Phase IV Multi-center Clinical Study of Kutai Concludes in Nanjing
March 24 2009 - 10:00AM
PR Newswire (US)
REVIEW OF RESULTS CONFIRM SAFETY AND EFFICACY FOR ROOM TEMPERATURE
STORAGE NANTONG CITY, China, March 24 /PRNewswire-FirstCall/ --
Sinobiopharma, Inc. (OTC:SNBP) (BULLETIN BOARD: SNBP) is pleased to
announce that its patented version of Cisatracurium besylate, a
pre-surgical skeletal muscle relaxant marketed as Kutai in China,
has successfully concluded its Phase IV Clinical Study. The
multi-center Phase IV Clinical Study investigated the safety and
effectiveness of Kutai's use at room temperature. The after-market
study, supported by the National Multi-center Clinical plan, was
concluded successfully on September 2, 2008. Kutai is a
non-depolarizing skeletal muscle relaxant for intravenous
administration. Compared to other neuromuscular blocking agents, it
is intermediate in its onset and duration of action. More than 30
clinical experts from seven participating medical centers within
China gathered in Nanjing for a conference to review the results of
the Phase IV of the Kutai Multi-center clinical study project. Ms.
Xinming Wu, Chief anesthetist of No.1 Hospital of Chinese Peking
University Anesthesia Department, presided over the conference and
delivered a summary report of the Phase IV project. Xuejun Chen,
Sinobiopharma's vice president of sales was also in attendance and
expressed Sinobiopharma's thanks to the participating experts for
their commitment to research on Kutai. Sinobiopharma has
established a highly specialized professional team of clinical
trial monitors as part of the project to keep close surveillance on
the patients. The manager of Sinobiopharma's Clinical Research
Department, Mr. Lei Wang, reported on the Phase IV project clinical
monitoring outcomes. The experts' consensus was that the Phase IV
study established Kutai as safe and effective for room temperature
storage. The year-long clinical research project showed no
significant differences between Kutai and imported Cisatracurium
besylate, and no significant differences for Kutai safety and
effectiveness when stored at either room temperature or a lower
temperature. All the participating parties followed the study
design and promote inter-communication to ensure compliance with
Good Clinical Practice (GCP). About Sinobiopharma Sinobiopharma,
Inc. is a fully integrated and highly innovative biotechnology
company engaged in the research and development, manufacture and
marketing of biopharmaceutical products in China, the world's
fastest growing pharmaceutical market. Known as Dong Ying (Jiangsu)
Pharmaceutical Co. Ltd. in China, the Company's current therapeutic
focus is on anesthesia-assisted agents and cardiovascular drugs.
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"forward-looking statements" regarding Sinobiopharma, Inc., and its
subsidiaries, business and project plans. Such forward looking
statements are within the meaning of Section 27A of the Securities
Act of 1933, as amended, and section 21E of the United States
Securities and Exchange Act of 1934, as amended, and are intended
to be covered by the safe harbor created by such sections. Where
Sinobiopharma, Inc. expresses or implies an expectation or belief
as to future events or results, such expectation or belief is
believed to have a reasonable basis. However, forward-looking
statements are subject to risks, uncertainties and other factors,
which could cause actual results to differ materially from future
results expressed, projected or implied by such forward-looking
statements. Sinobiopharma, Inc. does not undertake any obligation
to update any forward-looking statement, except as required under
applicable law. DATASOURCE: Sinobiopharma, Inc. CONTACT:
Sinobiopharma, Inc. Investor Relations, 1-877-568-0188 Web Site:
http://www.sinobiopharma.com/
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