2 Study of the Efficacy and Safety of Sotatercept When Added to Standard of Care for the Treatment of PAH" (Twitter) - May 19, 2021
- Zarzio (filgrastim biosimilar) / Novartis
[VIRTUAL] E-CADHERIN CONTROLS ERYTHROPOIESIS: A NOVEL AVENUE TO ANEMIA TREATMENT () - May 13, 2021 - Abstract #EHA2021EHA_615;
When serum erythropoietin (EPO) is low, MDS-patients are treated with EPO and/or Sotatercept, displaying a ~50% response rate in terms of erythroid hematological improvement...In extension, we suggest deficient E-cadherin to underlie inefficient stress erythropoiesis and anemia as we observe reduced protein expression in the erythroid lineage in MDS patient BM. Overall, E-cadherin signaling may underlie (stress) erythropoiesis by controlling differentiation of erythroid progenitors in human BM, and is an interesting candidate for targeted treatment of inefficient erythropoiesis.
- || sotatercept (MK-7962) / BMS, Merck (MSD)
Trial primary completion date: PULSAR: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) (clinicaltrials.gov) - May 5, 2021
P2, N=106, Active, not recruiting, Sponsor: Acceleron Pharma Inc.
Overall, E-cadherin signaling may underlie (stress) erythropoiesis by controlling differentiation of erythroid progenitors in human BM, and is an interesting candidate for targeted treatment of inefficient erythropoiesis. Trial primary completion date: Jan 2020 --> Dec 2021
- ||| sotatercept (ACE-011) / Acceleron, BMS
Clinical: Fresh insights on PAH patient screening, hemodynamic interpretation, medical therapy including sotatercept, vascular imaging and device-based monitoring...primed for the clinical community. https://t.co/rdLfbOhZf8 @ebrosenzweig @SteveAbman @HornEvelyn @HFpEF (Twitter) - Apr 17, 2021
- ||| sotatercept (ACE-011) / Acceleron, BMS
Clinical: "In patients with ESKD, sotatercept exhibited a favorable safety profile and was associated with trends in dose-related slowing of vascular calcification. Less-consistent trends in improved hemoglobin concentration and BMD were observed." https://t.co/uAc3MrI3gr (Twitter) - Apr 6, 2021
- |||| sotatercept (ACE-011) / Acceleron, BMS
Clinical, Adverse events: Raising hemoglobin was an "adverse effect". I will thread our pub on use of this for anemia in dialysis pts. Sotatercept for the Treatment of Pulmonary Arterial Hypertension | NEJM https://t.co/x9kWqIA3NZ (Twitter) - Apr 6, 2021
- | sotatercept (ACE-011) / Acceleron, BMS
Journal: Sotatercept for the Treatment of Pulmonary Arterial Hypertension. (Pubmed Central) - Apr 1, 2021
P2
Treatment with sotatercept resulted in a reduction in pulmonary vascular resistance in patients receiving background therapy for pulmonary arterial hypertension. (Funded by Acceleron Pharma; PULSAR ClinicalTrials.gov number, NCT03496207.).
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
New P3 trial: HYPERION: Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13) (clinicaltrials.gov) - Mar 22, 2021
P3, N=662, Not yet recruiting, Sponsor: Acceleron Pharma Inc.
- sotatercept (ACE-011) / Acceleron, BMS
[VIRTUAL] The SPECTRA Study: A Phase 2a Single-Arm, Open-Label, Multicenter Exploratory Study to Assess the Effects of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) () - Mar 14, 2021 - Abstract #ATS2021ATS_5011;
P2, P2a
Safety was consistent with previous reports in PAH and other patient populations. These results further highlight the clinical efficacy of sotatercept and its potential as a new treatment option for PAH patients.
- sotatercept (ACE-011) / Acceleron, BMS
[VIRTUAL] PULSAR Study Open-Label Extension: Interim Results from a Phase 2 Study of the Efficacy and Safety of Sotatercept When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) () - Mar 14, 2021 - Abstract #ATS2021ATS_3427;
P2
Improvements observed in patients re-randomized from the placebo group to sotatercept treatment aligns with the initial results from the placebo-controlled treatment period. Importantly, placebo assignment did not affect the ability to respond after 24 weeks.
- sotatercept (ACE-011) / Acceleron, BMS
[VIRTUAL] Sotatercept Analog RAP-011 Alleviates Cardiopulmonary Remodeling and Inflammation in a Model of Heritable PAH Arising from Bmpr2 Haploinsufficiency () - Mar 14, 2021 - Abstract #ATS2021ATS_2771;
These results indicate that treatment with RAP-011 suppresses macrophage infiltration and improves cardiopulmonary structure and function in a mouse model of heritable PAH arising from Bmpr2 haploinsufficiency. Together with our previous studies of induced experimental PAH, these findings suggest that therapeutic benefits of RAP-011 are robust and observed across multiple causative mechanisms in experimental PAH, including genetic and environmental factors, thus supporting evaluation of sotatercept broadly in heritable and idiopathic forms of human PAH.
- sotatercept (ACE-011) / Acceleron, BMS
[VIRTUAL] Sotatercept Analog RAP-011 Reduces Right Ventricular Hypertrophy and Alleviates Pulmonary Hypertension in A ZSF1 Rat Model of Heart Failure with Preserved Ejection Fraction () - Mar 14, 2021 - Abstract #ATS2021ATS_2288;
Therapeutic treatment with the rodent sotatercept analog RAP-011 reduces PH and right ventricular hypertrophy, reverses right ventricular remodeling, and improves right ventricular function in this ZSF1 rat model of HFpEF. These findings support evaluation of sotatercept in patients with PH-HFpEF (Group 2 PH) along with its ongoing evaluation in patients with PAH.
- |||||||||| Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
New P3 trial: SOTERIA: A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12) (clinicaltrials.gov) - Mar 11, 2021
P3, N=700, Not yet recruiting, Sponsor: Acceleron Pharma Inc.
- | Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Trial completion date, Trial primary completion date: Safety and Efficacy Study of Sotatercept in Adults With Transfusion Dependent Diamond Blackfan Anemia (clinicaltrials.gov) - Mar 4, 2021
P1/2, N=20, Recruiting, Sponsor: Northwell Health
These findings support evaluation of sotatercept in patients with PH-HFpEF (Group 2 PH) along with its ongoing evaluation in patients with PAH. Trial completion date: May 2021 --> May 2022 | Trial primary completion date: Mar 2021 --> Mar 2022
- | Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca, Simdax (levosimendan IV) / AbbVie
Journal: American Heart Association (AHA) Scientific Sessions 2020 (November 13-17, 2020 - Virtual Meeting). (Pubmed Central) - Feb 24, 2021
AHA 2020 was originally scheduled to be held in Dallas, Texas, but due to public health concerns surrounding the SARS-CoV-2 (COVID-19) crisis, it was instead presented as a virtual summit. The virtual online program included oral, poster and poster discussion presentations, as well as track-based clinical science symposia throughout the conference.
- | sotatercept (ACE-011) / Acceleron, BMS
Journal: RAP-011 Rescues the Disease Phenotype in a Cellular Model of Congenital Dyserythropoietic Anemia Type II by Inhibiting the SMAD2-3 Pathway. (Pubmed Central) - Feb 18, 2021
We demonstrate that treatment of these SEC23B-silenced K562 cells with RAP-011, a "murinized" ortholog of sotatercept, rescues the disease phenotype by restoring gene expression of erythroid markers through inhibition of the phosphorylated SMAD2 pathway. Our data also demonstrate the effect of RAP-011 treatment in reducing the expression of erythroferrone in vitro, thus suggesting a possible beneficial role of the use of sotatercept in the management of iron overload in patients with CDA II.
- | sotatercept (ACE-011) / Acceleron, BMS, Reblozyl (luspatercept-aamt) / Acceleron, BMS
Journal: Emerging therapies in β-Thalassemia: towards a new era in management. (Pubmed Central) - Feb 4, 2021
Advances in understanding the underlying pathophysiology of β-thalassemia enabled clinicians and researchers to move towards the development of novel therapeutic modalities. These can be classified into three categories based on their efforts to address different features of the underlying pathophysiology of β-thalassemia: correction of the globin chain imbalance, addressing ineffective erythropoiesis, and improving iron overload.Areas covered: In this review, we will provide an overview of the novel therapeutic approaches that are currently in development for β-thalassemia.Expert opinion: A thorough understanding of the pathophysiology and overall disease burden of β-thalassemia has aided clinicians and scientists to optimize disease management approaches and construct a plan for the development of novel therapies, with ultimate goals of prolonging longevity, reducing symptom burden, improving compliance and adherence for a better quality of life.
- | Winrevair (sotatercept-csrk) / BMS, Merck (MSD)
Enrollment closed: SPECTRA: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (clinicaltrials.gov) - Jan 5, 2021
P2a, N=19, Active, not recruiting, Sponsor: Acceleron Pharma, Inc.
These can be classified into three categories based on their efforts to address different features of the underlying pathophysiology of β-thalassemia: correction of the globin chain imbalance, addressing ineffective erythropoiesis, and improving iron overload.Areas covered: In this review, we will provide an overview of the novel therapeutic approaches that are currently in development for β-thalassemia.Expert opinion: A thorough understanding of the pathophysiology and overall disease burden of β-thalassemia has aided clinicians and scientists to optimize disease management approaches and construct a plan for the development of novel therapies, with ultimate goals of prolonging longevity, reducing symptom burden, improving compliance and adherence for a better quality of life. Recruiting --> Active, not recruiting