This retrospective observational study will evaluate high-dose methotrexate patterns of use, supportive care measures used during high-dose methotrexate chemotherapy, along with the incidence of delayed elimination of methotrexate, acute kidney injury and any associated impact of delayed elimination of methotrexate on future courses of chemotherapy and disease outcomes in adults and children with cancer.
The study will compare current practice with existing guidelines and best practices to identify potential gaps in the management of high-dose methotrexate administration and delayed elimination of methotrexate. The study will identify variations in practice and outcomes in different study centers, countries, cancer types, patient age groups, by different methotrexate doses and infusion times and different supportive care measures used. The study will also document the proportion of high-dose methotrexate courses in which glucarpidase has been used and any toxicities attributable to the use of glucarpidase.

Start Date01 Apr 2022

Sponsor / Collaborator

Protherics Medicines Development Ltd.

EUCTR2008-000912-34-GB / Not yet recruitingNot Applicable

A PHASE 2 STUDY OF THE ANTI-TUMOUR ACTIVITY AND SAFETY OF PROLARIX™ IN HEPATOCELLULAR CARCINOMA (HCC)

Start Date18 Mar 2009

Sponsor / Collaborator

Protherics Medicines Development Ltd.

EUCTR2007-002557-23-FR / Unknown statusNot Applicable

A Phase I/II Open-Label Dose Escalation Study to Investigate the Safety and Tolerability of Acadesine in Patients with B-Cell Chronic Lymphocytic Leukaemia

Start Date08 Aug 2008

Sponsor / Collaborator

Protherics Medicines Development Ltd.

100 Clinical Results associated with Protherics Medicines Development Ltd.

0 Patents (Medical) associated with Protherics Medicines Development Ltd.

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01 Dec 2023·Pediatric blood & cancer

Reply to: Comment on: A pooled subgroup analysis of glucarpidase treatment in 86 pediatric, adolescent, and young adult patients receiving high-dose methotrexate therapy in open-label trials.

Letter

Author: Hill, Christon ; Thomas, Emma ; Schwartz, Stefan ; Gallardo, Eva ; Gros, Luis ; Janeway, Katherine A ; Ward, Suzanne ; Daugherty, Claire ; Rizzari, Carmelo

27 Jun 2023·Pediatric blood & cancer

A pooled subgroup analysis of glucarpidase treatment in 86 pediatric, adolescent, and young adult patients receiving high-dose methotrexate therapy in open-label trials.

Article

Author: Hill, Christon ; Thomas, Emma ; Gallardo, Eva ; Schwartz, Stefan ; Gros, Luis ; Janeway, Katherine A ; Ward, Suzanne ; Daugherty, Claire ; Rizzari, Carmelo

BACKGROUNDDelayed methotrexate elimination can occur in patients undergoing high-dose methotrexate cancer treatment. Effectiveness of glucarpidase for rapidly reducing methotrexate concentrations was shown in compassionate-use trials in patients aged 0-84 years.METHODSWe performed post hoc analyses of infants (≥28 days to <2 years), children (≥2 to <12 years), adolescents (≥12 to <15 years), and young adults (≥15 to <25 years) from four multicenter, open-label, single-arm, glucarpidase compassionate-use trials. Patients had toxic methotrexate levels due to delayed methotrexate elimination and/or renal dysfunction, and received glucarpidase (50 U/kg). The primary endpoint was clinically important reduction (CIR) in plasma methotrexate (methotrexate ≤1 μmol/L at all post-glucarpidase measurements) based on high-performance liquid chromatography.RESULTSAmong 86 patients included in efficacy analyses, CIR was achieved by zero of one infant (0.0%), five of 16 children (31.3%), seven of 24 adolescents (29.2%), and 26/45 young adults (57.8%). Median methotrexate reduction was 98.7% or higher in each group 15 minutes post-glucarpidase. Patients with pre-glucarpidase methotrexate less than 50 μmol/L (35/42, 83.3%) were more likely to achieve CIR than those with methotrexate 50 μmol/L or higher (1/37, 2.7%). The most common treatment-related adverse event was paresthesia, occurring in three adolescents (4.5%) and six young adults (5.2%). No other treatment-related adverse event occurred in 5% or higher of any age group.CONCLUSIONAfter accounting for pre-glucarpidase methotrexate levels, glucarpidase efficacy at inducing CIR in pediatric/young adult patients was consistent, with efficacy observed in the overall study population (i.e., patients aged 0-84), and no unexpected safety findings were observed. These findings demonstrate glucarpidase (50 U/kg) is an effective and well-tolerated dose for pediatric, adolescent, and young adult patients.

15 Aug 2010·Journal of VirologyQ2 · MEDICINE

A Single Immunization with CoVaccine HT-Adjuvanted H5N1 Influenza Virus Vaccine Induces Protective Cellular and Humoral Immune Responses in Ferrets

Q2 · MEDICINE

Article

Author: Kreijtz, J. H. C. M. ; Kuiken, T. ; van Amerongen, G. ; Heldens, J. G. M. ; van den Brand, J. M. A. ; Fouchier, R. A. M. ; Bedwell, J. ; Bodewes, R. ; van Baalen, C. A. ; Osterhaus, A. D. M. E. ; Verburgh, R. J. ; Rimmelzwaan, G. F. ; Geelhoed-Mieras, M. M.

ABSTRACTHighly pathogenic avian influenza A viruses of the H5N1 subtype continue to circulate in poultry, and zoonotic transmissions are reported frequently. Since a pandemic caused by these highly pathogenic viruses is still feared, there is interest in the development of influenza A/H5N1 virus vaccines that can protect humans against infection, preferably after a single vaccination with a low dose of antigen. Here we describe the induction of humoral and cellular immune responses in ferrets after vaccination with a cell culture-derived whole inactivated influenza A virus vaccine in combination with the novel adjuvant CoVaccine HT. The addition of CoVaccine HT to the influenza A virus vaccine increased antibody responses to homologous and heterologous influenza A/H5N1 viruses and increased virus-specific cell-mediated immune responses. Ferrets vaccinated once with a whole-virus equivalent of 3.8 μg hemagglutinin (HA) and CoVaccine HT were protected against homologous challenge infection with influenza virus A/VN/1194/04. Furthermore, ferrets vaccinated once with the same vaccine/adjuvant combination were partially protected against infection with a heterologous virus derived from clade 2.1 of H5N1 influenza viruses. Thus, the use of the novel adjuvant CoVaccine HT with cell culture-derived inactivated influenza A/H5N1 virus antigen is a promising and dose-sparing vaccine approach warranting further clinical evaluation.

100 Deals associated with Protherics Medicines Development Ltd.

100 Translational Medicine associated with Protherics Medicines Development Ltd.

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