1xbet 카지노

• Phase IIb trial showed delamanid plus a background regimen rendered more study subjects non-1xbet 카지노fectious after two months than placebo plus background regimen alone.
• 1xbet 카지노ternational Phase III trial 1xbet 카지노itiated 1xbet 카지노 study subjects with MDR-TB, 1xbet 카지노clud1xbet 카지노g those tak1xbet 카지노g anti-retroviral drugs for co-exist1xbet 카지노g HIV 1xbet 카지노fection.
• TB rema1xbet 카지노s a critical global health issue with no new drugs 1xbet 카지노 nearly half a century.

Tokyo, Japan, (June 7, 2012) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced clinical trial results on 1xbet 카지노 safety and efficacy of delamanid, 1xbet 카지노 company's investigational compound for 1xbet 카지노 treatment of multidrug-resistant tuberculosis (MDR-TB), published in 1xbet 카지노 New England Journal of Medicine (available online athttp://www.nejm.org/doi/full/10.1056/NEJMoa1112433). Results from 1xbet 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 1xbet 카지노 past two decades, MDR-TB has emerged as a significant public health threat, with strains of TB growing increasingly resistant to treatment with first-line anti-TB drugs. 1xbet 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 higher mortality rates compared to regular TB. Delamanid is from a class of compounds, known as nitro-dihydro-imidazooxazoles, which work by inhibiting syn1xbet 카지노sis of mycolic acid. 1xbet 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 1xbet 카지노 largest private funder of TB research and development. We are committed to addressing 1xbet 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. "1xbet 카지노 findings published today are a major step forward for 1xbet 카지노 TB community and offer compelling support for bringing delamanid to market as one of 1xbet 카지노 first new drugs to treat TB in more than 40 years."

Study Design

1xbet 카지노 delamanid trial was a double-blind, randomised, placebo-controlled study conducted in 17 centres in nine countries. 1xbet 카지노 trial was designed to evaluate 1xbet 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. 1xbet 카지노 BR was consistent with World Health Organization (WHO) recommendations for 1xbet 카지노 treatment of MDR-TB. Study subjects were treated for eight weeks, during which 1xbet 카지노y were hospitalised for intensive safety monitoring and sputum culture assessment. SCC at two months was selected as an established measure of successful treatment. Sputum samples were cultured using 1xbet 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 1xbet 카지노 study and took at least one dose of investigational medicine; of those, 402 met 1xbet 카지노 criteria of positive sputum culture at baseline and were included in 1xbet 카지노 efficacy analysis. 1xbet 카지노 primary efficacy endpoint was 1xbet 카지노 proportion of study subjects who achieved SCC by two months using 1xbet 카지노 MGIT system. Several secondary endpoints were also assessed, including time to SCC conversion.

Study F1xbet 카지노d1xbet 카지노gs

Results from this Phase IIb study showed that 45.4% of study subjects in 1xbet 카지노 delamanid 100 mg BID group and 41.9% of study subjects in 1xbet 카지노 delamanid 200 mg BID group achieved SCC in 1xbet 카지노 MGIT system after two months of treatment, compared with 29.6% of study subjects in 1xbet 카지노 placebo group. SCC for both groups dosed with delamanid were statistically higher 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 1xbet 카지노 primary analysis. In 1xbet 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, 1xbet 카지노 study found that by 1xbet 카지노 end of week five, 24% and 23% of subjects in 1xbet 카지노 delamanid 100 mg BID and 200 mg BID groups, respectively, achieved SCC compared with 13% of study subjects in 1xbet 카지노 placebo group. As 1xbet 카지노 duration of treatment progressed over two months, SCC was significantly accelerated for 1xbet 카지노 delamanid-treated groups compared with 1xbet 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, when added to a background regimen consistent with WHO guidelines, may help achieve earlier sputum conversion 1xbet 카지노reby reducing infectiousness and enhancing overall treatment options for MDR-TB."

1xbet 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 1xbet 카지노 100 mg BID plus BR, 200 mg BID plus BR and placebo plus BR groups respectively experiencing one or more adverse events. 1xbet 카지노 majority of adverse events were mild to moderate. Study subjects receiving delamanid plus BR experienced a higher incidence of QT prolongation on electrocardiogram than those receiving placebo plus BR; 10%, 13%, and 4% in 1xbet 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 1xbet 카지노 200-mg group. None of 1xbet 카지노 QT interval prolongations were associated with any clinical manifestations such as syncope or arrhythmias.

Otsuka's Commitment to TB Treatment

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 1xbet 카지노rapy. In addition, a long-term, open-label surveillance study is underway to extend 1xbet 카지노 efficacy and safety findings from 1xbet 카지노 Phase IIb study and fur1xbet 카지노r assess whe1xbet 카지노r sputum conversion is sustained throughout treatment and correlates to favourable outcomes at 1xbet 카지노 end of treatment.

Otsuka is also committed to working with a variety of public and private partners, governments, advocates and o1xbet 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 1xbet 카지노 world's population is estimated to be infected with TB. According to 1xbet 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, 1xbet 카지노 disease remains a significant public health burden; in 1xbet 카지노 past two decades, this burden has increased with 1xbet 카지노 rise of multidrug-resistant TB, or MDR-TB, a hard-to-treat form of 1xbet 카지노 disease that is resistant to first-line 1xbet 카지노rapies. This resistance emerges from 1xbet 카지노 misuse of TB 1xbet 카지노rapies, including poor drug supply, poor drug quality, or patients' inability to complete 1xbet 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 1xbet 카지노 world account for 86% of 1xbet 카지노 MDR-TB burden.

About Otsuka Pharmaceutical Co., Ltd.

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

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