• Amylin Pharmaceuticals Inc., of San Diego, and Eli Lilly and Co., of Indianapolis, reported positive results from a 24-week study of monotherapy, or stand-alone, Byetta (exenatide) injection taken twice daily in drug-naive patients with Type II diabetes. Study participants taking 5 mcg or 10 mcg of monotherapy Byetta twice daily showed significant reductions in A1C (a measure of average blood sugar over three months) by 0.7 percentage points and 0.9 percentage points, respectively, from an average baseline A1C ranging from 7.8 to 7.9 percent. Also, approximately 60 percent of study participants on either 5 mcg or 10 mcg of monotherapy Byetta at the conclusion of the study had an A1C of 7 percent or less, a common target for good glucose control. The companies plan a regulatory submission to the FDA in the first half of 2008.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said it is voluntarily discontinuing its Phase IIb study of intravenous Fodosine (forodesine HCl) in patients with T-cell acute lymphoblastic leukemia/lymphoma. That was the only current trial using the intravenous formulation, and it was placed on hold in March after the company reported a stability issue. A pivotal Phase III study of oral Fodosine in cutaneous T-cell lymphoma continues to enroll patients. Fodosine is partnered overseas with Mundipharma International Holdings Ltd., of Cambridge, UK. (See BioWorld Today, March 28, 2007.)

• Keryx Biopharmaceuticals Inc., of New York, said the independent data safety monitoring committee raised no safety concerns regarding the ongoing Phase III study of Sulonex (sulodexide oral gelcaps), its lead candidate for diabetic nephropathy, which allows the company to continue the trial without alteration. Keryx reported in June that the study had completed patient randomization, and anticipates that the last patient will complete the active treatment period in mid-December and the two-month off-treatment period in mid-February. The primary endpoint of the study is defined as conversion from microalbuminuria to normalbuminuria at six months (as measured by albumin/creatinine ratio, or ACR), with at least a 25 percent reduction in ACR relative to baseline ACR. In addition, Sulonex is in a Phase IV program that, along with the Phase III trial, is being conducted under a special protocol assessment with the FDA.

• Napo Pharmaceuticals Inc., of South San Francisco, said its licensee Glenmark Pharmaceuticals Ltd., of Mumbai, India, has initiated a Phase II trial for crofelemer for acute infectious diarrhea at two sites in India. The placebo-controlled crofelemer trial is expected to conclude in six months. Glenmark licensed crofelemer for the indications of acute infectious diarrhea, chronic diarrhea in persons living with HIV/AIDS and pediatric diarrhea in more than 140 areas. Upon approval in those areas, Glenmark will pay ascending royalties to Napo on sales of crofelemer for those indications.

• Nventa Biopharmaceuticals Corp., of San Diego, completed enrollment and initiated dosing of the second cohort of patients in its Phase I trial of HspE7 in cervical dysplasia, a precursor to cervical cancer. Patients have received the first of three immunizations of 500 mcg of the drug with 500 mcg of adjuvant and will be evaluated for cytokine responses, anti-HspE7 antibodies and cellular immunology in addition to safety and tolerability. HspE7 is a therapeutic vaccine targeting human papillomavirus-related diseases. The Phase I study is expected to enroll up to five cohorts totaling 24 patients.

• Plethora Solutions Holdings plc, of London, said the first patients have been recruited into a Phase IIb study in dysmenorrhoea (period/menstrual pain). The study is of PSD508, which is a nonsteroidal anti-inflammatory which is administered intravaginally utilizing technology Plethora licensed from UK-based Metris Therapeutics Ltd. in 2006. The study is a double-blind, placebo-controlled, multiple-dose, crossover proof-of-concept study, which compares the efficacy of vaginally delivered PSD508 to that of oral NSAID and placebo in relieving menstrual-related pain.

• Rigel Pharmaceuticals Inc., of South San Francisco, will receive a $5 million milestone because its partner, Pfizer Inc., of New York, has begun a Phase I clinical trial of an inhaled formulation of Rigel's small-molecule syk kinase inhibitor, R343, for the treatment of allergic asthma. Rigel will receive the milestone under a 2005 collaboration agreement. Pfizer retains exclusive rights to R343 and is responsible for its clinical development. R343 will be delivered via the inhaled route using a dry powder inhaler and initially will be tested in healthy volunteers to evaluate its safety, dosing and pharmacodynamics.

• Theratechnologies, of Montreal, said data from its first Phase III clinical trial using tesamorelin (TH9507) were published in the Dec. 6, 2007, New England Journal of Medicine showing it improves excess visceral fat in HIV-infected patients with lipodystrophy. Top-line data were previously reported. A confirmatory Phase III trial is under way, and the last patient has been randomized.

• Vical Inc., of San Diego, said an expansion is planned of Phase I testing of its Vaxfectin-formulated plasmid DNA (pDNA) pandemic influenza vaccine to allow comparison of vaccination with needle and syringe to vaccination with the Biojector 2000 needle-free injection system. The Biojector 2000 needle-free injection system has been shown to enhance the immunogenicity of pDNA vaccines in previous animal studies, and has demonstrated encouraging safety and immunogenicity data in multiple human pDNA vaccine studies.

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