Lund, Sweden, April 1, 2020 /PRNewswire/ -- Alligator
Bioscience (Nasdaq Stockholm: ATORX), announced today a
temporary halt in the recruitment of new patients to the company's
ongoing Phase I clinical trials with the drug candidates ATOR-1015
and ATOR-1017. Patients currently enrolled in clinical studies are
expected to continue with their scheduled visits as planned. The
company intends to, in consultation with clinical sites and
authorities, resume the recruitment of patients as soon as
possible.
"Our first priority now is the health of our employees, our
patients, the employees of our clinical sites and our collaboration
partners. The Covid-19 pandemic has a major impact on society and,
not least, on the health care system which is heavily burdened and
faces many difficult priorities. We are thoroughly
monitoring the development and how it affects our ongoing clinical
studies and have a close dialogue with all concerned parties to
ensure that cancer patients will be able to participate in our
studies again as soon as possible", said Per Norlén, CEO of
Alligator Bioscience.
Alligator has moved quickly to more extensive virtual
operations, except for essential laboratory work which continues
with additional covid-19-related safety measures.
The company complies with the authorities' guidelines and is
evaluating appropriate measures to minimize any delay that may be
caused by the temporary pause in patient recruitment. For the time
being it is too early to estimate if the halt of recruitment
affects the study completion timelines.
ATOR-1015 is a bispecific antibody in clinical Phase
I targeting the CTLA-4and OX40 molecules, developed as targeted
therapy for metastatic cancer. ATOR-1015 is since March 2019 being evaluated in an ongoing dose
escalation study planned to comprise up to 53 patients. The
principal investigator is Dr Jeffrey
Yachnin from the Department of Oncology at Karolinska
University Hospital in Stockholm.
The primary endpoint of the study is to investigate the safety and
tolerability of ATOR-1015 and to determine the recommended dose for
subsequent Phase II studies.
ATOR-1017 is a monoclonal antibody in clinical Phase
I activating the 4-1BB receptor on T and NK cells in the tumor
region and has been developed for the treatment of metastatic
cancer. ATOR-1017 is since December
2019 being evaluated in an ongoing dose-ranging study
comprising up to 50 patients. The study is conducted at three
different clinics in Sweden. The
primary endpoint of the study is to investigate the safety and
tolerability of ATOR-1017, and to determine the recommended dose
for subsequent Phase II studies.
The clinical project AC101 (HLX22) is run and funded by
the Chinese company Shanghai Henlius. AC101 is in clinical phase I
and is developed primarily for the treatment of disseminated breast
cancer. Information about the ongoing study can be found at
https://www.clinicaltrials.gov/ct2/show/NCT03916094?term=Shanghai+Henlius+Biotech&draw=3.
For further information, please contact:
Cecilia Hofvander, Director
Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: cecilia.hofvander@alligatorbioscience.com
This information is such information as Alligator Bioscience
AB (publ) is obliged to make public pursuant to the EU Market Abuse
Regulation. The information was submitted for publication, through
the agency of the contact persons set out above, at 10:15
a.m. CEST on 1 April
2020.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology
company developing tumor-directed immuno-oncology antibody drugs.
Alligator's growing pipeline includes six lead clinical and
preclinical drug candidates: mitazalimab (ADC-1013), ATOR-1015,
ATOR-1017, ALG.APV-527 (co-developed with Aptevo Therapeutics
Inc.), ATOR-1144 and AC101 (in clinical development by Shanghai
Henlius Biotech Inc.). Alligator's shares are listed on Nasdaq
Stockholm (ATORX). The Company is headquartered in Lund, Sweden, and has approximately 55
employees. For more information, please visit
www.alligatorbioscience.com.
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Alligator Bioscience
informs about temporary halt of recruitment of new patients due to
the covid-19 pandemic
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