on June 26, 2017 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that patient enrollment has commenced in its Phase 2 clinical study of XBIO-101 (sodium cridanimod) in conjunction with progestin therapy for the treatment of endometrial cancer, in a population of patients who have either failed progestin monotherapy or who have been identified as having progesterone receptor negative ("PrR-") tumors (Press release, Xenetic Biosciences, JUN 26, 2017, View Source [SID1234519692]). Schedule your 30 min Free 1stOncology Demo! XBIO-101, Xenetic’s lead product candidate in development, is a small-molecule immunomodulator and interferon inducer which, in preliminary studies, has been shown to increase progesterone receptor ("PrR") expression in endometrial tumor tissue.
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"We are very pleased to commence patient enrollment in this Phase 2 study with our flagship product candidate and believe this trial is designed to provide greater understanding of XBIO-101 for the treatment of progestin resistant endometrial cancer," stated M. Scott Maguire, Xenetic’s CEO. "Based on these preliminary findings, we believe that XBIO-101 has the potential to increase the expression of PrR on endometrial tumors thereby making them more responsive to treatment with traditional progestin therapy, and ultimately provide a much-needed solution for late stage endometrial cancer patients."
The primary objective of the open-label, multi-center, single-arm, two-period Phase 2 study is to assess the antitumor activity of XBIO-101 in conjunction with progestin therapy as measured by Overall Disease Control Rate ("ODCR") in women with recurrent or persistent endometrial carcinoma not amenable to surgical treatment or radiotherapy who have either failed progestin monotherapy or who have been identified as PrR-. Secondary objectives include assessments of efficacy and safety/tolerability parameters.
The study is expected to enroll a total of 72 women with recurrent or persistent endometrial cancer not amenable to surgical treatment or radiotherapy but suitable to be treated with progestins. All subjects determined to be PrR- at screening, as well as those subjects who experience disease progression after at least 4 weeks of progestin monotherapy, will receive XBIO-101 in combination with continued progestin treatment. Subjects will receive treatment until disease progression as defined according to RECIST 1.1 criteria.
For more information about the Phase 2 clinical study of XBIO-101 in conjunction with progestin therapy for the treatment of endometrial cancer, please visit clinicaltrials.gov and reference Identifier NCT03077698.
About Endometrial Cancer
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. XBIO-101 may improve sensitivity to progestin therapy in subjects with advanced or recurrent PrR tumors.
About XBIO-101
XBIO-101 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.
Xenetic has commenced patient enrollment in the Phase 2 clinical study of XBIO-101 in conjunction with progestin therapy for the treatment of progestin resistant endometrial cancer, and has filed a protocol under its existing Investigational New Drug application ("IND") to expand the development of XBIO-101 into a biomarker study for the treatment of triple negative breast cancer ("TNBC").