Island is well positioned to execute a rapid path to the clinic for ISLA-101.
Based on the significant clinical experience with ISLA-101, the Company is able to leverage publicly available information as well as data from a previously filed IND in the US to expedite its path into the clinic.
Based on the trial design to be submitted under the IND application, the Company is collaborating with the State University of New York (SUNY) Upstate in Syracuse for the Phase II Clinical Trial. An agreement is currently being negotiated for the initiation of the trial.
The Company will be pursuing a prophylactic study in a DHIM in which healthy subjects are infected with an attenuated dengue virus and infection is studied in a controlled setting. This cutting-edge trial design provides significant competitive advantages, including the low number of subjects needed and the ability to control variables with strict enrolment criteria.
Island has a supply agreement in place with Catalent for manufacture of Fenretinide 100 mg softgels for dengue fever trial participants. It also has an agreement with Camargo to develop a nonclinical, clinical, clinical pharmacology and biopharmaceutics strategy and program.
In addition to the Company’s lead program it has research collaborations aimed at developing a robust anti-viral drug repurposing pipeline.
Infectious Disease expert Prof. Stephen Thomas MD, explains what is a Human Challenge Trial.
Detailing how volunteers are set to be experimentally infected with a weakened form of the virus to analyse the impact and to assess the development of a drug or vaccine.
Human challenge trials are regarded by some as a faster way to develop new drugs and vaccines.