Pharmakokinetics of Mistletoe Lectins after Intravenous Application of a Mistletoe Product in Healthy Subjects
Mistletoe lectins (ML) have cytotoxic and immunomodulating properties, and subcutaneously applied mistletoe products (MP) containing ML have approval for supportive cancer treatment. MP are also given off-label intravenously, but data about pharmacokinetics are widely lacking. Therefore, the aim of...
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Published in | Pharmaceuticals (Basel, Switzerland) Vol. 17; no. 3; p. 278 |
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Format | Journal Article |
Language | English |
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Abstract | Mistletoe lectins (ML) have cytotoxic and immunomodulating properties, and subcutaneously applied mistletoe products (MP) containing ML have approval for supportive cancer treatment. MP are also given off-label intravenously, but data about pharmacokinetics are widely lacking. Therefore, the aim of our phase I trial was to evaluate the pharmacokinetics and safety of intravenously applied natural ML. Initially, 12 healthy male volunteers were planned to receive a single infusion of 2000 mg Helixor
P. We had to terminate the study prematurely after the inclusion of eight subjects due to elevation of all subjects' liver enzymes. ML was detected in all subjects after infusion. The mean half-life of serum ML was 7.02 ± 2.01 h. Mean alanine transaminase increased from 23 ± 6 to a maximum of 445 ± 260 U/L, and mean aspartate aminotransferase increased from 24 ± 3 to a maximum of 318 ± 33 U/L 72 h after infusion. Severity grading for drug-induced liver injury was mild. Participants did not suffer from any liver-specific symptoms and recovered completely. As a conclusion, the dose of 2000 mg Helixor
P caused transient liver injury in healthy subjects and should, therefore, not be used for initial patient treatment. Liver enzymes should be monitored in patients receiving intravenous treatment with Helixor
P. |
---|---|
AbstractList | Mistletoe lectins (ML) have cytotoxic and immunomodulating properties, and subcutaneously applied mistletoe products (MP) containing ML have approval for supportive cancer treatment. MP are also given off-label intravenously, but data about pharmacokinetics are widely lacking. Therefore, the aim of our phase I trial was to evaluate the pharmacokinetics and safety of intravenously applied natural ML. Initially, 12 healthy male volunteers were planned to receive a single infusion of 2000 mg Helixor® P. We had to terminate the study prematurely after the inclusion of eight subjects due to elevation of all subjects’ liver enzymes. ML was detected in all subjects after infusion. The mean half-life of serum ML was 7.02 ± 2.01 h. Mean alanine transaminase increased from 23 ± 6 to a maximum of 445 ± 260 U/L, and mean aspartate aminotransferase increased from 24 ± 3 to a maximum of 318 ± 33 U/L 72 h after infusion. Severity grading for drug-induced liver injury was mild. Participants did not suffer from any liver-specific symptoms and recovered completely. As a conclusion, the dose of 2000 mg Helixor® P caused transient liver injury in healthy subjects and should, therefore, not be used for initial patient treatment. Liver enzymes should be monitored in patients receiving intravenous treatment with Helixor® P. Mistletoe lectins (ML) have cytotoxic and immunomodulating properties, and subcutaneously applied mistletoe products (MP) containing ML have approval for supportive cancer treatment. MP are also given off-label intravenously, but data about pharmacokinetics are widely lacking. Therefore, the aim of our phase I trial was to evaluate the pharmacokinetics and safety of intravenously applied natural ML. Initially, 12 healthy male volunteers were planned to receive a single infusion of 2000 mg Helixor P. We had to terminate the study prematurely after the inclusion of eight subjects due to elevation of all subjects' liver enzymes. ML was detected in all subjects after infusion. The mean half-life of serum ML was 7.02 ± 2.01 h. Mean alanine transaminase increased from 23 ± 6 to a maximum of 445 ± 260 U/L, and mean aspartate aminotransferase increased from 24 ± 3 to a maximum of 318 ± 33 U/L 72 h after infusion. Severity grading for drug-induced liver injury was mild. Participants did not suffer from any liver-specific symptoms and recovered completely. As a conclusion, the dose of 2000 mg Helixor P caused transient liver injury in healthy subjects and should, therefore, not be used for initial patient treatment. Liver enzymes should be monitored in patients receiving intravenous treatment with Helixor P. Mistletoe lectins (ML) have cytotoxic and immunomodulating properties, and subcutaneously applied mistletoe products (MP) containing ML have approval for supportive cancer treatment. MP are also given off-label intravenously, but data about pharmacokinetics are widely lacking. Therefore, the aim of our phase I trial was to evaluate the pharmacokinetics and safety of intravenously applied natural ML. Initially, 12 healthy male volunteers were planned to receive a single infusion of 2000 mg Helixor[sup.®] P. We had to terminate the study prematurely after the inclusion of eight subjects due to elevation of all subjects’ liver enzymes. ML was detected in all subjects after infusion. The mean half-life of serum ML was 7.02 ± 2.01 h. Mean alanine transaminase increased from 23 ± 6 to a maximum of 445 ± 260 U/L, and mean aspartate aminotransferase increased from 24 ± 3 to a maximum of 318 ± 33 U/L 72 h after infusion. Severity grading for drug-induced liver injury was mild. Participants did not suffer from any liver-specific symptoms and recovered completely. As a conclusion, the dose of 2000 mg Helixor[sup.®] P caused transient liver injury in healthy subjects and should, therefore, not be used for initial patient treatment. Liver enzymes should be monitored in patients receiving intravenous treatment with Helixor[sup.®] P. Mistletoe lectins (ML) have cytotoxic and immunomodulating properties, and subcutaneously applied mistletoe products (MP) containing ML have approval for supportive cancer treatment. MP are also given off-label intravenously, but data about pharmacokinetics are widely lacking. Therefore, the aim of our phase I trial was to evaluate the pharmacokinetics and safety of intravenously applied natural ML. Initially, 12 healthy male volunteers were planned to receive a single infusion of 2000 mg Helixor ® P. We had to terminate the study prematurely after the inclusion of eight subjects due to elevation of all subjects’ liver enzymes. ML was detected in all subjects after infusion. The mean half-life of serum ML was 7.02 ± 2.01 h. Mean alanine transaminase increased from 23 ± 6 to a maximum of 445 ± 260 U/L, and mean aspartate aminotransferase increased from 24 ± 3 to a maximum of 318 ± 33 U/L 72 h after infusion. Severity grading for drug-induced liver injury was mild. Participants did not suffer from any liver-specific symptoms and recovered completely. As a conclusion, the dose of 2000 mg Helixor ® P caused transient liver injury in healthy subjects and should, therefore, not be used for initial patient treatment. Liver enzymes should be monitored in patients receiving intravenous treatment with Helixor ® P. |
Audience | Academic |
Author | Rieger, Sabine Lederer, Ann-Kathrin Huber, Roman Schink, Michael |
AuthorAffiliation | 3 Helixor Heilmittel GmbH, Fischermühle 1, 72348 Rosenfeld, Germany 2 Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg University, 55131 Mainz, Germany 1 Center for Complementary Medicine, Department of Internal Medicine II, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg im Breisgau, Germany |
AuthorAffiliation_xml | – name: 2 Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg University, 55131 Mainz, Germany – name: 3 Helixor Heilmittel GmbH, Fischermühle 1, 72348 Rosenfeld, Germany – name: 1 Center for Complementary Medicine, Department of Internal Medicine II, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg im Breisgau, Germany |
Author_xml | – sequence: 1 givenname: Ann-Kathrin orcidid: 0000-0001-7984-9530 surname: Lederer fullname: Lederer, Ann-Kathrin organization: Department of General, Visceral and Transplant Surgery, University Medical Center, Johannes Gutenberg University, 55131 Mainz, Germany – sequence: 2 givenname: Sabine surname: Rieger fullname: Rieger, Sabine organization: Helixor Heilmittel GmbH, Fischermühle 1, 72348 Rosenfeld, Germany – sequence: 3 givenname: Michael surname: Schink fullname: Schink, Michael organization: Helixor Heilmittel GmbH, Fischermühle 1, 72348 Rosenfeld, Germany – sequence: 4 givenname: Roman surname: Huber fullname: Huber, Roman organization: Center for Complementary Medicine, Department of Internal Medicine II, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg im Breisgau, Germany |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38543063$$D View this record in MEDLINE/PubMed |
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Cites_doi | 10.1007/s12272-020-01247-w 10.1093/annonc/mdh469 10.1002/jat.2876 10.1016/j.ctim.2018.01.002 10.1177/15347354221133561 10.1158/2767-9764.CRC-23-0002 10.1177/1534735416658121 10.1136/bmj.282.6265.739-b 10.1053/sonc.2002.50006 10.1007/s00228-010-0830-5 10.1007/978-3-662-26751-6 10.1038/nbt0492-405 10.1007/s00103-020-03122-x 10.1007/s00520-022-06921-x 10.1186/s12906-017-1971-1 10.1186/1472-6882-11-72 10.1016/0014-5793(88)80853-6 10.1177/15347354231198074 10.1016/S0140-6736(83)91706-3 10.1186/s12906-020-03013-3 10.1016/j.jff.2018.03.015 10.1136/bmj.282.6259.186 10.1016/j.fct.2019.04.044 10.29121/granthaalayah.v5.i10.2017.2306 |
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Keywords | pharmacokinetics reversible liver injury viscum album mistletoe lectins phase I clinical trial |
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Med. contributor: fullname: Steele – volume: 282 start-page: 186 year: 1981 ident: ref_27 article-title: Mistletoe hepatitis publication-title: BMJ doi: 10.1136/bmj.282.6259.186 contributor: fullname: Harvey – volume: 129 start-page: 229 year: 2019 ident: ref_29 article-title: Biochemical and morphological changes in mouse liver induced by mistletoe toxins publication-title: Food Chem. Toxicol. doi: 10.1016/j.fct.2019.04.044 contributor: fullname: Wieczorek – ident: ref_20 – volume: 5 start-page: 307 year: 2017 ident: ref_13 article-title: Intravenous application of Helixor® in gynecological oncology: Is it safe? publication-title: Int. J. Res. GRANTHAALAYAH doi: 10.29121/granthaalayah.v5.i10.2017.2306 contributor: fullname: Ji |
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Snippet | Mistletoe lectins (ML) have cytotoxic and immunomodulating properties, and subcutaneously applied mistletoe products (MP) containing ML have approval for... |
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StartPage | 278 |
SubjectTerms | Analysis Cancer Care and treatment Chemical properties Enzymes Health aspects Liver Mistletoe mistletoe lectins Pharmacokinetics phase I clinical trial Plant lectins reversible liver injury Ribonucleic acid RNA viscum album |
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Title | Pharmakokinetics of Mistletoe Lectins after Intravenous Application of a Mistletoe Product in Healthy Subjects |
URI | https://www.ncbi.nlm.nih.gov/pubmed/38543063 https://www.proquest.com/docview/3003355845/abstract/ https://search.proquest.com/docview/3014005467 https://pubmed.ncbi.nlm.nih.gov/PMC10975571 https://doaj.org/article/8da5da4ce3b64bb78b2fcb0e88bd97f4 |
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