WALTHAM, Mass., July 05, 2016 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company focused on developing molecularly targeted and immuno-oncology drugs for the treatment of cancer, today announced the dosing of the first patient in China in a Phase I clinical trial of BGB-3111, an investigational Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of various B-cell malignancies.
“We believe BGB-3111 is the first BTK inhibitor being developed in China under the Category 1.1 domestic regulatory pathway to enter the clinic and to present clinical data. This agent has been in clinical testing since August 2014 in Australia, New Zealand, Korea and the United States, and we are hopeful that data from this dose-escalation study will pave the way to rapid development of BGB-3111 in China,” commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.
The Phase I multi-center, open label clinical trial of BGB-3111 is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of this agent in Chinese patients with B-cell malignancies, and to determine the recommended Phase II dose in Chinese patients. Professor Jun Zhu, MD, a medical oncologist at the Beijing Cancer Hospital will be the leading principal investigator of the study.
BGB-3111 is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that has demonstrated higher selectivity against BTK and higher exposure than ibrutinib, the only BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency. In addition, available clinical data with BGB-3111 demonstrated sustained 24-hour BTK occupancy in both the blood as well as the lymph node.
BeiGene is a global, clinical-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 250 scientists, clinicians and staff in China, the United States, Australia and Taiwan, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the future clinical development and regulatory milestones of BGB-3111. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates, the clinical results for its drug candidates, which may not support further development, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials, BeiGene's ability to achieve market acceptance in the medical community necessary for commercial success, BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs, BeiGene's reliance on third parties to conduct preclinical studies and clinical trials, and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.
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