Casi received the meeting minutes of FDA "guidance on clinical research and registration of enmd-2076 in the treatment of FLC"

Source: Biovalley 2015-02-12 Rockville, MD (February 11, 2015) - CASI pharmaceuticals, As a biopharmaceutical company, Inc (NASDAQ: CASI) is committed to the introduction, development and commercialization of innovative drugs, focusing on the global market, especially cancer and other unmet medical needs in China, and is pleased to announce that it has received the FDA's report on "enmd-2076 in the treatment of hepatic fibrolamellar carcinoma (FLC) ）The minutes of the formal meeting will enable enmd-2076 to enter the phase III clinical study The minutes of the meeting are from a recent informative meeting between CASI and FDA Ken K Ren, Ph.D., CASI's chief executive officer, commented that "we are greatly encouraged by FDA's feedback and appreciate their guidance and support for our development projects We believe that through this meeting, FDA provides clear guidance for future clinical research and registration application, especially for us to understand how to design clinical trials to support "enmd-2076 as a new drug application (NDA) for FLC first-line treatment" Dr Ren further commented that "the following are key elements of our clinical research and registration application, which have been approved by FDA:" we plan to conduct a single arm trial to evaluate the overall remission rate (ORR) of enmd-2076 as the primary endpoint in FCL patients The trial will be conducted in a Simon two-stage study and a mid-term analysis of ineffectiveness will be published after 16 patients reach the clinical end point If none of the patients experienced remission, the ineffectiveness would be declared and the study terminated However, if one or more patients show remission according to the RECIST 1.1 standard, other patients will continue to be recruited for study We hope to have a meeting with the FDA at that time to discuss what kind of criteria should be adopted for tumor remission so that clinical benefits can be confirmed based on alternative end points of tumor remission and accelerated approval can be supported Assuming that the results of the proposed study show that enmd-2076 can improve overall tumor remission, CASI would like to propose a confirmatory clinical trial and submit NDA under sub part h based on the overall tumor remission rate to accelerate the approval of new drugs for serious or life-threatening diseases Once the clinical data meet the appropriate criteria, CASI will submit a breakthrough treatment certification application to FDA " "We will continue to move forward in accordance with other FDA regulatory requirements, including the study of the impact of food on enmd-2076 in healthy human subjects, and work with dedicated researchers and FLC patient groups to start the trial as soon as possible As soon as the final version of the protocol is available, we will update our research protocol at www.clinicaltrials.gov We have received the US FDA qualification of orphan drugs for HCC, and plan to apply for the qualification of FLC orphan drugs in the EU " About CASI pharmaceuticals, Inc CASI pharmaceuticals, Inc is a biopharmaceutical company dedicated to the introduction, development and commercialization of innovative drugs, focusing on the global market, especially cancer and other unmet medical needs in China Casi's product lines include patents of Zevalin? (teyimosumab), marqibo? (vincristine sulfate liposome injection) and captisol enabledtm (excluding propylene glycol) in Greater China (including Taiwan, Hong Kong and Macao) Casi's R & D product line also includes its patent candidate drugs: a selective angiogenic kinase inhibitor enmd-2076, which is currently undergoing a number of phase 2 tumor research; and 2ME2 (2-methoxyestradiol), which is currently in the research and development of preparations Casi is headquartered in Rockville, MD it has a wholly-owned subsidiary (yingchuangyuanda Biotechnology) and R & D operation center in Beijing, China More information about CASI can be found at www.caspharmaceuticals.com and in the company's SEC filings Forward looking statements this press release contains forward-looking statements about future financial or business performance, strategies, expectations, and target prospects within the scope of the Private Securities Litigation Reform Act There are many assumptions, risks and uncertainties in forward-looking statements that may change over time The forward-looking statements can only reflect the situation on the date of release, and the company will not be responsible for the update of the forward-looking statements after release The actual results may differ significantly from current expectations due to the following factors: the risk that the company may not be able to continue to operate due to the inability to raise sufficient funds for operation; the possibility of delisting from Nasdaq capital market transactions; the volatility of our common stock market price; the difficulty of implementing our business strategy in China; the candidate products we propose or not The development, commercialization, manufacturing and sales of the candidate products cannot enter into the strategic partnership; the risks related to the need for additional capital and the uncertainty of ensuring the provision of additional funds on preferential terms; the risks related to our candidate products; the risks related to all the early and mid development products; the risks that lead to the preclinical model not necessarily representing the clinical results; and Uncertainties related to preclinical and clinical trials, including delay in starting such trials; unsuccessful clinical development of products; reliance on third-party institutions; risks, if any, related to the commercialization of our proposed products (such as sales, safety, management, patents, product liability, supply, competition and other risks); and the largest shares different from our other shareholders East's interest related risks; the major dilution of current shareholders in future stock issuance Among other factors, such factors may have a significant adverse impact on our transactions, results of operations and financial position We warn readers not to over trust any forward-looking statements, which can only reflect the situation at the date of release Additional information on the factors and risks that can affect our trading, financial condition and results of operations can be found in our SEC filings at www.sec.gov.