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