Outlook: Clinical Trials

MAY 01, 2008
Susan Farley

Ms. Farley is a freelance medical writer based in Wakefield, Rhode Island.

Blood Pressure Vaccine on the Horizon

A small study out of Lausanne, Switzerland, treated 72 patients with mild-to-moderate high blood pressure with either a vaccine or placebo. Patients in the vaccine group demonstrated a strong antibody response against angiotensin II, compared with those in the placebo group?the response was stronger when the vaccine?s dose was higher. Chief scientific officer, Dr. Martin Bachmann, at the vaccine?s developer, Cytos Biotechnology AG, noted that the vaccine was most effective in the early morning, which is considered the most dangerous time to have high blood pressure, as it further increases the risk of stroke and heart attack. He says that the vaccine acts like a sponge, emptying out at night when less angiotensin II is produced; that way, in the morning, the vaccine can take up all the angiotensin that is produced. Conventional drug therapies leave hypertensive patients most vulnerable in the morning, as they have not yet taken their meds. Also, conventional medications seem to increase renin levels, thereby increasing risk of kidney failure. The vaccine has no such risk. Although these results are promising, researchers agree that more work is needed to evaluate the vaccine?s clinical usefulness.

Positive Study Results for Osteoarthritis Drug

A phase 3 study of naproxcinod, the first compound in the cyclo-oxygenase? inhibiting nitric oxide donator class of drugs, showed that all 3 end points were met successfully, including pain, function, and patients? rating of disease status.

The study randomized 918 osteoarthritis patients to receive naproxcinod 375 mg bid, naproxcinod 750 mg bid, naproxen 500 mg bid, or placebo for 13 weeks. When compared with placebo, 3 different doses of naproxcinod demonstrated superiority to placebo at weeks 2, 6, and 13. Qualityof- life scores also were superior to those in the placebo group. According to the principal investigator, Thomas J. Schnitzer, MD, PhD, of Northwestern University Feinberg School of Medicine, ?These phase 3 results suggest that naproxcinod may offer a promising clinical and pharmacological profile for the treatment of the signs and symptoms of osteoarthritis.?

Bayer Drug Extends Survival with Lymphoma

A multinational phase 3 trial of ibritumomab tiuxetan (Zevalin) showed that the drug improves progression-free survival in patients with advanced follicular lymphoma (FL). Researchers observed 2 groups of FL patients: one that was given Zevalin in a single dose as a first-line therapy, and another group that received no further treatment. Patients taking Zevalin experienced a longer progression-free survival period, compared with the control group. Zevalin has been approved in Europe since 2004. Complete study results were presented at the 49th Annual Meeting of the American Society of Hematology in Atlanta.

Cetuximab Improves Survival Rates for Patients with Colorectal Cancer

A randomized, multicenter, phase 3 trial of cetuximab (Erbitux) revealed that the drug offered a ?significant improvement? in the overall survival for patients with metastatic colorectal cancer (mCRC). The study divided 572 patients into 2 study groups: one group receiving Erbitux and what is known as best supportive care (BSC), and another group receiving BSC only. These particular mCRC patients had seen their disease progress through all approved chemotherapy treatments. After patients in the study group received an initial dose of 400 mg/m2, they received 250 mg/m2 per week until the disease began to progress again or they experienced unacceptable toxicity. Results showed that the median survival rate for patients in the Erbitux group was 6.1 months, compared with 4.6 months for patients in the BSC-only group. The drug?s manufacturers, ImClone Systems and Bristol-Myers Squibb, note that Erbitux may provide mCRC patients with additional time, even after all other treatments have failed. These results prompted the FDA to approve a label change for Erbitux to include these survival data.