Salute e Benessere
Oncorena receives FDA approval to initiate studies in the US
The study is currently being conducted at Karolinska University Hospital in Stockholm, Sweden .
Börje Haraldsson, CEO & co-founder of Oncorena comments:
"This approval brings us closer to being able to evaluate the potential for this novel treatment in patients in desperate need for new and better options. We are excited to start the first US site, MD Andersson in Houston, Texas , where the study will be led by investigator Professor Nizar Tannir , a world-leading expert in renal cancer."
ONC175 is an investigational drug product under development that contains synthetically produced orellanine as active ingredient. Orellanine is highly specific to the kidney and induces irreversible renal failure. It is clinically well-known that orellanine does not affect organs other than the kidneys.
In pioneering preclinical studies ONC175 demonstrated a powerful and highly organ-specific mode of action capable of eradicating human metastatic renal cancer cells. The primary goal is to develop ONC175 as a potential curative treatment of metastatic renal cell carcinoma in patients with no remaining kidney function, i.e., patients on dialysis.
Approximately 400,000 patients are affected by kidney cancer globally according to the WHO. The disease can often be cured by surgery if detected early, but the prognosis is less favorable if there are metastases. Today, the disease is treated with various types of targeted and immuno-active drugs, that seldom are curative. There is therefore a great and urgent unmet medical need for new, effective and safe drugs.
Börje Haraldsson, M.D., Ph.D., CEO, and CSO Oncorena AB
E-mail: borje.haraldsson@oncorena.com
Phone: +46 70 267 9544
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https://news.cision.com/oncorena/r/oncorena-receives-fda-approval-to-initiate-studies-in-the-us,c4119632
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