Biopharmaceutical company Xenetic has received the US Food and Drug Administration (FDA) approval of an investigational new drug (IND) application to begin the Phase II clinical trial of Virexxa for the treatment of endometrial cancer in women.
Virexxa is a small-molecule immunomodulator and interferon inducer, which increases progesterone receptor (PrR) expression in endometrial tissue.
An increased expression of PrR is believed to re-sensitise endometrial tumour tissue to progestin therapy in previously unresponsive tumours.
The trial will examine women with recurrent or persistent endometrial cancer who have failed progestin monotherapy.
It is primarily focused on determining the efficacy of Virexxa in treating the cancerous tumour, while the secondary objectives of the trial are to evaluate the additional efficacy, pharmacokinetic and safety / tolerability characteristics of Virexxa.
Additionally, the trial has also been designed to assess the effect of Virexxa when combined with progestins, on the levels of progesterone receptor (PrR) and activated progesterone receptors (APrR) in tumour tissues.
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Xenetic CEO Scott Maguire said: “This IND clearance enables us to proceed with our Phase II study in endometrial cancer and represents a major step forward in our clinical development of Virexxa.
“We believe Virexxa to be a next-generation therapeutic that has the potential to provide women with no additional treatment options a novel and effective therapy."
Virexxa is currently being tested in an ongoing Phase II multi-national study, which involved 58 patients with progesterone receptor negative (PrR-negative) endometrial cancer as determined by tumour biopsy.