The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.

Start Date03 Dec 2021

Sponsor / Collaborator

University of Cincinnati (Ohio)

[+2]

NCT04444856 / CompletedNot Applicable

Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Retrospective Single-centre Cohort Study at the University Hospital of Bern

This non-interventional study will compare the clinical outcomes in women with an event of severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an event of severe postpartum haemorrhage not treated with NovoSeven®. The study will be a single centre retrospective cohort study of women with an event of severe postpartum haemorrhage, defined as 1.5 L of blood loss within 24 hours of delivery, in the period of 2005-2016.

Start Date29 Jun 2020

Sponsor / Collaborator

Novo Nordisk A/S

NCT04723979 / CompletedNot ApplicableIIT

Clinical Use and Outcome of NovoSeven® Treatment in Severe Postpartum Haemorrhage - Experiences From an Observational Multi-country (UK, DK, FR, NL) Retrospective Cohort Study

The overall aim of this project is to include currently available information from women with severe postpartum haemorrhage (sPPH) who were treated with NovoSeven® and to examine whether NovoSeven® may have affected the course of the PPH in these women, specifically the control of bleeding. Data will be included from previous cohort studies from four countries: United Kingdom (UK), the Netherlands, Denmark, and France.

Start Date01 May 2020

Sponsor / Collaborator

Academisch Ziekenhuis Leiden

[+4]

100 Clinical Results associated with Eptacog alfa(Novo Nordisk A/S)

100 Translational Medicine associated with Eptacog alfa(Novo Nordisk A/S)

100 Patents (Medical) associated with Eptacog alfa(Novo Nordisk A/S)

1,357

Literatures (Medical) associated with Eptacog alfa(Novo Nordisk A/S)

01 Nov 2024·INTERNATIONAL JOURNAL OF HEMATOLOGY

Changes in coagulation potential over time after administration of recombinant activated factor VII in an emicizumab-treated hemophilia A patient with inhibitors

Article

Author: Ogiwara, Kenichi ; Osuna, Mitsumasa ; Nogami, Keiji ; Nakajima, Yuto

We describe a 67-year-old patient with hemophilia A and inhibitors (PwHA-I) receiving emicizumab prophylaxis who underwent surgical treatment for pseudoaneurysm. He was treated with a bolus infusion of recombinant factor VIIa (rFVIIa; 79 μg/kg) immediately before surgery, and a second dose of rFVIIa after an initial treatment on day 1. A third rFVIIa bolus was infused 17 h after the second dose on day 2, and the treatment was continued every 24 h on day 3 and day 4. Treatment with rFVIIa was discontinued on day 4. No perioperative bleeding or thrombotic events were observed. Coagulation potentials at 8 h after rFVIIa administration determined by clot waveform analysis (CWA) and thrombin generation assay (TGA) were within near-normal ranges, and results at 17 h after rFVIIa administration showed coagulation function comparable to that in the patient without rFVIIa. Our experimental data suggest that the coagulation potential in FVIII-deficient plasma spiked with both 0.28 µg/mL (11.2 μg/kg) rFVIIa and emicizumab was equivalent to or greater than that spiked with 2.2 µg/mL (90 μg/kg) rFVIIa alone. Thus, administration of rFVIIa every 8 h may be feasible for managing perioperative treatment in emicizumab-treated PwHA-I.

23 Sep 2024·GeroScience

Acquired hemophilia A as a disease of the elderly: A comprehensive review of epidemiology, pathogenesis, and novel therapy.

Review

Author: Bodó, Imre ; Fekete, Mónika ; Mikala, Gábor ; Lehoczki, Andrea

Acquired hemophilia A (AHA) is a rare autoimmune bleeding disorder characterized by the development of neutralizing autoantibodies (inhibitors) against coagulation factor VIII (FVIII). This review provides an in-depth exploration of AHA, covering its epidemiology, pathogenesis, clinical presentation, diagnosis, complications, and treatment strategies, focusing on recent advancements. AHA can manifest in both men and women with no prior bleeding history. The annual incidence is estimated to be approximately 1 case per million individuals in the general population. The incidence increases significantly with age: the incidence among individuals aged 60 years or older is approximately 3 to 4 cases per million individuals per year. Typically, patients present with an acquired bleeding disorder that is characterized by an isolated, prolonged activated partial thromboplastin time stemming from FVIII deficiency. Diagnosis relies on the detection of neutralizing antibodies using the Nijmegen-modified Bethesda assay. Hemostatic control strategies involve bypassing agents like recombinant activated factor VII, activated prothrombin complex concentrate, and recombinant porcine FVIII for bleeding patients. Emicizumab, a novel bypassing agent, exhibits several potential advantages. In the realm of immunosuppressive treatment for inhibitor eradication, the CyDRi regimen emerged as a remarkable advancement, significantly enhancing the outlook for the management of AHA even in the elderly frail population.

02 Aug 2024·MEDICINE

Severe acquired hemophilia A associated with COVID-19 vaccination: A case report and literature review

Review

Author: Han, Jae Joon ; Lee, Jun Ho ; Jung, Ye Ji ; Lee, Hyun Jung ; Maeng, Chi Hoon ; Kim, Hong Jun ; Baek, Sun Kyung

Rationale::

Acquired hemophilia A (AHA) is a rare autoimmune disease caused by an antibody that inhibits coagulation factor VIII activity. More than half of patients with AHA cannot identify underlying disorders. The remaining patients are associated with malignancies, autoimmune diseases, skin diseases, infections, and medications. Here, we present a case of 56-year-old Korean man with underlying hypertension, dyslipidemia, and diabetes mellitus who developed AHA following the second dose of BNT162b2 COVID-19 vaccination.

Patient concerns::

He presented with a large 20 × 30 cm-sized hematoma along the psoas muscle and intracranial hemorrhage, necessitating intensive care with mechanical ventilation and continuous renal replacement therapy. Laboratory testing demonstrated that activated partial thromboplastin time and prothrombin times were 74.7 seconds (normal range 29–43 seconds) and 17.2 seconds (normal range 12.5–14.7 seconds), respectively.

Diagnoses::

Laboratory tests confirmed AHA with undetectable factor VIII activity (<1.5%) and a positive factor VIII antibody with a titer of 8.49 Bethesda units/mL.

Interventions::

Recombinant factor VIIa (NovoSeven®) was administered every 2 hours to control the bleeding, alongside immunosuppression with methylprednisolone 1 mg/kg daily and cyclophosphamide 2 mg/kg daily to eliminate the autoantibody.

Outcomes::

Despite the treatments, the patient developed sepsis and succumbed 14 weeks after admission.

Lessons::

This rare case underscores the importance of monitoring for AHA following COVID-19 vaccination. Although the benefits outweigh the risks of vaccination, AHA should be considered in the differential diagnosis of unusual bleeding following the vaccinations. Early diagnosis and management before severe bleeding are critical for successfully controlling life-threatening bleeding.

News (Medical) associated with Eptacog alfa(Novo Nordisk A/S)

06 Oct 2024

·pipelinereview.com

TiumBio Announces First Patient Dosed in Phase 2 Clinical Trial of Oral Immuno-Oncology Drug TU2218

BOSTON, MA, USA and SEONGNAM, South Korea I October 4, 2024 I TiumBio Co., Ltd. (Kosdaq: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, announced today that the first patient has been dosed in its Phase 2 clinical trial of TU2218. TU2218 is a novel oral dual inhibitor targeting TGFR1 and VEGFR2. TGF-ß and VEGF pathways are known to suppress the activity of immune checkpoint inhibitors (ICIs), so TU2218 is expected to improve the efficacy of ICIs by blocking the two pathways. In Phase 1a and 1b clinical trials, TiumBio evaluated the safety, pharmacokinetics, and pharmacodynamics of TU2218 as a monotherapy and in combination with Keytruda (pembrolizumab) in 41 patients with advanced solid tumors. These profiles were used to determine the dose levels for Phase 2 trials. The Phase 2a trial is designed to assess the safety and efficacy of TU2218 in combination with Keytruda in patients with head and neck squamous cell carcinoma (HNSCC), biliary tract cancer (BTC), and colorectal cancer (CRC). The Phase 2 trial begins at Seoul National University Hospital and Asan Medical Center in South Korea, which is planned to expand to hospitals in the United States. The first dose was administered to an HNSCC patient. HNSCC refers to malignant tumors that occur in the oral cavity, throat, larynx, or salivary glands. The standard treatment typically involves surgery and radiation therapy. According to Global Data, as of 2023, the number of HNSCC patients worldwide is estimated to be around 610,000, and it is expected to exceed 670,000 by 2030. “HNSCC is a disease with a high unmet medical need, as the average survival rate for first-line treatments is known to be only about one year,” said Hun-taek Kim, Ph.D., MBA, CEO of TiumBio. “We have selected cancer types for the Phase 2 clinical trial based on other trials that demonstrated strong anti-cancer effects from targeting TGF- ß or VEGF pathways. Our goal is to develop TU2218 as a first-line treatment for HNSCC,” he added. In the Phase 1b trial, among 10 patients with advanced solid tumors who received a 195mg daily dose (the determined dose for Phase 2) of TU2218 with Keytruda, three patients achieved partial response (PR) and five patients had stable disease (SD), yielding an 80% disease control rate (DCR). About TiumBio Co., Ltd. TiumBio (Kosdaq: 321550) is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapeutics for patients with rare and incurable diseases. Its mission is to expand the hope and happiness of mankind through our science. TiumBio boasts three leading pipeline assets: merigolix (code name: TU2670), TU2218, and TU7710, all in various stages of clinical development. Merigolix is a once-daily, oral GnRH receptor antagonist being developed for the treatment of endometriosis and uterine fibroids and is undergoing in global Phase 2 clinical trials. TU2218 is a first-in-class oral immune-oncology therapy targeting TGF-β and VEGF pathways to promote response rates in cancer patients when used in combination with immune checkpoint inhibitors. TU7710 is a novel rFVIIa designed to extend its half-life in order to provide more clinical benefits to hemophilia patients with inhibitors. With its expertise in drug development, TiumBio is committed to the discovery and development of innovative treatments to ease the burden of debilitating diseases. For further information, visit our website at www.tiumbio.com/en and connect with us on LinkedIn . Contacts: Junseok Jang, Head of Corporate Communications & Investor Relations junseokjang@tiumbio.com Suna Cho, Manager, Corporate Communications & Investor Relations sunacho@tiumbio.com Da-ye Song, Manager, Corporate Communications & Investor Relations dayesong@tiumbio.com SOURCE: TiumBio

Phase 2ImmunotherapyPhase 1Clinical Result

04 Oct 2024

·www.prnewswire.com

TiumBio Announces First Patient Dosed in Phase 2 Clinical Trial of Oral Immuno-Oncology Drug TU2218

TU2218 is a potentially first-in-class dual inhibitor targeting transforming growth factor beta receptor 1 (TGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) The first patient with head and neck squamous cell carcinoma was dosed in the Phase 2a clinical trial of TU2218 The Phase 2a trial of TU2218 starts with head and neck squamous cell carcinoma, as well as biliary tract cancer patients. It will be later expanded to colorectal cancer patients BOSTON and SEONGNAM, South Korea, Oct. 4, 2024 /PRNewswire/ -- TiumBio Co., Ltd. (Kosdaq: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, announced today that the first patient has been dosed in its Phase 2 clinical trial of TU2218. TU2218 is a novel oral dual inhibitor targeting TGFR1 and VEGFR2. TGF-ß and VEGF pathways are known to suppress the activity of immune checkpoint inhibitors (ICIs), so TU2218 is expected to improve the efficacy of ICIs by blocking the two pathways. In Phase 1a and 1b clinical trials, TiumBio evaluated the safety, pharmacokinetics, and pharmacodynamics of TU2218 as a monotherapy and in combination with Keytruda (pembrolizumab) in 41 patients with advanced solid tumors. These profiles were used to determine the dose levels for Phase 2 trials. The Phase 2a trial is designed to assess the safety and efficacy of TU2218 in combination with Keytruda in patients with head and neck squamous cell carcinoma (HNSCC), biliary tract cancer (BTC), and colorectal cancer (CRC). The Phase 2 trial begins at Seoul National University Hospital and Asan Medical Center in South Korea, which is planned to expand to hospitals in the United States. The first dose was administered to an HNSCC patient. HNSCC refers to malignant tumors that occur in the oral cavity, throat, larynx, or salivary glands. The standard treatment typically involves surgery and radiation therapy. According to Global Data, as of 2023, the number of HNSCC patients worldwide is estimated to be around 610,000, and it is expected to exceed 670,000 by 2030. "HNSCC is a disease with a high unmet medical need, as the average survival rate for first-line treatments is known to be only about one year," said Hun-taek Kim, Ph.D., MBA, CEO of TiumBio. "We have selected cancer types for the Phase 2 clinical trial based on other trials that demonstrated strong anti-cancer effects from targeting TGF- ß or VEGF pathways. Our goal is to develop TU2218 as a first-line treatment for HNSCC," he added. In the Phase 1b trial, among 10 patients with advanced solid tumors who received a 195mg daily dose (the determined dose for Phase 2) of TU2218 with Keytruda, three patients achieved partial response (PR) and five patients had stable disease (SD), yielding an 80% disease control rate (DCR). About TiumBio Co., Ltd. TiumBio (Kosdaq: 321550) is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapeutics for patients with rare and incurable diseases. Its mission is to expand the hope and happiness of mankind through our science. TiumBio boasts three leading pipeline assets: merigolix (code name: TU2670), TU2218, and TU7710, all in various stages of clinical development. Merigolix is a once-daily, oral GnRH receptor antagonist being developed for the treatment of endometriosis and uterine fibroids and is undergoing in global Phase 2 clinical trials. TU2218 is a first-in-class oral immune-oncology therapy targeting TGF-β and VEGF pathways to promote response rates in cancer patients when used in combination with immune checkpoint inhibitors. TU7710 is a novel rFVIIa designed to extend its half-life in order to provide more clinical benefits to hemophilia patients with inhibitors. With its expertise in drug development, TiumBio is committed to the discovery and development of innovative treatments to ease the burden of debilitating diseases. For further information, visit our website at and connect with us on LinkedIn. Contacts: Junseok Jang, Head of Corporate Communications & Investor Relations [email protected] Suna Cho, Manager, Corporate Communications & Investor Relations [email protected] Da-ye Song, Manager, Corporate Communications & Investor Relations [email protected] SOURCE TiumBio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultImmunotherapyPhase 1Radiation Therapy

01 Jun 2024

·www.prnewswire.com

TiumBio Presents Phase 1b Interim Results for TU2218 in Combination with Pembrolizumab at ASCO 2024 Annual Meeting

Poster presentation features the interim data from an ongoing Phase 1b clinical trial of TU2218 plus Keytruda combination therapy in patients with advanced solid tumors A 40% overall response rate (ORR) and 100% disease control rate (DCR) were achieved in high-dose cohort (195 mg/day) TU2218 was well-tolerated as a monotherapy and combination therapy with pembrolizumab, with no dose limiting toxicities (DLTs) to date BOSTON and SEONGNAM, South Korea, June 1, 2024 /PRNewswire/ -- TiumBio Co., Ltd. (Kosdaq: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, announced interim results from the Phase 1b clinical trial of TU2218 in combination with pembrolizumab at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. TU2218 is a novel oral dual inhibitor targeting transforming growth factor beta receptor 1 (TGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2). TGF-ß and VEGF pathways in tumor microenvironment interfere with the anti-tumor activity of immune checkpoint inhibitors, so TU2218 is expected to maximize the efficacy of immuno-therapies by inhibiting them. TiumBio's ongoing Phase 1b clinical trial (NCT05784688) in the United States evaluates safety, pharmacokinetics, and preliminary efficacy of TU2218 in combination with Keytruda (pembrolizumab) in patients with advanced solid tumors. The study consists of three dosage groups (105 mg, 150 mg, and 195 mg/day), and the presentation at the ASCO Annual Meeting included results from 12 patients across the three cohorts. Data from the full Phase 1b trial, which includes 18 patients, will be available in the second half of 2024. In the poster released at the 2024 ASCO Annual Meeting, five patients treated at the recommended phase 2 dose (RP2D) of 195mg/day TU2218 in combination with pembrolizumab demonstrated an ORR of 40% at PR (n=2) and 60% at SD (n=3) with a DCR of 100%. And across all dosage groups, patients (n=12) receiving the combination therapy showed PR at 16.7% (n=2), SD at 50.0% (n=6) and PD at 25.0% (n=3). In this study, TU2218 was well-tolerated as a combination therapy with pembrolizumab, showing no signs of DLTs, which is consistent with a previous monotherapy trial. "We are encouraged by the preliminary efficacy results with a favorable safety profile in patients with advanced tumors and are looking forward to top-line data from the study, which is expected in the second half of this year," said Hun-Taek Kim, Ph.D., MBA, CEO at TiumBio. "We plan to initiate a Phase 2a clinical trial in head and neck cancer, biliary tract cancer, and colorectal cancer to develop an innovative novel drug for patients with limited treatment options," he added. About TiumBio Co., Ltd. TiumBio (Kosdaq: 321550) is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapeutics for patients with rare and incurable diseases. Its mission is to expand the hope and happiness of mankind through our science. TiumBio boasts three leading pipeline assets: merigolix (code name: TU2670), TU2218, and TU7710, all in various stages of clinical development. Merigolix is a once-daily, oral GnRH receptor antagonist being developed for the treatment of endometriosis and uterine fibroids and is undergoing in global Phase 2 clinical trials. TU2218 is a first-in-class oral immune-oncology therapy targeting TGF-β and VEGF pathways to promote response rates in cancer patients when used in combination with immune checkpoint inhibitors. TU7710 is a novel rFVIIa designed to extend its half-life in order to provide more clinical benefits to hemophilia patients with inhibitors. With its expertise in drug development, TiumBio is committed to the discovery and development of innovative treatments to ease the burden of debilitating diseases. For further information, visit our website at and connect with us on LinkedIn. Contacts: Junseok Jang, Head of Corporate Communications & Investor Relations [email protected] Suna Cho, Manager, Corporate Communications & Investor Relations [email protected] Da-ye Song, Manager, Corporate Communications & Investor Relations [email protected] SOURCE TiumBio

Clinical ResultPhase 1ImmunotherapyASCOPhase 2

100 Deals associated with Eptacog alfa(Novo Nordisk A/S)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Eptacog alfa(Novo Nordisk A/S)	B02BD08	DB00036

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemorrhage	AU	Novo Nordisk Pharmaceuticals Pty Ltd.	01 May 2013
Glanzmann Thrombasthenia, Autosomal Dominant	KR	Novo Nordisk Pharma Korea Ltd.	31 May 2010
Factor VII Deficiency	JP	Novo Nordisk Pharma Ltd.	10 Mar 2000
Hemophilia A	JP	Novo Nordisk Pharma Ltd.	10 Mar 2000
Hemophilia B	JP	Novo Nordisk Pharma Ltd.	10 Mar 2000
Acquired hemophilia	US	Novo Nordisk, Inc.	25 Mar 1999
Hemophilia	EU	Novo Nordisk A/S	23 Feb 1996
Hemophilia	IS	Novo Nordisk A/S	23 Feb 1996
Hemophilia	LI	Novo Nordisk A/S	23 Feb 1996
Hemophilia	NO	Novo Nordisk A/S	23 Feb 1996
Thrombasthenia	EU	Novo Nordisk A/S	23 Feb 1996
Thrombasthenia	IS	Novo Nordisk A/S	23 Feb 1996
Thrombasthenia	LI	Novo Nordisk A/S	23 Feb 1996
Thrombasthenia	NO	Novo Nordisk A/S	23 Feb 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Postpartum Hemorrhage	NDA/BLA	EU	Novo Nordisk A/S	23 Apr 2022
Hemorrhagic stroke	Phase 3	US	Novo Nordisk A/S	03 Dec 2021
Hemorrhagic stroke	Phase 3	JP	Novo Nordisk A/S	03 Dec 2021
Hemorrhagic stroke	Phase 3	CA	Novo Nordisk A/S	03 Dec 2021
Hemorrhagic stroke	Phase 3	DE	Novo Nordisk A/S	03 Dec 2021
Hemorrhagic stroke	Phase 3	ES	Novo Nordisk A/S	03 Dec 2021
Hemorrhagic stroke	Phase 3	GB	Novo Nordisk A/S	03 Dec 2021
Wounds and Injuries	Phase 3	US	Novo Nordisk A/S	01 Oct 2005
Wounds and Injuries	Phase 3	BR	Novo Nordisk A/S	01 Oct 2005
Wounds and Injuries	Phase 3	CZ	Novo Nordisk A/S	01 Oct 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISTH2020	Not Applicable	Thrombasthenia	-	Novoseven	yhcwtsmxjz(xvqzfwrsyd) = wimtweclca dauebyfnjv (bnusvmgpit ) View more	-	12 Jul 2020
EHA2015	Not Applicable	-	-	Recombinant Activated Factor VII (NovoSeven)	tqbsdyioue(sqazdtwljg) = zacwlqjqln mtqbrsaozs (duyckpyqqo )	-	21 May 2015
ASCO2012	Not Applicable	Neoplasms \| Hemophilia A	-	Recombinant human activated FVII	cehoxwfphs(hoewftuyoo) = ukylgxbizw atldiqrxbg (drsvqmninb )	-	20 May 2012

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