TREATMENT OF THE DISEASES

The Treatment of Inflammatory Bowel Disease

At present there is no cure for Inflammatory Bowel Disease. The goal of medical treatment therefore is to suppress the inflammatory response so that the intestinal tissue may heal and the patient is relieved from symptoms, such as bleeding, diarrhea and abdominal pain. For patients who suffer from intermittent forms the goal of medical therapy is, furthermore, to decrease the frequency of disease recurrences by the administration of maintenance medications to prevent a relapse of the disease. However, the groups of pharmaceutical products currently used are accompanied by unwanted negative effects and may not attain the best possible therapeutic results.

The following groups of pharmaceutical products are currently used to treat Inflammatory Bowel Disease:

Aminosalicylates (5-ASA):

This class of anti-inflammatory pharmaceutical products is typically used to treat mild to moderate forms of Inflammatory Bowel Disease.

Corticosteroids:

Corticosteroids are used to treat moderate to severely active cases of Inflammatory Bowel Disease that do not respond to treatment with Aminosalicylates. These pharmaceutical products have significant side effects which make their long-term use problematic.

Immunosuppressive Pharmaceutical Products:

Immunosuppressive pharmaceutical products inhibit the general immune system by inhibiting cell division including the cloning of white blood cells that is part of the immune response. They are used to treat severe cases and may help to decrease corticosteroid dosage and to heal fistulas. Also, these products may lead to side effects if they are used for a prolonged time and in high dosages, as they negatively affect the whole immune response of the patient.

TNF Alpha Inhibitors:

TNF alpha is a protein that is released by activated white blood cells, triggering more inflammation, an immune system response and more damage to the mucosa of the colon. Certain pharmaceutical products inhibit TNF alpha, hence reducing inflammation and immune system involvement. TNF alpha inhibitors are usually given as an intravenous infusion. They are very useful for inducing and maintaining a remission of Crohn's Disease and Ulcerative Colitis. TNF alpha inhibitors have important side effects which can make their long term use problematic.

In the USA and EU around 32 million colonoscopies are performed every year.

Colon infections

Colon infections are usually treated with antibiotics that are targeted at the specific pathogen. 

Colon Cancer Prevention

In order to prevent colon cancer, polyps must be identified early on and safely and entirely removed. In order to identify polyps, endoscopists perform colonoscopies which allow a visual inspection of the colon via endoscope. During colonoscopy, endoscopists strive to identify all polyps and remove those potentially dangerous. Identification to date has focused on developing better endoscopes with higher resolution, higher maneuverability and varying optical filters. As an alternative, endoscopists selectively use a procedure where they spray suspicious colonic areas with dyes with the intention of having these dyes better identify tissues structures.

In a third step the identified polyps must be removed. Removal of polyps can be challenging, especially if the polyp is flat or positioned in difficult areas.

Oral vital dye applications:

Oral vital dye applications deliver the dye orally during the colon cleansing process. This saves equipment (no spray catheters are needed), time (the tablet is taken by the patient during colon cleaning i.e. no time is lost in a spraying procedure), allows the dye to penetrate the cell and better depict the cell structure (in spray applications the dye is not on the targeted tissues for enough time to penetrate the cell) and is not subjective (the entire colon is stained and not only the area the endoscopist selects).

LuMeBlue is the only known project that brings vital dyes to the colon by oral form during the colon cleansing procedure.

In a third step the suspicious tissue has to be removed. To this end, the med tech industry has developed a series of instruments such as needles, tweezers, electric knives and snares. The needles are attached to catheters and allow the injection of substances under the polyp with the intention of separating the tissue that is to be removed from the underlying colonic wall. The tweezers and snares then allow the endoscopist to grab the identified tissue and cut it out. Great care must be taken to remove all of the affected tissue and to ensure that underlying tissue is not also removed.

Sub-mucosal injectable compositions:

Classically the endoscopist tries to separate the tissue that is to be removed from the underlying healthy tissue by injecting a saline solution between the tissue layers. This requires constant injections respectively a process where the endoscopist injects and removes at the same time because the saline solution constantly dissipates. In all those cases where a more permanent separation of the tissues is necessary, the endoscopist needs to use injectable compositions that create a longer lasting cushion.

In the US no approved sub-mucosal composition is currently in use. Endoscopists that need lasting cushions to safely remove polyps thus all use self-developed solutions, frequently using hyaluronic acid.

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