• Adventrx Pharmaceuticals Inc., of San Diego, said an independent data safety monitoring board recommended that a Phase IIb study of CoFactor (ANX-510) continue without any modifications after a planned interim analysis. CoFactor is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouracil (5-FU). The evaluation was based on data from 150 patients, half of the planned total.

• Antares Pharma Inc., of Exton, Pa., is planning to begin a Phase III program for Anturol in patients with urge and mixed urinary incontinence after holding an end-of-Phase II meeting with the FDA. The pivotal protocol will evaluate the effect of 12 weeks of treatment, though the finalization of specific details is still pending. Anturol is an oxybutynin gel product for overactive bladder. Antares expects to file for approval before the end of next year.

• DeCode Genetics Inc., of Reykjavik, Iceland, said preliminary Phase IIa results showed that asthma patients receiving CEP-1347 exhibited a dose-dependent improvement in some parameters of lung function examined in the study, including methacholine challenge test and peak expiratory flow rates, as well as in a biomarker associated with asthma severity and inflammation. There was no evidence of safety issues or tolerability concerns. CEP-1347 is partnered with Cephalon Inc., of Frazer, Pa., and is being developed through a collaborative agreement based upon DeCode's discovery of variants in the gene encoding the MAP3K9 kinase, which acts within a pathway targeted by CEP-1347.

• Genaera Corp., of Plymouth Meeting, Pa., began a Phase II trial to explore the efficacy and safety of four doses of Evizon (squalamine lactate) in up to 140 patients with wet age-related macular degeneration treated. Labeled MSI-1256F-212, the multicenter, open-label, pharmacodynamic trial will test 40-mg, 80-mg, 120-mg and 160-mg doses over a 20-week period.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., said in a preliminary Phase I trial, its nasal spray dosage form of parathyroid hormone (PTH1-34) provided comparable exposure levels to the approved subcutaneous product, Forteo (teriparatide), in elderly subjects. Data were presented at the 88th annual meeting of the Endocrine Society. The study was conducted in 25 healthy human subjects between the ages of 66 and 77. Forteo is approved for postmenopausal osteoporosis.

• OSI Pharmaceuticals Inc., of Melville, N.Y., and Pfizer Inc., of New York, started a Phase IV trial that will explore the safety and efficacy of Macugen (pegaptanib sodium injection) as a maintenance therapy for patients who have received prior neovascular age-related macular degeneration treatment and experienced improvement in macular disease. The 54-week trial will involve up to 1,000 patients at 100 sites across the country.

• Pozen Inc., of Chapel Hill, N.C., and GlaxoSmithKline plc, of London, said findings reported at the American Headache Society meeting in Los Angeles showed treatment with Trexima (sumatriptan succinate/naproxen sodium) led to superior sustained pain-free results in treating acute migraine pain compared to use of sumatriptan alone, naproxen sodium alone or placebo. Other findings from two identical studies of migraine sufferers also showed more patients in the Trexima arm reported pain relief at two hours and four hours compared to sumatriptan alone or placebo. In addition, use of the compound was statistically superior in producing pain-free rates as early as 30 minutes, and significantly more patients reached pain-free status at two hours, a result that was sustained for 24 hours without the use of additional medicine. Lastly, the product proved effective in treating migraine-associated neck pain/discomfort and sinus pain/pressure. Trexima was the subject of a recent approvable letter from the FDA. (See BioWorld Today, June 12, 2006.)

• The Immune Response Corp., of La Jolla, Calif., said preliminary Phase II results reported at the International Symposium on HIV & Emerging Infectious Diseases in Toulon, France, showed that its second-generation HIV immunotherapy, IR103, demonstrated a positive safety profile and enhanced immunomodulatory effects over Remune, the company's first-generation immunotherapy. IR103 is a co-formulation of Remune and a synthetic Toll-like receptor agonist adjuvant, Amplivax.

• ZymoGenetics Inc., of Seattle, and Serono SA, of Geneva, said Phase Ib data reported at the European Congress of Rheumatology Clear demonstrated TACI-Ig's biologic effect as patients showed schedule- and dose-dependent decreases in the levels of immunoglobulin and serum rheumatoid factor levels. The trial included 73 patients with rheumatoid arthritis. A soluble fusion protein that neutralizes molecules implicated in the pathogenesis of several autoimmune diseases, it appeared to be well tolerated across all dose levels and schedules. The partners expect to begin Phase II in this indication in the second half of this year.

No Comments