On March 23, 2017 Alligator reported that the phase I trial, which began in April 2015, is a dose-escalation study involving intratumoral and intravenous administration of ADC-1013 at five clinical sites in Sweden, Denmark and the UK (ClinicalTrials.gov: NCT02379741). The study is sponsored by Alligator and includes 24 patients and ten different tumor types (Press release, Alligator Bioscience, MAR 23, 2017, View Source [SID1234538688]).
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The data will now be analyzed, focusing on safety and tolerability, pharmacokinetics, immunogenicity, biomarker response and clinical response evaluation. The aim is to present the results during the fourth quarter of 2017 at a scientific meeting, followed by a publication in a scientific journal.
"The study has progressed very well and we look forward to evaluating the data," said Per Norlén, CEO at Alligator Bioscience. "I would like to extend my warmest gratitude to all the patients and their families, as well as the investigators and clinical study staff who enabled this study to be successfully completed ahead of time."
In August 2015, Alligator entered a collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, which has the global development rights to ADC-1013.
In October 2016, Janssen Biotech Inc. started a second phase I clinical study (ClinicalTrials: NCT02829099). This study is an intravenous dose escalation study with ADC-1013 (JNJ-64457107).
Webcast
The webcast can be accessed live on the link below and will be available on the company website 30 minutes after the broadcast.
Phone numbers for participants from:
UK: +44 2030089806
SE: +46856642669
US: +18558315944
For further information, please contact:
Per Norlén, CEO
Telephone: + 46 46 286 42 80 (switchboard)
E-mail: [email protected]
Rein Piir, VP Investor Relations
Telephone: +46 708 537292
E-mail: [email protected]
Per-Olof Schrewelius, CFO
Telephone: +46 46 286 42 85
E-mail: [email protected]
The information in the press release is such that Alligator Bioscience AB is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 08.00 CET on 23 March, 2017.