Outlook: Clinical Trials

SEPTEMBER 01, 2008
Susan Farley

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

Budesonide for Childhood Sleep Apnea

A recent study showed that a nasal spray form of the corticosteroid budesonide improves nighttime breathing for children with mild sleep apnea. Previous studies demonstrated that intranasal corticosteroids reduce the size of the nasal tissues in the upper airway. While the treatment is usually reserved for children with more severe obstructive sleep apnea, this study sought to determine effects on children with milder apnea. The 62 study participants received either a spray of budesonide or a spray of placebo in each nostril at bedtime for 6 weeks, at which time they switched to the other treatment for 6 weeks. Children who received the budesonide sprays had significant improvements to their quality of sleep, as well as significant reductions in the size of their adenoids. Study authors are encouraged by these results and hope that this data supports "temporarily throwing away the scalpel" for children with mild sleep apnea. The report appears in the July 2008 issue of Pediatrics.

Osteoporosis Drug Update

A recent news release announced that Amgen's osteoporosis drug denosumab performed well in late-stage clinical trials. After testing the drug on 1400 men over a 3-year period, researchers found that denosumab increased bone density in the lumbar spine when compared with placebo. Men who were taking denosumab also reported fewer fractures in the vertebrae than those in the placebo group. In the company?s largest drug development venture to date, Amgen is testing the drug in 19,000 patients who are being treated for bone cancer or cancer-related bone loss.

Azilect Slows PD Progression

Based on the results of the ADAGIO study, Teva Pharmaceuticals plans to submit results to regulatory authorities in the United States and Europe, which could lead to Azilect becoming the first treatment for Parkinson?s disease (PD) to have a label for disease modification. The ADAGIO study was a 1176-patient, randomized, multicenter, double-blind, placebo-controlled study of rasagiline and its ability to modify PD in untreated patients. Study participants were divided into 2 groups: (1) the earlystart group that received 1 or 2 mg/ day of rasagiline for 72 weeks or (2) the delayed-start group that received 36 weeks of placebo followed by 36 weeks of rasagiline 1 to 2 mg/day. Teva announced at the 12th Congress of European Federation of Neurological Societies in August that Azilect slowed the progression of PD with the 1-mg dose and met all 3 primary end points, as well as the secondary end point with statistical significance.

Company Gears Up for 2 New Obesity Drugs

Orexigen Therapeutics is randomizing patients for a phase 2b trial of Empatic (a combination of zonisamide and bupropion, both approved by the FDA)—1 of 2 obesity drugs that they have in the works. The trial will be a randomized, double-blind, placebo-controlled trial of 720 generally healthy, nondiabetic obese patients at 20 US sites. For the study, patients will be placed in 6 treatment groups, which include 2 of the Empatic doses associated with weight loss in the previous phase 2b trial. Researchers will compare the drug with zonisamide monotherapy, bupropion monotherapy, and placebo. Orexigen expects results in mid- to late-2009. Results from the company's previous trial were highly encouraging in terms of safety and efficacy. Those study results included weight loss at 48 weeks ranging from 11% to 15%. Discontinuation rates were not statistically different from placebo. Orexigen's other drug is Contrave, now in phase 3 trials. The company is anticipating great potential in both drugs.

New Hope for Melanoma Treatment

A new drug combination of interferon alfa-2b and lovastatin from NeoPlas Innovation has stopped the progress or eradicated the tumors in at least 80% of melanoma patients. Although testing is in early stages, researchers point to the case of the first person treated with NeoPlas' protocol. Diagnosed with stage 4 melanoma and a life expectancy of only 8 weeks, this patient was treated with the NeoPlas drug combination and had a complete response, remaining disease-free for 8 years. While complete eradication of tumors or long-term stability is most common with this treatment, many patients will at least see their disease progression slow substantially. According to research, the drugs included in the combination are not effective when administered alone, but when given as part of a combination therapy, the dosages are lower, more tolerable, and much more effective. The unique combination works by disabling specific abnormal cellular processes that are typical of aggressive malignancies. Researchers are hopeful that this combination can be effective not only for melanoma but pancreatic cancer, colon cancer, renal cancer, mesothelioma, osteosarcoma, chondrosarcoma, and malignant fibrous histiocytoma.