Dr. Morgenthau is the inventor of technology relating to the use of the drug, KiactaTM, for the treatment of sarcoidosis. Dr. Morgenthau transferred his rights to the technology to the Icahn School of Medicine at Mount Sinai. Mount Sinai has applied for a provisional patent with respect to the technology and has licensed the technology to Auven Therapeutics, a global private equity company focused on the accelerated development of breakthrough therapeutic drugs. Dr. Morgenthau has collaborated with Auven to develop a novel Phase II/III clinical trial protocol to evaluate the safety and efficacy of KiactaTM for the treatment of sarcoidosis. . A multicenter clinical trial is anticipated in 2017.
While developing the Kiacta study protocol, Dr. Morgenthau collaborated with Transparency Life Sciences (TLS), a drug development company based on open innovation, to utilize crowdsourcing and mobile health technology to develop protocols that are focused on parameters most relevant to clinical decision-makers and patient needs.
In September 2014, TLS launched an online tool to solicit feedback about the protocol, clinical trial design and utilization of mobile health technology intended for use in the clinical trial evaluating Kiacta in sarcoidosis. The answers to the questions posed in the survey tool were used to fine tune the design of the protocol for the impending clinical trial. More than 200 researchers, physicians and patients participated in the survey. The crowdsourcing provided valuable information, which improved the design of the trial and will likely enhance patient participation. The protocol has been submitted to the FDA for regulatory approval. A phase 2/3 clinical trial evaluating the safety and efficacy of Kiacta in patients with sarcoidosis is expected in 2017.
Dr. Chandramani-Shivalingappa is evaluating the immunologic mechanisms underlying granuloma formation and maintenance in sarcoidosis, and his work is being funded by a philanthropist named Leslie Maltz.
The goal of Dr. Chandramani-Shivalingappa’s project is to establish and utilize a novel histological assessment method, which has been termed the Granuloma Immune MicroArchitecture in Sarcoidosis (GIMA-S), to better characterize histologic phenotypes of disease, correlate these with clinical phenotypes and to assess treatment responses and prognosticate clinical outcomes.
In collaboration with Dr. Morgenthau, Dr. Chandramani-Shivalingappa is conducting preliminary in vitro assays to evaluate novel therapies for the treatment of sarcoidosis.
Dr. Becker is the principal architect of the project that Dr. Chandranmani-Shivalingappa has begun. The Granuloma Immune MicroArchitecture in Sarcoidosis (GIMA-S) is a histological method designed to better characterize histologic phenotypes of disease, correlate them with clinical phenotypes and to assess treatment responses and prognosticate clinical outcomes.
Dr. Becker was involved in a project to provide complex immunophenotyping surveillance on patients undergoing a clinical treatment trial with MCSF-Ab. He developed complex immunophenotyping panels to monitor relevant immune cell subsets at the pharmacodynamically relevant time-point