Shiloh
Editor, Senior Moderator
Source: http://www.cidrap.umn.edu/news-perspective/2016/08/news-scan-aug-01-2016
News Scan for Aug 01, 2016
C diff drug fails in trial; More anthrax in Siberia
Filed Under:
Fecal transplants; Antimicrobial Stewardship; Clostridium difficile; Anthrax
[h=3]Microbiome treatment for C diff fails in phase 2 trial[/h] Biotechnology firm Seres Therapeutics announced late last week that SER-109, a drug designed to treat patients with recurring Clostridium difficile infections (CDIs), failed in a phase 2 study.
The randomized, double-blind, placebo-controlled study was intended to determine whether SER-109?essentially a collection of good bacteria from the human microbiome in pill form?could reduce the risk of CDI over an 8-week period. A total of 89 subjects were enrolled in the trial, with 59 receiving SER-109 and 30 receiving a placebo. Based on the 8-week data, CDI recurrence occurred in 44% of the subjects who received treatment with SER-109, compared with 53% in the placebo group?a difference that was not statistically significant.
The company said that the results were unexpected in light of the positive data from earlier trials, and that it plans to make appropriate adjustments to development plans for the drug in consultation with the Food and Drug Administration.
"C. difficile infection treatment options, including unregulated fecal microbial transplants, remain poor," Seres Therapeutics President and CEO Roger Pomerantz, MD, said in a company news release. "We will take our learnings from this study and continue in our pioneering efforts to develop meaningful new microbiome therapeutics for C. difficile infection and other serious diseases."
The Centers for Disease Control and Prevention estimates that C difficile caused nearly 500,000 infections in 2011, and 29,000 patients died within 30 days of the initial diagnosis.
Jul 29 Seres Therapeutics news release
[h=3]Siberia anthrax outbreak grows to 40 suspected cases[/h] Siberia is reporting 40 cases of suspected anthrax in hospitalized nomadic herders, up from 13 cases last week, the Siberian Times reported on Jul 30.
The infections may be linked to the carcasses of decades-old reindeer thawing during unseasonably hot weather and releasing Bacillus anthracis, the bacterium that causes anthrax.
According to a Popular Science report today, high temperatures have melted a layer of permafrost in Siberia and exposed the carcasses of reindeers that died during an anthrax outbreak in 1941. B anthracis, which lives in soil, can infect and kill humans and animals. Humans can contract the bacteria when they touch infected animals, inhale spores, or eat contaminated foods.
The Siberian Times reports that half of the suspected cases are in children, and that 1,200 reindeer have already died of suspected anthrax infection. The outbreak is in the Yamalo-Nenets region, which is above the Arctic Circle. That area had a heat wave in July, with several days in the 90s.
Jul 30 Siberian Times article
Aug 1 Popular Science article
Jul 29 CIDRAP News scan on earlier reports
CIDRAP overview on anthrax
News Scan for Aug 01, 2016
C diff drug fails in trial; More anthrax in Siberia
Filed Under:
Fecal transplants; Antimicrobial Stewardship; Clostridium difficile; Anthrax
[h=3]Microbiome treatment for C diff fails in phase 2 trial[/h] Biotechnology firm Seres Therapeutics announced late last week that SER-109, a drug designed to treat patients with recurring Clostridium difficile infections (CDIs), failed in a phase 2 study.
The randomized, double-blind, placebo-controlled study was intended to determine whether SER-109?essentially a collection of good bacteria from the human microbiome in pill form?could reduce the risk of CDI over an 8-week period. A total of 89 subjects were enrolled in the trial, with 59 receiving SER-109 and 30 receiving a placebo. Based on the 8-week data, CDI recurrence occurred in 44% of the subjects who received treatment with SER-109, compared with 53% in the placebo group?a difference that was not statistically significant.
The company said that the results were unexpected in light of the positive data from earlier trials, and that it plans to make appropriate adjustments to development plans for the drug in consultation with the Food and Drug Administration.
"C. difficile infection treatment options, including unregulated fecal microbial transplants, remain poor," Seres Therapeutics President and CEO Roger Pomerantz, MD, said in a company news release. "We will take our learnings from this study and continue in our pioneering efforts to develop meaningful new microbiome therapeutics for C. difficile infection and other serious diseases."
The Centers for Disease Control and Prevention estimates that C difficile caused nearly 500,000 infections in 2011, and 29,000 patients died within 30 days of the initial diagnosis.
Jul 29 Seres Therapeutics news release
[h=3]Siberia anthrax outbreak grows to 40 suspected cases[/h] Siberia is reporting 40 cases of suspected anthrax in hospitalized nomadic herders, up from 13 cases last week, the Siberian Times reported on Jul 30.
The infections may be linked to the carcasses of decades-old reindeer thawing during unseasonably hot weather and releasing Bacillus anthracis, the bacterium that causes anthrax.
According to a Popular Science report today, high temperatures have melted a layer of permafrost in Siberia and exposed the carcasses of reindeers that died during an anthrax outbreak in 1941. B anthracis, which lives in soil, can infect and kill humans and animals. Humans can contract the bacteria when they touch infected animals, inhale spores, or eat contaminated foods.
The Siberian Times reports that half of the suspected cases are in children, and that 1,200 reindeer have already died of suspected anthrax infection. The outbreak is in the Yamalo-Nenets region, which is above the Arctic Circle. That area had a heat wave in July, with several days in the 90s.
Jul 30 Siberian Times article
Aug 1 Popular Science article
Jul 29 CIDRAP News scan on earlier reports
CIDRAP overview on anthrax