Phase II Trial of Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to Treatment With Teclistamab in Relapsed or Refractory Multiple Myeloma (RRMM)

The purpose of this study is to examine the safety, efficacy and feasibility of the use of one standard dose of siltuximab prior to teclistamab infusion. Siltuximab is an investigational (experimental) drug that works by binding directly to human interleukin-6 (IL-6). IL-6 is a cytokine; these are products that are secreted by certain cells of the immune system and effect other cells in participant's body. IL-6 regulates immune, inflammatory and metabolic processes. Siltuximab has already been tested and approved for use by the FDA in participants with a condition called multicentric Castleman's disease, which is a lymphoproliferative disorder. This study is being conducted to investigate if administration of a single dose of siltuximab will reduce the rates of and severity of Cytokine Release Syndrome (CRS) and Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) in participants prior to teclistamab administration. CRS and ICANS are adverse effects commonly experienced by participants being treated with teclistamab that are related to inflammation in the body. Siltuximab is experimental because it is not approved by the Food and Drug Administration (FDA) for prophylactic use prior to administration of teclistamab infusion.

Start Date01 Jan 2025

Sponsor / Collaborator

The Case Comprehensive Cancer Center

NCT06679829

/ RecruitingPhase 2IIT

Phase II Randomized Trial of Population PK Dosed Melphalan With Interleukin-6 Blockade With Siltuximab Vesrus BSA Based Melphalan in Patients With Multiple Myeloma Over Age 60 Undergoing Autologous Stem Cell Transplantation

The purpose of this study is to see if siltuximab plus population pharmacokinetic (PK)-dosed melphalan works as well as the usual approach (body surface area [BSA]-dosed melphalan) in people with multiple myeloma (MM) who are receiving an autologous stem cell transplant (ASCT) as part of their standard treatment. The researchers will also see if siltuximab in combination with population PK-dosed melphalan works to decrease symptoms after an ASCT, and will study the safety of siltuximab.
For the run-in, 15 patients will receive siltuximab, 11 mg/kg, seven days before and 14 days after autologous hematopoietic stem cell infusion (+/-2 day).

Start Date06 Nov 2024

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

NCT05684692

/ RecruitingPhase 2IIT

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

This is a placebo-controlled, multi-arm phase II platform screening trial designed to test the safety, pain responses, and pharmacodynamic activity of multiple experimental therapies simultaneously in participants with moderate-to-severe pain due to schwannomatosis (SWN).
This Master Study is being conducted as a platform that may allow participants with pain associated with schwannomatosis to receive a novel intervention throughout this study. Embedded within the Master Study are individual drug sub-studies:
Investigational Drug Sub-Study A: Siltuximab
Investigation Drug Sub-Study B: Erenumab-Aooe

Start Date31 Aug 2023

Sponsor / Collaborator

The Schwartz Center for Compassionate Healthcare

[+2]

100 Clinical Results associated with Siltuximab

100 Translational Medicine associated with Siltuximab

100 Patents (Medical) associated with Siltuximab

385

Literatures (Medical) associated with Siltuximab

17 Jan 2025·MEDICINE

Osteosarcoma biomarker analysis and drug targeting prediction based on pyroptosis-related genes

Article

Author: Zhuang, Yuxiang ; Li, Xiaofeng

Osteosarcoma is a malignant bone tumor originating from mesenchymal tissue. Recent studies have found that the tumor inflammatory microenvironment plays an important role in promoting the malignant characteristics and metastatic potential of malignant tumors. Pyroptosis, an inflammatory programmed cell death, elicits immune responses that exhibit anti-tumor effects through released factors and contents. Therefore, improving anti-tumor immunity by targeting osteosarcoma-related pyroptosis genes and pathways may be of great significance in delaying early metastasis of osteosarcoma and improving patient survival rate. The study aimed to identify pyroptosis-related genes and biomarkers in osteosarcoma, predicting therapeutic drugs targeting these genes. Gene expression profiles of osteosarcoma were retrieved from Gene Expression Omnibus and cross-referenced with GeneCards and Comparative Toxicogenomics Database to identify differentially expressed pyroptosis-related genes. We conducted enrichment analysis on intersecting genes to identify their biological processes and signaling pathways and assessed immune cell composition in the tumor microenvironment through immune infiltration analysis. In addition, we further utilized Cytoscape software to screen out the top 10 genes with Degree values among the intersected genes as hub genes and performed GSEA analysis and drug prediction based on the hub genes. A total of 22 differentially expressed pyroptosis-related genes were identified in osteosarcoma, with 10 of them (TP53, CYCS, IL-1A, IL-1B, IL-18, CASP-3, CASP-8, IL-6, TNF, CASP-1) pinpointed as hub genes. Enrichment analysis found that the 22 intersection genes are mainly associated with pyroptosis, apoptosis, immune regulation, and related biological processes. The results of data validation targeting hub genes suggest that IL-18, CASP-1, and CASP-8 may be key genes involved in the regulation of pyroptosis in osteosarcoma. Immune infiltration analysis shows statistical differences in the distribution of immune cells like naive B cells, monocytes, M2 macrophages, and dendritic/mast cells, suggesting they play a role in the osteosarcoma tumor microenvironment. Hub gene drug targets suggest Triethyl phosphate, Plinabulin, and Siltuximab as potential osteosarcoma treatments. Our findings suggest potential mechanisms of action for 22 pyroptosis-related genes in osteosarcoma and preliminarily predicted that the occurrence of osteosarcoma is closely related to pyroptosis, apoptosis, and immune regulation. Predicted Triethyl phosphate, Plinabulin, Siltuximab as potential osteosarcoma treatments.

14 Jan 2025·Blood Advances

Siltuximab for chimeric antigen receptor T-cell therapy–related CRS and ICANS: a multicenter retrospective analysis

Article

Author: Galal, Ahmed ; Tossey, Justin ; Ahmed, Nausheen ; Frame, David ; Geer, Marcus ; Ghosh, Monalisa ; Maakaron, Joseph ; Bajwa, Amneet ; Caimi, Paolo ; Voorhees, Timothy ; de Lima, Marcos ; Zhao, Qiuhong ; Westholder, James ; Epperla, Narendranath ; Lin, Chenyu ; Denlinger, Nathan ; Bezerra, Evandro

Abstract:

Chimeric antigen receptor T-cell (CAR-T) therapies are effective in many hematologic malignancies; however, adverse events including cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS) can affect a significant number of patients. Those who develop refractory CRS or ICANS have few treatment options. Siltuximab, a monoclonal antibody binding circulating interleukin-6, has been proposed to have clinical activity in both CRS and ICANS. We conducted a multicenter retrospective analysis of siltuximab treatment for CRS and ICANS after CAR-T therapy in a real-world cohort from 6 academic centers. Fifty-four patients were evaluated. Sixteen patients had CRS previously treated with tocilizumab and 17 patients had ICANS previously treated with steroids. Of the patients with CRS at the time of siltuximab, 75% had improvement in CRS grade. Of the patients with ICANS at the time of siltuximab, 60% had improvement in ICANS grade. To our knowledge, this is the largest cohort of patients treated with siltuximab for CRS and/or ICANS after CAR-T therapies. Siltuximab appeared to be effective for both CRS and ICANS, including previously treated toxicities. These data support the use of siltuximab in CRS and ICANS as well as provide rationale for future prospective studies.

14 Jan 2025·Retinal cases & brief reports

Multicentric Castleman’s Disease presenting with bilateral panuveitis

Article

Author: Anjos, Rita ; Murta, Afonso ; Pinheiro, Sofia ; Saunders, Christopher ; Costa, Lívio ; Alves, Nuno Rodrigues ; Cunha, Bruna ; Mota, Catarina

Purpose::

To report a rare case of Multicentric Castleman’s Disease presenting with bilateral panuveitis.

Methods::

Case report.

Results::

A 65-years-old caucasian man presented with progressive blurred vision in both eyes for two weeks, along with weight loss, polyarthralgias and reduced muscle strength persisting for about a year. Examination revealed bilateral panuveitis after intraocular lymphoma being initially considered. CT scans showed multiple lymph node enlargements suggestive of lymphoproliferative disorder. Excisional biopsy of an axillary lymph node confirmed the diagnosis of plasmacytic type Castleman’s disease. Treatment was started with topical dexamethasone and tropicamide for anterior chamber inflammation, followed by oral prednisolone. After definitive diagnosis, treatment with siltuximab was initiated, which led to significant improvement in panuveitis and systemic symptoms. The patient became off corticosteroids and continued on siltuximab with stable visual acuity and low-grade vitritis.

Conclusion::

To the best of our knowledge we described the first case in which the diagnosis of Multicentric Castleman’s Disease was established through the investigation of bilateral panuveitis, which was successfully managed with corticosteroids and siltuximab.

139

News (Medical) associated with Siltuximab

10 Jan 2025

·www.globenewswire.com

Tourmaline Strengthens Cardiovascular Scientific Advisory Board with Appointment of Dr. Paul M. Ridker

NEW YORK, Jan. 10, 2025 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today announced that Paul M. Ridker, MD, MPH, Eugene Braunwald Professor of Medicine at the Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, has joined Tourmaline’s Cardiovascular Scientific Advisory Board (CV SAB). “We are beyond honored to welcome Dr. Ridker, a luminary in the field who has helped to fundamentally transform our understanding of cardiovascular disease,” said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline. “Dr. Ridker’s many contributions to cardiovascular disease research cannot be overstated. His work over decades has illuminated the critical role of inflammation in atherosclerosis, as well as the potential therapeutic benefit of directly addressing inflammation to reduce the risk of major adverse cardiovascular events. We are thrilled to have his invaluable strategic guidance as we await the results from our Phase 2 TRANQUILITY trial and prepare for the expected future development of pacibekitug to reduce inflammation in cardiovascular diseases.” Over a 30-year period, Dr. Ridker has led a paradigm shift in the understanding of atherosclerotic cardiovascular disease (ASCVD), highlighting the critical importance of inflammation, and in doing so, has impacted international guidelines for the diagnosis, treatment, and prevention of ASCVD. He and his collaborators provided the first FDA-approved diagnostic test for vascular inflammation (high-sensitivity C-reactive protein, or hs-CRP); the first demonstration that statin therapy is both lipid-lowering and anti-inflammatory; and the first proof-of-principle for the inflammation hypothesis of atherothrombosis in humans, in addition to bringing into clinical practice worldwide the concept of “residual inflammatory risk.” As a direct result of his work, multiple novel anti-inflammatory agents targeting interrelated aspects of heart disease ranging from chronic ASCVD to acute myocardial ischemia to heart failure are under development worldwide. Dr. Ridker, a Distinguished Scientist of the American Heart Association and an elected member of the National Academy of Medicine, is known for his leadership of over 15 major, multi-national, randomized clinical trials. He has received continuous funding from the National Institutes of Health and is the recipient of multiple honorary degrees and international awards. “Dr. Ridker is a world-renowned pioneer in inflammation and cardiovascular disease whose ground-breaking work bridges population science, translational research, and clinical trials,” said Emil deGoma, MD, Senior Vice President of Medical Research at Tourmaline. “We are grateful to have his expert guidance as we advance development of pacibekitug for the treatment of patients with cardiovascular disease driven by residual inflammatory risk. Research he has led for decades, including prospective cohort studies of hs-CRP and the landmark CANTOS IL-1β inhibition trial, provides foundational evidence to support the therapeutic potential of IL-6 inhibition, which is currently being tested in multiple cardiovascular outcome trials.” About Tourmaline BioTourmaline is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Tourmaline’s lead asset is pacibekitug (also referred to as TOUR006). For more information about Tourmaline and pacibekitug, please visit https://www.tourmalinebio.com or follow us on LinkedIn or X. About Pacibekitug Pacibekitug (also referred to as TOUR006) is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. Pacibekitug has been previously studied in approximately 450 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is currently developing pacibekitug in atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED) as its first two indications, with plans to expand into abdominal aortic aneurysm (AAA) and additional diseases in the future. Cautionary Note Regarding Forward-Looking StatementsAny statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe,” “designed to,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Tourmaline’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of pacibekitug; the timing of initiation, progress and results of Tourmaline’s current and future clinical trials for pacibekitug, including reporting of data therefrom; the timing of Phase 3 clinical trial readiness; and the timing and potential to expand pacibekitug into additional indications. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Tourmaline’s current or future product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Tourmaline’s current or future product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Tourmaline’s current or future product candidates; the risk that Tourmaline’s current or future product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Tourmaline anticipates; risks regarding the accuracy of Tourmaline’s estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; unexpected litigation or other disputes; the impacts of macroeconomic conditions Tourmaline’s business, clinical trials and financial position; and other risks and uncertainties that are described in Tourmaline’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (“SEC”) on November 7 2024 and other filings that Tourmaline makes with the SEC from time to time. Any forward-looking statements speak only as of the date of this press release and are based on information available to Tourmaline as of the date hereof, and Tourmaline assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Media ContactScient PRSarah MishekSMishek@ScientPR.com Investor ContactMeru AdvisorsLee M. Sternlstern@meruadvisors.com

Executive ChangeAHA

27 Dec 2024

·www.pharmaceutical-technology.com

Mankind Pharma and Innovent partner for Sintilimab commercialisation in India

Under the agreement, Mankind Pharma will have the exclusive rights to register, import, market, sell, and distribute Sintilimab in India. Credit: Piotr Swat/Shutterstock. Mankind Pharma has entered into a partnership with Innovent Biologics for exclusively licensing and commercialising Sintilimab, an immunotherapy for cancer treatment in India. This strategic move is aimed at addressing significant challenges in cancer care and enhance patient access to new therapeutic options. Sintilimab, known as TYVYT (sintilimab injectable) in China, was developed through a collaboration between Eli Lilly and Innovent. Currently, the asset is not approved in India, IIFL Capital reported. Earlier next year, Mankind Pharma plans to seek regulatory approval in India and complete all regulatory processes, including the conduct of a Phase III study in the country. The study will commence once the company receives regulatory approval to conduct such studies. Under the agreement, Mankind Pharma will have the exclusive rights to register, import, market, sell, and distribute Sintilimab in India. Innovent will oversee the manufacturing and supply of the product to ensure steady availability and adherence to quality standards. Innovent Biologics chief business officer Samuel Zhang said: “The company is committed to advancing patient care in India by making cutting-edge treatments more accessible and affordable.” In July 2024, Mankind Pharma entered into a definitive agreement to acquire 100% of Bharat Serums and Vaccines (BSV) from private equity investor Advent International for an enterprise value of approximately Rs136.3bn ($1.59bn). Bharat Serums, a biopharmaceutical company founded in 1971, has a research and development centre in the Indian city of Mumbai with over 100 scientists. It operates in more than 70 countries, with subsidiaries in Germany, the Philippines, and the US.

License out/inImmunotherapyAcquisitionPhase 3Drug Approval

10 Dec 2024

·www.globenewswire.com

Tourmaline Bio Highlights Cardiovascular Inflammation Focus and Announces Key Clinical and Strategic Updates at Investor Day

– Phase 2 TRANQUILITY trial surpasses enrollment target, with 143 total patients enrolled; topline data expected in second quarter of 2025 – – Deepak L. Bhatt, MD, MPH, MBA and Dipender Gill, MD, PhD join Cardiovascular Scientific Advisory Board – – Company nominates abdominal aortic aneurysm as second cardiovascular indication for pacibekitug, expanding development for inflammation-driven cardiovascular disease – NEW YORK, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today is hosting its Investor Day, beginning at 10 a.m. ET, during which it will outline progress across its pipeline and provide updates on its strategic priorities. “We continue to be laser-focused on our development efforts for pacibekitug in order to maximize the potential of this program,” said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline Bio. “Today’s updates, including the over-enrollment of our TRANQUILITY trial, the expansion of our Cardiovascular Scientific Advisory Board, and the addition of a new indication, reflect the strength of our science, the caliber of our team, and our commitment to redefining standards of care for patients worldwide.” Phase 2 TRANQUILITY Trial ProgressTourmaline today is announcing the over-enrollment of its Phase 2 TRANQUILITY trial, which evaluates quarterly and monthly subcutaneous dosing of pacibekitug in patients with elevated high-sensitivity C-reactive protein and chronic kidney disease. A total of 143 patients have been enrolled in the Phase 2 TRANQUILITY trial, as compared to 120 patients originally anticipated. Tourmaline expects to report topline data from this trial in the second quarter of 2025. The TRANQUILITY trial is the starting point of Tourmaline’s clinical development program for pacibekitug for the potential treatment of atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases. If successful, results from the TRANQUILITY trial are expected to position Tourmaline to be Phase 3-ready for ASCVD. Expansion of Cardiovascular Scientific Advisory Board (CV SAB)Tourmaline has expanded its CV SAB with two new appointments: Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC, MSCAI joins as Chair of the Tourmaline CV SAB. Dr. Bhatt is the Director of the Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai in New York City. Dr. Bhatt has served as principal investigator for a number of groundbreaking cardiovascular clinical trials, bringing to the CV SAB decades of clinical trial expertise.Dipender Gill, MD, PhD is the CEO of Sequoia Genetics and a specialist in leveraging human genetic evidence for drug development. Dr. Gill adds deep translational insight to Tourmaline’s strategic focus. Indication Expansion in Cardiovascular InflammationTourmaline has nominated abdominal aortic aneurysm (AAA) as an additional indication within its cardiovascular inflammation disease focus for pacibekitug. Tourmaline expects to provide additional details on a planned Phase 2 proof-of-concept trial in AAA after topline results from the Phase 2 TRANQUILITY trial are reported in Q2 2025. Update on Thyroid Eye Disease (TED) Development ProgramIn light of Tourmaline’s focus on cardiovascular inflammation, initiation of a Phase 3 trial in TED will be dependent upon results from the ongoing Phase 2b spiriTED trial. Topline data from the Phase 2b spiriTED trial are expected in the second half of 2025; Tourmaline expects to provide additional information on its future development plans in TED at that time. Investor Day Event InformationTourmaline’s Investor Day will take place on December 10, 2024, beginning at 10 a.m. ET. To register for Tourmaline’s Investor Day, please click here or visit the Events and Presentations section of Tourmaline’s website. A replay of the webcast will be available on Tourmaline’s website following the event. It is recommended that participants register at least 15 minutes in advance of the event. About Tourmaline BioTourmaline is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Tourmaline’s lead asset is pacibekitug (also referred to as TOUR006). For more information about Tourmaline Bio and pacibekitug, please visit https://www.tourmalinebio.com or follow us on LinkedIn or X. About Pacibekitug Pacibekitug (also referred to as TOUR006) is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. Pacibekitug has been previously studied in approximately 450 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is currently developing pacibekitug in atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED) as its first two indications, with plans to expand into abdominal aortic aneurysm (AAA) and additional diseases in the future. Cautionary Note Regarding Forward-Looking StatementsAny statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe,” “designed to,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Tourmaline’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of pacibekitug; the timing of initiation, progress and results of Tourmaline’s current and future clinical trials for pacibekitug, including reporting of data therefrom and additional details regarding the planning thereof; the timing of future announcements regarding Tourmaline’s development plans and the content of such announcements; the timing of a planned Phase 2 proof-of-concept clinical trial and of Phase 3 clinical trial readiness; and the timing and potential to expand pacibekitug into additional indications. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Tourmaline’s current or future product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Tourmaline’s current or future product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials and clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Tourmaline’s current or future product candidates and/or current or future target indications; the risk that Tourmaline’s current or future product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Tourmaline anticipates; risks regarding the accuracy of Tourmaline’s estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; unexpected litigation or other disputes; the impacts of macroeconomic conditions Tourmaline’s business, clinical trials and financial position; and other risks and uncertainties that are described in Tourmaline’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (“SEC”) on November 7, 2024 and other filings that Tourmaline makes with the SEC from time to time. Any forward-looking statements speak only as of the date of this press release and are based on information available to Tourmaline as of the date hereof, and Tourmaline assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Media ContactScient PR Sarah Mishek SMishek@ScientPR.com Investor ContactMeru AdvisorsLee M. Sternlstern@meruadvisors.com

Phase 2Executive ChangeAHA

100 Deals associated with Siltuximab

External Link

KEGG	Wiki	ATC	Drug Bank
D09669	Siltuximab	L04AC11	DB09036

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Multi-Centric Castleman's Disease	US	Recordati Rare Diseases, Inc.	23 Apr 2014
Multi-Centric Castleman's Disease	US	EUSA Pharma (UK) Ltd.	23 Apr 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Castleman Disease	NDA/BLA	CN	-	20 Jan 2021
Pneumonia	Phase 3	US	EUSA Pharma (UK) Ltd.	13 Nov 2020
Respiratory Distress Syndrome, Acute	Phase 3	US	EUSA Pharma (UK) Ltd.	13 Nov 2020
Refractory Multiple Myeloma	Phase 3	US	Centocor, Inc.	01 Jul 2011
Refractory Multiple Myeloma	Phase 3	AU	Centocor, Inc.	01 Jul 2011
Refractory Multiple Myeloma	Phase 3	BE	Centocor, Inc.	01 Jul 2011
Refractory Multiple Myeloma	Phase 3	BG	Centocor, Inc.	01 Jul 2011
Refractory Multiple Myeloma	Phase 3	CA	Centocor, Inc.	01 Jul 2011
Refractory Multiple Myeloma	Phase 3	CZ	Centocor, Inc.	01 Jul 2011
Refractory Multiple Myeloma	Phase 3	IN	Centocor, Inc.	01 Jul 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04191421 (AACR2024) Manual	Phase 1/2	Pancreatic Cancer	-	Siltuximab	xqfgblqirj(vsqomybsud) = gugqipmvnm sypuuossgx (hzqqhgzrvs ) View more	Positive	05 Apr 2024
NCT04191421 (AACR2024) Manual	Phase 1/2	Pancreatic Cancer	-	SiltuximabSiltuximab 11 mg/kg	xqfgblqirj(vsqomybsud) = gyybodhuzo sypuuossgx (hzqqhgzrvs ) View more	Positive	05 Apr 2024
Tandem Meetings ASTCT and CIBMTR2024 Manual	Not Applicable	Hematologic Neoplasms	-	Siltuximab	suwdkyffoi(uthusitexy) = hkdmmoqjgi cthnklahwh (wwcscvenfm ) View more	Positive	01 Feb 2024
Tandem Meetings ASTCT and CIBMTR2024 Manual	Phase 1	B-Cell Lymphoma	11	Siltuximab	qlsoxjcitw(qgafxkncqy) = nhgayushea qwtijoaanq (hrythddbpe ) View more	Positive	01 Feb 2024
ASH2023	Not Applicable	-	52	Siltuximab	hgiqdjojry(btawezxkcd) = krnxsljohc gvpyewozei (njquecgwvz )	-	11 Dec 2023
ASCO2023	Not Applicable	Castleman Disease	40	Siltuximab	gqocpwfuwh(vwytulyyce) = anallxksdh rdopzjqxzx (sthkktoehi, 59.7)	Positive	31 May 2023
EBMT2023	Not Applicable	Cytokine Release Syndrome Interleukin-6 (IL6) receptor \| interleukin-1 (IL1)	-	Anakinra	sbsntjyuph(vxnaubptuy) = lzlqeytzhk pqtftchney (pfiblbhlgg ) View more	-	23 Apr 2023
NCT01024036 (EHA2022)	Phase 2	Multi-Centric Castleman's Disease	79	Siltuximab	gvxpftjtaw(doxlxttzem) = ggouvwfdvg wxrjpdyjay (hwwcktvvop ) View more	-	12 May 2022
NCT01024036 (EHA2022)	Phase 2	Multi-Centric Castleman's Disease	79	Placebo	gvxpftjtaw(doxlxttzem) = yvtvffaxvk wxrjpdyjay (hwwcktvvop, 13.6 - upper bound not reached) View more	-	12 May 2022
ARVO2021	Not Applicable	Retinal Diseases	8	Anti-Interleukin-6 Monoclonal Antibodies	jlkecrdewy(qslqzhasxz) = hmoxqlszmi idhpziwdnh (ihsnminzly ) View more	-	01 Jun 2021
NCT01400503 (Pubmed \| Lancet Haematol) Manual	Phase 2	Multi-Centric Castleman's Disease	60	Siltuximab	xbsiirxkag(pxzffimwqq) = eyhhmoitns pqhbgvjxjw (xbtgncduiw ) View more	Positive	01 Mar 2020
NCT01484275 (CTgov)	Phase 2	Smoldering Multiple Myeloma \| Multiple Myeloma	85	Siltuximab (Siltuximab)	czfroykkvd(vncpylmcfu) = rwuxmpvfqt vnxqalgsjf (fuzoxnkmzt, abugfhpule - iwadazjxec) View more	-	27 Jan 2020
NCT01484275 (CTgov)	Phase 2	Smoldering Multiple Myeloma \| Multiple Myeloma	85	Placebo (Placebo)	czfroykkvd(vncpylmcfu) = fbiswovzrv vnxqalgsjf (fuzoxnkmzt, uceaqnrxfn - qopogcxzuq) View more	-	27 Jan 2020

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