On August 19, 2016 Xenetic Biosciences, Inc. (OTCQB: XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company developing next-generation biologic drugs and novel orphan oncology therapeutics, reported that an Investigational New Drug (IND) application for the Company’s product candidate, Virexxa (sodium cridanimod), has been allowed to proceed by the U.S. Food and Drug Administration (FDA) (Press release, Xenetic Biosciences, AUG 19, 2016, View Source [SID:1234514655]). This enables Xenetic to initiate a Phase 2 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. Schedule your 30 min Free 1stOncology Demo! "This IND clearance enables us to proceed with our Phase 2 study in endometrial cancer and represents a major step forward in our clinical development of Virexxa," stated Scott Maguire, CEO. "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."
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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 United States, 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 US. 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.
About Virexxa
Virexxa is a small-molecule immunomodulator and interferon inducer which, in preliminary studies, has been shown to increase progesterone receptor (PrR) expression in endometrial tissue. Restoration of PrR expression may re-sensitize endometrial tumor tissue to progestin therapy in previously unresponsive tumors.
Virexxa is currently being studied in an ongoing Phase 2 multi-national study enrolling 58 subjects with documented evidence of progesterone receptor negative (PrR-negative) endometrial cancer as determined by tumor biopsy. This study is being conducted in conjunction with Pharmsynthez PJSC (St. Petersburg Russia) and its subsidiary AS Kevelt (Tallinn, Estonia). For more information on this Phase 2 study of Virexxa for the treatment of PrR-negative endometrial cancer, please visit www.clinicaltrials.gov and reference Identifier NCT02064725.