Byclot (freeze-dried activated human blood coagulation factor VIIa concentrate containing factor X) / Meiji Seika - LARVOL DELTA

Coagulation potentials of plasma-derived factors VIIa and X mixture (Byclot ) evaluated by global coagulation assay in patients with acquired haemophilia A. (PubMed, Haemophilia) - No abstract available

Journal • Hematological Disorders • Hemophilia • Rare Diseases

Factor X consumption could cause attenuation of emicizumab effect; A case report of severe hemophilia A with inhibitor treated by emicizumab and factor VIII-bypassing agents (ISTH 2023) - "Considering consumption of FX, plasma-derived FVIIa/FX agent (pdFVIIa/X; Byclot®, available only in Japan) was administered, resulting in considerable recovery of ROTEM parameters. The FX:Ag was 107.5% at his baseline. Administration of pdFVIIa/FX restored FX:Ag (pre/post 47.2%/125.5%) and peak thrombin (pre/post 181 nM/336 nM). In vitro addition of anti-emicizumab antibody depressed peak thrombin to 20 nM in pre-sample and to 87 nM in post-sample."

Clinical • Gastroenterology • Hematological Disorders • Hemophilia • Hepatology • Rare Diseases

Factor X enhances the coagulant potentials of Emicizumab. (ISTH 2023) - "A combined product of plasma-derived factor (F)VIIa and FX (pd-FVIIa/FX; Byclot®) is available for haemostatic treatment of PwHA-Inh in Japan and the concomitant coagulant potentials of FVIIa/FX and Emi have already been reported. Ad|min1| and PeakTh levels in FVIII-deficient plasmas spiked with Emi were increased in a FX concentration dependent manner. The highest Ad|min1| value was 7.03±0.24 (Normal range: 6.972±0.753) and PeakTh value was 460±83 nM (Normal range: 501±70 nM) in the presence of Emi and FX 780nM, indicating that these results were not beyond normal values. In animal studies, hFX dose-dependently shortened CT+CFT and shortest CT+CFT was observed when Emi and hFX 500U/kg were injected.Conclusion(s): The co-presence of FX and Emi could improve coagulation potential in PwHA."

Hematological Disorders • Hemophilia • Rare Diseases

Identification of CaPs locus involving in purple stripe formation on unripe fruit, reveals allelic variation and alternative splicing of R2R3-MYB transcription factor in pepper (Capsicum annuum L.). (PubMed, Front Plant Sci) - "We mapped the CaPs locus to an 841.39 kb region between markers M-CA690-Xba and MCA710-03 on chromosome 10...Thus, the functional transcript of CA10g11690 appeared to be primarily involved in the development of purple phenotype in the exocarp. Our data provide new insight into the mechanism of anthocyanin biosynthesis and a theoretical basis for the future breeding of purple striped pepper varieties."

Journal

Plasma-derived factor VIIa and factor X mixture agent (MC710) prophylaxis in haemophilia B patients with inhibitors. (PubMed, Haemophilia) - "MC710 prophylaxis is considered to be decrease the bleeding rate in haemophilia B patients with inhibitors without safety concerns."

Journal • Hematological Disorders • Hemophilia • Rare Diseases

In vitro evaluation of global coagulation potentials in the co-presence of plasma-derived factors Viia/X products (Byclot ) and emicizumab in patients with haemophilia A and inhibitors and acquired haemophilia A: A pilot study. (PubMed, Haemophilia) - No abstract available

Journal • Preclinical • Hematological Disorders • Hemophilia • Rare Diseases

"Sexual innuendo is everywhere—including … baby clothes https://t.co/oas7cEUtpK @BuzzFeedNews @SexualityToday @SexualInnuendo @Onesiesofficial @BoobMerchant @LadykillerRocks @JoePaoletti @buybuyBaby @BabyClothesz" (@cherylwk1)

Plasma-derived factors VIIa and X mixtures (Byclot) significantly improve impairment of coagulant potential ex vivo in plasmas from acquired hemophilia A patients. (PubMed, Int J Hematol) - "Moreover, the addition of pd-FVIIa/FX led to a greater improvement in the coagulant potentials in AHA plasmas than those of rFVIIa and/or aPCC. These data suggest that pd-FVIIa/FX significantly improves the impaired coagulant potentials in AHA and is potentially therapeutic."

Journal • Hematological Disorders • Hemophilia • Rare Diseases

A Phase II clinical trial of a mixture of plasma-derived factor VIIa and factor X (MC710) in haemophilia patients with inhibitors: haemostatic efficacy, safety and pharmacokinetics/pharmacodynamics (Haemophilia) - P2, N=NA; PMID: 23738888; "The haemostatic potential of MC710 was confirmed at doses of 60 and 120 μg kg-1 in this trial. MC710 is thus expected to be a safe and efficacious novel bypassing agent for controlling bleeding in haemophilia [sic] patients with inhibitors."

P2 data • Hemophilia

Estimation of APTT improvement due to MC710 administration in hemophilia patients with inhibitors (ISTH 2015) - Abstract #OR142; P1, N=NA; "The estimated APTT value calculated from this approximate equation was compared with the actual measured APTT value from the Phase II clinical trial, and showed little difference. These results suggest that approximate APTT can be predicted from the administration dosage of MC710 and elapsed time from administration."

PK/PD data • Hemophilia

Long Term Hemostatic Efficacy of Once a Week Administration with a Combination Medicine of Plasma Derived Factor Viia and Factor X for a Hemophilia B Patient with Inhibitor (ISTH 2017) - "Both bleeding episodes and infusion times decreased by 68.4% and 79.8% respectively in Byclot®. The ABR also reduced from 45 to 14.5 after introducing once a week administration with Byclot®. Our experiences suggested that once a week administration with Byclot® might be a new option as a regular treatment in hemophilia patients with inhibitor."

Clinical • Biosimilar • Cardiovascular • Gene Therapies • Genetic Disorders • Hematological Malignancies • Hemophilia • Oncology • Renal Disease • Venous Thromboembolism

A phase III clinical trial of a mixture of plasma-derived factor VIIa and factor X (MC710) in hemophilia patients with inhibitors: hemostatic efficacy and safety (WFH 2014) - P3, N=21; Sponsor: rEVO Biologics; NCT02020369; "In 21 treatments for bleeding episodes, 19 were rated “excellent” or “effective” according to the investigator rating system 8 h after the last treatment. The VAS significantly decreased over time and the ROM significantly improved over time compared with the value before treatment. One mild adverse reaction and two serious adverse events were observed within one week after first administration with no significantly effect on safety."

P3 data • Hemophilia

Perioperative safety and haematostatic efficacy of a new bypassing agent pd-FVIIa/FX (Byclot) in haemophilia patients with high-responding type inhibitors. (PubMed, Blood Coagul Fibrinolysis) - "No thrombotic adverse effects were reported. This study's results suggest that both combination and sequential therapy of pd-FVIIa/FX and other bypassing agents are well tolerated and effective for the control of perioperative bleeding in haemophilia patients with high-responding inhibitors."

Clinical • Journal