Silicon Valley-based KaloBios Pharmaceuticals, Inc., a privately held bio-pharmaceutical company, this week announced the initiation of a clinical trial of KB001, a high-affinity antibody fragment that the firm is developing for the treatment of P. aeruginosa lung infections. The trial is being conducted in conjunction with the Cystic Fibrosis Foundation, and others

The blind, placebo-controlled trial is being conducted at over 10 sites across the U.S., and will enroll up to 48 patients with cystic fibrosis who will receive either one of two dose levels of KB001 or placebo. Goals for the trial include determination of safety, reduction of P. aeruginosa bacteria, and inflammatory markers.

“KB001 is a very novel approach that targets the principal mechanism by which P. aeruginosa becomes pathogenic,” said Geoffrey Yarranton, chief scientific officer.

Researchers demonstrated in both laboratory and rodent studies that KB001 is active against drug resistant strains of this bacterium.

P. aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. These include the approximately 70,000 worldwide patients with cystic fibrosis where P. aeruginosa is a major causative agent in the progressive loss of lung function resulting from recurrent and chronic respiratory tract infections.

This is a phase 1/2 clinical trial, which means that the data from a small previously conducted human trial of healthy volunteers indicated that there were limited or no side effects, and so KB001 is now being tested in cystic fibrosis patients between 18 and 45 years of age with P. aeruginosa in their lungs. KB001 is a fragment of a monoclonal antibody — a biologic drug.

The drug must be given intravenously or as an injection, but its effects may last for weeks.

The technology developed by KaloBios is a proprietary method for converting non-human antibodies into engineered human antibodies.

– by Gene J. Koprowski, Editorial Director

P. aeruginosa infection can be quite harmful for those with CF.

Posted: March 31st, 2008 under Antibiotic Resistant, Feature Stories.
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Scientists, public health workers, and police have worked together to stop alleged traders of fake “anti-malarial drugs” in southern China, according to foreign media reports. The project led to the seizure of a large quantity of counterfeit drugs. The seizure demonstrates the growing threat posed by fake pharmaceuticals and the complexities of tracking down those responsible its proliferation.

Called Operation Jupiter, the investigation was coordinated by the International Criminal Police Organization (INTERPOL), the World Health Organization’s Western Pacific Regional Office, and the Wellcome Trust-University of Oxford Southeast Asian Tropical Medicine Research Program, in close cooperation with Chinese authorities.

Scientists from five other laboratories analyzed the composition of the fake drugs and their packaging. The results of this collaboration are published today in the medical journal PLoS Medicine.

Counterfeit anti-malarial drugs are an increasingly serious problem, particularly in South-East Asia and Africa. In countries with a large burden of malaria, such as Burma, Laos, Cambodia, and Vietnam, as many as “half of all artesunate” tablets—one of the most effective anti-malarial drugs—are counterfeit.

Most of the counterfeits examined as part of Operation Jupiter contained no artesunate. Some contained a wide range of potentially toxic wrong active ingredients. Counterfeiters sometimes included small amounts of artesunate in the tablets. This is to evade screening tests of drug quality, but these doses are too low to be effective, yet potent enough to contribute to malaria parasites becoming resistant to this class of drugs.

“Artesunate, as part of artemisinin-based combination therapy, is vital for malaria treatment and is one of the most effective weapons we have against this terrible scourge,” says Paul Newton of the Wellcome Trust-University of Oxford South East Asian Tropical Medicine Research Program. “If malaria becomes resistant to artesunate, the effect on public health in the tropics will be catastrophic.”

The evidence suggests that at least some of the counterfeit artesunate came from southern China, and this was supported by examination of the mineral calcite, found in some of the samples.

One suspect is alleged to have traded 240,000 blisterpacks of counterfeit artesunate, enough to “treat” almost a quarter of a million adults with a medicine with no activity against a potentially fatal disease. Whilst the Chinese authorities were able to seize 24,000 of these packs, the remainder are alleged to have been sold at crossings on the border of Yunnan and Burma, almost a half of all blisterpacks of artesunate sold to the region.

“Criminal investigations and legal action are important in disrupting and inhibiting the trade in fake medicines, but to be effective these will require financial support and resources,” says Newton.

– by Gene J. Koprowski, Editorial Director

Fake anti-malaria drugs proliferate in China, Africa.

Posted: March 31st, 2008 under Feature Stories, Malaria.
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http://www.care-mates.com/main/index.asp?p=About_Us

Former Secretary of State (now a health television host) Alexander Haig discusses infectious diseases with Shepard Medical CEO Chris Wright.

Posted: March 31st, 2008 under Audio-Video Reports, Infection Protection.
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http://www.shinglesinfo.com/symptoms-of-shingles.html

Good information.

– by Chris Wright, Publisher

Posted: March 31st, 2008 under Audio-Video Reports, Shingels.
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http://www.youtube.com/watch?v=BQR5z_omnhg

We’ve seen this disease presenting in a middle-aged female patient at a Chinese medical clinic in Chicago. Very scary. Medical doctors think it may be a psychiatric disorder, but other scientists are unsure of the etiology. The Morgellons Research Foundation is leading the effort to understand the disease.

– The Editors

Posted: March 31st, 2008 under Audio-Video Reports, Morgellons Disease.
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http://www.youtube.com/watch?v=ZPnpmVWU0Hk

Informative presentation.  

– by The Editors

Posted: March 31st, 2008 under Audio-Video Reports, Parkinson's.
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http://www.youtube.com/watch?v=o1YI3pNATCU

Well-produced.

– The Editors

Posted: March 31st, 2008 under Alzheimer's, Audio-Video Reports.
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Posted: March 31st, 2008 under Audio-Video Reports, Developing Diseases.
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http://www.youtube.com/watch?v=gLX4KF7xzv0

Important information here.

– The Editors

Posted: March 31st, 2008 under Audio-Video Reports, Lyme disease.
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View the Introduction. http://www2.onu.edu/~n-oliver/reed.htm
If you would like to take this course, go to our web site and click on continuing education. After you have registered, we will send you your password to take the course. http://www.care-mates.com/main/index.asp?p=Continuing_Education

Posted: March 29th, 2008 under Audio-Video Reports, Continuing Education, Infection Protection.
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