• Bioheart Inc., of Sunrise, Fla., said it is expanding its U.S. and European trials of MyoCell adult myogenic stem cell composition and MyoCath needle-injection catheter product candidates. In October, the company finalized its proposed protocol for a U.S. Phase II trial, which is designed to enroll up to 450 patients to confirm the safety and efficacy of adult myogenic stem cell transplantation in treating heart failure. In Europe, Bioheart expanded its Phase IIa trial from five testing centers to 12.

• CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, began an open-label, Phase II trial of intravenous PXD101 for myelodysplastic syndromes (MDS). The study, which will enroll up to 55 patients who will receive five daily treatments of the small-molecule histone deacetylase (HDAC) inhibitor administered every three weeks (one cycle), is being sponsored by the National Cancer Institute under a clinical trials agreement with CuraGen. Patients demonstrating complete or partial responses will continue to receive PXD101 treatment for up to eight cycles or until disease progression. The primary endpoint is the proportion of confirmed responses as defined by the International Working Group, and secondary endpoints include time to progression, overall survival, duration of response and toxicity.

• Isotechnika Inc., of Edmonton, Alberta, said initial data from its Phase IIb trial of ISA247, an immunosuppressive drug, in kidney transplant patients showed an 8 percent rate of acute rejection in the overall ISA247-treated group, compared to a 14 percent rate in the tacrolimus group. The groups receiving low and mid doses of ISA247 show similar episodes of rejection, while the high-dose group has yet to experience rejection. Data were presented at the American Society of Nephrology meeting in San Diego.

• MediciNova, of San Diego, initiated a Phase III program for MN-001, an orally bioavailable compound, for bronchial asthma. The first Phase III trial is a 12-week randomized, placebo-controlled, double-blind study of about 700 patients with mild to moderate asthma at 75 to 90 U.S. sites. The primary endpoint is the change from baseline in mean FEV1 (forced expiratory volume in one second) after 12 weeks. The compound has been shown to block a number of the inflammatory mechanisms activated by mast cell degranulation (leukotriene receptor antagonism and inhibition of phosphodiesterases III and IV, 5-lipoxygenase, phospholipase C and thromboxane A2). MediciNova also is developing MN-001 for interstitial cystitis.

• Sonus Pharmaceuticals Inc., of Bothell, Wash., completed enrollment in the pivotal Phase III trial of Tocosol Paclitaxel in women with metastatic breast cancer. Tocosol is a formulation of the cancer drug, paclitaxel, using Sonus' vitamin E-based emulsion technology. The company expects data from the trial in the third quarter of 2007, with submission of a new drug application targeted for the end of 2007.

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