Delving into the Latest Updates on Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited) with Synapse

Overview

Basic Info

Drug Type

Recombinant coagulation factor

Synonyms

Factor I/factor IIa, Factor IIa/factor I, Fibrinogen/thrombin dry powder - Mallinckrodt

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Target-

Action-

Mechanism-

Therapeutic Areas

Hemic and Lymphatic DiseasesOther Diseases

Active Indication-

Inactive Indication

Blood Coagulation DisordersHemorrhagePostoperative Hemorrhage

Originator Organization

Mallinckrodt Pharmaceuticals Ireland Ltd.

Active Organization-

Inactive Organization

Mallinckrodt PlcMallinckrodt Pharmaceuticals Ireland Ltd.Mallinckrodt LLC

+ [1]

Drug Highest PhaseWithdrawn

First Approval Date

European Union (19 Mar 2015),

Blood Coagulation Disorders

Regulation-

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The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis.
The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.

Start Date21 May 2012

Sponsor / Collaborator

Mallinckrodt Plc

100 Clinical Results associated with Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

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100 Translational Medicine associated with Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

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100 Patents (Medical) associated with Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

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6

Literatures (Medical) associated with Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

01 Jan 2019·Oral Surgery, Oral Medicine, Oral Pathology and Oral RadiologyQ4 · MEDICINE

Functional outcomes after glossectomies: Pilot study on use of a thrombin-fibrinogen biosponge (TachoSil)

Q4 · MEDICINE

Article

Author: Sieira-Gil, Ramón ; Pozuelo-Arquimbau, Laura ; Arranz-Obispo, Carlos D ; Cuesta-González, Francisco J ; Marí-Roig, Antoni

OBJECTIVEThe aim of this study was to investigate whether the use of a thrombin-fibrinogen biosponge (TachoSil) has any advantage in tongue healing.STUDY DESIGNA retrospective study with 30 patients treated with partial glossectomy (below half a tongue) was designed. We compared the results from a group using the biosponge (n =15 patients) and a control group (n = 15). Variables taken into consideration were bolus clearance, frenulum flexibility, and oral transit time. With these parameters, we formulated a "tongue remaining functional" (TRF) scale to assess tongue functionality after the surgery. We also evaluated long-term quality of life by using the Functional Intraoral Glasgow Scale (FIGS).RESULTSIn this study, TRF score, bolus clearance, oral transit time, and frenulum flexibility were significantly improved in the biosponge group. However, there were no differences between the 2 groups in the FIGS scores.CONCLUSIONSThe use of the biosponge in this pilot study showed positive long-term effects in lingual healing and functionality after partial glossectomies.

01 Nov 2015·Journal of Vascular SurgeryQ2 · MEDICINE

Randomized trial of a dry-powder, fibrin sealant in vascular procedures

Q2 · MEDICINE

Article

Author: Moneta, Gregory L ; Gupta, NavYash ; Hayes, Paul ; Pribble, John P ; Zuckerman, Linda A ; Chetter, Ian ; O-Yurvati, Albert H ; Shenoy, Surendra

OBJECTIVETopical hemostats are important adjuncts for stopping surgical bleeding. The safety and efficacy of Fibrocaps, a dry-powder, fibrin sealant containing human plasma-derived thrombin and fibrinogen, was evaluated in patients undergoing vascular surgical procedures.METHODSIn this single-blind trial (clinicaltrials.gov: NCT01527357), adult patients were randomized 2:1 to Fibrocaps plus gelatin sponge (Fibrocaps) vs gelatin sponge alone. Results are presented for the patient subset undergoing vascular procedures with suture hole bleeding. The primary efficacy endpoint compared time to hemostasis (TTH) over 5 minutes. Safety follow-up continued to day 29.RESULTSA total of 175 patients were randomized and treated (Fibrocaps, 117; gelatin sponge, 58). Patients were predominately male (69%) and underwent arterial bypass (81%), arteriovenous graft formation (9%), or carotid endarterectomy (9%). Fibrocaps significantly reduced TTH compared with gelatin sponge (hazard ratio [HR], 2.1; 95% confidence interval [CI], 1.5-3.1; median TTH, 2 minutes; 95% CI, 1.5-2.5 vs 4 minutes; 95% CI, 3.0-5.0; P < .002). Significant reductions were also observed in patients receiving concomitant antiplatelet agents alone (HR, 2.8; 95% CI, 1.0-7.4; P = .03; n = 33), anticoagulants alone (HR, 2.0; 95% CI, 1.0-4.0; P = .04; n = 43), or both antiplatelet agents and anticoagulants (Fibrocaps vs gelatin sponge, HR, 2.3; 95% CI, 1.2-4.3; P = .008; n = 65). Incidences of common adverse events (procedural pain, nausea, constipation) were generally comparable between treatment arms. Anti-thrombin antibodies developed in 2% of Fibrocaps-treated patients and no-gelatin-sponge patients.CONCLUSIONSFibrocaps, a ready-to-use, dry-powder fibrin sealant, was well-tolerated and reduced TTH in patients undergoing vascular procedures, including those receiving antiplatelet agents and/or anticoagulants, demonstrating its safety and usefulness as an adjunct to hemostasis.

01 Aug 2015·Clinical Drug Investigation

Raplixa™: A Review in Improving Surgical Haemostasis

Review

Author: McKeage, Kate

Raplixa™ is a novel fibrin sealant containing a blend of human fibrinogen and thrombin in powder form. It is approved in adults to help control bleeding when standard surgical techniques have been insufficient. This article summarizes the product characteristics of Raplixa and provides a narrative review of its clinical use and tolerability. Unlike other available fibrin sealants, including liquid agents and lyophilized powders, the dry-powder, ready-to-use formulation of Raplixa provides potential advantages, including ease of storage and use. In the randomized, phase III FINISH-3 study, Raplixa plus gelatin sponge was superior to gelatin sponge alone in reducing the time to haemostasis in adults who developed mild or moderate bleeding uncontrolled by conventional surgical techniques while undergoing spinal, vascular, hepatic or soft-tissue surgical procedures. Raplixa was well tolerated, with a similar safety profile to that observed in the gelatin-sponge-alone group. Thus, Raplixa provides an easy to store and use option for improving haemostasis in adults when standard surgical techniques are ineffective or impractical.

1

News (Medical) associated with Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

02 Nov 2023

·www.biospace.com

Endeavor BioMedicines Appoints Paul Frohna, M.D., Ph.D., as Chief Medical Officer

SAN DIEGO--(BUSINESS WIRE)-- Endeavor BioMedicines, a clinical-stage company developing therapies for of fibrotic disease and oncology, today announced the appointment of Paul Frohna, M.D., Ph.D., as its Chief Medical Officer. Dr. Frohna is a physician-scientist with over 20 years of experience in the biotech industry in the fields of translational medicine, clinical trial design, and clinical and regulatory strategy. “We’re pleased to welcome Paul as our Chief Medical Officer, and we look forward to his leadership as we progress our pipeline of therapies for patients with fibrosis and cancer,” said John Hood, Ph.D., Co-Founder, CEO and Chairman, Endeavor BioMedicines. “Paul’s deep experience as a physician-scientist and impressive track record in clinical development and translational medicine will be valuable additions to Endeavor as we advance our programs, including our Phase 2 trial of ENV-101 in idiopathic pulmonary fibrosis (IPF) and the first-in-human trial for our HER3-targeted ADC in oncology.” Dr. Frohna joins Endeavor from ImCheck Therapeutics in Marseille, France, where he served as Chief Medical Officer and Head of Research and Development responsible for overseeing programs in oncology and infectious disease. Prior to ImCheck, he was Chief Medical Officer at Bioniz Therapeutics, where he led clinical and regulatory affairs functions and was responsible for operational oversight of the company's clinical programs in T-cell leukemia and lymphoma as well as autoimmune diseases. Prior to this role, he held senior roles at Receptos Inc., ProFibrix, Inc. and Fibrogen. Dr. Frohna began his biotech career at Genentech where he patented and initially tested the therapeutic approach of B-cell depleting therapy for relapsing and progressive multiple sclerosis. “It is a privilege to join Endeavor as the company enters its next stage of growth," said Dr. Frohna. “I look forward to contributing my clinical development experiences in fibrosis and oncology to demonstrate the therapeutic promise of our pipeline of medicines in order to help patients who deserve better treatments for their deadly diseases.” Over the course of his career, Dr. Frohna has built and led departments and teams responsible for candidate selection, IND/CTA filings, Phase I to III clinical trials and global development partnerships. He has successfully designed and initiated translational and clinical programs for biologics, small molecules and stem cells across multiple therapeutic areas. He played critical roles in multiple development programs including Receptos' ozanimod (Zeposia® marketed by BMS), Profibrix’s Raplixa™ and Genentech's Rituxan®, Tarceva® and Raptiva® programs. Dr. Frohna received his pharmacy degree from the University of Texas at Austin College of Pharmacy, his Ph.D. in Pharmacology from the University of Pennsylvania School of Medicine, and his M.D. from Georgetown University School of Medicine. About Endeavor BioMedicines Endeavor BioMedicines, Inc., is a clinical stage company developing novel therapies for fibrosis and oncology. We combine best-in-class therapeutics with an evolved understanding of terminal diseases to develop medicines with the potential to reverse severe health conditions. Our lead program, ENV-101, is a Hedgehog signalling inhibitor currently in Phase 2 studies treating IPF. The second program is a HER3-targeted ADC that will begin clinical development in 2024 for the treatment of multiple solid tumors. At Endeavor, we are an innovative and focused team that has come together to develop therapeutics that help patients feel better and live longer. Please visit us on our website at and on our LinkedIn and X (formerly Twitter) pages. View source version on businesswire.com: Contacts Will Zasadny Evoke Canale Will.zasadny@evokegroup.com Source: Endeavor BioMedicines View this news release online at:

Phase 2Executive ChangePhase 1

100 Deals associated with Human Fibrinogen / Human Thrombin(Mallinckrodt Pharmaceuticals Ireland Limited)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Postoperative Hemorrhage	Phase 1	United States	Mallinckrodt Plc	21 May 2012
Postoperative Hemorrhage	Phase 1	Netherlands	Mallinckrodt Plc	21 May 2012
Postoperative Hemorrhage	Phase 1	United Kingdom	Mallinckrodt Plc	21 May 2012
Postoperative Hemorrhage	Phase 1	Belgium	Mallinckrodt Plc	21 May 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02117349 (CTgov)	Phase 2	Postoperative Hemorrhage	55	Gelfoam+Raplixa	pstxogwzxa(kvsavgzofz) = qarzqpzxwu faigifdbfq (rpwbonnpis, lcpndgazqd - epkncfumxs) View more	-	05 Feb 2020
NCT01527357 (FINISH-3, CTgov)	Phase 3	Postoperative Hemorrhage	721	Gelatin sponge+Fibrocaps (Fibrocaps + Gelatin Sponge)	sxbyjxtapx(qxodtrjgti) = azhzkizikn ghthwbozkn (ytliyvayow, hyuzwzntdr - kuoxqbnjnl) View more	-	18 Dec 2019
				Gelatin sponge (Gelatin Sponge)	sxbyjxtapx(qxodtrjgti) = yksvjxnyoj ghthwbozkn (ytliyvayow, qjhqlnlopl - lfcmbrjbmi) View more
NCT01256190 (CTgov)	Phase 2	Postoperative Hemorrhage	56	Gelatin sponge+Fibrocaps (fibrin sealant) (Fibrocaps + Gelatin Sponge)	onnqnhgrny(efdnowrvoz) = axsbbbyczk aecbsfxwmd (kvywdkacrc, zioiiautkp - hcnatcqder) View more	-	15 May 2014
				Gelatin sponge (Gelatin Sponge)	onnqnhgrny(efdnowrvoz) = fqsliyhcjv aecbsfxwmd (kvywdkacrc, qsahdoyzhz - ncfmdmxwke) View more

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