An Open-label, Multicenter, Phase 4 Study to Assess the Effects of a Prophylactic Immune Tolerizing Regimen in MPS II Treatment-Naïve Patients Planned to Receive ELAPRASE Who Are at Risk of Developing Persistent Neutralizing Antibodies

The main aim of this study is to evaluate the ability of a prophylactic immune tolerizing regimen (ITR) to prevent or reduce the development of high titer anti-idursulfase antibodies in treatment-naïve participants with Hunter syndrome.
In this open label, single arm study, all participants will receive ELAPRASE treatment and a prophylactic ITR.
Participants will be treated with ELAPRASE for up to 104 weeks. The prophylactic ITR will start 1 day prior to the start of ELAPRASE. The prophylactic ITR will consist of a 5-week cycle of: Rituximab (intravenously [IV], weekly for 4 weeks); Methotrexate (oral, 3 times per week for 5 weeks) and intravenous immunoglobulin (IVIG) (IV, every 4 weeks of the cycle).
Following the completion of 1 cycle, an assessment will be made at Month 6, 12, and 18 regarding the need for administering another 5-week cycle of the ITR.
Participants will be in the study for approximately 112 weeks (including 6 weeks for screening, up to 104 weeks for treatment, and 2 weeks for follow-up).

Start Date28 Feb 2023

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

[+1]

NCT05211401 / RecruitingPhase 2IIT

Rituximab in Patients With ST-elevation Myocardial Infarction: A Phase 2 Placebo-controlled Randomized Clinical Trial: RITA-MI 2

The main objective is to compare the effect of a single injection of two doses of rituximab versus placebo on 6 months left ventricular systolic function, using CMR, in patients who have had an acute anterior STEMI.
The primary endpoint is the left ventricular ejection fraction (LVEF) by CMR at 6 months.

Start Date01 Jun 2022

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

[+1]

NCT04833114 / RecruitingPhase 3IIT

Open-label, Prospective Phase III Clinical Study to Compare Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) With Rituximab, Ifosfamide, Carboplatin and Etoposide (R-ICE) Alone as Salvage Therapy in Patients With Primary Refractory or Relapsed Diffuse Large B-cell Lymphoma (DLBCL)

An open-label, prospective Phase III clinical study to compare polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) with rituximab, ifosfamide, carboplatin and etoposide (R-ICE) alone as salvage therapy in patients with primary refractory or relapsed diffuse large B-cell lymphoma (DLBCL)

Start Date30 Apr 2021

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

100 Clinical Results associated with Rituximab/Hyaluronidase

100 Translational Medicine associated with Rituximab/Hyaluronidase

100 Patents (Medical) associated with Rituximab/Hyaluronidase

Literatures (Medical) associated with Rituximab/Hyaluronidase

01 Dec 2022·Diagnostic PathologyQ4 · MEDICINE

Establishment of an antibody specific for AMIGO2 improves immunohistochemical evaluation of liver metastases and clinical outcomes in patients with colorectal cancer

Q4 · MEDICINE

ArticleOA

Author: Goto, Keisuke ; Yamamoto, Manabu ; Kazuki, Yasuhiro ; Okada, Futoshi ; Tanio, Akimitsu ; Satofuka, Hiroyuki ; Kugoh, Hiroyuki ; Oshimura, Mitsuo ; Osaki, Mitsuhiko ; Sasaki, Ryo ; Ito, Hisao ; Fujiwara, Yoshiyuki ; Tanaka, Hiroshi ; Izutsu, Runa

AbstractInstructionThe human amphoterin-induced gene and open reading frame (AMIGO) was identified as a novel cell adhesion molecule of type I transmembrane protein. AMIGO2 is one of three members of the AMIGO family (AMIGO1, 2, and 3), and the similarity between them is approximately 40% at the amino acid level. We have previously shown that AMIGO2 functions as a driver of liver metastasis. Immunohistochemical analysis of AMIGO2 expression in colorectal cancer (CRC) using a commercially available anti-AMIGO2 mouse monoclonal antibody clone sc-373699 (sc mAb) correlated with liver metastasis and poor prognosis. However, the sc mAb was found to be cross-reactive with all three molecules in the AMIGO family.MethodsWe generated a rat monoclonal antibody clone rTNK1A0012 (rTNK mAb) for human AMIGO2. The rTNK mAb was used to re-evaluate the association between AMIGO2 expression and liver metastases/clinical outcomes using the same CRC tissue samples previously reported with sc mAb.ResultsWestern blot analysis revealed that a rTNK mAb was identified as being specific for AMIGO2 protein and did not cross-react with AMIGO1 and AMIGO3. The rTNK mAb and sc mAb showed higher AMIGO2 expression, which correlates with a high frequency of liver metastases (65.3% and 47.5%, respectively), while multivariate analysis showed that AMIGO2 expression was an independent prognostic factor for liver metastases (p = 7.930E-10 and p = 1.707E-5). The Kaplan-Meier analyses showed that the rTNK mAb (p = 0.004), but not sc mAb (p = 0.107), predicted worse overall survival in patients with high AMIGO2 expression. The relationship between AMIGO2 expression and poor disease-specific survival showed a higher level of significance for rTNK mAb (p = 0.00004) compared to sc mAb (p = 0.001).ConclusionsThese results indicate that the developed rTNK1A0012 mAb is an antibody that specifically recognizes AMIGO2 by immunohistochemistry and can be a more reliable and applicable method for the diagnostic detection of liver metastases and worse prognosis in patients with high AMIGO2-expressing CRC.

01 Dec 2020·Journal of Translational MedicineQ2 · MEDICINE

Glycemic variability: prognostic impact on acute ischemic stroke and the impact of corrective treatment for hyperglycemia. The GLIAS-III translational study

Q2 · MEDICINE

ArticleOA

Author: Santamaría, María ; Lisbona, Arturo ; López-Fernández, María ; Laso-García, Fernando ; Freijo, Mar M ; Soto, Alfonso ; Díez-Tejedor, Exuperio ; Delgado-Mederos, Raquel ; Rodríguez-Pardo, Jorge ; Gutiérrez-Zúñiga, Raquel ; Gutiérrez-Fernández, María ; Díez-González, Noemí ; Otero-Ortega, Laura ; Ortega-Casarrubios, MÁngeles ; Calleja, Ana ; de Celis, Elena ; González-Pérez de Villar, Noemí ; Gómez-de Frutos, Mari Carmen ; Portilla-Cuenca, Juan Carlos ; Zandio, Beatriz ; Pastor-Yborra, Silvia ; Fuentes, Blanca

AbstractIntroductionGlycemic variability (GV) represents the amplitude of oscillations in glucose levels over time and is associated with higher mortality in critically ill patients. Our aim is to evaluate the impact of GV on acute ischemic stroke (IS) outcomes in humans and explore the impact of two different insulin administration routes on GV in an animal model.MethodsThis translational study consists of two studies conducted in parallel: The first study is an observational, multicenter, prospective clinical study in which 340 patients with acute IS will be subcutaneously implanted a sensor to continuously monitor blood glucose levels for 96 h. The second study is a basic experimental study using an animal model (rats) with permanent occlusion of the middle cerebral artery and induced hyperglycemia (through an intraperitoneal injection of nicotinamide and streptozotocin). The animal study will include the following 6 groups (10 animals per group): sham; hyperglycemia without IS; IS without hyperglycemia; IS and hyperglycemia without treatment; IS and hyperglycemia and intravenous insulin; and IS and hyperglycemia and subcutaneous insulin. The endpoint for the first study is mortality at 3 months, while the endpoints for the animal model study are GV, functional recovery and biomarkers.DiscussionThe GLIAS-III study will be the first translational approach analyzing the prognostic influence of GV, evaluated by the use of subcutaneous glucose monitors, in acute stroke.Trial registrationhttps://www.clinicaltrials.gov (NCT04001049)

01 Jan 2020·Archives of Gynecology and ObstetricsQ4 · MEDICINE

Can glyburide be advocated over subcutaneous insulin for perinatal outcomes of women with gestational diabetes? A systematic review and meta-analysis

Q4 · MEDICINE

Review

Author: Badr, Mohammad Samir ; Helal, Khaled Fathy ; Elnagar, Walid Mohamed ; Lashin, Mohamed El-Bakry ; Rafeek, Mohamed El-Sayed

PURPOSETo obtain precise findings from published studies about the efficacy and safety of glyburide versus subcutaneous insulin in patients with gestational diabetes mellitus (GDM).METHODSWe searched PubMed, Cochrane Library, Web of Science, and Scopus, up to January 2019, for relevant studies that compared glyburide with subcutaneous insulin for patients with GDM. We extracted maternal and neonatal outcomes from included studies, performed meta-analysis, evaluated heterogeneity, assessed the risk of bias of included studies, and conducted subgroup and sensitivity analyses.RESULTSA total of 24 studies (11 randomized controlled trials (RCTs) and 13 observational cohort studies) with a total of 24,517 women were included in the present study. The pooled estimate showed that glyburide significantly decreased the need for cesarean section (OR = 0.87, 95% CI [0.82, 0.92], p < 0.0001), fasting blood glucose (MD - 5.63 mg/dL, 95% CI [- 10.97, - 0.28], p = 0.04), and Apgar score at 5 min (MD - 0.30, 95% CI [- 0.36, - 0.23], p < 0.001) than insulin. However, glyburide significantly increased the risk of neonatal hypoglycemia (OR = 1.42, 95% CI [1.03, 1.95], p = 0.03) and neonatal intensive care unit admission duration (NICU) (MD 4.26 days, 95% CI [2.65, 5.86], p < 0.01) compared to insulin. The overall results did not favor either group in terms of macrosomia (OR = 1.14, 95% CI [0.92, 1.41], p = 0.25) and large for gestational age (LGA) (OR = 1.38, 95% CI [0.99, 1.92], p = 0.06). While subgroup analysis of RCTs showed that maternal hypoglycemia and LGA rates were significantly higher in glyburide than insulin and cesarean section rates were comparable between both compared groups.CONCLUSIONOur study suggests that glyburide is an effective and well-tolerated drug compared to insulin in the management of women with GDM, provided neonates are monitored for hypoglycemia and Apgar score. In addition, glyburide was associated with lower cesarean sections, which may add to the potential clinically benefits of glyburide compared to insulin.

News (Medical) associated with Rituximab/Hyaluronidase

13 Sep 2024

·www.fiercepharma.com

Roche doubles down with another subcutaneous FDA nod, this one for MS star Ocrevus

The FDA has signed off on Genentech's subcutaneous version of multiple sclerosis blockbuster Ocrevus, which will give patients a convenient alternative to the treatment's original infused formulation. When Roche's Genentech gained approval for Ocrevus in 2017, the first-in-class infused drug quickly became the best-selling treatment in a crowded multiple sclerosis (MS) market. Three years later, Novartis’ next-in-class Kesimpta stole some of Ocrevus’ thunder, offering a convenience edge with its once-monthly, at-home prefilled injection. Now, Genentech has responded with a new formulation as the FDA has endorsed a subcutaneous version of Ocrevus. While it can’t match the at-home convenience of Kesimpta, subcutaneous Ocrevus Zunovo, with its twice-a-year, under-the-skin dosing regimen, provides an attractive option.“This is something than can be provided in clinics and doesn’t require people to go to an infusion center,” David Jones, Genentech’s medical director for MS, said in an interview. “This will expand access to individuals who may not be able to access Ocrevus now, especially for reasons like geography or rural setting, individuals that might have challenges with their healthcare provider.”Ocrevus Zunovo can be injected in 10 minutes, compared to the two-plus hours needed for an infusion of the drug. For patients who experience side effects, the intravenous infusion can take up to four hours. Oddly enough, on Thursday, Genentech also earned an FDA nod for a subcutaneous formulation of another of its key products as cancer drug Tecentriq Hybreza got a thumbs-up.Setting up Ocrevus Zunovo’s approval was a phase 3 study that showed its noninferiority to its original version as measured by the level of drug in the blood 12 weeks after administration. The injected formulation also matched the performance of the infused treatment in controlling magnetic resonance imaging lesion activity in the brain over 12 weeks.A later look at the OCARINA II study showed that 97% of patients on subcutaneous Ocrevus experienced no relapses for up to 48 weeks after injection. The subcutaneous treatment also suppressed brain lesions by 97%. Most patients had no T1 gadolinium-enhancing lesions or worsening T2 lesions, which are markers of active inflammation and burden of disease. Ocrevus Zunovo requires more medicine, at 920 mg per dosing, versus 600 mg for an infusion, which is “not really surprising because not all of the drug is going to be absorbed,” Jones said. Ocrevus is designed to target CD20-positive B cells, which are responsible for inflammatory damage to nerve cells in MS.Ocrevus Zunovo was developed using Halozyme Therapeutics’ Enhanze drug delivery technology, which employs an enzyme to allow large molecules like Ocrevus to be given under the skin.The hookup between the companies is well established as it paved the way for the Tecentriq Hybreza FDA nod as well as approvals for subcutaneous versions of Genentech’s blood cancer drug Rituxan Hycela and injectable cancer treatments Herceptin Hylecta and Phesgo. Ocrevus is currently Roche’s top-selling product, with 2023 sales reaching 6.38 billion Swiss francs ($7 billion), which was good for 13% growth over 2022 at constant exchange rates. Ocrevus holds about a 24% MS patient share across the U.S. and five largest European markets.Meanwhile, Kesimpta doubled sales in 2023 to $2.17 billion. The drug has secured new-to-brand share leadership in seven of the 10 major markets outside of the U.S., according to a Novartis report in January.The two CD20 antibodies are among the most expensive MS treatments. While Ocrevus carries a list price of $79,000 annually, Kesimpta goes for $83,000 per year before rebates and discounts.Another force in the MS market is Merck KGaA’s DMD treatment Mavenclad, which generated sales of $1.1 billion last year. Former MS blockbusters that have lost their market exclusivity in the last few years include Teva’s Copaxone, Sanofi’s Aubagio and Novartis’ Gilenya.

Clinical ResultPhase 3Drug Approval

25 Jan 2021

·www.biospace.com

KSQ® Therapeutics Appoints Qasim Rizvi, MB ChB., M.B.A., as Chief Executive Officer

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- KSQ, a biotechnology company using its proprietary CRISPRomics® discovery platform to systematically screen the whole genome to identify optimal gene targets for oncology and autoimmune disease, today announced it has appointed Qasim Rizvi as chief executive officer. Dr. Rizvi joins KSQ today as CEO and will also become a member of the company’s board of directors. Dr. Rizvi is a highly accomplished healthcare executive with broad experience in the biopharmaceuticals industry and was most recently senior vice president of operations and chief commercial officer at Kiniksa Pharmaceuticals. This press release features multimedia. View the full release here: Qasim Rizvi, MB.ChB. (Photo: Business Wire) “Qasim is an accomplished leader with a distinguished track record of innovation and operational excellence, coupled with a strong commitment to collaboration and teambuilding. He joins KSQ at an important inflection point in the company’s strategic evolution, as we advance our expanding pipeline and prepare to transition to development stage,” said Theo Melas-Kyriazi, chair of the KSQ board of directors. “The board is confident that Qasim, along with the entire KSQ leadership team, will provide the expertise, vision and leadership required to advance KSQ’s ambitions to deliver breakthrough products for patients.” Dr. Rizvi commented, “This is an exciting time for the company. KSQ has created the most comprehensive capability to identify and validate novel targets in cancer cells and T cells. Its approach has broad implications across a range of oncology, immuno-oncology, and immune indications. The recently completed Takeda collaboration provides a world-class strategic partner for our immuno-oncology programs and validation for our truly groundbreaking CRISPR-based discovery platform. In addition, the company recently presented data on KSQ-4279 at the 32nd EORTC-NCI-AACR Symposium in October 2020, demonstrating the power of its approach. There is much work to be done. I am humbled and excited to serve as KSQ’s CEO, and I’m very much looking forward to diving in with the full team to deliver on the platform’s potential and positively impact the lives of patients.” Prior to joining KSQ, Dr. Rizvi was senior vice president of operations & chief commercial officer at Kiniksa Pharmaceuticals. He held previous positions at Genentech, where he most recently served as vice president and franchise head of Tecentriq®, with commercial responsibilities for Genentech’s cancer immunotherapy portfolio. Earlier, he led Roche’s hematology franchise, as VP of global product strategy and lifecycle leader for Hemlibra® for hemophilia A. Dr. Rizvi has a record of success in building exceptional teams that deliver results. He has extensive launch experience in the oncology space; having launched Herceptin®, Perjeta® and Kadcyla® for HER2-positive breast cancer as well as Venclexta® for chronic lymphocytic leukemia and Gazyva® for follicular lymphoma. Under his leadership, Rituxan Hycela® received FDA approval as the first sub-cutaneous treatment for non-Hodgkin’s lymphoma. Prior to joining Genentech, Dr. Rizvi was at Novo Nordisk and Eli Lilly, where he served in numerous roles in sales, marketing, business development and new product planning. Dr. Rizvi earned an MB.ChB. from the University of Dundee Medical School in Scotland. He completed his residency in general surgery, including rotations in neurosurgery, orthopedics, ENT and accident and emergency care. He also holds an M.B.A. from the Ross School of Business at the University of Michigan. About KSQ Therapeutics KSQ Therapeutics is advancing a pipeline of tumor- and immune-focused drug candidates for the treatment of cancer across multiple drug modalities including targeted therapies, adoptive cell therapies and immuno-therapies. KSQ’s proprietary CRISPRomics® discovery engine enables genome-scale, in vivo validated, unbiased drug discovery across broad therapeutic areas. KSQ was founded by thought leaders in the field of functional genomics and pioneers of CRISPR screening technologies. For more information, please visit the company’s website at and follow @ksq_tx on Twitter. View source version on businesswire.com:

Cell TherapyImmunotherapyAACR

100 Deals associated with Rituximab/Hyaluronidase

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Indication	Country/Location	Organization	Date
Follicular Lymphoma	US	Genentech, Inc.	22 Jun 2017
Chronic Lymphocytic Leukemia	CA	Roche Holding AG	22 Nov 2016
Diffuse Large B-Cell Lymphoma	CA	Roche Holding AG	22 Nov 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


LYSA Study (Pubmed)	Phase 3	Follicular Lymphoma First line	-	Rituximab, intravenous route	(ptogtooaql) = ybhetetxfi kwiinxhibq (fqfctxetlv )	Positive	18 Apr 2023
				Rituximab, subcutaneous route	(ptogtooaql) = trszbfutne kwiinxhibq (fqfctxetlv )
NCT04189952 (CTgov)	Phase 2	Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type \| Recurrent Transformed Chronic Lymphocytic Leukemia \| Marginal Zone B-Cell Lymphoma	2	Etoposide+Carboplatin+Acalabrutinib+Ifosfamide+Rituximab	qwsihzqhxm(asqhzpxrie) = iidlswhndx bvamzjkeft (aailvycvji, eufhtcbhsp - sclagtxiim) View more	-	19 Sep 2022
REDO trial (ACR2021)	Not Applicable	Rheumatoid Arthritis	142	Rituximab 1000mg	suaypasufy(mkndeqqnod) = mqgjxmwebq vpzfkqktnw (bwjadeiisw, 704 - 1425)	Positive	08 Nov 2021
				Rituximab 500mg	suaypasufy(mkndeqqnod) = vmnwbgbivl vpzfkqktnw (bwjadeiisw, 704 - 1425)
EULAR2021	Not Applicable	Rheumatoid Arthritis	755	Rituximab 2x500mg	swiojbgkjf(jeycgynczp) = mbnlhlwgip szyiiflxhd (ylhssciprw )	-	02 Jun 2021
				Rituximab 2x1000mg	swiojbgkjf(jeycgynczp) = dcbnliampr szyiiflxhd (ylhssciprw )
ESMO2020	Not Applicable	Chronic Lymphocytic Leukemia \| Non-Hodgkin Lymphoma	-	Subcutaneous rituximab	rbppixpjhz(fhrvtyjssy) = dynyutfkwy ioksvivwfv (faaapdhyik ) View more	-	17 Sep 2020
				Intravenous rituximab	pzxtcvgqou(iilbfuoqgw) = geddwkmoih qqcstvcgxc (gguiwrdhmx ) View more
NCT01125176 (ThRiL, CTgov)	Phase 2	Chronic Lymphocytic Leukemia	15	Lenalidomide+thalidomide+rituximab	aiudltafkz(ditgazlggl) = zxxslhejrh uryzoisvro (oigurzjiae, sqdqqnlkqv - zmeahamonn) View more	-	26 Aug 2019
NCT02390362 (RAMP, CTgov)	Phase 3	Nephrotic Syndrome	3	Rituximab (Rituximab)	buvcrmdtvy(obinwgvzfg) = ohvhcxqjhp gzlvshvfkn (tkwlhamqut, ewyoudbprr - awwluiafsk) View more	-	26 Mar 2019
				MMF (Mycophenolate Mofetil (MMF))	buvcrmdtvy(obinwgvzfg) = coahyhqbic gzlvshvfkn (tkwlhamqut, thrgezfqug - jhwfiwbvrg) View more
NCT00545714 (CTgov)	Phase 2	Chronic Lymphocytic Leukemia	86	Fludarabine+cyclophosphamide+Rituximab	hfezcoivnx(qajacfrvnc) = rfodnsebvx titoskgfbw (obsbsvakrj, cydxhjjcwq - zqudpmfynk) View more	-	16 Jan 2019
NCT02169219 (SCOUT, CTgov)	Phase 4	Granulomatosis With Polyangiitis \| Microscopic Polyangiitis	20	Glucocorticoids+Rituximab	(ngsqrprgqg) = kjnomsfjbj fvmhzypzxo (gmlfgahmir, ewktttjwhv - hwnlivhqxu) View more	-	17 Aug 2018
NCT01271010 (CTgov)	Phase 4	Chronic Lymphocytic Leukemia	89	Fludarabine+Cyclophosphamide+Rituximab	tlxvnilrxb(rfdmhhtixf) = lkgnlbthkt abbfbeqkcl (pnfkbluake, tjsucnmswa - ghpcpcwebw) View more	-	20 Mar 2018

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