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本帖最后由 newchinabok 于 2018-6-15 07:46 编辑
June 14, 2018
EDISON, N.J., June 14, 2018 (GLOBE NEWSWIRE) -- ContraVir Pharmaceuticals, Inc. (NASDAQ:CTRV), a biopharmaceutical company focused on the development and commercialization of therapeutic drugs for the treatment of hepatitis B virus (HBV), announced today, the initiation of the clinical development program of CRV431, pursuant to the acceptance of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration’s (FDA).
With the FDA’s approval, ContraVir plans to begin a streamlined early clinical program of CRV431 to test the clinical safety and efficacy profile in healthy volunteers and HBV-infected patients in the United States. With an agreement of an accelerated clinical program, ContraVir plans to bridge from a single ascending dose treatment of healthy volunteers to a single dose drug-drug interaction study with Viread®, tenofovir disoproxil fumarate (currently approved for the treatment of chronic HBV infection), and ultimately into a multi-dose 28-day pilot in HBV patients.
The randomized, partially-blinded, placebo-controlled study will be conducted in the United States and will consist of three parts. The first part will assess the safety, tolerability, and pharmacokinetic (PK) profile of CRV431 as it is administrated as a single dose in healthy volunteers. The second part of the study will be a single dose drug-drug interaction pilot study in stable HBV patients with CRV431 co-treated with Viread®. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with Viread® in stable HBV patients.
“We are extremely excited to commence our first clinical studies for CRV431 in the United States,” said James Sapirstein, Chief Executive Officer of ContraVir. “The FDA’s approval of our development strategy in accelerating the clinical development of CRV431 allows us to move into patient trials in an expedited manner. The achievement of this milestone marks ContraVir as one of the few companies with two anti-HBV assets in clinical development. This progress is a testament to our team and the underlying dedication we have to streamline development of two very promising drugs in our pipeline, TXL™ and CRV431, both of which have the potential to be part of one or more curative treatments. |
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发表于 2018-6-15 07:45
