EQS-Adhoc

Polyphor completes recruitment in Phase III trial of balixafortide in metastatic breast cancer - Seite 2

The FORTRESS study (POL6326-009) is an international, multicenter, randomized active-controlled, open-label Phase III trial which investigates 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.

Subject to the data, Polyphor may submit a filing for accelerated approval in the US based on the analysis of the ORR, confirmed by an independent blinded review, and of the associated durability of response. The full approval would be based on the magnitude of PFS on blinded independent review, supported by an overall survival trend favoring the 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. [phone] [e-mail]

Mary-Ann Chang LifeSci Advisors Tel: [phone] [e-mail]

 

For Media:

Bernhard Schmid
LifeSci Advisors
[phone]
[e-mail]

About Polyphor
Polyphor is a research-driven clinical-stage, Swiss biopharmaceutical company committed to discovering and developing best-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.