PCI Biotech: Independent Data Monitoring Committee recommends continuation of two treatments in the RELEASE trial
Oslo (Norway), 13 December 2021 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, todayannounced that the Independent Data Monitoring Committee (IDMC) has reviewed the safety data collected thus far in the RELEASE trial and recommends that the trial continues
Oslo (Norway), 13 December 2021 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, todayannounced that the Independent Data Monitoring Committee (IDMC) has reviewed the safety data collected thus far in the RELEASE trial and recommends that the trial continues with up to two fima Chem treatments as stated in the protocol.
The ongoing pivotal RELEASE trial with registration intent was initiated with a planned safety review for the first eight patients receiving two fima Chem treatments. In the previously completed Phase I study a total of five patients received two treatments and now with additional eight patients reviewed for safety after two treatments, the RELEASE trial seamlessly continues to enrol patients for up to two fima Chem treatments.
Per Walday, CEO of PCI Biotech, said : “With this positive initial safety clearance for repeated treatments, PCI Biotech continue to focus on execution of the pivotal trial and we are eager to see the benefits fima Chem hopefully can provide to the patients in need of better local treatment options. So far, a clear majority of patients eligible to receive two treatments in RELEASE opted for the second treatment, which is an early encouraging sign on the acceptability of the treatment modality, both from a patient- and clinician perspective . "
The IDMC consists of international experts in bile duct cancer and medical statistics and is chartered to monitor the safety of participants in the RELEASE trial. The primary purpose of the IDMC is the protection of participants in the trial and the maintenance of trial integrity. The IDMC recommendation isbased on a review of the available trial safety data, includingdata from eight patients that had undergone two fima Chem treatments.
Dette var en gledens dag! Endelig!
“With this positive initial safety clearance for repeated treatments, PCI Biotech continue to focus on execution of the pivotal trial and we are eager to see the benefits fimaChemhopefully can provide to the patients in need of better local treatment options. So far, a
clear majority of patients eligible to receive two treatments in RELEASE opted for the second treatment, which is an early encouraging sign on the acceptability of the treatment modality, both from a patient- and clinician perspective.”
Med så tydelig usikkerhet i markedet og lave forventninger og markedsverdi er de-risking som dette svært kjærkomment! Risikoreduserende!
