On November 8, 2021 Scandion Oncology A/S, the Cancer Drug Resistance Company, reported that the timeline for read-out of the dose-finding clinical Phase Ib study PANTAX will be extended, and read-out is now expected in Q2-Q3 2022 (Press release, Scandion Oncology, NOV 8, 2021, View Source,c3448642 [SID1234594784]). The reasons are challenging patient recruitment and a staggered study design. Disregarding this postponement, the study is performing as well as the Company could have hoped for.
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In the PANTAX study, Scandion Oncology enrolls patients with unresectable or metastatic pancreatic cancer. The recruitment rate of patients in this very fragile patient population has been lower than anticipated. At the same time, the clinical sites have opened slower than planned. As previously communicated, the study expanded to Germany as a way to increase recruitment rate and to internationalize the study in preparation for the anticipated randomized Phase II study.
However, the German Competent Authority has required the study to change to a staggered design which implies that patient enrollment is slower than previously anticipated since single patients are only allowed to be included every two weeks until a cohort is completed, followed by a four-week interval between cohorts. The result is a very thorough dose-finding study, requiring longer time to completion.
Currently, there are four sites recruiting, two in Denmark and two in Germany. To further increase the recruitment rate, Scandion Oncology will open one additional site in Germany.
All in all, the consequence is that the timeline for a read-out of the study will be postponed, and the read-out is now expected in Q2-Q3 2022.
"It is very important to state that the timelines are delayed solely due to an unfortunate situation of slower recruitment rates and the impact of the staggered design from the German Competent Authority. Disregarding the delay, the study is performing as well as we could have hoped for. We see a strong potential in combining SCO-101 with nab-paclitaxel and gemcitabine for first line metastatic or inoperable pancreatic cancer", said Bo Rode Hansen, President & CEO of Scandion Oncology.
PANTAX is a dose-finding clinical Phase Ib study in patients with unresectable or metastatic pancreatic cancer who are offered SCO-101 as a first line add-on therapy to their standard chemotherapy.
This information is information that Scandion Oncology A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on November 8, 2021, at 08:30 CET