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Xenetic's IND to Start Phase II Virexxa Study Accepted in U.S.

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Xenetic Biosciences, Inc. (XBIO - Free Report) announced that the FDA has accepted the company’s Investigational New Drug (IND) application to initiate a phase II study on Virexxa (sodium cridanimod) in endometrial cancer.
    
The study will evaluate 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 the assessment of anti-tumor activity of Virexxa, while secondary objectives include the evaluation of additional efficacy, pharmacokinetic and safety/tolerability parameters of the candidate.

Note that, Virexxa is currently being evaluated in phase II study in patients with documented evidence of progesterone receptor-negative endometrial cancer as determined by tumor biopsy. The candidate enjoys Orphan drug status in the U.S. for the treatment of progesterone receptor-negative endometrial cancer.

We remind investors that in Nov 2015, Xenetic signed an Asset Purchase Agreement with Estonian biotech company, AS Kevelt and OJSC Pharmsynthez related to Virexxa. Under the terms of the agreement, the company received the worldwide rights to develop, market and license Virexxa for all uses, except for certain uses within the Commonwealth of Independent States (CIS).

As per the company’s press release, over 60,050 patients are diagnosed with endometrial cancer each year in the U.S. Moreover, about 10,470 deaths occur from the disease, representing about 1.8% of all cancer-related deaths in the U.S.

Investors looking for a well-placed stock in the health care sector may consider Actelion Ltd. , Anika Therapeutics Inc. (ANIK - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All of these stocks sport a Zacks Rank #1 (Strong Buy).

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