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Xenetic Biosciences' IND application accepted by the US FDA for Phase 2 clinical trial of Virexxa in endometrial cancer.

M2 EQUITYBITES-August 22, 2016-Xenetic Biosciences' IND application accepted by the US FDA for Phase 2 clinical trial of Virexxa in endometrial cancer


Biopharmaceutical company Xenetic Biosciences (OTCQB:XBIO) announced on Friday that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for the product candidate, Virexxa (sodium cridanimod), to initiate its Phase 2 Clinical Trial of Virexxa in endometrial cancer, 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.

The company will start its 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.

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.

According to the company, 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.

Currently, Virexxa is 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 in conjunction with Pharmsynthez PJSC (St. Petersburg Russia) and its subsidiary AS Kevelt (Tallinn, Estonia), concluded the company..

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Publication:M2 EquityBites (EQB)
Date:Aug 22, 2016
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