A Phase 2a, Prospective, Open-label, Single-arm, Single Center, Proof of Concept Study to Evaluate the Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis

The purpose of this study is to evaluate the safety and efficacy of IGIV 10% in patients with autoimmune encephalitis

Start Date20 Nov 2019

Sponsor / Collaborator

Green Cross Co., Ltd.

NCT04003844

/ CompletedPhase 4

Multicenter, Single-arm, Phase IV Study to Evaluate the Efficacy, Safety of Combined Therapy of Aspirin and IVIG-SN 10% in Pediatric Patients With Kawasaki Disease

The purpose of this study is to evaluate the efficacy and safety of high-dose human Immunoglobulin G Intravenous (IGIV) 10% in subjects with Kawasaki diseases (KD).

Start Date01 Feb 2019

Sponsor / Collaborator

Green Cross Co., Ltd.

NCT01524939

/ CompletedPhase 4

Multicenter, Single-arm, Phase IV Study to Evaluate the Efficacy, Safety of Combined Therapy of Aspirin and High Dose "IVIG-SN" in Pediatric Patients With Kawasaki Disease

The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.

Start Date01 Jan 2012

Sponsor / Collaborator

Green Cross Co., Ltd.

100 Clinical Results associated with Immunoglobulin G(Green Cross Corporation)

100 Translational Medicine associated with Immunoglobulin G(Green Cross Corporation)

100 Patents (Medical) associated with Immunoglobulin G(Green Cross Corporation)

399

Literatures (Medical) associated with Immunoglobulin G(Green Cross Corporation)

16 Nov 2024·Pathogens and Global Health

Clinical applications of immunoglobulin G against different individual Aspergillus species for the diagnosis of chronic pulmonary aspergillosis among at-risk populations

Article

Author: Liu, Chia-Jung ; Lee, Meng-Rui ; Chen, Jung-Yueh ; Wang, Jann-Yuan ; Lin, Chen-Chieh ; Wu, Chang-Wei ; Chang, Lih-Yu ; Keng, Li-Ta

Aspergillus fumigatus-specific IgG is often used as a diagnostic test for chronic pulmonary aspergillosis (CPA), but few studies have evaluated the performance and serology of IgGs from species other than A. fumigatus. In this study, we evaluated the serology and performance of different Aspergillus species-specific IgG antibodies in patients with CPA and at-risk populations and whether different Aspergillus species-specific IgGs could be of clinical utility and aid in the diagnosis of CPA caused by all Aspergillus species. A total of 187 participants were included between 2020 and 2022 (12 with CPA, 75 with old tuberculosis [TB], 45 with active TB and 55 with bronchiectasis). We measured the serum Aspergillus fumigatus, flavus, terreus, niger-specific, and mixed Aspergillus IgG levels (Phadia ImmunoCap). The correlation was the strongest between A. fumigatus and A. niger (Spearman's rank: 0.940), followed by A. niger and A. flavus (Spearman's rank: 0.915). A. terreus-specific IgG was less strongly correlated with the other three Aspergillus species-specific IgG (Spearman's rank: 0.828-0.849). A. flavus (4 of 6, 67%) was the dominant species. Using the at-least-one-positive approach, the highest performance was obtained when A. fumigatus and A. flavus IgGs were used (sensitivity, 0.75; specificity, 0.84). Significant cross-reactivity exists among different Aspergillus-species IgGs although the correlation may be less significant for A. terreus. In addition to the commonly used A. fumigatus IgG test, IgGs specific to local prevalent Aspergillus species may provide additional clinical utility.

01 Nov 2024·JOURNAL OF CLINICAL IMMUNOLOGY

Insights into Patient Experiences with Facilitated Subcutaneous Immunoglobulin Therapy in Primary Immune Deficiency: A Prospective Observational Cohort

Article

Author: Bilgic Eltan, Sevgi ; Dikici, Ummugulsum ; Ozdemir, Oner ; Can, Salim ; Meric, Zeynep ; Aydogan, Metin ; Yalcin Gungoren, Ezgi ; Orhan, Fazil ; Kiykim, Ayca ; Karabiber, Esra ; Baris, Safa ; Karakoc-Aydiner, Elif ; Ozen, Ahmet ; Yorgun Altunbas, Melek ; Cokugras, Haluk ; Yakici, Nalan ; Eser Simsek, Isil

Abstract:

Background:

Immunoglobulin G replacement therapy (IgRT), intravenous (IV) and subcutaneous (SC) routes, is pivotal in treatment of primary immunodeficiencies (PID). In recent years, facilitated subcutaneous immunoglobulin (fSCIG), a combination of rHuPH20 and 10% IgG has emerged as a delivery method to combine advantages of both IV and SC.

Method:

In an observational prospective cohort, we investigated patient experience with fSCIG in PID patients from 5 PID centers for up to 12 months. We assessed the efficacy and safety of this treatment with patient/caregiver- and physician-reported indicators. Additionally, we analyzed patient treatment satisfaction (TSQM-9) and quality of life (QoL).

Results:

We enrolled 29 patients (22 pediatric and 7 adults; 14 females and 15 males; (median: 15, min–max: 2–40.9 years) who initiated fSCIG as IgRT-naive (n = 1), switched from conventional rapid-push 10% SCIG (n = 6) or IVIG (n = 22). Among the participants, 19 (65%) exhibited antibody deficiencies, 8 (27%) combined immunodeficiencies, and 2 (7%) immune dysregulations. Remarkably, targeted trough immunoglobulin G levels were achieved under all previous IgRTs as well as fSCIG. No severe systemic adverse drug reactions were documented, despite prevalent local (%86.45) and mild systemic (%26.45) adverse reactions were noted with fSCIG. Due to mild systemic symptoms, 2 patients switched from fSCIG to 10% SCIG. The patient satisfaction survey revealed a notable increase at 2-4th (p = 0.102); 5-8th (p = 0.006) and 9-12th (p < 0.001) months compared to the baseline. No significant trends were observed in QoL surveys.

Conclusion:

fSCIG demonstrates admissable tolerability and efficacy in managing PIDs in addition to notable increase of patients’ drug satisfaction with IgRT. The identified benefits support the continuation of this therapy despite the local reactions.

01 Nov 2024·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Variants in IGLL1 cause a broad phenotype from agammaglobulinemia to transient hypogammaglobulinemia

Review

Author: Trück, Johannes ; Pac, Małgorzata ; Nichols, Kim E ; Theodoropoulou, Katerina ; Akgül, Gülfirde ; Freiberger, Tomas ; Pachlopnik Schmid, Jana ; Kraemer, Dennis ; Oak, Ninad ; Stoltze, Ulrik Kristoffer ; Bloomfield, Markéta ; Sogkas, Georgios ; Zeyda, Maximillian ; Förster-Waldl, Elisabeth ; Bily, Viktor ; Stittrich, Anna ; Elgizouli, Magdeldin ; Brodszki, Nicholas ; Krüger, Renate ; Schmiegelow, Kjeld ; Šedivá, Anna ; Wong, Melanie ; Giżewska, Maria ; Kölsch, Uwe ; Klocperk, Adam ; Candotti, Fabio ; Prader, Seraina ; Wadt, Karin ; Soomann, Maarja ; von Bernuth, Horst

BACKGROUND:

Agammaglobulinemia due to variants in IGLL1 has traditionally been considered an exceedingly rare form of severe B-cell deficiency, with only 8 documented cases in the literature. Surprisingly, the first agammaglobulinemic patient identified by newborn screening (NBS) through quantification of kappa-deleting recombination excision circles harbored variants in IGLL1.

OBJECTIVE:

We comprehensively reviewed clinical and immunologic findings of patients with B-cell deficiency attributed to variants in IGLL1.

METHODS:

NBS programs reporting the use of kappa-deleting recombination excision circle assays, the European Society for Immunodeficiencies Registry, and authors of published reports featuring patients with B-cell deficiency linked to IGLL1 variants were contacted. Only patients with (likely) pathogenic variants, reduced CD19⁺ counts, and no alternative diagnosis were included.

RESULTS:

The study included 13 patients identified through NBS, 2 clinically diagnosed patients, and 2 asymptomatic siblings. All had severely reduced CD19⁺ B cells (< 0.1 × 10⁹/L) at first evaluation, yet subsequent follow-up assessments indicated residual immunoglobulin production. Specific antibody responses to vaccine antigens varied, with a predominant reduction observed during infancy. Clinical outcomes were favorable with IgG substitution. Two patients successfully discontinued substitution therapy without developing susceptibility to infections and while maintaining immunoglobulin levels. The pooled incidence of homozygous or compound heterozygous pathogenic IGLL1 variants identified by NBS in Austria, Czechia, and Switzerland was 1.3:100,000, almost double of X-linked agammaglobulinemia.

CONCLUSION:

B-cell deficiency resulting from IGLL1 variants appears to be more prevalent than initially believed. Despite markedly low B-cell counts, the clinical course in some patients may be milder than reported in the literature so far.

News (Medical) associated with Immunoglobulin G(Green Cross Corporation)

09 Sep 2024

·www.prnewswire.com

GC Biopharma Launches ALYGLO™ (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults, an Immune Globulin for the Treatment of Primary Humoral Immunodeficiency (PI) - Now Available in the US Marketplace

TEANECK, N.J., Sept. 9, 2024 /PRNewswire/ -- GC Biopharma USA, Inc. announced the launch and distribution of its immunoglobulin (IG) product ALYGLO (immune globulin intravenous, human-stwk), the company's first 10% intravenous immunoglobulin therapy for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI). ALYGLO is a treatment option for patients with PI. This rare and chronic disorder occurs when the body's ability to produce antibodies is impaired, affecting the immune system's ability to fight infections. ALYGLO, an immune globulin formulation, has met the primary endpoints for both safety and efficacy as established by the FDA recommended guidelines in our Phase 3 clinical trials. Its novel manufacturing process may help improve patient safety by using Cation Exchange Chromatography (CEX) to remove coagulation factor XIa (FXIa) to undetectable levels. ALYGLO was approved by the U.S. Food and Drug Administration (FDA) on Dec. 15, 2023. Dr. Eun Chul Huh, President and CEO of GC Biopharma, said, "The US launch of ALYGLO by GC Biopharma USA is a historic milestone for the company and patients with primary immunodeficiency disease. It executes GC Biopharma's mission to improve the health and lives of individuals who suffer from rare and chronic diseases globally. GC Biopharma's commitment to the US further reflects its investment in R&D and a pipeline of future products to the US marketplace that will benefit patients and healthcare professionals." ALYGLO® is available to patients and healthcare professionals through a limited distribution network of top national Specialty Pharmacy providers. These partnerships provide a national footprint, delivering high-quality patient care for the primary immune deficiency population. ALYGLO is also available through specialty distributors throughout the United States. "ALYGLO expands patients' treatment options and improves access within the US marketplace," stated Dr. Lisa Betts, Chief Operating Officer for GC Biopharma USA, Inc. "GC Biopharma is committed to providing life-saving therapies to people with rare diseases. We are excited to offer the primary immune deficiency population another immune globulin therapeutic option." Please see Important Safety Information for ALYGLO on the following pages and refer to the full Prescribing Information (PI) or visit Alyglo.com For any medical or scientific questions regarding ALYGLO, call the GC Biopharma USA medical department at 1-833-426-6426. About ALYGLO ALYGLO is a liquid solution containing 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma from US donors. The manufacturing process includes multiple steps to reduce the risk of virus transmission. These include fractionation, solvent/detergent treatment, and nanofiltration. ALYGLO also uses its novel Cation Exchange Chromatography (CEX) in the manufacturing process for removing FXIa to undetectable levels. About Primary Humoral Immunodeficiency (PI) refers to a group of disorders where the body's ability to produce antibodies is impaired, affecting the immune system's ability to fight infections. In PI, there's a deficiency or absence of B cells or plasma cells, which are key in producing antibodies, particularly immunoglobulin G. This leads to increased susceptibility to infection, especially bacterial infections affecting the respiratory and gastrointestinal tracts. The PI indication for ALYGLO includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. About GC Biopharma Corp. GC Biopharma Corp. (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers lifesaving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is a leading global plasma protein and vaccine product manufacturer dedicated to quality healthcare solutions for over half a century. About GC Biopharma USA, Inc. GC Biopharma USA, Inc., headquartered in Teaneck, NJ, established its sales, marketing, and business operations in 2018 to serve customers and patients throughout the US. Our foundation is built on the expertise of our parent company, GC Biopharma's, expertise—a leading biopharmaceutical company delivering plasma therapies and vaccines worldwide. With GC Biopharma USA, Inc., GC Biopharma further intends to extend its footprint, bringing its expertise and legacy to the United States. Forward-Looking Statements This press release may contain forward-looking statements that express the current beliefs and expectations of GC Biopharma USA management within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements and do not represent any guarantee by GC Biopharma USA or its management of future performance and involve known and unknown risks, uncertainties, and other factors. When used herein, words including "anticipate," "believe," "can," "continue," "could," "designed," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company's current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. GC Biopharma USA undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. INDICATION ALYGLO™ is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. IMPORTANT SAFETY INFORMATION Contraindications: ALYGLO is contraindicated in patients who have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Hypersensitivity: In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. Epinephrine should be available for immediate treatment of severe acute hypersensitivity reactions. Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur. Aseptic Meningitis Syndrome (AMS): Aseptic meningitis syndrome (AMS) may occur, especially with high doses or rapid infusion. AMS usually begins within several hours to 2 days following ALYGLO treatment. Discontinuation of treatment has resulted in remission of AMS within several days without sequelae. Hemolysis: Delayed hemolytic anemia due to enhanced red blood cell (RBC) sequestration and acute hemolysis consistent with intravascular hemolysis have been reported. Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV. Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors. Transfusion-Related Acute Lung Injury: Noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) may occur. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Patients with TRALI may be managed using oxygen therapy with adequate ventilator support. Monitor patients for pulmonary adverse reactions. Transmissible Infectious Agents: Because ALYGLO is made from human blood, it may carry a risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent). Interference with Laboratory Tests: After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for a misleading interpretation. Adverse reactions (observed in ≥ 5% of study subjects) were headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle pain/aches, infusion site pain/swelling, abdominal pain/discomfort, cough, and dizziness. It is recommended that ALYGLO be administered separately from other drugs or medications. ©2024 GC Biopharma USA, Inc. All rights reserved. ALYGLO is a trademark of Green Cross Corporation. SOURCE GC Biopharma USA Inc.

Clinical ResultDrug ApprovalImmunotherapyPhase 3Vaccine

18 Dec 2023

·www.prnewswire.com

GC Biopharma Announces US FDA Approval for ALYGLO™ (Immune Globulin Intravenous, Human-stwk) 10% Liquid for Adults with Primary Humoral Immunodeficiency (PI)

YOGIN, South Korea, Dec. 17, 2023 /PRNewswire/ -- GC Biopharma Corp (006280.KS) today announces that the US Food and Drug Administration (FDA) has approved ALYGLO (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as "GC5107," for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI). The ALYGLO pivotal phase 3 clinical study followed FDA guidance for the treatment of patients with PI. The clinical trial (NCT02783482) GC5107B was a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study to assess the efficacy and safety of GC5107B in patients with a confirmed diagnosis of PI. The studies were conducted in the United States and Canada. Key findings from the phase 3 clinical trial for patients aged 17 years and older include the following: A primary efficacy end point of 0.03 acute serious bacterial infections (aSBIs) per patient-year, which met the FDA efficacy requirement of less than one aSBI per patient-year. The proportion of infusions with temporally associated adverse events occurring during or within 72 hours after infusion was 0.22 (95% one-sided upper confidence bound: 30%), which met the FDA-required prespecified end point of less than 0.40. Secondary analyses were annual rate or days of other infections, antibiotic use, days out of work/school/day care or unable to perform normal activities due to infection, and days of hospitalization due to infection. The results of the phase 3 trial by GC Biopharma are published in Frontiers in Immunology (2021). Dr. Elena Perez, MD., Allergy Immunologist from Allergy Associates of the Palm Beaches, and lead study investigator, said, "Alyglo will significantly impact clinical practice in the U.S. due to its strong safety and efficacy profile. It is an important treatment option for primary immune-deficient patients. This product provides additional confidence in treatment options for this important patient population." In addition, ALYGLO uses its novel Cation Exchange Chromatography (CEX) in the manufacturing process for removing coagulation factor XIa (FXIa) to undetectable levels. The presence of residual activated FXIa in some commercial IGIV products has been identified as the root cause of a small number of thromboembolic events in patients receiving immunoglobulin infusions. A recent study published in Frontiers in Cardiovascular Medicine details the extensive testing of ALYGLO and its results of the GC Biopharma manufacturing process. GC Biopharma is committed to evaluating how this new manufacturing process serves to further improve product safety. Dr. Eun-chul Huh, President and CEO of GC Biopharma, said, "The approval of ALYGLO by the US FDA is a significant milestone for GC Biopharma and patients with primary immunodeficiency disease. It reinforces GC Biopharma's commitment to patients and health care professionals by expanding our product portfolio globally to serve individuals with rare diseases. We are pleased to offer patients another important treatment option in the coming months that is both safe and effective." For any medical or scientific questions regarding ALYGLO, call the GC Biopharma USA medical department at 1-833-426-6426, or email [email protected]. About ALYGLO ALYGLO is a liquid solution containing 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma from US donors. The manufacturing process includes three steps to reduce the risk of virus transmission. These include fractionation, solvent/detergent treatment, and nanofiltration. ALYGLO also uses its novel Cation Exchange Chromatography (CEX) in the manufacturing process for removing FXIa to undetectable levels. About PI Primary Humoral Immunodeficiency (PI) refers to a group of disorders where the body's ability to produce antibodies is impaired, affecting the immune system's ability to fight infections. In PI, there's a deficiency or absence of B cells or plasma cells, which are key in producing antibodies, particularly immunoglobulin G. This leads to increased susceptibility to infection, especially bacterial infections affecting the respiratory and gastrointestinal tracts. People with PI might experience frequent infections, some of which can be severe or chronic. Treatment often involves immunoglobulin replacement therapy to boost the immune system. Vaccinations and antibiotics may also be used to prevent and treat infections. The exact type and severity of PI can vary widely among individuals. The PI indication for ALYGLO includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. About GC Biopharma Corp. GC Biopharma Corp. (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers lifesaving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is a leading global plasma protein and vaccine product manufacturer and has been dedicated to quality health care solutions for over half a century. About GC Biopharma USA, Inc. GC Biopharma USA, Inc., headquartered in Teaneck, NJ, established its sales, marketing, and business operations in 2018 to serve customers and patients throughout the US. Our foundation is built on the expertise of our parent company, GC Biopharma's, expertise—a leading biopharmaceutical company delivering plasma therapies and vaccines worldwide. With GC Biopharma USA, Inc., GC Biopharma further extends its footprint, bringing its expertise and legacy to the United States. This press release may contain forward-looking statements that express the current beliefs and expectations of GC Biopharma Corp. management. Such statements do not represent any guarantee by GC Biopharma Corp. or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma Corp. undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. INDICATION ALYGLO™ is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. IMPORTANT SAFETY INFORMATION WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE Thrombosis may occur with immune globulin intravenous (IGIV) products, including ALYGLO. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ALYGLO does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer ALYGLO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Contraindications: ALYGLO is contraindicated in patients who have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Hypersensitivity: In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. Epinephrine should be available for immediate treatment of severe acute hypersensitivity reactions. Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur. Aseptic Meningitis Syndrome (AMS): Aseptic meningitis syndrome (AMS) may occur, especially with high doses or rapid infusion. AMS usually begins within several hours to 2 days following ALYGLO treatment. Discontinuation of treatment has resulted in remission of AMS within several days without sequelae. Hemolysis: Delayed hemolytic anemia due to enhanced red blood cell (RBC) sequestration and acute hemolysis consistent with intravascular hemolysis have been reported. Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV. Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors. Transfusion-Related Acute Lung Injury: Noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) may occur. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Patients with TRALI may be managed using oxygen therapy with adequate ventilator support. Monitor patients for pulmonary adverse reactions. Transmissible Infectious Agents: Because ALYGLO is made from human blood, it may carry a risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent). Interference with Laboratory Tests: After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for a misleading interpretation. Adverse reactions (observed in ≥ 5% of study subjects) were headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle pain/aches, infusion site pain/swelling, abdominal pain/discomfort, cough, and dizziness. It is recommended that ALYGLO be administered separately from other drugs or medications. For more information about ALYGLO, please see full Prescribing Information. GC Biopharma Contact Seunghyun Baek [email protected] Sohee Kim [email protected] Yelin Jun [email protected] GC Biopharma USA Contact (Media) Robin Zvonek [email protected] (312) 636-5744 ©2023 GC Biopharma USA, Inc. All rights reserved. ALYGLO is a trademark of Green Cross Corporation. SOURCE GC Biopharma

Clinical ResultPhase 3Drug ApprovalImmunotherapyVaccine

100 Deals associated with Immunoglobulin G(Green Cross Corporation)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hashimoto's Encephalitis	Phase 2	United States	Green Cross Co., Ltd.	20 Nov 2019

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2022	Not Applicable	Complication	-	Immunoglobulin G IV therapy	oazcwibuwa(vsylebwrcp) = ovvwmpkqak lvulqvbovc (imusaydvcp ) View more	-	05 Nov 2022
				No Immunoglobulin G IV therapy	tgwzjjvaih(lljxlzujfv) = bhuwqhwjfx husajsigxo (jgnrbzghsv )
IEC2019	Not Applicable	NMDAR subunits \| IgG	158	Immunoglobulin G (Teratoma with NMDAR subunits and IgG)	bmgicehhep(tqtlpzbkxv) = brfksphbai irzwxrtmib (czlbjlifij ) View more	Positive	25 Jun 2019
				Immunoglobulin G (Patients without teratoma)	bmgicehhep(tqtlpzbkxv) = fnhlhpubep irzwxrtmib (czlbjlifij ) View more
EULAR2007	Not Applicable	Arthritis	-	IMMUNOGLOBULIN G (GPI immunized DBA/1 mice derived splenocytes and GPI)	sberjjjwuu(eatigrrmog) = ryedskjnqz euhnxjbsee (dwmgvjnpbo )	-	13 Jun 2007
				IgG from GPI immunized DBA/1 mice and CD19 + cell depleted splenocytes	sberjjjwuu(eatigrrmog) = hhpizijkir euhnxjbsee (dwmgvjnpbo )

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