Category Archives: Transhuman News

Phase 2 human trial set to examine effectiveness of topical gel in treating post-surgical orthopedic infections

Newswise PHILADELPHIA A team of researchers led by Samir Mehta, MD, chief of the Orthopaedic Trauma & Fracture Service at the Perelman School of Medicine at the University of Pennsylvania, has received a $2.5 million grant from the Congressionally Directed Medical Research Program (CDMRP), provided through the U.S. Department of Defense (DoD), to begin Phase 2 human trials of a study that examines the effective treatment of post-surgical orthopedic infections using Microbion Corporations topical BisEDT drug. The University of Pennsylvania will work with a team of researchers from Microbion and the University of California-San Francisco on the trial, set to begin pending FDA approval.

Were honored to be given this award from the DoD, and are hopeful that the Phase 2 trial will allow us to offer improved treatments and standards of care to a significant number of patients, said Mehta. Orthopaedic trauma and fracture patients are at an increased risk for infection. If successful, this new treatment strategy could be a significant step toward reducing instances of amputation, disability, and even death.

Studies show that patients requiring orthopaedic trauma surgery may be three times more likely to experience post-operative infections (8.7 percent) than patients undergoing other forms of surgery (2.8 percent) as a result of the high-energy nature of the injury. With approximately 2.6 million orthopaedic devices implanted annually in the United States, approximately 4.3 percent (112,000 patients) will suffer from a post-operative infection.

Orthopaedic extremity injuries also constitute the majority (65 percent) of combat casualties experienced in recent U.S. military conflicts. The risk of infection developing after surgical treatment of traumatic, open military wounds represents an extremely serious threat; reports indicate that military wound infection rates may be as high as 77 percent. Such infections frequently lead to death, amputation, disability, and other significant morbidity, despite the best available care.

The goal of our study is to examine the efficacy and safety of administering a single application of Microbions topical BisEDT gel to infected extremity wounds, said Annamarie Horan, MPA, PhD, director of Clinical Research for Penn Orthopaedics. The gel is not a replacement for standard antibiotics, but the promising results of the Phase 1 trial provide strong evidence suggesting the drug may be an effective supplemental treatment.

Phase 1 human trials of BisEDT were successfully completed in 2011. In June 2012, the CDMRP award team met with the FDA in Washington D.C. to discuss the teams plan to advance to Phase 2 human clinical studies for the treatment of infections associated with orthopedic trauma. Clinical studies for Phase 2 will begin next year at the Hospital of the University of Pennsylvania, and at UCSF/San Francisco General Hospital.

Last year, the World Health Organization noted a significant rise in the rate of infections that are able to ward off antibiotic treatment. The alarming rate of antibiotic resistant infections has since been labeled a global health crisis. The research team is hopeful that future research and development of drugs like BisEDT will lead to new standards of health care and improved treatments for all patients.

Dr. Mehta and Dr. Horan do not have any financial affiliation with Microbion Corporation.

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U.S. Department of Defense Awards Penn Researchers Funding to Investigate New Anti-Infection Drug

The Associated Press Published Wednesday, Oct. 3, 2012 7:15AM EDT Last Updated Wednesday, Oct. 3, 2012 8:28AM EDT

HONG KONG -- When two boats filled with people collided on Hong Kong's busy waterways, the impact knocked a hole in one vessel's engine room and the water poured in too fast to stop it from sinking. Passengers struggled to find life vests and dozens drowned in the turbulent waters.

Rather than rush to help, however, the crew of the other vessel, a ferry, seemed paralyzed, according to witnesses. After pausing briefly near the doomed ship filled with holiday revelers, the ferry continued on to its berth.

Shock over Monday's crash, which left 38 dead, gave way to outrage Wednesday over what experts concluded was human error. Investigators have not publicly offered a theory of how the collision occurred but have arrested seven crew members, including both captains.

The ferry company denied accusations that the boat left immediately after the crash, but did not say whether its crew did anything to help the other vessel as it rapidly sank.

The captain of the Sea Smooth ferry was in a hospital with rib injuries Wednesday, said Nelson Ng, general manager of Hong Kong and Kowloon (Ferry) Holdings. He said staff members tried to talk to the captain, but he added, "We have to wait for the psychologist's report. ... He doesn't really want to say anything."

When asked whether the captain blames himself for the accident, Ng said, "He's emotionally depressed, so I believe he probably does." He did not release the captain's name.

The collision, Hong Kong's deadliest maritime accident since 1971, has hit at the heart of the semiautonomous territory's identity. Fleets of ferry boats form the backbone of the transport network, and much of Hong Kong's economy relies on its reputation as a well-managed shipping hub.

"We cannot help but be shocked and angry," the English-language South China Morning Post said in an editorial Wednesday. It said "pinpointing fault and ensuring that there is no repeat" would be a matter of "safety, reputation and financial well-being."

All 38 people killed had been on the Lamma IV, a boat owned by utility company Hong Kong Electric, which was taking about 120 of its workers and their families to watch fireworks in celebration of China's National Day and mid-autumn festival.

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Outrage over human errors in deadly Hong Kong boat crash

Wednesday 03 October 2012 by John Hyde

Campaign group Justice has appointed human rights lawyer Andrea Coomber (pictured) as its new director.

Coomber, currently legal director of the international human rights organisation Interights, replaces Roger Smith. Smith announced his decision to step down in May after 11 years in the post.

Coomber will become the fifth director in Justices 55-year history when she takes up the post on 18 February 2013.

She said: Justice has a rich history in this country and an international reputation for excellence in providing thoughtful legal analysis of critical rule of law and human rights issues.

I am honoured to be part of its future and look forward to working with staff to build on its many successes.

Coomber is an Australian-qualified lawyer who spent five years working in human rights in New Delhi, Geneva and Cairo. She joined Interights in 2002 and has advised and co-represented applicants before the European Court of Human Rights, the African Commission on Human and Peoples Rights and UN treaty bodies.

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Justice names new chief