Polyphor announces positive results from the FDA Type B Guidance meeting on the planned Phase III study for balixafortide
Polyphor AG / Key word(s): Study
Allschwil, Switzerland, December 3, 2018
Polyphor announced today that it has received the meeting minutes from a Type B Guidance meeting with the US FDA on the study design and statistical analysis plan of the planned Phase III study POL6326-009, that will evaluate the efficacy and safety of balixafortide and eribulin versus eribulin monotherapy in patients with locally recurrent and/or metastatic breast cancer (MBC).
About Balixafortide (POL6326)
Balixafortide is being developed to improve therapy outcomes in cancer, when used in combination with other agents. Balixafortide is the only CXCR4 antagonist in development for breast cancer and is the most advanced CXCR4 antagonist, being developed in solid tumors, being the first product candidate to reach proof of concept. The molecule was discovered based on Polyphor's proprietary macrocycle technology platform. Balixafortide showed strong results in a Phase Ib/proof of concept clinical trial in combination with eribulin in patients affected with advanced metastatic breast cancer. The development path identified with the input of the FDA is to conduct a single pivotal study to achieve approval in HER-2 negative metastatic breast cancer patients who previously received at least two chemotherapeutic regimens in the metastatic setting. Additionally, there is the possibility of achieving an accelerated approval based on interim results. Polyphor is also conducting preclinical work to establish the potential for balixafortide in combination with other drugs and in other oncology indications.
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