Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounces a suc­cess­ful com­ple­tion of en­roll­ment in the pivotal phase 3 study OCEAN for the treat­ment of re­lapsed re­frac­tory mul­ti­ple myeloma. The study in­cludes 450 patients from more than 100 hos­pi­tals around the world. Top line re­­sults are ex­pected to be pre­sented later this year.

OCEAN is a ran­dom­ized, comparative study be­tween mel­flu­fen and poma­lido­mide in patients with re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM). The patients have been treated with immuno­modu­la­tory in­hib­i­tors (IMiD) and pro­te­a­some in­hib­i­tors (PI), they have devel­oped re­sis­tance to their last …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounces to­day the final top­line re­­sults from the pivotal phase 2 HORIZON study eval­u­ating mel­flu­fen in re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM) patients. These re­­sults will form the basis for the up­com­ing NDA for ac­cel­er­ated ap­­prov­al in the US. The appli­ca­tion is on track for a sub­mission to the FDA at the end of Q2 2020. Oncopeptides will host a webcast to­day to provide an up­date on the final study re­­sults at 14.00 (CET).

The final HORIZON re­­sults rep­re­sent an Over­all Re­sponse Rate (ORR) …

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 …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounced to­day that, after dis­cus­sions with the FDA, the com­pany has ini­ti­ated the preparation for submitting a New Drug Appli­ca­tion (NDA) for ac­cel­er­ated ap­­prov­al of mel­flu­fen for the treat­ment of patients with triple-class re­frac­tory mul­ti­ple myeloma. The com­pany targets to submit the appli­ca­tion in the first quarter of 2020.

During the spring, Oncopeptides has been engaged in dialogue with the FDA to explore whether mel­flu­fen could be eli­gible for ac­cel­er­ated ap­­prov­al based on the promising data gen­er­ated in the on­go­ing phase 2 HORIZON …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounces to­day that the com­pany will provide an up­date on patient recruitment in the on­go­ing phase 3 study OCEAN, as well as a general up­date from all the com­pany's clin­i­cal stud­ies in a webcast at 10.00am (CET) to­day.

Conference call for in­­vestors, analysts and the media, Wednesday, 24 April 2019, at 10 am (CET).

CEO Jakob Lindberg will provide an overview of on­go­ing clin­i­cal stud­ies and ac­­tiv­i­ties in con­nec­tion with these.

Phone num­bers for par­tic­i­pants from:

Sweden: +46850558357
Europe: +443333009030
USA: …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stockholm: ONCO) to­day an­nounced that the US pat­ent and trademark office has issued a notice that they in­tend to grant addi­tional pat­ents to Oncopeptides AB in the US. Oncopeptides has pre­vi­ously re­ceived the corresponding pat­ent pro­tec­tion both in Japan and Europe.

These pat­ents (application numbers 14/438473 and 15/225323) pro­tect, inter alia, the freeze-dried for­mu­la­tion. The pat­ent pro­tec­tion extends to 2033. The freeze-dried preparation with melflufen is in­tended to be mar­keted at a future ap­­prov­al.

"We have now approved for­mu­la­tion pat­ents in all major key mar­kets …

Stockholm (Press Release) - Oncopeptides AB, a com­pany work­ing to en­hance on­col­ogy ther­a­pies, to­day an­nounced that the first patient has been dosed as part of a Phase II study in mul­ti­ple myeloma patients with its drug can­di­date melflufen (previously called J1).

The trial is an open-label Phase II study de­signed to de­ter­mine the level of ef­fi­cacy of melflufen in com­bi­na­tion with dexa­meth­a­sone, for late stage, relapsing or relapsing/refractory patients. The pri­mary end point is, best re­sponse in accordance with the Inter­na­tional Myeloma Work­ing Group criteria during up to eight cycles of treat­ment.

The trial is being …