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Patient Recruitment In The Pivotal Phase 2 Study HORIZON Completed

Published: Sep 26, 2019 9:12 am
Patient Recruitment In The Pivotal Phase 2 Study HORIZON Completed

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounced to­day that the last patient has been in­cluded in the OP-106 HORIZON pivotal phase 2 clin­i­cal study eval­u­ating mel­flu­fen with dexa­meth­a­sone in patients with re­lapsed / re­frac­tory mul­ti­ple myeloma (RRMM). Oncopeptides has pre­vi­ously com­mu­ni­cated a target en­roll­ment of 150 patients in the study be­fore the end of Sep­tem­ber, which now has been achieved.

Oncopeptides is engaged in preparations for submitting a New Drug Appli­ca­tion (NDA) to the U.S. Food & Drug Admin­istra­tion (FDA) for ac­cel­er­ated mar­ket ap­­prov­al in the United States based on avail­able data from the HORIZON study. The objective is to submit the appli­ca­tion in the first quarter of 2020. This could then poten­tially lead to the first mar­ket ap­­prov­al for mel­flu­fen in the U.S. in 2020.

"The HORIZON study was initially in­tended as an exploratory study in late-stage patients with re­lapsed and/or re­frac­tory mul­ti­ple myeloma when started in Jan­u­ary­ 2017. As pos­i­tive ef­fi­cacy and safety data were gen­er­ated, the study was ex­panded to in­clude 150 patients and now forms the basis of our planned appli­ca­tion for ac­cel­er­ated mar­ket ap­­prov­al in the United States. We are en­cour­aged that the data to-date sup­port the poten­tial for mel­flu­fen to offer a new treat­ment op­tion in this im­por­tant setting, especially for patients with severe and widespread mul­ti­ple myeloma. This is an im­por­tant mile­stone in Oncopeptides' history and signifies that we are on track for submitting our NDA in the U.S. as planned, which will com­pletely trans­form the com­pany if ap­prov­ed," says Jakob Lindberg, CEO of Oncopeptides.

About the OP-106 HORIZON study

Patient recruitment in the pivotal HORIZON study is now com­pleted. The patients in the study are re­frac­tory to poma­lido­mide and/or dara­tu­mu­mab after failing on immuno­modu­la­tory drugs (IMiDs) and pro­te­a­some in­hib­i­tors (PIs). The interim data pre­sented at IMW 2019 was based on a data cut-off dated July 30, 2019, with 136 patients treated. The goal is to present up­dated data at the American Society of Hema­tol­ogy (ASH) annual meeting in De­cem­ber, pend­ing abstract ac­ceptance.

More in­for­ma­tion on the IMW 2019 pre­sen­ta­tion can be found at:

https://www.oncopeptides.se/en/new-interim-data-in-rrmm-patients-with-extramedullary-disease-from-the-pivotal-phase-2-horizon-study-presented-at-international-myeloma-workshop/

More in­for­ma­tion can be found at:

https://clinicaltrials.gov/ct2/show/NCT02963493?term=melflufen&rank=2

About Melflufen

Melflufen is a lipophilic peptide-conjugated al­kyl­ator that rapidly de­livers a highly cyto­toxic pay­load into myeloma cells through peptidase ac­­tiv­ity. It belongs to the novel class Peptidase Enhanced Cytotoxics (PEnC), which is a family of lipophilic peptides that exhibit in­creased ac­­tiv­ity via peptidase cleavage and have the poten­tial to treat many can­cers. Peptidases play a key role in pro­tein homeo­stasis and feature in cel­lu­lar processes such as cell-cycle pro­gres­sion and pro­grammed cell death. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and im­medi­ately cleaved by peptidases to de­liver an entrapped hydrophilic al­kyl­ator pay­load. In vitro, mel­flu­fen is 50-fold more potent in myeloma cells than the al­kyl­ator pay­load itself due to the peptidase cleavage, and induces irreversible DNA damage and apop­tosis. 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 Oncopeptides

Oncopeptides is a pharma­ceu­tical com­pany focused on the devel­op­ment of targeted ther­a­pies for dif­fi­cult-to-treat hema­to­logical can­cers. The com­pany is focusing on the devel­op­ment of the lead prod­uct can­di­date mel­flu­fen, a novel lipophilic peptide con­ju­gated al­kyl­ator, belonging to a new class of drugs called Peptidase Enhanced Cytotoxics (PEnC). Melflufen is in devel­op­ment as a new treat­ment for the hema­to­logical can­cer mul­ti­ple myeloma, in­clud­ing the Phase 2 pivotal trial HORIZON cur­rently underway and a global con­firmatory Phase 3 trial (OCEAN) continuing en­roll­ment. Oncopeptides' head­quar­ters is located in Stock­holm, Sweden, and the com­pany is listed in the Mid Cap segment on Nasdaq Stock­holm with the ticker ONCO.

Source: Oncopeptides.

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