Oncorena Receives FDA Approval for Phase I/II Studies in the US for Kidney Cancer Treatment
Oncorena, a Swedish biopharmaceutical company focused on innovative cancer treatments, has announced its recent approval from the FDA to initiate a clinical study on its potential renal cancer therapy, ONC175. This decision marks a significant milestone for the company as it heads towards better treatment solutions for patients suffering from severe forms of kidney cancer, particularly those with very limited options left.
The approved study, designated as Oncorella-1, is a Phase I/II open-label, single-arm investigation geared towards assessing the safety, tolerability, and anti-tumor efficacy of ONC175 in patients diagnosed with metastatic clear-cell or papillary renal cell carcinoma who are also in need of dialysis. Thus far, the investigation is set to involve up to 75 patients deemed to have exhausted their treatment avenues. The trial has been assigned the identifier NCT05287945, known as ONC001-CL-001.
Börje Haraldsson, the CEO and co-founder of Oncorena, expressed his enthusiasm regarding this approval, stating that it brings them one step closer to potentially revolutionizing treatment options for patients in dire need of new and efficient therapies. The trials are currently underway at Karolinska University Hospital in Stockholm, Sweden, and the company is excited to commence the first U.S. site located at MD Anderson in Houston, Texas. Esteemed investigator, Professor Nizar Tannir, who is recognized as a leading authority in renal cancer treatment, will lead this particular study.
A Closer Look at ONC175
ONC175 is an investigational drug under development with orelannine as its active pharmaceutical ingredient. It is specifically tailored to target renal tissue, inducing irreversible renal failure in neoplastic cells while sparing other bodily organs from detrimental effects. Through pioneering preclinical studies, ONC175 has exhibited a robust and highly targeted action mechanism that effectively eradicates human metastatic renal cancer cells. The overarching aim is to advance ONC175 as a potentially curative option for patients suffering from metastatic renal cell carcinoma who no longer possess any kidney functionality, leading them to rely on dialysis.
The Reality of Kidney Cancer
Globally, kidney cancer impacts approximately 400,000 patients, as highlighted by World Health Organization data. Early detection can often lead to successful surgical interventions; however, treatment becomes considerably more complicated with the presence of metastasis. Currently available therapies mainly encompass various types of targeted drugs and immunotherapeutic regimens, which unfortunately seldom lead to complete cures. This creates a pressing need for new, effective, and safer medication to aid the kidney cancer population, many of whom are left in challenging medical situations.
With its recent strides, Oncorena aims to bridge this critical gap, offering hope to many individuals facing this debilitating disease. The company’s forward-thinking approach and commitment to addressing unmet needs in the field exemplify the possibilities modern medicine holds. As discussions around this innovative treatment continue, all eyes will be on the forthcoming trial results, which may offer groundbreaking advancements in battling kidney cancer.
For additional information or inquiries, interested parties are encouraged to reach out to Börje Haraldsson, M.D., Ph.D., CEO, and CSO at Oncorena via email at [email protected] or by phone at +46 70 267 9544.
The approved study, designated as Oncorella-1, is a Phase I/II open-label, single-arm investigation geared towards assessing the safety, tolerability, and anti-tumor efficacy of ONC175 in patients diagnosed with metastatic clear-cell or papillary renal cell carcinoma who are also in need of dialysis. Thus far, the investigation is set to involve up to 75 patients deemed to have exhausted their treatment avenues. The trial has been assigned the identifier NCT05287945, known as ONC001-CL-001.
Börje Haraldsson, the CEO and co-founder of Oncorena, expressed his enthusiasm regarding this approval, stating that it brings them one step closer to potentially revolutionizing treatment options for patients in dire need of new and efficient therapies. The trials are currently underway at Karolinska University Hospital in Stockholm, Sweden, and the company is excited to commence the first U.S. site located at MD Anderson in Houston, Texas. Esteemed investigator, Professor Nizar Tannir, who is recognized as a leading authority in renal cancer treatment, will lead this particular study.
A Closer Look at ONC175
ONC175 is an investigational drug under development with orelannine as its active pharmaceutical ingredient. It is specifically tailored to target renal tissue, inducing irreversible renal failure in neoplastic cells while sparing other bodily organs from detrimental effects. Through pioneering preclinical studies, ONC175 has exhibited a robust and highly targeted action mechanism that effectively eradicates human metastatic renal cancer cells. The overarching aim is to advance ONC175 as a potentially curative option for patients suffering from metastatic renal cell carcinoma who no longer possess any kidney functionality, leading them to rely on dialysis.
The Reality of Kidney Cancer
Globally, kidney cancer impacts approximately 400,000 patients, as highlighted by World Health Organization data. Early detection can often lead to successful surgical interventions; however, treatment becomes considerably more complicated with the presence of metastasis. Currently available therapies mainly encompass various types of targeted drugs and immunotherapeutic regimens, which unfortunately seldom lead to complete cures. This creates a pressing need for new, effective, and safer medication to aid the kidney cancer population, many of whom are left in challenging medical situations.
With its recent strides, Oncorena aims to bridge this critical gap, offering hope to many individuals facing this debilitating disease. The company’s forward-thinking approach and commitment to addressing unmet needs in the field exemplify the possibilities modern medicine holds. As discussions around this innovative treatment continue, all eyes will be on the forthcoming trial results, which may offer groundbreaking advancements in battling kidney cancer.
For additional information or inquiries, interested parties are encouraged to reach out to Börje Haraldsson, M.D., Ph.D., CEO, and CSO at Oncorena via email at [email protected] or by phone at +46 70 267 9544.
Topics Health）
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