has been demonstrated in phase II clinical trials for Crohn’s Disease, HIV/AIDS, Fibromyalgia, MS, Autism and Cancer that in the presence of LDN, the numbers of T-cells, both CD4+ helper T cells and CD8+ cytotoxic T cells, may increase by more than 300%.



The OGF-OGFr peptide and receptor have been detected in a wide variety of cancers, including thyroid cancer (e.g. follicular-derived thyroid cancers), ovarian cancer, triple negative breast cancer, hepatocellular carcinoma, squamous cell carcinoma of the head and neck, pancreatic cancer, renal cancer, neuroblastoma, and colon cancer.



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There are numerous published studies using LDN and MENK.  Please note, this is a dynamic list and is continually being modified.


Cytocom’s’ Business Development priorities are:

  1. Development of IRT-103 for Pediatric and Adult Crohn’s that can reach Phase III within 12 months.
  2. Request Fast Track and Break through therapy for Pediatric Crohn’s Disease
  3. Request Rare Pediatric Disease Priority Review Voucher Program for Crohn’s Disease as well as other orphan indication we are qualified for.
  4. The in licensing or co-development of clinical stage IRT-103 for targeted indications with high unmet medical need in oncology.
  5. The in licensing or co-development of highly innovative IRT-103, with potential to be used either as a stand along therapy or in conjunction with existing therapies that can reach Phase III within 12 months.
  6. Co development IRT-101 and IRT-103, using immune modulating properties for autoimmune disease

The Business Case for Cytocom Immuno-Therapies:

The repurposing of drugs remains one of the most attractive investment areas in the biopharmaceutical industry.

  • Established Patent Protection
  • Promising Pipeline with phase II clinical data
  • The recent US Healthcare Law provided a minimum of 7 years marketing exclusivity for orphan drugs.

The market for therapeutic immunology therapies continues to grow and it estimated to reach 34 billion by 2017.

Highly Efficient Pathway to Commercialization

  • Repurposed drugs have a 50% higher development success rate with the FDA, according to the Tufts Center for the Study of Drug Development.
  • 505(b)(2) pathway therapies have a faster clinical development and regulatory review,
  • Orphan Drug Designation has a faster clinical development pathway and regulatory review process.

IRT-101 and ITR-103 are attractive since they can be used as a stand-alone therapy or in conjunction with existing therapies.

IRT-101 and IRT-103 offer opportunities for distinctive innovation and continued reduction in manufacturing costs.