Cytocom’s proprietary immunology technology platform is based on two interrelated cytokine drug therapies—IRT-103 and IRT-101 Low-Dose Naltrexone (LDN) and Methionine Enkephalin (MENK)—which work by triggering a number of receptors one is the opioid and T Cell receptors on immune cells and activate or balance various cells of the immune system. It also triggers the tolling receptors to shift Th1 (pro-inflammatory) to Th2 (anti-inflammatory), which is critical when dealing with autoimmune and inflammatory disease
The safety, improved efficacy and PK profile for IRT-101 and IRT-103 have been established in numerous phase II clinical trials for both autoimmune disease and cancer.
Both therapies have been decades in the making at institutions with phase I and phase II clinical trials successfully run by some of the leading Medical Schools and Researchers including the Pennsylvania State University Medical School at Hershey, University of Chicago, State University of New York, and Multiple Sclerosis Center at UCSF. These efforts were pioneered by leading immunologists: Dr. Nicholas Plotnikoff, Dr. Ronald Herberman, Dr. Bernard Bihari, Angus Dalgleish, Ian S. Zagon, Dr. Jill Smith, Patricia McLaughlin, and Dr. Jaquelyn McCandless etc.
The significant long-term potential for IRT-101 and IRT-103 lies in the fact that our therapies can work as a stand-alone treatment or as an adjunct to many existing drug therapies to improve outcomes. This would include the use of IRT-101 and IRT-103 in conjunction with existing autoimmune suppression treatment including chemotherapy, anti-retroviral, paclitaxel, as well as novel chemotherapeutics. Since both immuno-suppressing drug therapies as well as chemotherapies are extremely toxic to the body, any reduction in toxicity could help dramatically improve patient outcomes by leaving the immune system in tact to continue fighting the disease.
IRT-101 and IRT-103 hold a number of distinct advantages over current therapies due to it proven safety profile and its immunomodulating properties. Thus, IRT-103 and IRT-101 mechanisms of action enhance the efficacy of the chemotherapeutic agent and could lead to a reduction in many of the toxic side effects.
15 years of R&D have led to a robust platform that delivers:
- Potential for both rapid and durable responses
- Extensive Safety Profile (505(b)(2) pathway
- Stable, easily manufactured drugs
- Clear regulatory pathway in both US and UK
- Excellent tolerability profile in clinical trials
- Clear evidence of anti-tumor activity in man
- Clear evidence of anti- inflammatory activity
- Increase in met-enkephalin (an endorphin produced in large amounts in the adrenal medulla) and β-endorphin in the blood stream;
- Increase in the number and density of opiate receptors on the tumor cell membranes, thereby making them more responsive to the growth-inhibiting effects of the already present levels of endorphins, which in turn induces apoptosis in the cancer cells; and
- Increase in absolute numbers of circulating cytotoxic T cells (CD8+/TH1) and natural killer cells (“NK cells”) as well as NK cell activity.