GNI GROUP LTD.
is focusing on radiation-induced pneumonitis (RP) treatment as the next therapy indication for its flagship Etuary® product. The pre-Phase III pilot study, with the goal to evaluate the safety and efficacy of Etuary® in the therapy of radiation-induced pneumonitis, will be a multi-dose, multi-center open study enrolling up to 48 patients. The principal investigator
for the pilot study will be Dr. Lvhua Wang, Vice President of the Cancer Hospital of the Chinese Academy of Medical Sciences. Dr. Wang is also Chairman-elect of the Society of Radiation Cancer Therapy, Society of Medicine of China.
Radiation therapy is an important treatment for multiple thoracic malignancies, including lung cancer, breast cancer, lymphoma, or thymoma. Injury to lungs, which are particularly susceptible to radiation, is unavoidable and is a dose-limiting factor for radiation therapy. Acute pneumonitis and/or subsequent fibrosis are common severe side effects with morbidity rate about 30-50% in patients who have undergone thoracic radiation therapy. Radiation-induced pneumonitis typically occurs within 6 months following treatment. Symptoms can include low-grade fever, cough, and fullness in the chest. Severe reactions can result in dyspnea, pleuritic chest pain, hemoptysis, acute respiratory distress, and death. Fibrosis can occur without previous pneumonitis. However, once pneumonitis occurs fibrosis is almost certain to follow. Fibrosis causes lung tissue to become hard and stiff, hindering the air exchange ability of lungs and causing shortness of breath. Other than steroids, there is currently no effective preventive measure for radiation-induced pneumonitis.
We believe that there is no impact on the Company's Forecasts of Consolidated Financial
Results for Fiscal 2015 (January 1, 2015 to December 31, 2015) issued on February 13,
2015. The revised forecasts will be published as soon as recognized.
About GNI
GNI Group Ltd. is a vertical integrated pharmaceutical company focused on research, development, manufacture, and commercialization of therapeutic agents for endemic diseases in Asia. In addition to its CFDA Class 1.1 approved drug Etuary®, the only approved therapy for Idiopathic Pulmonary Fibrosis, GNI has a robust drug development pipeline focused on innovative therapeutic agents for diseases including radiation pneumonitis, diabetic nephropathy, liver fibrosis (cirrhosis), acute-on-chronic liver failure (ACLF) and chronic obstructive pulmonary disease (COPD). GNI is listed on the Tokyo Stock Exchange Mothers Market, Code 2160, with
1
headquarters in Tokyo and subsidiaries in Hong Kong, Shanghai, Beijing and the United States. For further information, please visit www.gnipharma.com.
For further inquiries+81 (03) -6214-3600
Email: infojapan@gnipharma.com
This press release contains "forward-looking" statements, including statements related to our group's plans to pursue development of product candidates and the timing thereof. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "continue," "expected to", "will" and similar expressions are intended to identify these forward-looking statements. There are a number of important factors that could cause our group's results to differ materially from those indicated by these forward-looking statements, including risks associated with the timing and success of clinical trials and the commercialization of product candidates. Our group does not undertake any obligation to update forward-looking statements.
2
|
distributed by
|
