Teratology studies in mice and rabbits have shown no difference in fetal abnormalities in control animals and animals given thymosin alpha 1.
The following information was filed by Sciclone Pharmaceuticals Inc (SCLN) on Monday, March 6, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. The primary end point is the 28-day mortality rate, with secondary endpoints, including measurement of immunomodulatory parameters. ZADAXIN is our flagship product, and the leading branded thymalfasin on the market in China.
Please also refer to other risks and uncertainties described in SciClone's filings with the SEC. It should be reconstituted with 1.0 ml of the diluent provided, which consists of 1.0 ml Sterile Water for Injection, immediately prior to use. Patients will be dosed with 3.2 mg per day for one week. The drug firm's flagship product Zadaxin is approved for use in more than 30 countries, including China, its primary market. The Phase 3 trial is designed to generate data confirmatory of ZADAXIN's effectiveness in treating sepsis. It is not known whether ZADAXIN (thymalfasin) can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. For further information contact SciClone Pharmaceuticals SciClone obtained exclusive development and commercialization rights to PT-112 from Phosplatin Therapeutics for Greater China and Vietnam, along with option rights in South Korea and Taiwan.This press release contains forward-looking statements regarding expected future events and SciClone's expectations, including but not limited to the therapeutic potential and expected development and regulatory timelines for ZADAXIN in sepsis and PT-112 in cancer. Mutagenicity studies with thymosin alpha 1 showed no adverse findings.Safety and effectiveness have not been established in patients below the age of 18 years.ZADAXIN thymosin alpha 1 (thymalfasin) for injection is manufactured for SciClone Pharmaceuticals International Ltd., by PATHEON Italia S.p.A., Monza, Italy. The adverse effects of this class of chemotherapeutics, including renal and neurotoxicity, have limited their use. FOSTER CITY, CA--(Marketwire - March 22, 2013) - SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced the appointment of Hong Zhao as Chief Executive Officer, China Operations.Mr. All forward-looking statements are based on information currently available to SciClone and SciClone assumes no obligation to update any such forward-looking statements.FOSTER CITY, Calif., Sept. 26, 2016 /PRNewswire/ -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced two important achievements in advancing the Company's clinical pipeline and development portfolio in Greater China. Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of syringes or needles. ZADAXIN are registered trademarks of SciClone Pharmaceuticals, Inc. in the United States and numerous other countries.Continued Dr. Blobel: "PT-112 is a valuable addition to our development portfolio, with the potential to meaningfully expand our oncology business in China for the future. See what's happening in the market right now with MarketBeat's real-time news feed. SciClone Pharmaceuticals is a revenue-generating, specialty pharmaceutical company with a substantial commercial business in China and a product portfolio spanning major therapeutic markets including oncology, infectious Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "designed," "goal," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking.
FOSTER CITY, CA--(Marketwire - December 04, 2012) - SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that its newly created anti-counterfeiting Pharma-Comb Void label for ZADAXIN has won the prestigious "Innovator Award" in the annual competition sponsored by the Tag and Label Manufacturers … The adverse effects of this class of chemotherapeutics, including renal and neurotoxicity, have limited their use.Friedhelm Blobel, PhD, SciClone's President and Chief Executive Officer, commented: "In different ways, both of these clinical development programs represent essential strategies to ensure SciClone's continued growth over the near and long term.
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