Main trends of LB51 research

Anti cancer activity

More than 70 strains of micro-organisms were tested for anti cancer activity, but only the strain ” LB51®” gave a pronounced tumor necrotizing effect.

The technique for testing the activity has been chosen to be similar to what we observe in the human oncology – when the diagnosis is stipulated the tumor is already grown. The model has been chosen to be with one of the most malignant experimental tumors – Sarcoma 180 – giving 100% mortality.

The first publications about the anti cancer activity of the substance produced by “LB51®” against Sarcoma 180 were made in 1958. Since then extracts from Lactobacillus Bulgaricus “LB51® have been tested on different experimental and spontaneous tumors in different institutes and laboratories. “LB51® has demonstrated antitumor effect in vivo on transplanted tumors in mice (Sarcoma 180, Ehrlich’ solid carcinoma, melanoma, melanosarcoma B-16, plasmocytoma MOPS 315, adenocarcinoma ACATOL), and has been used for anti cancer therapy in humans.

It was believed that “LB51®” had dual effect: a direct necrotizing effect on malignant tumors and an indirect stimulating effect on the immune mechanisms.

More than 2000 fractions of extract from “LB51®” have been tested for Tumor Necrotizing Activity on more than 150 000 mice. The very quick necrosis which occurs after the i.v. application of Blastolysin leads to toxic effects due to the disintegration of the tumor mass.

That is the reason for the conservation of the clinical application of the i.v. substance and the search for other ways of application.

Immunomodulating activity

In 1967 Dr. Ivan Bogdanov started applying an oral preparation. The tumornecrotizing activity of the oral preparation is presented much more mildly, in a relatively longer period of time and without any side effects. Another advantage of the oral application of DEODAN® is the well-known harmlessness of lactobacilli ingested with yoghurt. The studies on the acute and chronic toxicity of DEODAN® in mice, rats and dogs showed that 750 mg/kg administered daily for 6 months did not cause any pathological changes. LD50 for mice was more than 5000 mg/kg per os and 1700 mg/kg i.p..

A mediated effect through the immune system is revealed by the development of leukocytosis, stimulation of antitumor activity of macrophages. It was shown that DEODAN® stimulates the phagocytosis and enzyme activity of mouse peritoneal macrophages without further investigations on the effect on cytokine production.

The preliminary clinical investigations done by Dr. Ivan Bogdanov have been published in a small monograph: “Observations on the therapeutic effect of the anti-cancer preparation from from Lactobacillus Bulgaricus LB51® tested on 100 oncologic patients”.

The first thing to be observed was a very definite improvement of the general condition of the patients, demonstrated by normalizing of the blood count as a result of the regeneration processes mainly in the bone marrow. That was the reason for us to search for laboratory confirmation and explanation on cellular level of the mechanism of the stimulation of the regenerative processes and the immunity, discovered initially during the preliminary clinical observations.

Experiments were carried out with ‘long term murine bone marrow cell culture’ The influence of DEODAN® is by stimulation of the stromal cells in the bone marrow. Those data as well as the therapeutic effect of the preparation for restoration and regeneration processes after heavy damages of the haemopoesis caused by chemo- and/or radiation therapy gave us the reason to suppose that the DEODAN® induces endogenous colony-stimulating factors. Further investigations are on the way.

Our results show that DEODAN® has an activating effect on macrophage functions and correlate well with that reported for other muramyl peptide-containing biological response modifiers. The dose of DEODAN® required for augmentation of the spreading ability, phagocytic activity, and cytokine production of macrophages (150 mg/kg) is the same as the dose which has an antitumor effect in humans and in mice with transplanted tumors.

Our experiments on the in vitro and in vivo effects of DEODAN® on macrophages/monocytes show that the preparation activates these cells to synthesize and secrete TNF IL-6 and IL-1. Our present studies indicate that the administration of DEODAN® may lead to endogenous production of TNF. The importance of generation of endogenous TNF in tumor regression has been reported. It is believed that natural TNF released in the body has a greater cytotoxic activity and less toxic effects than recombinant TNF. The antitumor effect of DEODAN®, observed in recent clinical trials can be attributed to the activation of macrophages and production of TNF-alpha, IL-6 and IL-1. It is possible, however, that DEODAN® induces other cytokines beside IL-1, IL-6 and TNF through the activation of the cytokine network.

Recently clinical trials on 10 patients with AIDS were made in Italy by Dr. Edoardo Pacelli. The promising results from these experiments manifested the efficient immunomodulating activity of the preparation on such conditions, and could be considered as a stepping stone for a new approach.

Antiulcer and antibiotic activity

On the basis of the active principle ” LB51®” a biological preparation called GASTROPHARM has been developed for the treatment of ulcers and gastritis. The product does not contain alkalizing and analgesic substances.

The antibiotic qualities of the strain ” LB51®” had been used by Dr. Ivan Bogdanov in the creation of the healing preparation ‘NORMOFLOR®‘ which consists of dried (or lyophilized) living bacteria measured in high titres of living cells per gram and which is produced by DeoDan Ltd. The clinical trials of NORMOFLOR® in both human and veterinary sectors of application showed the perspectives of such kind of biological preparations.

Health foods, dietetic products and yoghurt

The strain “LB51®” has been used in developing ‘know-how’ for production of dietetic and health food products such as: drinks, ice creams, mayonnaise, candies, soy yoghurt and yoghurt.