IC-MedTech is a specialty pharmaceutical company developing small molecule drugs for the treatment of inflammatory diseases and cancer. Its most advanced program is for commercialization of the cellular redox modulator Apatone®. This safe and clinically effective product has the potential for use as a stand-alone therapy for inflammation-based pathologies, or as a pan-adjuvant therapy for solid and hematological tumors.
Apatone is a synergistic combination of two well-known pharmacological agents. It is remarkably safe, orally available and has been administered to 54 patients in several small phase 2 clinical trials with no serious adverse events. To date it has demonstrated strong efficacy results for two indications: an inflammatory disorder and an advanced metastatic cancer.
While Apatone must be administered in large doses, its biological effect is self-limiting as the inflammation or tumor burden decreases. Preclinical science behind the drug is extensive, with published literature corroborating its role as a redox modulator in transformed cells, or in cells growing in an inflamed environment. Due to its unique redox modulatory mechanism of action, we view Apatone as a general adjuvant that will synergize with both cytotoxic and targeted cancer therapies that operate by orthogonal mechanisms.
Apatone may be manufactured inexpensively by well-developed synthetic methods under GMP. Manufacturing is in place that can produce multi-ton amounts by 2016. IC MedTech has secured three orphan indications for the product and has defined a regulatory pathway for approval in several indications.
The global potential for Apatone in the many potential indications identified by IC-MedTech offers the promise of safer, better and more affordable treatments. IC-MedTech is developing Apatone for regulatory approval and will consider partnering to test Apatone as an adjuvant with new or approved drugs in cancer trials, or as a stand-alone therapy in various inflammatory diseases, e.g., aseptic osteolysis or polycystic kidney or liver disease.