Clean-Surface Nanosuspension™ (CSN) technologyClean-Surface Nanosuspension™ (CSN) technology is Clene’s innovative approach to therapeutic development where traditional pharmaceutical compounds have had limited success in modifying the natural history of disease. CSN technology provides a platform for a rich pipeline of new drug candidates with potential application across a wide spectrum of diseases, creating new hope for patients with unmet medical needs.
An Investigational New Drug (IND) application for CNM-Au8, Clene’s first CSN-developed nanotherapeutic, was submitted to the United States Food and Drug Administration in the Fourth Quarter of 2014. An Investigational Medicinal Products Dossier (IMPD) application was submitted to the Netherlands Competent Medical Authority and Ethics Committee in the First Quarter of 2015. Clene began its Phase 1 clinical study of CNM-Au8 in healthy human volunteers in May 2015.
CLENE’S INITIAL FOCUS CENTERS ON TWO DISTINCT DISEASE AREAS: DEMYELINATING DISORDERS AND ONCOLOGYDEMYELINATION TARGETS
CNM-Au8, an orally available nanosuspension of Clean-Surface gold nanocrystals, represents Clene’s most advanced research program. CNM-Au8 has demonstrated efficacy and successful immunomodulation of important markers in established demyelination animal models. Clene’s initial focus is on the demyelinating disorder neuromyelitis optica (NMO). Other demyelinating diseases, including multiple sclerosis, represent additional areas of potential investigation for CNM-Au8.
Oncology TargetsCNM-PtAu7 is an orally available gold-platinum nanotherapeutic, which was also developed through Clene’s CSN process. Initial in vitro research has demonstrated broad-spectrum efficacy in a variety of tumor cell lines.
Additional preliminary research in animal xenograft models has shown inhibition of tumor volume and mass with a signal indicating potential benefit similar to cisplatin and survival rates at least equivalent to those with reference cisplatin therapy. Further evaluation is ongoing.