Cellceutix Corp., of Beverly, Mass., said it has recruited the first patients with advanced solid tumors for clinical studies of cancer candidate Kevetrin

Thus, Calderon said she "would recommend requiring clinical studies to fully evaluate the abuse potential" of products submitted for review that exceed that level

Cytori Therapeutics Inc., of San Diego, said two independent investigator-sponsored and funded cell therapy clinical trials in Japan have been approved...Patients will be monitored for development of clinical symptoms and viral shedding...Initiation of the study followed a successful, dose-escalation Phase I study in which clinical activity was observed in five of seven patients receiving the two highest dose levels

The company planned to switch from a bovine to a recombinant form of its AKI treatment, alkaline phosphatase. (See BioWorld Today, Sept. 14, 2011.) Bunnik, the Netherlands-based AM-Pharma had then gained only preliminary data from two small-scale clinical trials suggesting that bovine alkaline phosphatase improves kidney function and reduces the need for dialysis...Puma is working on neratinib, an oral, irreversible kinase inhibitor for HER2-posistive metastatic breast cancer. (See BioWorld Today

Hadasit Bio-Holdings Ltd., of Jerusalem, said portfolio company Enlivex completed a 13-patient clinical trial of cellular treatment ApoCell for graft-vs.-host disease (GvHD), with results indicating efficacy and safety in recipients of bone marrow transplants from foreign donors...The primary endpoint of the 33-patient study is to determine the clinical benefit rate, while secondary objectives include progression-free survival and safety and tolerability

Mirna will be the first company in clinical trials with a miRNA replacement therapy, and that fresh and different approach may have helped the company to attract its large, deep-pocketed investors...Shares of XOMA (NASDAQ:XOMA) fell 23 cents, to close at $2.99 Wednesday.

The funds were raised from accredited investors and will be used to advance multiple clinical development programs

Derma Sciences Inc., of Princeton, N.J., said it plans to begin its Phase III program in December for DSC127, a clinical formulation of NorLeu3-A(1,7), in diabetic foot ulcers, to support the filing of a new drug application

Investigators said 47 percent of patients receiving Simponi 50 mg and 51 percent of patients receiving Simponi 100 mg maintained clinical response through week 54 compared with 31 percent of patients on placebo (p = 0.01 and p < 0.001, respectively...Investigators will report clinical response, clinical remission and mucosal healing results through one year at the American College of Gastroenterology meeting in Las Vegas

The clinical relevance of neratinib as a 'pan-HER' family inhibitor and it being irreversible is yet to be proven," the paper said...Funds will be used to support the clinical development of cancer drugs aldoxorubicin and tamibarotene and for general corporate purposes, which could include working capital, capital expenditures, R&D and commercial activities.

Funds will be used to support the clinical development of cancer drugs aldoxorubicin and tamibarotene and for general corporate purposes, which could include working capital, capital expenditures, R&D and commercial activities...Net proceeds are expected to total $19.3 million and will be used for ongoing clinical development of dendritic cell-based vaccine ICT-107 and for general corporate purposes

Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index

The study showed that the drug was safe and well tolerated at all dose levels, and that more patients in the higher-dose cohorts showed improvement in their clinical disease activity index than patients in the lower-dose or placebo cohorts

The investors were very enthusiastic about the results from the Phase I/II clinical trial...APIM Therapeutics A/S, of Trondheim, Norway, closed a financing round to fund ATX-101, its lead compound, toward clinical trials...Proceeds would be used for R&D activities, clinical trials, investment in capital equipment and for working capital and other general corporate purposes

Biogen Idec Inc., of Weston, Mass., reported data from studies testing oral BG-12 (dimethyl fumarate) at the European Committee for the Treatment and Research of Multiple Sclerosis meeting in Lyon, France, supporting clinical and radiological effects of the drug in people with relapsing-remitting multiple sclerosis (MS

StemCells Inc., of Newark, Calif., said two papers reporting clinical and preclinical data demonstrating the therapeutic potential of the company's HuCNS-SC cells (purified human neural stem cells) for a range of myelination disorders were published in the Oct. 10, 2012, edition of Science Translational Medicine

Intercept estimated that remaining clinical development for OCA for PBC will take about $40 million, and that the current offering, plus $29.8 million from its recent Series C financing, plus its cash will be enough to put it over the top. (See BioWorld Today, Sept. 6, 2012.) That clinical development includes completion of the POISE trial and initiation of its long-term safety extension, initiation of a Phase III outcomes trial, carcinogenicity studies in animals, a Phase I safety trial in

Canyon Pharmaceuticals Inc., of Parsippany, N.J., said results from its open-label, single-arm study, dubbed DESIR-ABLE, showed that desirudin (Revasc, Iprivask) demonstrated clinical utility and safety for the prevention of dangerous blood clots in a broad population of surgical and medically ill patients...Results were published in Clinical and Applied Thrombosis and Hemostasis

Guinea pigs showed a 45 percent reduction in duration, and a 55 percent reduction in severity, of clinical symptoms...A clinical program is slated to start next year, and GEN-004 "potentially can be taken in directions that cover new diseases," since the bug that causes pneumonia is responsible for other illnesses as well...LoneStar Heart Inc., of San Francisco, completed a milestone-based equity financing worth up to $20 million to support the clinical testing and regulatory clearance of its lead