ISR is developing ISR048 for the novel treatment of viral infected patients with a focus on HIV.
ISR has conducted a Phase I/IIa clinical trial on treatment naïve patients with HIV human immunodeficiency virus infection (HIV) with excellent effects already after one month of ISR048 treatment..
The positive outcome of the clincal HIV trial in South Africa has further been verified in preclinical studies. This new concept of treating HIV infected patients represents a major technological and scientific breakthrough within the field, and is presently tested in a Phase II clinical trial of patients on anti-retroviral therapy (ART) in Sweden.
ISR048 treatment has the potential to circumvent several of the problems associated with standard ART.
We are conducting a Phase IIa clinical trial in Sweden where HIV patients on ART therapy are randomized to receive ISR048 or continue with ART alone, where integrated HIV reservoirs will be evaluated.
In addition, we are planning to conduct a Phase IIa clinical trial
on patients with ART resistance in Berlin, Germany, where HIV patients no longer responding to ART will be treated using ISR048, and the regress in mutated HIV strains will be evelauated.
A second generation, tailor made, immunostimulatory candidates, developed from our Immunorhelin platform is under development. Based on ISR’s current technology, the new chemistry is expected to have clinical advantages over ISR048. The work required is underway and ISR has signed a collaboration agreement with Isomerase Therapeutics, Cambridge, United Kingdom to undertake the Immunorhelin development. Further patents based on new chemistry will be developed once this stage is completed.
In addition, ISR is currently developing a third line of chemical entities, Immunolides, where ISR050 is the lead candidate. ISR050 has unique immunostimulatory properties activating immune cells, cells that when activated will be benifical for treating HBV and cancer. We have interesting results in animal models of diseases, and we are therefore conducting the investigation to apply for an investigational new drug (IND) status, allowing for clinical trial.
Looking into the future ISR intends on prioritizing research into using its current technology to create new therapies stimulating the immune system for HIV, HBV and cancer. ISR will focus on the discovery and development of more potent molecules based on ISR’s current technology platform.