Archivum immunologiae et therapiae experimentalis
-
Arch. Immunol. Ther. Exp. (Warsz.) · Apr 2014
ReviewCall for a dedicated European legal framework for bacteriophage therapy.
The worldwide emergence of antibiotic resistances and the drying up of the antibiotic pipeline have spurred a search for alternative or complementary antibacterial therapies. Bacteriophages are bacterial viruses that have been used for almost a century to combat bacterial infections, particularly in Poland and the former Soviet Union. The antibiotic crisis has triggered a renewed clinical and agricultural interest in bacteriophages. ⋯ One important consideration is whether bacteriophage therapy development occurs on an industrial scale or a hospital-based, patient-specific scale. More suitable regulatory standards may create opportunities to improve insights into this promising therapeutic approach. In light of this, we argue for the creation of a new, dedicated European regulatory framework for bacteriophage therapy.
-
Arch. Immunol. Ther. Exp. (Warsz.) · Dec 2013
ReviewBlood specimen biomarkers of inflammation, matrix degradation, angiogenesis, and cardiac involvement: a future useful tool in assessing clinical outcomes of COPD patients in clinical practice?
Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation that is not fully reversible; this airflow limitation is both progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gasses. COPD is undoubtedly an umbrella term, and it seems unlikely that all patients with COPD have the same underlying disease processes; thus, there is a need for differential treatment of different subgroups. A potential solution is to find modifiable biomarkers that can assist in drug development and distinguish subgroups of COPD. ⋯ Troponin and natriuretic peptides are presented as biomarkers of cardiac involvement in the light of COPD comorbidities. Trials based on research on known clinical variables such as FEV1, BODE, and 6MWT in combination with biomarkers from lung and blood specimens will probably clarify part of the prognosis and natural history of the disease. This will also represent an additional step in COPD phenotyping and new treatment possibilities.
-
Arch. Immunol. Ther. Exp. (Warsz.) · Jun 2012
ReviewOptimizing the European regulatory framework for sustainable bacteriophage therapy in human medicine.
For practitioners at hospitals seeking to use natural (not genetically modified, as appearing in nature) bacteriophages for treatment of antibiotic-resistant bacterial infections (bacteriophage therapy), Europe's current regulatory framework for medicinal products hinders more than it facilitates. Although many experts consider bacteriophage therapy to be a promising complementary (or alternative) treatment to antibiotic therapy, no bacteriophage-specific framework for documentation exists to date. ⋯ This paper argues for a reduced documentation threshold for Phase 1 clinical trials of bacteriophages and maintains that bacteriophages should not be categorized as classical medicinal products for at least two reasons: (1) such a categorization is scientifically inappropriate for this specific therapy and (2) such a categorization limits the marketing authorization process to industry, the only stakeholder with sufficient financial resources to prepare a complete dossier for the competent authorities. This paper reflects on the current regulatory framework for medicines in Europe and assesses possible regulatory pathways for the (re-)introduction of bacteriophage therapy in a way that maintains its effectiveness and safety as well as its inherent characteristics of sustainability and in situ self-amplification and limitation.
-
Arch. Immunol. Ther. Exp. (Warsz.) · Apr 2012
ReviewAntibodies in the treatment of aplastic anemia.
Antibodies have been the cornerstone of treatment of acquired aplastic anemia for more than 25 years. Treatment with antithymocyte globulin (ATG) is considered pivotal and the addition of cyclosporine improves the overall response rate. This antibody is heterogeneous and horse ATG is apparently more effective than rabbit ATG. ⋯ In recent years, alternative immunosuppressive therapy has been proposed and new antibodies have emerged: porcine ATG, alemtuzumab, daclizumab, and rituximab. Experience with these antibodies is limited to a few studies with alemtuzumab being the most promising, but the results are interesting and provocative. More studies are needed to find the perfect antibody.
-
Arch. Immunol. Ther. Exp. (Warsz.) · Feb 2012
ReviewMolecular mechanisms and pathological consequences of endotoxin tolerance and priming.
Lipopolysaccharide (LPS), a component of Gram-negative bacteria, is a potent inflammatory stimulant, with high doses due to disseminated bacterial infection resulting in systemic inflammatory response syndrome and death. Lower doses can induce a state of tolerance to subsequent toxic doses of LPS, but extremely low doses have an opposite effect, priming the immune system for an even more violent response to subsequent challenge. ⋯ Comparatively little is known about the mechanisms or indeed the phenomenon of priming, particularly regarding the shift from a priming to a tolerizing response. Our aim is to review recent findings in the field of the inflammatory response to endotoxin, with a focus on highlighting the gaps in current understanding and attempting to reconcile the competing tolerance and priming phenomena.