• Allos Therapeutics Inc., of Westminster, Colo., announced the initiation of patient enrollment in a Phase II, open-label, single-arm, multicenter study of PDX (pralatrexate), a novel, small-molecule chemotherapeutic agent that inhibits dihydrofolate reductase that is involved in the building of DNA and other processes, in patients with advanced or metastatic relapsed transitional cell carcinoma of the urinary bladder. The primary endpoint of the study is complete and partial response rate, and the secondary endpoints include duration of response, clinical benefit rate, progression-free survival, overall survival and the safety and tolerability of PDX.

• Ambrilia Biopharma Inc., of Montreal, said it initiated a Phase I/II clinical development program of its proprietary, three-month formulation of goserelin (Zoladex, AstraZeneca), a luteinizing hormone-releasing hormone analogue, in hormone-sensitive prostate cancer patients. The study is designed to assess the hormonal efficacy, pharmacokinetic and safety of its formulation of goserelin in prostate cancer patients.

• Goodwin Biotechnology Inc., of Plantation, Fla., said its melanin-binding IgM antibody was used in a successful Phase I trial for the treatment of melanoma. The results announced earlier this month, conducted by Pain Therapeutics Inc., of San Mateo, Calif., and its collaborators, showed that the antibody binds to melanoma tumor sites, as evidenced by imaging data obtained by planar scintigraphy and SPECT/CT (single photon emission computed tomography combined with computed tomography). GBI was selected to develop the process and produce the preclinical and clinical material for this and future trials.

• Insmed Inc., of Richmond, Va., completed enrollment in its six-month, randomized, double-blind, placebo-controlled Phase II trial of Iplex for myotonic muscular dystrophy. Iplex is a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and binding protein IGFBP-3 (rhIGFBP-3) and is approved for of children with growth failure due to severe primary IGF-I deficiency.

• The Multiple Myeloma Research Consortium, of Norwalk, Conn., initiated a Phase I/II study of elotuzumab (or Huluc63), a humanized anti-CS1 monoclonal IgG1 antibody administered intravenously, in combination with Velcade (bortezomib) for injection for the treatment of relapsed multiple myeloma. The study, sponsored by PDL BioPharma Inc., of Redwood City, Calif., will evaluate the safety and efficacy of the combination in patients who have received one to three prior therapies.

• Repros Therapeutics Inc., of The Woodlands, Texas, said the results of the initial Phase I/II trial of Proellex conducted in Europe will be published in US Obstetrics and Gynecology Review in early August. In the study, women with fibroids were treated with Lucrin (or Lupron), one of three doses of Proellex, or placebo. Decreases in fibroid size were detected by ultrasound, and there was a notable reduction in vaginal bleeding. Few adverse events could be attributed to Proellex.

• Schering-Plough Corp., of Kenilworth, N.J., and Merck & Co., of Whitehouse Station, N.J., released data from a large study showing their cholesterol drug Vytorin does not lower the risk of major heart valve problems and the need for related surgical procedures. The drug performed no better than placebo at lowering the risk of major cardiovascular events in patients suffering from a condition that blocks blood flow to part of the heart. The study, called SEAS (Simvastatin and Ezetimibe in Aortic Stenosis), included 1,873 patients with aortic stenosis, a condition in which blood flow to the heart is blocked. Vytorin also failed to meet a secondary goal of improving aortic valve disease events, which included valve replacement surgery, hospitalization because of heart failure and death related to heart. The drug also failed to meet the secondary endpoint of reducing atherosclerotic disease. Events included in the study assessment were nonfatal heart attacks, the need for bypass surgery and strokes. Researchers also said they discovered more cancer deaths in patients taking Vytorin, though the study said those data are based on a small number of people and could have occurred by chance. Shares of Schering-Plough (NYSE:SGP) fell 11.6 percent, or $2.49, to close at $18.95, and shares of Merck (NYSE:MRK) dropped $2.35, or 6.2 percent, to close at $35.33.

• Targacept Inc., of Winston-Salem, N.C., initiated a Phase IIb trial of TC-5214 as an augmentation therapy for patients with major depressive disorder who have not responded to the selective serotonin reuptake inhibitor citalopram hydrobromide. The primary endpoint will be improvement according to the Hamilton Depression Rating Scale. TC-5214 is a broad-spectrum neuronal nicotinic receptor antagonist.