• 7TM Pharma A/S, of Hørsholm, Denmark, reported positive Phase I/II results showing that TM30338 met both the primary and secondary objectives, demonstrating that the drug candidate is safe and well tolerated in humans. A dual Y2-Y4 receptor agonist being developed for obesity and related diseases, its once-daily use in obese patients inhibited food intake at a statistically significant level up to at least nine hours after dosing. Moving forward, a Phase IIa study of TM30338 is being planned and another obesity candidate, a selective Y4 receptor agonist peptide labeled TM30339, is expected to enter Phase I/II studies later this year.

• Antisoma plc, of London, completed patient recruitment in its Phase II trial of AS1404 for ovarian cancer, keeping the company on course to report data this year. Endpoints include tumor response rates, time to tumor progression and survival. Antisoma also is conducting two other Phase II trials of the small-molecule, vascular-disrupting agent in lung and prostate cancers. All three are evaluating the benefit of adding AS1404 to standard chemotherapy treatment.

• BioMimetic Therapeutics Inc., of Franklin, Tenn., initiated three trials to evaluate GEM OS1 Bone Graft for use in foot and ankle fusion procedures and the treatment of unstable distal radius fractures. GEM OS1 is a bioactive drug-device combination product that combines recombinant human platelet-derived growth factor with a synthetic bone matrix, beta-tricalcium phosphate.

• Boston Life Sciences Inc., of Hopkinton, Mass., saw its stock jump 30 percent Monday after notifying the FDA of its intention to halt its Phase III Parkinson’s or Essential Tremor (POET-1) trial for Altropane earlier than expected, in order to analyze the full set of data for efficacy. No safety issues have been identified in the study, which was initiated in May 2004. The company said it believes it has enrolled enough subjects to evaluate the efficacy of Altropane single photon emission computed tomography (SPECT) imaging in the differentiation of Parkinsonian syndrome tremors from non-Parkinsonian or essential tremors. About 200 patients have been enrolled. Findings are expected in the third quarter. Shares of Boston Life Sciences (NASDAQ:BLSI) closed at $3.07, up 80 cents. (See BioWorld Today, May 21, 2004.)

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, said the FDA granted orphan drug status to its most advanced product, Ceflatonin, for chronic myeloid leukemia. The compound is the first of a new class of drugs that induces apoptosis and inhibits angiogenesis, and its clinical trials are evaluating its use in a range of conditions such as CML, myelodysplastic syndromes and acute myeloid leukemia. In Europe, Ceflatonin has orphan status for that latter indication.

• Corautus Genetics Inc., of Atlanta, said the FDA placed the Phase IIb GENASIS (Genetic Angiogenic Stimulation Investigational Study) trial on clinical hold, following the study’s voluntary suspension by Corautus and partner, Natick, Mass.-based Boston Scientific Corp. earlier this month. The trial is designed to evaluate the safety and efficacy of Corautus’ vascular endothelial growth factor-2 (VEGF-2), administered using Boston Scientific’s Stiletto endocardial direct injection catheter system, in patients with severe angina. At the time of the study’s halt due to an incidence of three cases of pericardial effusion within a two-week time period, 295 of 404 patients had been treated. The companies are working to address the issues, with hopes to resume clinical testing. (See BioWorld Today, March 15, 2006.)

• Isotechnika Inc., of Edmonton, Alberta, reported preliminary 48-week data obtained from its Phase III psoriasis and extension trials of its immunosuppressive drug, ISA247. Data from 193 patients showed that those in the low-dose group for the first 24 weeks experienced an improvement in mean percent decrease in PASI scores from baseline of 41 percent to 64 percent after an additional 24 weeks on the mid-dose. Patients previously in the mid- and high-dose groups remained stable with mean percent decrease from baseline PASI scores of 61 percent and 66 percent, respectively, after 48 weeks of treatment. Those results confirm the trends observed in the 12-week and 24-week data reported last year. (See BioWorld Today, Sept. 22, 2005, and Nov. 8, 2005.)

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., said the FDA granted orphan drug designation to thymalfasin, the chemical composition of Zadaxin, for Stage IIb to Stage IV malignant melanoma. Zadaxin is being investigated in combination with dacarbazine chemotherapy with and without low-dose interferon alpha in a large, multicentered Phase II Stage IV malignant melanoma trial in Europe. The company reported encouraging interim tumor response data in December and expects to announce additional data and preliminary survival information later this year.

• Sunesis Pharmaceuticals Inc., of South San Francisco, said patient treatment began in a Phase II trial of SNS-595 to treat small-cell lung cancer. The trial is an open-label, multicenter study designed to examine the safety and efficacy of the product as a second-line agent in patients who have failed first-line therapy. SNS-595 is a first-in-class cell-cycle modulator that kills proliferating cells in vitro by inducing apoptosis as cells progress through the S phase of the cell cycle. SNS-595 also is in an open-label Phase II study in patients with non-small-cell lung cancer, and a Phase I dose escalation safety clinical study in patients with acute leukemias.

• SurModics Inc., of Eden Prairie, Minn., completed patient enrollment in the STRIDE (Sustained Triamcinolone Release for Inhibition of Diabetic Macular Edema) Phase I study. The trial is evaluating the safety and tolerability of the I-vation Intravitreal Implant, aimed at delivering triamcinolone acetonide on a sustained basis for long-term administration. SurModics expects to complete a six-month follow-up and submit results to the FDA later this year.