A Medical Device Daily

A study presented at the American Society of Hypertension (ASH; New York) 22nd Annual Scientific Meeting and Exposition in Chicago reports that the HemoCue Albumin 201 system, a point-of-care diagnostic test developed by HemoCue (Angelhom, Sweden), can detect microalbuminuria, a biological marker for kidney and cardiovascular disease, as accurately as conventional laboratory tests.

The investigators found that quantitative test results using the HemoCue Albumin 201 system are as accurate as laboratory albumin-to-creatinine (ACR) estimations and are at least as sensitive and specific for microalbuminuria detection.

The HemoCue Albumin 201 system showed a sensitivity of 92% and a specificity of 98% for the diagnosis of elevated urine albumin excretion (UAE). Estimation of ACR, a method typically performed in a laboratory setting, displayed sensitivity of 73% and specificity of 96% for the diagnosis of elevated UAE.

The positive predictive value and negative predictive value of each test for the diagnosis of elevated UAE were 92% and 98% for the HemoCue system and 85% and 92% for ACR. The study involved 165 subjects with various risk factors for cardiovascular and chronic kidney disease.

"The availability of a point-of-care test method that is as accurate as a lab test in quantitatively measuring albumin in urine is expected to have a positive impact on the diagnosis and treatment of chronic kidney disease in at-risk populations," said the study's lead investigator, professor George Bakris, MD, director of the Hypertensive Diseases Center at the University of Chicago-Pritzker School of Medicine.

Microalbuminuria is a condition characterized by increased level of albumin excretion in urine, well-recognized as a marker for endothelial dysfunction, and established as the first indication of diabetic nephropathy. Microalbuminuria is also associated with higher risk for cardiovascular events.

HemoCue is a business of Quest Diagnostics (Lyndhurst, New Jersey).

In other reports:

• In a paper to be presented at the Nano Science and Technology Institute (NSTI; Cambridge, Massachusetts) Nanotech 2007 Conference in Santa Clara, California, researchers at the University of California, San Francisco (UCSF) will discuss the creation nanotubes from biocompatible metal oxides that can hold therapeutic proteins or drugs and deliver these agents in a controlled manner. The fabrication strategies developed by the authors is flexible in terms of controlling the diameter and length scales of the tubes. By changing these physical parameters of nanotubes, they could precisely control the dosage and deliver drugs at physiological rates for desired duration of time.

In the case of orthopedic implants with nanotubes on the implant surfaces, drugs such as antibiotics can be loaded in the tubes and released right at the site of implantation. This method, which targets the drug where it is needed, can avoid the side effects due to high dosages normally given to patients. Further, in cases where a very long treatment regimen is needed, such as in growth factor therapy, nanotubes may provide superior performance.

"When a person has an orthopedic implant surgery, they normally will have to take antibiotics and growth factors either orally or by injection," said Ketul Popat, MD, a principal investigator. "There are several side effects associated with taking drugs this way which can be very painful for the patient. However, by placing the drugs on to the surface of these implants, we can deliver them right where they are needed and can avoid larger doses and side effects."

The presentation, "Drug-Eluting Nanostructured Coatings," will be given today.

• Cougar Biotechnology (Los Angeles) reported that positive Phase I and Phase II data on the company's prostate cancer drug candidate CB7630 (abiraterone acetate) was presented at the annual meeting of the American Urological Association (AUA; Linthicum, Maryland) annual meeting in Anaheim, California.

The data was presented by Timothy Yap, MD, from the Cancer Research UK Centre for Cancer Therapeutics at the Institute of Cancer Research (London).

The Phase I/II trial of CB7630 was conducted at The Institute of Cancer Research and at the Royal Marsden NHS Foundation Trust in the UK.

In the trial, CB7630 was administered orally, once daily, to chemotherapy-na ve patients with castration refractory prostate cancer (CRPC), who had progressive disease despite treatment with LHRH analogues and multiple other hormonal therapies, including antiandrogens, diethylstilboestrol and dexamethasone.

Yap reported that in the 38 patients treated in this trial thus far, CB7630 was well tolerated at doses as high as 2000 mg/day with minimal toxicity. Moreover, no dose limiting toxicity has been observed in the trial to date. In the 30 patients evaluable in the Phase I/II trial, 18 patients (60%) experienced a confirmed decline in PSA levels of greater than 50%, with 10 of the 30 patients experiencing PSA declines of greater than 90%. Six additional patients experienced a decline in PSA that was less than 50%.

Of the 20 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses (as measured by the RECIST criteria) in 11 patients (55%), with seven patients demonstrating ongoing stable disease and three experienced regressing bone disease. Individual patients treated with CB7630 also experienced improvement in pain and a reduction in opioid use.