• Alkermes plc, of Dublin, Ireland, said it will discontinue development of ALKS 37 in opioid-induced constipation after top-line results from a Phase IIb dose-ranging study failed to meet a predetermined product profile for advancing the compound. The company also stopped a second Phase IIb study of ALKS 37 in the same indication. The study was designed to assess the safety, tolerability, pharmacokinetic profile and efficacy of ALKS 37 in approximately 150 patients. The company said the compound was well tolerated at all dose levels, and it will consider out-licensing opportunities.

• Cell Therapeutics Inc., of Seattle, said results from its PIX301 Phase III trial of Pixuvri (pixantrone) were published online in The Lancet Oncology. Results of the PIX301 trial were the basis for conditional marketing authorization of Pixuvri in the European Union as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas. The aza-anthracenedione has structural and physiochemical properties that resulted in greater antilymphoma activity than doxorubicin in preclinical models. In January, CTI voluntarily withdrew its new drug application for Pixuvri in the U.S. after the FDA's Office of New Drugs denied the company's appeal of the Oncologic Drugs Advisory Committee's 2010 rejection of the drug. (See BioWorld Today, March 23, 2010, May 4, 2011, and Jan. 31, 2012.)

• Genta Inc., of Berkeley Heights, N.J., said it has accrued its first patient in a trial of tesetaxel as initial chemotherapy for advanced or recurrent breast cancer. The randomized Phase IIb trial will enroll approximately 220 patients at 15 sites in the U.S. and Western Europe. Accrual is projected to take 12 months, with a 12-month follow-up period. Patients who have not previously received chemotherapy will be enrolled to receive tesetaxel once every three weeks, tesetaxel once weekly for three weeks or Xeloda (capecitabine, Roche AG) twice per day for 14 days. The primary endpoint is overall response. Secondary endpoints include progression-free survival and safety.

• ImmunoCellular Therapeutics Ltd., of Woodland Hills, Calif., will present new data from its previously completed Phase I trial of ICT-107 in glioblastomoa multiforme at the American Society of Clinical Oncology meeting in Chicago. Those data showed that ICT down-regulates tumor-associated antigens as well as cancer stem cell marker CD-133, in some patients. The results supported the strategy of targeting antigens that are highly expressed by cancer stem cells.

• Omeros Corp., of Seattle, began a pharmacokinetic (PK) substudy in its Phase III program for OMS302 in lens replacement surgery. The PK substudy will confirm low levels of systemic exposure previously documented in preclinical studies. Blood samples collected prior to and within 24 hours after surgery from patients treated with OMS302 and placebo will be examined. The data will be included in marketing applications submitted in the U.S. and Europe.

• Oxygen Biotherapeutics Inc., of Morrisville, N.C., said its randomized, double-blind, placebo-controlled study of the efficacy of Dermacyte for histamine-induced pruritis showed that the drug produced a larger reduction in Visual Analogue Scale scores after standard histamine skin prick than placebo. The primary endpoint of the study was assessment of the potential of Dermacyte Concentrate skin cream to reduce the itch, redness and swelling of histamine-mediated allergic skin reactions. The study enrolled 30 healthy volunteers. The sample size did not allow a demonstration of statistical significance, but the firm said it provided support for the program as the company works to finalize its design for the next study.

• Photocure ASA, of Oslo, Norway, said the Phase IIb study of Visonac (methyl aminolevulinate) in acne demonstrated a statistically significant reduction in inflammatory lesions and overall improvement in acne severity. The study enrolled 153 patients with severe acne vulgaris who were randomized either to Visonac topically followed by red light illumination or to vehicle cream followed by red light illumination. The treatment regimen consisted of four treatments administered two weeks apart, with efficacy and safety assessed six weeks following the final treatment. Visonac was well tolerated, and no serious adverse events were reported.

• RXi Pharmaceuticals Corp., of Worcester, Mass., said the FDA accepted its investigational new drug application, providing clearance to initiate trials of RXI-109, a self-delivering RNAi compound that selectively targets connective tissue growth factor. The Phase I study will evaluate safety and tolerability and look for surrogate parameters that might predict the potential of the compound to reduce dermal scarring in planned surgeries. The company said the trial represents the first for a self-delivering RNAi technology in humans.

• Taiho Pharmaceutical Co. Ltd., of Tokyo, said it will initiate a global Phase III trial, dubbed RECOURSE, for the combination antimetabolite TAS-102 in June. The study will compare the oral nucleoside with best supportive care to investigate efficacy and safety in advanced recurrent colorectal cancer that is unresectable and relapsed or refractory to standard chemotherapies. The trial will enroll 800 patients, with a primary endpoint of overall survival.

• Tau Therapeutics LLC, of Charlottesville, Va., launched a Phase Ib study with the National Cancer Institute's Adult Brain Tumor Consortium of lead product candidate mibefradil in recurrent high-grade glioma. The dose-escalation trial will evaluate the safety and pharmacokinetics of mibefradil when sequentially administered with temozolomide in an approach Tau calls interlaced therapy. A T-type calcium channel blocker, mibefradil has the potential to synchronize the division of tumor cells and thereby significantly increase their sensitivity to subsequent treatment with chemotherapy. Tau plans to present results of the trial in 2013.

• Veloxis Pharmaceuticals A/S, of Horsholm, Denmark, said a subgroup analysis of Study 3001, a Phase III noninferiority study of LCP-Tacro, showed that African-American stable kidney transplant patients may be safely converted from twice-daily Prograf (tacrolimus, Astellas Pharma Inc.) to once-daily LCP-Tacro. The company also noted a trend toward fewer biopsy-proven acute rejections with LCP-Tacro compared to Prograf. It will present the results at the American Transplant Congress meeting in Boston. Three other presentations will address the activity and tolerability of LCP-Tacro in kidney and liver transplant patients.