ISR Immune System Regulation Holding AB starts two new programs against TBC and cancer
Based on the concept of stimulating the immune system, ISR is currently developing a second line of immune-activating chemical entities together with the Cambridge based company Isomerase. The studies in the new indications will focus on TBC and cancer. Many bacteria and tumours have developed systems that help them avoid recognition and activation of the immune system. Therefore, there is a big and increasing medical need for immune stimulatory drugs.
ISR-50, our IP protected lead drug candidate has enhanced immune stimulatory properties currently explored in vitro and in animal models of chronic bacterial infections and cancer. With the ISR-50 program ISR will address markets with high demands and large unmet medical needs, initially targeting tuberculosis, which is a global threat estimated to affect 8.6 million cases and to cause 1.3 million deaths on an annual basis.
In addition, with the ISR-50 pre-clinical development program the effects in animal models of cancer are under evaluation.
According to GLOBOCAN (www.globocan.iarc.fr), approximately 15.2 Million cases of cancer were registered in 2015. This number is forecasted to reach an approximate of 19.3 Million and 21.6 Million by 2025 and 2030, respectively. The new safety/toxicity testing program for ISR-50 is expected to be completed during Q2 2018. Plans to initiate a phase I safety study in humans during the fall of 2018 are under way.
In 2017, ISR continued to advance the registrational clinical trials for its first candidate ISR-48. ISR has previously conducted a Phase IIa clinical study in South Africa with four-weeks treatment with ISR-48, where an activation of the immune system demonstrated positive clinical effects on the HIV infection with decreasing virus levels in 26 treatment naive HIV-infected study participants. The discovery that manipulations of the hormone system directly affects the immune system is an immunological principle not hitherto recognized.
As previously communicated, ISR has in January 12, 2018, received an approval by the Swedish Medical Product Agency to conduct a Phase IIa study, where HIV-infected patients on anti-retroviral therapy (ART) will be treated with GnRH agonist (ISR-48). The Study will be conducted in Sweden with a plan to start during Q1 2018 and conclusive results are expected in Q4 2018.
ISR recognises the possibilities in entering into a limited number of deals with partners that have the capability and experience to take our lead drug candidates to the market and assist in protecting our candidates against intellectual property infringements.
”ISR is now entering an exciting year with initiation of clinical trials and development of our novel immune-stimulatory compounds”, comments Ola Winqvist, CEO ISR.
For additional information, please contact:
Ola Winqvist, CEO, ISR Immune System Regulation Holding AB
Ph: +46 (0)70 5427939
Denna information är sådan information som ISR Immune System Regulation Holding AB (publ) är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 22 januari 2018 kl. 08:26 CET.
[Om ISR Immune System Regulation Holding AB (publ)
ISR är ett innovationsdrivet läkemedelsutvecklingsbolag inom immunterapi. Bolaget har fokus på klinisk och preklinisk forskning med syfte att utveckla en bredspektrum antiviral terapiplattform inom immunreglerande läkemedel. Erik Penser Bank är bolagets Certified Adviser och nås på 08-463 80 00.]
Ola Winqvist, VD
ISR Immune System Regulation Holding AB (publ)
Phone: +46 (0) 70 54 27 939
113 40 Stockholm, Sweden