Efficacy of PMBL to reduce infection risks in COPD patients by almost three-fold: Study

Ancillary immunological results of an on-going COPD clinical study were recently published on-line(1), indicating a significant benefit of Lallemand Pharma sublingual tablets PMBL to reduce the risk of acute infections in elderly patients with Chronic Obstructive Pulmonary Disease (COPD). Over the six-month study, 25 per cent of the patients experienced a single acute episode in the PMBL group, while 72 per cent of patients in the placebo group experienced at least one acute episode (27 per cent of these patients experienced multiple episodes) (p <0.05). These results confirmed previous clinical trials in COPD, and, showed an effective and direct immunostimulating activity of the drug.

COPD is ranked by World Health Organisation (WHO) among the top-10 causes of mortality and projected to become the fourth one by 2030. In its latest White Book released a few weeks ago, the European Respiratory Society estimated the annual economic burden of COPD to at least €48.4 billion in Europe, and has pointed prevention of respiratory infections as one of its key objectives(2).

The present ancillary study concerned a subset of 23 COPD patients and is part of a larger multi-centric randomised control trial involving 288 patients in total. Its aim was to get a better insight of PMBL modes of action in vivo: many immunological parameters were monitored. The six-month study includes a three month treatment period (one daily administration of PMBL or placebo sub-lingual tablet for ten consecutive days at the beginning of each month) plus a three month follow-up period. The benefits reported included a statistically significant reduction of the number of acute infectious episodes in patients (p <0.05).

The clinical benefits were correlated with serological signs of an efficient specific (memory) and non-specific immune response against bacteria as well as viruses. Moreover, it also showed that PMBL had a stimulating effect against vaccinal antigens, which can be described a real ‘vaccine boosting’ effect. These results complement previous findings(3) and further indicate that PMBL is able to stimulate both innate and adaptive immune response, even in elderly COPD patients.

To the authors’ knowledge, “These are the first results that show a clear correlation between the loco-regional administration of a bacterial lysate and the laboratory evidence of an efficient and wide immune-response at serological and systemic level.”

PMBL is a bacterial lysate obtained mechanically for optimal preservation of the antigens structures. PMBL contains a blend of 13 inactivated bacterial strains of the most common pathogens involved in infections of the upper and lower respiratory tract. It is formulated in sublingual tablets, described as an optimal route of administration to stimulate strong and long-lasting immune response and enhance anti-microbial defences. A recent meta-analysis encompassing the data of 15 randomised clinical studies using PMBL in both upper and lower respiratory tract infections concluded that it is effective in both children and adults in preventing respiratory tract infections.

References:
1. Ricci R, Palmero C, Bazurro G, Riccio AM, Garelli V, Di Marco E, Cirillo C, Braido F, Canonica GW, Melioli G. The administration of a polyvalent mechanical bacterial lysate in elderly patients with COPD results in serological signs of an efficient immune response associated with a reduced number of acute episodes. Pulm Pharmacol Ther. 2013 Jun 21. pii: S1094-5539(13)00124-7. doi: 10.1016/j.pupt.2013.05.006. [Epub ahead of print]
2. http://www.erswhitebook.org/
3. Lanzilli G, Traggiai E, Braido F, Garelli V, Folli C, Chiappori A, Riccio AM, Bazurro G, Agazzi A, Magnani A, Canonica GW, Melioli G. Administration of a polyvalent mechanical bacterial lysate to elderly patients with COPD: Effects on circulating T, B and NK cells. Immunol Lett. 2013 Jan;149 (1-2):62-7

EP News Bureau – Mumbai