(Alliance News) - Faron Pharmaceuticals Ltd said Thursday US regulators approved its Clevegen cancer treatment as an investigational new drug, allowing the expansion of a clinical trial into the US.
Shares in Faron were 37% higher at 225.80 pence in London on Thursday following the announcement.
The US Food & Drug Administration approved the IND application for Clevegen, an immunotherapy targeting tumour associated with macrophages in some metastatic or inoperable solid tumours.
The drug is currently undergoing the Matins clinical trial in Europe. Following FDA approval, Faron anticipates to open new study sites in the US.
"We are very pleased to receive this IND approval from the FDA, marking another milestone in the development of Clevegen," Chief Executive Officer Markku Jalkanen said.
"This approval will allow us to expand Matins into the US using the same protocol both in Europe and in the US, accelerating our understanding of this novel precision medicine in cancer patients who are refractory to all other treatment options and streamlining the regulatory processes," Jalkanen added. "With the US IND now approved, in due course, we plan to file applications for Breakthrough status in the US and Prime status in Europe, further facilitating regulatory interactions during the development of Clevegen."
By Ahren Lester; ahrenlester@alliancenews.com
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Faron Pharma (FARN)