LUND, Sweden, March 1, 2021 /PRNewswire/ -- Oncorena,
dedicated to developing a unique and potential breakthrough therapy
for metastatic renal cancer, today announces the Swedish Medical
Products Agency's approval of the Phase 1/2 of First in Patient
trial of the first-in-class compound, orellanine in patients with
metastatic renal cancer in dialysis.
Preclinical evidence shows that orellanine, a well known fungus
toxin, specifically exerts powerful anti-tumor effects on
metastatic renal cancer in different preclinical models. Orellanine
has a unique mode of action. All preclinical activities have been
completed and the Swedish Medical Products Agency has approved
Oncorena's first clinical trial in patients with metastatic renal
cancer on dialysis.
"Evaluating orellanine in patients with metastatic renal cancer
is a key milestone in our efforts to demonstrate the clinical
features of this promising compound," said Lars Grundemar
M.D., Ph.D., Chief Executive Officer of Oncorena.
"I am thrilled that Oncorena now is transforming into a clinical
stage company. The scientific advances Oncorena has made during the
years can be crucial for patients in the future. In the same way,
the progress is crucial for the company's continued development and
enables new ventures in the field of kidney cancer," said Andreas
Segerros, Oncorena's Chairman of the Board of Directors.
About the clinical Phase 1/2 trial
The Phase 1/2 multicenter, open-label, clinical trial of
orellanine, to be conducted at the Centre for Clinical Cancer
Studies at the Karolinska University Hospital, Stockholm, Sweden, will enrol patients with
metastatic renal cancer already on dialysis due to renal failure.
Orellanine will be given intravenously. The trial is divided into a
dose escalation part followed by a repeated dose expansion part to
examine safety, tolerability, pharmacokinetics and signs of
anti-tumor effects. The Phase 1/2 trial will include up to 40
patients and will be expanded also to other countries.
About orellanine
Orellanine is a well known nephrotoxin from the Cortinarius family
of mushrooms. Since many people have inadvertently ingested the
mushroom the effects of orellanine are well documented and are
limited to the kidneys. Experimental studies have shown powerful
anti-tumor effects on metastatic renal cancer. Orellanine has
a novel mechanism of action. The target group for the potential
orellanine treatment is patients with metastatic kidney cancer who
are undergoing dialysis. These patients have renal failure,
however, they have an urgent need for treatment of the metastatic
disease and may potentially benefit from treatment effect of
orellanine.
About kidney cancer
Approximately 400,000 patients are affected by kidney cancer
globally and more than 131,000 die of the disease every year,
source WHO. 80% of the patients are between 40 and 69 years of age
when they are diagnosed. The disease can often be cured by surgery
if detected in time, but unfortunately the diagnosis is often made
when the tumor has already spread to other organs. The prognosis is
then considerably less favorable and certain groups have a median
survival of less than two years. Today the disease is treated with
various types of targeted and immuno-active drugs, often with
severe side effects, and standard chemotherapy drugs have only very
limited effect. There is therefore an urgent and high unmet medical
need for new, effective and safe drugs.
For further information, please contact
Lars Grundemar, M.D., Ph.D., Chief Executive Officer, Oncorena
AB
E-mail: lars.grundemar@oncorena.com
Telephone +46 (0)76 209 5518
Pål Falck, Ph.D., Chief Business Officer, Oncorena AB
E-mail: pal.falck@oncorena.com
Telephone +47 920 36 764
About Oncorena
Oncorena AB is a Swedish privately-held limited pharma company
headquarted in Lund. The company
develops a completely new and potentially revolutionizing treatment
for patients with metastatic kidney cancer. The treatment is based
on research at the University of Gothenburg, Sweden, led by professors Börje
Haraldsson and Jenny Nyström. The project was initially developed
with support from Vinnova, Sweden's Innovation Agency, and GU Ventures at
the University of Gothenburg and is now mainly financed by the
biotechnology company AQILION AB and HealthCap, a major European
venture capital fund investing globally in life sciences.For more
information, please visit Oncorena's website
at www.oncorena.com
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Press release
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https://news.cision.com/oncorena-ab/i/lars-grundemar-ceo-oncorena-ab,c2882692
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Lars Grundemar CEO
Oncorena AB
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