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Ark Therapeutics receives Cerepro verdict from EMEA
Ark Therapeutics has announced that the European Committee for Medicinal Products (EMEA) has reached a verdict on the approval of its marketing authorisation application for Cerepro.
The EMEA has adopted a negative opinion of the novel gene-based therapy for operable malignant glioma, or brain cancer.
Now, the firm plans to re-apply for the licence and provide further data to support the treatment from phase III trials that were conducted into the efficacy of the therapy.
“It is significant that the adenovirus platform technology has no outstanding issues and I believe it is a matter of time before the product gains approval,” stated professor Seppo Yla-Herttuala, consultant director of molecular medicine at Ark Therapeutics.
In other company news, Ark revealed in September that trials involving its VEGF D refractory angina treatment appear to be promising and are progressing well.
VEGF D – an adenoviral short-form Vascular Endothelial Growth Factor D gene construct (Ad-VEGF D) – is undergoing clinical development in Finland.
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