POLYPHOR AG SF2 WKN: A2JK4Q ISIN: CH0106213793 Kürzel: SPEX Forum: Aktien Thema: Hauptdiskussion

Daher der Kurssprung letzte Woche... wussten ein paar schon ein bisschen früher davon.

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Autsch! Das gibt jetzt heute bestimmt ein Blutbad. Ich tippe auf Miinus 30%.

Wegen?

Good news heute: „Allschwil, Switzerland, August 3, 2020 Polyphor announces second positive Data Safety Monitoring Board recommendation to continue Phase III FORTRESS study without modifications Polyphor AG (SIX: POLN) announced today that the Phase III clinical trial independent Data Safety Monitoring Board (DSMB) has completed the second, pre-specified interim analysis on July 31 of safety outcomes for 284 randomized patients (data lock June 1st) in the Phase III pivotal study with balixafortide in HER2 negative, locally recurrent or metastatic breast cancer patients. The DSMB indicated that the Phase III clinical study should continue without modifications. "While we approach the completion of the enrollment of the FORTRESS study in the near future and many patients continue on their treatment, we are very pleased with the DSMB recommendation that the Phase III clinical trial with balixafortide continues without any protocol modification", said Frank Weber, MD, CMDO of Polyphor. "Despite the unprecedented challenges posed by the COVID-19 pandemic, and thanks to the tremendous efforts of our teams and investigators around the world, we have been able to randomize 339 patients to date." FORTRESS (POL6326-009) is an international, multicenter, randomized active-controlled, open-label Phase III trial which will investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, locally recurrent or metastatic breast cancer. The study will comprise a total of 384 patients with HER2 negative MBC, with at least 320 patients receiving third or subsequent line and 64 patients receiving second line chemotherapy. Subject to the data Polyphor may be able to submit a filing for accelerated approval approximately six months after the recruitment is completed on the basis of the analysis of the overall response rate (ORR), confirmed by an independent blinded review, and of the associated durability of response. The full approval would be based on the magnitude of Progression Free Survival (PFS) on blinded independent review, supported by an overall survival trend favoring balixafortide arm and a favorable risk-benefit profile.“

Wenn man Mut hat: Ja. Sonst eher nein. Ist ein Top oder Flop-Investment. Entweder sie schaffen es in 18 Monaten oder sie sind Pleite.

Lohnt es sich hier zu investieren?

Spannendes Chartbild. 50er durchbricht 200er-Durchschnitt am Montag, wenn alles gut geht. Starkes Kaufsignal. Bin gespannt, was POLN draus macht.

News von heute: Polyphor announces acceptance of balixafortide abstract at the American Society of Clinical Oncology (ASCO) 2020 virtual scientific program Polyphor AG (SIX: POLN) a research-driven clinical-stage, Swiss biopharmaceutical company committed to discovering and developing first-in-class molecules in oncology and antimicrobial resistance announced today that the abstract "Balixafortide (a CXCR4 antagonist) plus eribulin in HER2 negative metastatic breast cancer: dose-response analysis of efficacy from Phase I single arm trial" has been accepted for the ASCO 2020 Virtual Conference, which is being held from May 29-31. The data, published online on the ASCO Meeting Library, show a consistent dose response of increasing doses of balixafortide in combination with the approved dose of eribulin. "This analysis published and supported by the steering committee of the study demonstrates an impressive overall efficacy of balixafortide at the dose of 5.5mg/kg in comparison to lower doses of balixafortide and to historical results of eribulin monotherapy in comparable populations. This benefit is observed consistently throughout all efficacy endpoints," said Peter Kaufman, Professor of Medicine, and Hematology/Oncology, at the University of Vermont Cancer Center and lead author of the abstract. Frank Weber, MD, CMDO of Polyphor adds: "Polyphor is looking forward to the results of the ongoing Phase III study FORTRESS which investigates the efficacy and safety of balixafortide at the 5.5mg/kg dose in combination with eribulin. We have randomized a total of 273 patients by today and plan to complete the enrollment of 384 patients into FORTRESS by September 2020." The FORTRESS (POL6326-009) is an international, multicenter, randomized active-controlled, open-label Phase III trial which will investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, locally recurrent or metastatic breast cancer. The study will comprise a total of 384 patients with HER2 negative MBC, of which 320 patients receiving third or subsequent line and 64 patients receiving second line chemotherapy. Subject to the data Polyphor will have the possibility to submit a filing for accelerated approval approximately six months after the recruitment is completed on the basis of the analysis of the objective response rate (ORR), confirmed by an independent blinded review, and of the associated durability of response. The full approval would be based on the magnitude of Progression Free Survival (PFS) on blinded independent review, supported by an overall survival trend favoring balixafortide arm and a favorable risk-benefit profile.