Biotechnology Healthcare - September/October 2008 - (Page 8)

DRUG TRACK Research, Conferences, and FDA Actions Michael D. Dalzell, Editor Rheumatology agents The long-awaited results of the pivotal phase 3 trial of denosumab proved to be good news for Amgen: The bone drug produced statistically significant reductions in the incidence of vertebral, nonvertebral, and hip fractures compared with placebo. Moreover, Amgen reported no major side-effect concerns in the treatment cohort — a departure from smaller studies that suggested an elevated risk of serious infections, such as tuberculosis, or cancer. More than 7,800 women with osteoporosis took part in the 3-year international study. The positive news for Amgen came on the heels of a British study of its best-selling TNF-α inhibitor, etanercept (Enbrel), that documented prompt remission of rheumatoid arthritis when it is given early in the course of the disease. A regimen of etanercept and methotrexate in patients whose RA had been classified as moderate to severe for less than 2 years led to remission in about half of the 542 people studied. After 1 year, disease progression stopped in 8 of 10 people who received the combination therapy, compared with about 6 of 10 patients who were treated with methotrexate alone. Hoping to make its own inroads in the RA market, Roche released more positive data from two phase 3 trials of its interleukin 6 receptor blocker, tocilizumab (Actemra). One of the studies, published in Annals of Rheumatic Diseases, evaluated difficult-to-treat patients with moderate to severe RA who had failed previous anti-TNF-α therapies. Half of those receiving tocilizumab achieved ACR20. Oncology trials Median survival and time to radiologic progression were 3 months longer for advanced liver cancer patients treated with Bayer’s sorafenib (Nexavar) than those who were given placebo. The multicenter, double-blind, placebo-controlled trial of 602 patients was published in the New England Journal of Medicine. Acknowledging that it had lost the race with Bayer to bring a liver cancer treatment to market, Progen Pharmaceuticals abandoned development of its main product, PI88. The novel antithrombotic had been studied not only for liver cancer but also for skin and lung malignancies, with mixed success. Ofatumumab (formerly HuMax CD20) hit primary and secondary endpoints in a phase 3 trial in patients with chronic lymphotic leukemia (CLL) who did not respond to methotrexate or TNF-α inhibitors. GlaxoSmithKline, which spent $2 billion to license ofatumumab from Genmab, plans to seek U.S. Food and Drug Administration approval before the end of the year. Ofatumumab also is being investigated for RA, multiple sclerosis, and non-Hodgkin’s lymphoma (NHL). In a mid-stage study, bendamustine (Treanda), Cephalon’s infusion therapy for CLL, induced a clinical response in patients with NHL when used in combination with rituximab (Rituxan). Ark Therapeutics reported positive results from a late-stage trial of sitamagene (Cerepro), its gene therapy for malignant brain tumors. Motesanib, one of five Amgen oncology drugs in phase 3 testing, delayed or reversed the growth of thyroid tumors, found a study published in NEJM. In high-risk melanoma patients, sargramostim (Leukine) increased mature dendritic cells, which help the immune system recognize cancer cells. Bayer reported results of the prospective phase 2 study. A late-stage trial of TroVax, Oxford BioMedica’s therapeutic vaccine for renal cancer, will not hit its endpoint because of too many patient deaths in the trial. A data safety monitoring board said the trial could continue, but wanted further vaccinations discontinued. Other research of note Elan and Wyeth will proceed to a phase 3 study to determine the usefulness of bapineuzumab in patients with Alzheimer’s disease. Mid-stage results, presented at the International Conference on Alzheimer’s Disease, showed that bapineuzumab improved 3 of 4 measures of cognitive tasks in Alzheimer’s patients without ApoE4, a genetic variation found in about half of those people with Alzheimer’s and that predisposes them to the condition. But the drug failed to improve dementia symptoms. If bapineuzumab makes it to market, it could be the first disease-modifying Alzheimer’s drug available, now that Myriad Genetics and Lundbeck have discontinued development of tarenflurbil (Flurizan). So concluded Decision Resources in an analysis issued after tarenflurbil’s late-stage failure to stop the buildup of toxic plaques. AtheroGenics’ antioxidant, succinobucol, appears to slow or prevent progression to diabetes in cardiovascular patients with a prediabetic condition, according to data extracted from a 6,000-patient, phase 3 study. Topline results from a 8 BIOTECHNOLOGY HEALTHCARE · SEPTEMBER/OCTOBER 2008

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Biotechnology Healthcare - September/October 2008 Openers Editorial/David B. Nash, MD, MBA Contents At a Glance: Multiple Sclerosis Drug Track Personalized Medicine Healthcare Reform’s Effects on Biologic Access Breast Cancer Status Testing: A Crapshoot With Deadly Odds Trends, Issues, and Perspectives In the Management of MS So High-Tech, Yet So Simple The Evolution of Ascertaining the Value Proposition Specialty Pharmacy Employer to Employer Health Plan Confidential Trends

Biotechnology Healthcare - September/October 2008

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