A Medical Device Daily

Health agencies from the U.S., Canada and Mexico agreed last week to strengthen cross-border coordination and cooperation in the surveillance, prevention and control of infectious diseases.

The memorandum of understanding, signed by U.S. Secretary of Health and Human Services Mike Leavitt, Canadian Minister of Health Tony Clement and Mexican Secretary of Health Jose Angel Cordova Villalobos, commits the three countries to assist one another during a public health emergency and sets forth examples of the types of aid the countries may provide to and accept from one another during such an emergency.

“The health of our three nations relies upon our cooperation with and assistance to each other in times of need,” Leavitt said. “As North American neighbors, we owe it to our citizens to work together whenever possible to minimize the spread and impact of an infectious disease outbreak or other public health emergency that may affect our nations.”

Clement said that threats to public health and safety “transcend borders, and this agreement represents a meaningful step forward in improving our nations’ readiness.”

Villalobos said that the memorandum “reflects a true cooperative intention from our nations to join forces during exceptional public health emergencies of international concern, and may be used as a model for other countries and regions of the world.”

The three countries agree to cooperate to improve their public health emergency preparedness and response as to border health, laboratory testing, diagnosis and treatment, epidemiological investigation, and infectious disease control. It also commits them to strengthen their procedures and processes for the sharing of lab information before and during an emergency; to continue technical review and sharing of assay methods, reagents and laboratory results; and to participate in trilateral or bilateral exercises to assess and strengthen public health emergency response.

Hemopurifier trials begin in India

Aethlon Medical (San Diego), a developer of devices to treat infectious disease, reported initiating clinical testing of the Aethlon Hemopurifier in human studies at Fortis Hospital (Delhi, India) to evaluate safety of the Hemopurifier in up to 10 patients with end-stage renal disease.

The company said the Hemopurifier removes infectious viruses and immunosuppressive proteins from circulation, allowing the natural immune response to overcome viral infection. “The launch of this study is a significant milestone, as its successful completion will trigger our commercialization efforts in India,” said James Joyce, CEO and chairman of Aethlon.

Aethlon said commercialization of the Hemopurifier in India “will be based on obtaining sufficient clinical data to drive practitioner confidence and acceptance in the marketplace. Pending the successful completion of the study, Aethlon will focus on medical conditions of greatest concern to the people of India, [including] Dengue hemorrhagic fever and HIV/AIDS.”

Joyce said the study’s demonstration of safety, “combined with supporting data from our numerous research collaborations will provide the opportunity to treat India’s most significant infectious disease threats.”

Vijay Kher, MD, principal study investigator, is director of nephrology at Fortis. He previously acted as principal investigator of a Hemopurifier study conducted at the Apollo Hospital (Delhi). That study documented initial safety of the Hemopurifier and provided early efficacy observations during 24 treatments administered to dialysis patients co-infected with hepatitis-C.

Aethlon said that in a recent collaboration with researchers at India’s National Institute of Virology documented that the Hemopurifier is “highly efficient in capturing infectious dengue virus from blood.” In preliminary studies, the Aethlon Hemopurifier removed up to 90% of live dengue virus in 30 minutes.

The company said it also is discussing the treatment of HIV-infected patients with India’s National AIDS Research Institute. It is estimated that India had 5.7 million HIV cases last year, the largest infected population of any other country.

Central American CRO bought by Quintiles

Quintiles Transnational (Research Triangle Park, North Carolina) said that its Quintiles Latin America (Argentina) subsidiary has purchased Bio-Trials (Panama), a Central American clinical research organization with offices in Costa Rica, Guatemala, Ecuador and Peru.

Bio-Trials provides clinical monitoring, clinical site coordination, regulatory support, study management and supply distribution services and has conducted about 30 clinical trials in 10 Central and South American countries, and it has supply distribution points in Panama, Costa Rica, Guatemala and Peru.

“The acquisition of Bio-Trials gives Quintiles an experienced, well-established team as well as access to an experienced network of independent investigators in the increasingly important Central American region,” said Jeff Thomis, president of Quintiles’ global clinical development services. “Our customers are increasingly including Central America as part of their global ... program[s].”

Quintiles Latin America, founded in 1995, has nearly 600 employees in six countries and has conducted more than 300 studies involving more than 30,000 patients.

CURE to build Bethlehem hospital

CURE International (Lemoyne, Pennsylvania), a Christian charity operating teaching hospitals throughout the developing world, has reported plans to open a $16.5 million medical training center and hospital in Bethlehem, Palestine. The facility will be the first specialty surgical care available to Palestinian children in the West Bank, CURE said.

“This cardiac and orthopedic hospital fills a major need in the West Bank where medical care is severely limited,” said Scott Harrison, MD, an orthopedic surgeon who founded CURE International 10 years ago and is its president/CEO. “We are encouraged by the great support we’ve already received from both the Israeli and Palestinian governments ... .”

Harrison said that the Bethlehem hospital “is unique in that it is bringing together three faith groups to build a facility of healing in a very volatile region. Christians and Muslims will serve together at the hospital and will receive additional training at some of the leading hospitals in Jerusalem including Hadassah and Schneider.”