Earlier achievement of clinical and endoscopic remission in the form of complete healing of ulcer defect is
by the 21 day from the start of drug uptake in the recommended doses.

What is ULCEP?

ULCEP is the brand new unique drug obtained from plant cells intended to treat peptic and duodenal ulcers. Its action is based on triggering of the regenerating mechanisms in the damaged sections of the gastrointestinal tract mucosa.

The active ingredients are produced from dividing plant cells (corn, potato, dahlias, etc.) by high-yield liquid chromatography, gel filtration and molecular membrane technologies. The final product includes a purified fraction of polysaccharides that contains arabinose, galactose and uranic acids.

Principles of ULCEP action

ULCEP administration results in accelerated and high-quality healing of ulcer defects due to activation of regenerative and repair processes in the stomach mucosa that lead to the recovery of anatomic and physiological functions achieved through triggering of differentiation of special cells of various body tissues.
  
The result is a complete recovery of the stomach glandular epithelium, normalization of connective tissue components of the stomach submucosa layer and intensification of the trophism of the damaged section, which is not encouraged by any of the known antiulcer drugs.
By creating special conformities, molecules of the active ingredient can influence cell receptors forcing them to «recollect» their original healthy form and recover it.
  
Simultaneously, the drug is able to stabilize the portion of T-lymphocytes required by the body, thus suppressing the mucosa inflammatory process.
Drug is able to stabilize the portion of T-lymphocytes required by the body, thus suppressing the mucosa inflammatory process.

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The molecules of the substance contained in ULCEP have the ability to influence specific cell receptors. The cells perceive the contact as a command to recover their original form. The process of damaged tissue regeneration starts. Notably, non- damaged cells do not react to this stimulus. As is known, all the information in the body is transferred through cells. ULCEP launches a cascade reaction. Thus, body cells receive the command to recover their integrity not only from the influence of the polysaccharides, but from neighboring cells too. Thus, successful regeneration doesn’t require large repeat drug doses.
To win over inflammation, our body needs TH2 lymphocytes. But continuous mucosal irritation causes production of TH1 in the body that supports inflammation as a natural reaction. In this way a vicious circle of self-reproduced inflammation forms. Tissue regeneration cannot take place in this situation.
  
The result is a complete recovery of the stomach glandular epithelium, normalization of connective tissue components of the stomach submucosa layer and intensification of the trophism of the damaged section, which is not encouraged by any of the known antiulcer drugs.

History of Scientific Discovery

Long-term research resulted in the discovery of the property of large (over 1,000,000 D) polysaccharide molecules to form a special quaternary structure (conformation) under a certain influence. In the process of work, this influence was expanded to molecules over 10,000 D.
  
This controlled biosynthesis resulted in the development of new substances with unique physicochemical and biological properties.
The experiments performed allow us to claim that with the help of the obtained polysaccharides previously undescribed mechanisms of self- stabilization and self-recovery of vitally important body reactions and functions, including homeostasis maintenance on a genetically mediated level, were discovered ULCEP’s molecular weight is 5,6 · 104 D to 8,4 · 104, it contains an arabinogalactan polysaccharide chain. The UF-range of ULCEP has its base maximum at 205 ± 2 nm, the drug pH is 4.0 to 7.0.
ULCEP is the brand new unique drug obtained from plant cells intended to treat peptic and duodenal ulcers. Its action is based on triggering of the regenerating mechanisms in the damaged sections of the gastrointestinal tract mucosa.

History of Scientific Discovery

Traditional medicine, biology and pharmacology rely on chemistry and knowledge of protein bodies. Properties of other natural substances, such as polysaccharides, and their influence on cells have just started to be studied. In this sense, future science has a lot of work to do. And it is even more interesting that the first results look impressive.
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Clinical Studies

From November 2008 through May 2010, open multicenter studies of the finished drug product ULCEP (3 phase) without a control group, in which 150 patients took part, were performed in the Russian Federation at 6 research bases with appropriate state license.
  
To heal ulcer formation, ULCEP was prescribed to be injected three times within 14 days according to the following scheme: one intravenous injection every 7 days - on the 1st, 7th, and 14th day of studies. It was administered as monotherapy without application of other drugs.
In standard clinical conditions in the process of course monotherapy, ULCEP demonstrated reliability and high efficiency in healing of an ulcer defect of stomach and/or duodenum, regardless the presence or absence of helicobacter infection in the patient and the level of secretory activity of gastrointestinal juice.
The deep scientific studies conducted have shown not only the relevance of this direction but also its obvious prospects for obtaining drugs of a brand new character of action similar to ULCEP that encourage qualitative improvement, substantial simplification and cost reduction of standard therapy schemes in the treatment of illnesses like peptic and duodenal ulcer.

Clinical Studies

From November 2008 through May 2010, open multicenter studies of the finished drug product ULCEP (3 phase), in which 150 patients took part...

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Side Effects

Unwanted side effects were not registered in these studies, therefore there was no need for early drug withdrawal, study discontinuation and prescription of medicines for management or prevention of possible negative manifestations in the patient’s health.

No substantial changes were detected in the arterial pressure level and heart rate when controlling hemodynamic parameters during intravenous injection of the drug ULCEP. During the observation period, no substantial dynamics of the respiratory rate were registered. ULCEP doesn’t cause heart rate changes, dyspeptic disorders and skin allergic responses.

Safety

The drug is not a potential carcinogen (it doesn’t stimulate the growth of tumour cells), it doesn’t have a negative influence on humoral and cell immunity and human reproductive function, and it’s not allergenic. The studies have shown that even exceeding the therapeutic dose by 10,000 times doesn’t produce a toxic effect.

Utilization is based on enzyme degradation with one’s own enzymes. Polysaccharide degrades into monosugars utilized by body cells. ULCEP doesn’t tax the liver and doesn’t influence laboratory blood values.

The drug is well tolerated by patients, irrespective of their age, gender and the character and localization of the ulcer defect. Based on the subjective (patients' complaints) and objective (physical and laboratory data) study of the drug, its tolerability and safety were estimated as good.

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