Policy & Regulation
Oncopeptides restarts patient enrolment for melflufen clinical programme following temporary pause due to COVID-19
28 May 2020 -

Pharmaceutical company Oncopeptides AB (Nasdaq Stockholm:ONCO) said on Wednesday that it is relaunching patient enrolment to its clinical programme for melflufen (melphalan flufenamide) following a temporary recruitment pause due to the COVID-19 pandemic.

Patient enrolment will start as soon as possible in the ANCHOR combination study, the BRIDGE study and the AL Amyloidosis study, while the LIGHTHOUSE combination study will start after the summer.

The temporary pause did not impact the pivotal phase 2 HORIZON study and the company is on track to submit a file to the US FDA by the end of Q2.

Melflufen is a first-in-class anti-cancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumour cells. It displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

The clinical programme will be resume at sites where local regulations and patient safety enable a restart and where recruitment, treatment and adherence to protocol, as well as safety and data monitoring, are feasible, the company stated.