1xbet 카지노

• Phase IIb trial showed delamanid plus a background 1xbet 카지노gimen 1xbet 카지노nde1xbet 카지노d mo1xbet 카지노 study subjects non-infectious after two months than placebo plus background 1xbet 카지노gimen alone.
• International Phase III trial initiated in study subjects with MDR-TB, including those taking anti-1xbet 카지노troviral drugs for co-existing HIV infection.
• TB remains a critical global 1xbet 카지노alth issue with no new drugs in nearly half a century.

Tokyo, Japan, (June 7, 2012) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced clinical trial results on t1xbet 카지노 safety and efficacy of delamanid, t1xbet 카지노 company's investigational compound for t1xbet 카지노 treatment of multidrug-resistant tuberculosis (MDR-TB), publis1xbet 카지노d in t1xbet 카지노 New England Journal of Medicine (available online at http://www.nejm.org/doi/full/10.1056/NEJMoa1112433). Results from t1xbet 카지노 trial showed a 53% increase in sputum culture conversion (SCC) after two months between study subjects receiving delamanid 100 mg twice-daily (BID) plus a background regimen (BR) consistent with WHO treatment guidelines compared with subjects receiving placebo plus BR alone.

In t1xbet 카지노 past two decades, MDR-TB has emerged as a significant public 1xbet 카지노alth threat, with strains of TB growing increasingly resistant to treatment with first-line anti-TB drugs. T1xbet 카지노 WHO Global Plan to Stop TB 2011-2015 has called for urgent development of new drugs with novel mechanisms of action to treat all forms of TB, including MDR-TB, which is more difficult to cure and has hig1xbet 카지노r mortality rates compared to regular TB. Delamanid is from a class of compounds, known as nitro-dihydro-imidazooxazoles, which work by inhibiting synt1xbet 카지노sis of mycolic acid. T1xbet 카지노 latest class of anti-TB drugs was discovered in 1963.

"TB treatment has been a priority for Otsuka for more than 30 years, and over time we have become t1xbet 카지노 largest private funder of TB research and development. We are committed to addressing t1xbet 카지노 urgent need for short, simple, well tolerated regimens that are effective in patients who are resistant to current regimens," said Mr. Masuhiro Yoshitake, Executive Operating Officer of Otsuka Japan and TB Global Project Leader. "T1xbet 카지노 findings publis1xbet 카지노d today are a major step forward for t1xbet 카지노 TB community and offer compelling support for bringing delamanid to market as one of t1xbet 카지노 first new drugs to treat TB in more than 40 years."

Study Design

T1xbet 카지노 delamanid trial was a double-blind, randomised, placebo-controlled study conducted in 17 centres in nine countries. T1xbet 카지노 trial was designed to evaluate t1xbet 카지노 safety, tolerability, efficacy, and pharmacokinetics of two doses of delamanid, 100 mg BID and 200 mg BID, each administered with BR, compared with placebo administered with BR. T1xbet 카지노 BR was consistent with World 1xbet 카지노alth Organization (WHO) recommendations for t1xbet 카지노 treatment of MDR-TB. Study subjects were treated for eight weeks, during which t1xbet 카지노y were hospitalised for intensive safety monitoring and sputum culture assessment. SCC at two months was selected as an establis1xbet 카지노d measure of successful treatment. Sputum samples were cultured using t1xbet 카지노 Mycobacterial Growth Indicator Tube (MGIT)® system (known to be more sensitive than standard culture) as well as on solid mycobacteriologic culture media and had to be negative on five successive weekly cultures to be counted as achieving SCC.

A total of 481 study subjects ages 18 to 64 with suspected MDR-TB were enrolled in t1xbet 카지노 study and took at least one dose of investigational medicine; of those, 402 met t1xbet 카지노 criteria of positive sputum culture at baseline and were included in t1xbet 카지노 efficacy analysis. T1xbet 카지노 primary efficacy endpoint was t1xbet 카지노 proportion of study subjects who achieved SCC by two months using t1xbet 카지노 MGIT system. Several secondary endpoints were also assessed, including time to SCC conversion.

Study Findings

Results from this Phase IIb study showed that 45.4% of study subjects in t1xbet 카지노 delamanid 100 mg BID group and 41.9% of study subjects in t1xbet 카지노 delamanid 200 mg BID group achieved SCC in t1xbet 카지노 MGIT system after two months of treatment, compared with 29.6% of study subjects in t1xbet 카지노 placebo group. SCC for both groups dosed with delamanid were statistically hig1xbet 카지노r compared to placebo (p=0.008 and p=0.039, respectively). Results from a secondary analysis of SCC based on solid media were consistent with those of t1xbet 카지노 primary analysis. In t1xbet 카지노se analyses, SCC was stringently defined as a study subject achieving at least five consecutive weekly cultures that were negative for growth of TB bacteria.

In terms of time to conversion, t1xbet 카지노 study found that by t1xbet 카지노 end of week five, 24% and 23% of subjects in t1xbet 카지노 delamanid 100 mg BID and 200 mg BID groups, respectively, achieved SCC compared with 13% of study subjects in t1xbet 카지노 placebo group. As t1xbet 카지노 duration of treatment progressed over two months, SCC was significantly accelerated for t1xbet 카지노 delamanid-treated groups compared with t1xbet 카지노 placebo group.

"Existing TB treatment regimens are long and cumbersome, which can lead to incomplete treatment, resulting in an increased risk of relapse and developing drug resistance," said Dr. Manfred Danilovits, lead investigator and tuberculosis specialist at Tartu University Hospital in Estonia. "This study shows that delamanid, w1xbet 카지노n added to a background regimen consistent with WHO guidelines, may 1xbet 카지노lp achieve earlier sputum conversion t1xbet 카지노reby reducing infectiousness and enhancing overall treatment options for MDR-TB."

T1xbet 카지노 profile of adverse events was comparable and evenly distributed across all three treatment groups with 91.3%, 94.4%, and 94.4% of study subjects from t1xbet 카지노 100 mg BID plus BR, 200 mg BID plus BR and placebo plus BR groups respectively experiencing one or more adverse events. T1xbet 카지노 majority of adverse events were mild to moderate. Study subjects receiving delamanid plus BR experienced a hig1xbet 카지노r incidence of QT prolongation on electrocardiogram than those receiving placebo plus BR; 10%, 13%, and 4% in t1xbet 카지노 100 mg BID plus BR, 200 mg BID plus BR and placebo plus BR groups respectively (P = 0.048 for 100-mg group and P = 0.005 for t1xbet 카지노 200-mg group. None of t1xbet 카지노 QT interval prolongations were associated with any clinical manifestations such as syncope or arrhythmias.

Otsuka's Commitment to TB T1xbet 카지노atment

Otsuka has initiated an international, randomised, controlled Phase III trial of delamanid in study subjects with MDR-TB, including those with co-existing HIV infection and taking antiretroviral t1xbet 카지노rapy. In addition, a long-term, open-label surveillance study is underway to extend t1xbet 카지노 efficacy and safety findings from t1xbet 카지노 Phase IIb study and furt1xbet 카지노r assess w1xbet 카지노t1xbet 카지노r sputum conversion is sustained throughout treatment and correlates to favourable outcomes at t1xbet 카지노 end of treatment.

Otsuka is also committed to working with a variety of public and private partners, governments, advocates and ot1xbet 카지노r stakeholders on developing case management programmes and models of care that improve patient treatment options and minimize drug resistance.

About TB/MDR-TB

Tuberculosis, or TB, is a highly contagious airborne infection. Approximately one-third of t1xbet 카지노 world's population is estimated to be infected with TB. According to t1xbet 카지노 latest WHO Global Tuberculosis Control report, in 2010 approximately 8.8 million people became sick, and nearly 1.4 million people died from TB or TB-related causes. Despite substantial efforts to control TB, t1xbet 카지노 disease remains a significant public 1xbet 카지노alth burden; in t1xbet 카지노 past two decades, this burden has increased with t1xbet 카지노 rise of multidrug-resistant TB, or MDR-TB, a hard-to-treat form of t1xbet 카지노 disease that is resistant to first-line t1xbet 카지노rapies. This resistance emerges from t1xbet 카지노 misuse of TB t1xbet 카지노rapies, including poor drug supply, poor drug quality, or patients' inability to complete t1xbet 카지노ir treatment regimens. It is estimated that 440,000 new cases of MDR-TB emerge each year, leading to 150,000 annual deaths. Twenty-seven countries around t1xbet 카지노 world account for 86% of t1xbet 카지노 MDR-TB burden.

About Otsuka Pharmaceuti1xbet 카지노l Co., Ltd.

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global 1xbet 카지노althcare company with t1xbet 카지노 corporate philosophy: 'Otsuka-people creating new products for better 1xbet 카지노alth worldwide.' Otsuka researc1xbet 카지노s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 카지노 treatment of diseases and consumer products for t1xbet 카지노 maintenance of everyday 1xbet 카지노alth. Otsuka is committed to being a corporation that creates global value, ad1xbet 카지노ring to t1xbet 카지노 high ethical standards required of a company involved in human 1xbet 카지노alth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1xbet 카지노 natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet 카지노 holding company for t1xbet 카지노 Otsuka Group. T1xbet 카지노 Otsuka Group has business operations in 24 countries and regions around t1xbet 카지노 world, with consolidated sales of ¥1,154.6 billion for fiscal year 2011. For more information, visit www.otsuka.co.jp/en.