FDA acceptance of Xenetic’s phase II endometrial cancer IND
Xenetic Biosciences, a biopharmaceutical company developing next-generation biologic drugs and novel orphan oncology therapeutics, has announced that an Investigational New Drug (IND) application for the company's product candidate, Virexxa (sodium cridanimod), has been allowed to proceed by the FDA.
This enables Xenetic to initiate a phase II clinical study of Virexxa in conjunction with progestin therapy for the treatment of endometrial cancer in women with recurrent or persistent disease who have failed progestin monotherapy. The primary objective of the study is to assess the anti-tumor activity of Virexxa. Secondary objectives include assessment of additional efficacy, pharmacokinetic and safety/tolerability parameters. Further translational objectives are to observe the effect of Virexxa in combination with progestins, on the levels of progesterone receptor (PrR) and activated progesterone receptors (APrR) in tumor tissues.
Endometrial cancer is the most common malignancy of the female genital tract and represents a major health concern, as overall five-year survival rates have not improved over the past three decades. Annually in the U.S., an estimated 60,050 patients are diagnosed with endometrial cancer and 10,470 deaths occur from this disease, representing 1.8% of all cancer deaths in the U.S. The incidence of endometrial cancer is on the rise with a lifetime risk of approximately 3% while the disease-specific mortality of endometrial carcinoma has been rising in the last 25 years. Endometrial cancer patients whose tumors no longer express progesterone receptors are not candidates for progestin-based therapy. Patients who fail monotherapy with progestins have no additional treatment options. Virexxa may improve sensitivity to progestin therapy in subjects with advanced or recurrent PrR-negative tumors.