IGEN BIOLAB is a clinical research company that develops, among others, new therapeutic formulations for the treatment and prevention of diseases related to the dysfunction of the human microbiome.
IGEN BIOLAB owns several different protein profiles, peptides and amino acids of microbial origin used as active ingredients in a pharmaceutical formulation that can induce an antitumor response, for the treatment of advanced metastatic solid tumors.
Two multi-center studies are currently underway. A study in colorectal cancer, and another in patients with lung cancer in a clinically advanced stage, in phase II, comparative, both of them randomized. Patients have the best standard of care plus / minus the IGEN BIOLAB formulation, with the primary objective of Quality of Life and Overall Survival. Clinical and radiological response, nutritional / biochemical markers, and microbiota variations will also be measured.
We are also trying to develop a new therapy and prevention clinical trials, that include:
- Autism spectrum disorders
- Rheumatoid Arthritis
- Skin Health
- Women’s health
- Oral health
- Anemic state
- Intestinal diseases
- Age-related macular degeneration (ARMD)
Thus far, two multi-center trials are underway :
Quality of life assessment in patients with metastatic non-small cell lung cancer supplemented with IGEN-0206.
- 280 patients
- Recruitment phase completed
- Start of trial: June 2019
- End of trial: approx mid-2023
- Primary objective of quality of life, consistent with official questionnaires.
- Secondary objectives: changes in body mass index, microbiota profiles, changes in interleukin and cytokine profiles.
- For further information: https://clinicaltrials.gov/ct2/show/study/NCT04009122
Clinical trial to evaluate the response of a postbiotic in patients with macular degeneration. (ARMD)
- 48 patients
- In recruitment phase
- Start of trial: December 2020
- End of trial: early 2023 approximately.
- Primary objective: Changes in the size of microperimetry and vision.
- Secondary objectives: changes in visual acuity, photosensitivity, and other measurements.
- For further information:
Our pipeline also includes the development of postbiotics for a wide range of non-oncological indications, which are in earlier stages of development waiting to start the next phase. These developments are as follows:
- Oral health: The oral cavity contains different microbial communities that influence oral and systemic health. Protection against the most prevalent diseases such as dental and periodontal cavities is associated with the modulation of the oral microbiota so as to maintain and restore a healthy oral ecosystem.
- Skin health: The skin is colonized by a wide diversity of microorganisms that make up the skin microbiota. The alteration of its balance may be related to the development of inflammatory skin diseases such as atopic dermatitis and psoriasis. The interconnection between the oral and intestinal microbiota is increasingly evident, so therapy and prevention involve modulating both.
- Anti-aging: As it ages, the intestinal microbiota is exposed to factors such as diet, diseases or environmental factors that can affect its composition. Restraining their fluctuations and maintaining a healthy gut microbiota can prevent the development of age-related diseases.
- Mood: The microbiota plays an important role in communication between the gut and the central nervous system. In subjects, for example, with depression, the diversity of the intestinal microbiota decreases by increasing the presence of certain edges. Acting on the gut microbiota can potentially mitigate frequent symptoms of depression.
- Autism spectrum disorders: The composition of the gut microbiota may play a role in the development of ASD and in the gut problems characteristic of individuals with autism. Modulation of the microbiota with the use of postbiotics is shown as a potential therapy, in addition to providing benefits by minimizing adverse effects in children with ASD.
- Women’s health: The composition of the vaginal microbiota can vary throughout a woman’s life in response to endogenous and exogenous factors. Its alteration can favor the overgrowth of pathogens that can cause infections such as bacterial vaginosis or others. Microbiota repair acts as a protective barrier against harmful agents.
- Rheumatoid arthritis: The gut microbiota has an important role in the pathogenesis of rheumatoid arthritis. Dysbiosis induces a chronic inflammatory response that may be linked to the development of the disease. Using postbiotics may be a potential possibility for the treatment and prevention of rheumatoid arthritis.
- Food: Food can be a means of incorporating beneficial health effects. The design of fermented foods with improved properties aimed at different sectors of the population potentially contributes to the prevention of different diseases.