• Alder Biopharmaceuticals Inc., of Bothell, Wash., will receive a $15 million milestone payment from Bristol-Myers Squibb Co. (BMS), of New York, for the initiation of a Phase IIb trial in rheumatoid arthritis for ALD518/BMS-945429, an investigational antibody therapeutic that blocks interleukin-6. The payment is part of a 2009 collaboration in which Alder received $85 million up front in exchange for giving BMS worldwide exclusive rights to develop and commercialize ALD518/BMS-945429 for all potential clinical uses, with the exception of cancer treatment and cancer supportive care. (See BioWorld Today, Nov. 11, 2009.)

• In response to the recent E. coli outbreak, Alexion Pharmaceuticals Inc., of Cheshire, Conn., is enrolling patients in Germany in an open-label clinical trial to investigate eculizumab (Soliris) as a treatment for Shiga-toxin producing E. coli hemolytic uremic syndrome (STEC-HUS). Alexion had been providing eculizumab free of charge in Germany, but as the number of cases of the rare, life-threatening syndrome increased – about 800 have been confirmed – the company and the government agreed a clinical trial would be the best way to provide the investigational therapy in a safe, controlled manner. The trial will provide a framework for a coordinated collection of data and an assessment of the potential of eculizumab to treat patients with STEC-HUS.

• Allos Therapeutics Inc., of Westminster, Colo., reported results from a retrospective analysis of data from its pivotal PROPEL study of single-agent antifolate drug Folotyn (pralatrexate injection) as a second-line treatment in patients with relapsed or refractory peripheral T-cell lymphoma who received CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) as their first-line treatment, showing that, of the 15 evaluable patients, seven (47 percent) had objective responses as assessed by independent central review. Complete responses were observed in three patients (20 percent), and median duration of response had not yet been reached at the time of analysis. Those and other data were presented at the International Conference on Malignant Lymphoma in Lugano, Switzerland.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., reported that data from an FDA-requested QTc study of Northera (droxidopa) confirmed the drug's safe cardiovascular profile. The company plans to file a new drug application next quarter with the FDA for the treatment of symptomatic neurogenic orthostatic hypotension. Northera, Chelsea's lead candidate, also is in a Phase II trial for fibromyalgia and has completed Phase II in intradialytic hypotension. (See BioWorld Today, Feb. 3, 2011.)

• Concert Pharmaceuticals Inc., of Lexington, Mass., announced that its CTP-499 is progressing into Phase II clinical trials for diabetic nephropathy, and its C-21191 has been selected as a lead candidate for spasticity. Both programs are part of the company's deuterated chemical entity platform. Concert said it intends to advance CTP-499 into a 170 patient Phase II proof-of-concept study by year-end.

• GTx Inc., of Memphis, Tenn., initiated a Phase IIb trial evaluating Capesaris, a selective estrogen receptor alpha agonist, compared to Lupron Depot (leuprolide acetate for depot suspension) for first-line treatment of advanced prostate cancer. The company said that the trial is an open-label study of 156 men with advanced prostate cancer. The primary endpoint is the proportion of patients who achieve castration by day 60.

• Immunovaccine Inc., of Halifax, Nova Scotia, said that the FDA cleared its investigational new drug application for a Phase I/II study with DPX-Survivac, a therapeutic cancer vaccine that will be tested in patients with ovarian cancer.

• Prolor Biotech Inc., of Nes-Ziona, Israel, said its pediatric investigation plan for clinical development of its long-acting human growth hormone (hGH-CTP) was accepted for review by the European Paediatric Committee. The company previously showed promising efficacy and safety data in a Phase II trial of hGH-CTP in growth hormone-deficient adults.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said various studies of Zevalin (ibritumomab tiuxetan) were presented at the International Conference on Malignant Lymphoma in Lugano, Switzerland. Among the data presented were results from a Phase II study showing that Zevalin after chemotherapy in untreated mantle cell lymphoma patients is safe and improves percent of response and the quality of response. Data from a study of Zevalin and high-dose therapy in poor prognosis patients with diffuse large B-cell lymphoma showed that the addition of Zevalin offered minimal additional toxicity compared with chemotherapy alone and yielded good efficacy.

• Topica Pharmaceuticals Inc., of Palo Alto, Calif., reported that results from its Phase I/IIa trial evaluating a 10 percent solution of luliconazole after maximal use topical application in adults with moderate-to-severe distal subungual onychomycosis of the toenails showed that all 24 patients enrolled completed the trial at the starting dose, that the 10 percent luliconazole solution was well tolerated, and that steady state levels of luliconazole were reached in the plasma by day eight due to the time required for the drug to cross the nail plate and nail bed before reaching circulation. The company said it plans to conduct a Phase II trial with approximately 240 patients with mild-to-moderate distal subungual onychomycosis.