Biotechnology Healthcare - November/December 2008 - (Page 14) DRUG TRACK Research, Conferences, and FDA Actions Schuyler Matthews, Contributing Editor Selected late-stage trials Amgen released additional data from two previously reported studies of denosumab. The investigational osteoporosis therapy reduced new spinal fractures by 68 percent and hip fractures by 40 percent compared to placebo in postmenopausal women with osteoporosis. And, in a head-to-head comparison with oral alendronate (Fosamax), three quarters of patients said they preferred the twiceyearly, subcutaneous denosumab injections to a weekly tablet. Amgen’s TNF-α inhibitor, etanercept (Enbrel), did not fare as well in the first head-to-head comparison of two biologic psoriasis treatments. In a randomized trial of 903 patients with moderate to severe plaque psoriasis, Centocor declared its interleukin-12/-23 blocker ustekinumab (Stelara) superior to etanercept on the basis of 12-week outcomes. Patients given ustekinumab received low- or high-dose injections twice during the study period; 68 percent of those given the lower dose and 74 percent of those given the higher dose experienced a 75 percent or greater reduction in psoriasis severity (PASI-75). Among patients treated with twice-weekly Meeting highlights ASCO Breast Cancer Symposium September 2008 Interim results from a study evaluating molecular breast imaging (MBI) as a screening method show that MBI is a better method than mammography in women with mammographically dense breasts, as well as in women who are at increased risk for breast cancer. MBI detected three times as many cancers as mammography. Of the 13 cancers that were detected, 8 were detected by MBI alone. Researchers measuring quality of life among women with HER2positive, metastatic breast cancer treated with either lapatinib (Tykerb) alone or lapatinib with trastuzumab (Herceptin) reported a similar QOL among patients who received combination therapy as those given lapatinib alone. The fact that the combination therapy — for which studies have shown a significant clinical benefit — maintained QOL was heralded as a key consideration for patient care. The combination of oxaliplatin chemotherapy and trastuzumab in patients with HER2-positive breast cancer was reported to be well tolerated, with no significant toxicities. … Trastuzumab monotherapy was compared to trastuzumab in combination with chemotherapy as a firstline treatment for HER2-positive breast cancer. Results suggest equivalent efficacy and similar safety and tolerability profiles for the two approaches, but phase 3 trials are needed to confirm these results. Another study found no cardiac events associated with a regimen of bevacizumab (Avastin) and trastuzumab, or when bevacizumab was combined with docetaxel chemotherapy in HER2-positive patients. injections of etanercept (50 mg), 57 percent achieved PASI-75. Amgen downplayed the results, saying that the long-term efficacy of the new product had not yet been established. Recombinant human C1 inhibitor (Rhucin), derived from the milk of genetically modified rabbits, was denied approval by the European Medicines Agency in March. In response, Pharming, a Dutch biotech, issued a safety analysis of more than 300 administrations — half of which were repeat treatments — showing no adverse incidents. Pharming plans to submit a biologics license application with the U.S. Food and Drug Administration by the end of this year. Rhucin was developed for the treatment of hereditary angioedema, and is a potential competitor to Dyax’s HAE drug, DX-88 (ecallantide), which has orphan and fast track status in the United States. Dyax included recent phase 3 data of DX-88, documenting symptom reductions in 94 percent of HAE patients taking the drug, in its September BLA. Well known as a wrinkle cure, botulinum toxin type A (Botox) also works for chronic migraines, according to Allergan, which completed a phase 3 study that documented a reduction in the number of headache days. A second phase 3 study, using headache days as the endpoint, showed reductions in both headache days and headache episodes. Allergan intends to file a supplemental BLA for the new indication by the middle of next year. Cell Genesys terminated VITAL-2, the second of two phase 3 trials of its GVAX prostate cancer vaccine, after revealing that 67 patients who 14 BIOTECHNOLOGY HEALTHCARE · NOVEMBER/DECEMBER 2008
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