Polyphor N Aktie

ISIN: CH0106213793 Land: Sonstiges
Branche: Sonstiges
Sektor: Sonstiges
boerse.de Prädikat:
aktueller Kurs:
6,81 EUR
Veränderung:
0,03 EUR
Veränderung in %:
0,44 %
weitere Analysen einblenden

EQS-Adhoc: Polyphor announces third positive Data Safety Monitoring Board (DSMB) recommendation to continue Phase III balixafortide FORTRESS study without modifications

Montag, 14.12.20 07:30
Newsbild
Bildquelle: fotolia.com

EQS Group-Ad-hoc: Polyphor AG / Key word(s): Study
Polyphor announces third positive Data Safety Monitoring Board (DSMB) recommendation to continue Phase III balixafortide FORTRESS study without modifications

14-Dec-2020 / 07:30 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 KR
The issuer is solely responsible for the content of this announcement.


Allschwil, Switzerland, December 14, 2020

Polyphor announces third positive Data Safety Monitoring Board (DSMB) recommendation to continue Phase III balixafortide FORTRESS study without modifications

Polyphor AG (SIX: POLN) announced today that the clinical trial independent Data Safety Monitoring Board (DSMB) has completed the third, pre-specified interim analysis, of safety outcomes based on a data cut off of 401 randomized patients 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.

"We are pleased with the DSMB recommendation that the Phase III clinical trial continues without any protocol modification." said Frank Weber, MD, CMDO of Polyphor. "We have completed the enrollment of the FORTRESS study with a total of 432 patients and are looking forward to data readouts on overall response rate (ORR) and Progression Free Survival (PFS) in Q2 and Q4 2021 respectively."

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 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.

For more information about the POL6326-009 clinical trial of balixafortide, please visit www.clinicaltrials.gov (Identifier: NCT03786094).
 

For further information please contact:

For Investors>:>

Hernan Levett
Chief Financial Officer
Polyphor Ltd.
+41 61 567 16 00

IR@polyphor.com
Mary-Ann Chang
LifeSci Advisors
Tel: +44 7483 284 853
mchang@lifesciadvisors.com
 


For Media:

Bernhard Schmid
LifeSci Advisors
+41 44 447 12 21

bschmid@lifesciadvisors.com

About Polyphor
Polyphor is a research-driven clinical-stage, Swiss biopharmaceutical company committed to discovering and developing first-in-class molecules in oncology and antimicrobial resistance leveraging the company's leading macrocyclic peptide technology platform. Polyphor is advancing balixafortide (POL6326) in a Phase III trial in combination with eribulin in patients with advanced breast cancer and exploring its potential in other cancer indications. In addition, it has discovered and is developing the Outer Membrane Protein Targeting Antibiotics (OMPTA). OMPTA are potentially the first new class of antibiotics in clinical development in the last 50 years against Gram-negative bacteria. The company's lead OMPTA program is an inhaled formulation of murepavadin for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis. Polyphor is based in Allschwil near Basel and is listed on the SIX Swiss Exchange (SIX: POLN). For more information, please visit www.polyphor.com.

Disclaimer
This press release contains forward-looking statements which are based on current assumptions and forecasts of the Polyphor management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Polyphor's results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Polyphor disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.



End of ad hoc announcement
Language: English
Company: Polyphor AG
Hegenheimermattweg 125
4123 Allschwil
Switzerland
Phone: +41 61 567 1600
Fax: +41 61 567 1601
E-mail: info@polyphor.com
Internet: www.polyphor.com
ISIN: CH0106213793
Valor: POLN
Listed: SIX Swiss Exchange
EQS News ID: 1154780

 
End of Announcement EQS Group News Service

1154780  14-Dec-2020 CET/CEST

fncls.ssp?fn=show_t_gif&application_id=1154780&application_name=news&site_id=boerse_de



Quelle: DGAP




Heute im Fokus

2021: Diese Aktien sollten Sie im Depot haben!
2021: Welche Aktien sollten Sie im Depot haben?
2021: Welche Aktien sollten Sie im Depot haben?
Das turbulente Börsenjahr 2020 ist Geschichte! Doch welche Aktien sollten Sie 2021 im Depot haben?...

News und Analysen

EQS-Adhoc: Polyphor to present full-year 2020 financial results on March 5

EQS Group-Ad-hoc: Polyphor AG / Key word(s): Annual Results Polyphor to present full-year 2020 financial results on March 5 26-Feb-2021 / 07:30 CET/CEST Release of an ad hoc announcement ...weiterlesen

Seite: 1 | 2 | ►

Polyphor N Aktie Chart Profichart

Chart
© 1994-2021 by boerse.de - Quelle für Kurse und Daten: ARIVA.DE AG - boerse.de übernimmt keine Gewähr