Lallemand Pharma announced that the ancillary results of the on-going AIACE(1) clinical study were presented by Prof M Cazzola, at the international workshop on lung health dedicated to Chronic Obstructive Pulmonary Disease (COPD), which took place in Monaco in December 2013. These results represented a further proof of concept of the immunostimulating effect of PMBL in patients. COPD is ranked by the World Health Organization (WHO) among the top-10 causes of mortality worldwide, projected to become the fourth one by 2030, and its economic burden has been estimated to €48.4 billion in Europe (2).
Cazzola’s presentation was titled ‘Polyvalent Mechanical Bacterial Lysate as a Potentially Effective Approach In Preventing Acute Exacerbations of COPD’. He exposed PMBL activity on both innate and adaptive immune response, linked to a proven clinical efficacy in reducing acute exacerbations in COPD patients. This has been confirmed by a meta-analysis of all randomised clinical trials, indicating that PMBL induced a significant reduction in AECOPDs (RR, 0.83; 95 per cent CI, 0.77–0.89).
In the ancillary clinical study (3), it was shown for example that during the study, 25 per cent of 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). The aim of this ancillary study was to get a better insight of PMBL modes of action in vivo: many immunological parameters were monitored. Interestingly, it was shown that the clinical benefits observed were correlated with serological signs of an efficient specific (memory) and non-specific immune response against bacteria as well as viruses. Moreover, the study 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 and further indicate that PMBL is able to stimulate both innate and adaptive immune response, even in elderly COPD patients.
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 a 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. Advanced Immunological Approach Against COPD Exacerbations, a Phase IV clinical trial in COPD patients
2. http://www.erswhite book.org/
3. 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.
EP News Bureau – Mumbai
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