The temporary pause did not impact the pivotal phase 2 HORIZON study and the company is on track to submit a file to the FDA based on these data by the end of Q2.
"Relapsed and refractory multiple myeloma is a life-threatening disease with limited treatment alternatives in later stages. A clinical trial may offer patients new treatment options. The pandemic has had a major impact on clinical trial activities with many of them closed to recruitment or halted. As the general situation now is improving, clinical trials can be re-initiated in regions where the potential risk-benefit for the patient is positive", says Luděk Pour, MD, PhD, Clinic of Internal Medicine - Hematology and Oncology, University Hospital Brno, Czech Republic.
Patient enrollment will start as soon as possible in the following studies; the ANCHOR combination study, the BRIDGE study and the AL Amyloidosis study. The LIGHTHOUSE combination study will start after the summer.
"I am really pleased that despite the ongoing pandemic we can restart our clinical program for melflufen in a safe and responsible way," says
For more information, please contact:
E-mail: klaas.bakker@oncopeptides.com
Cell: +44 7818 523903
E-mail: rein.piir@oncopeptides.com
Cell phone: +46 70 853 72 92
The information in the press release is information that
About melflufen
Melflufen (melphalan flufenamide) is a first-in-class anti-cancer peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration.
Melflufen 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.
About
More information is available on www.oncopeptides.com.
https://news.cision.com/oncopeptides-ab/r/oncopeptides-reinitiates-patient-enrollment-to-the-melflufen-clinical-program-following-a-temporary-,c3121790
https://mb.cision.com/Main/15404/3121790/1254868.pdf
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