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

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

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

Patients receiving a higher dose of DPX-Survivac in combination with cyclophosphamide produced immune responses after only one vaccination and generally exhibited higher antigen-specific immunity than those receiving the combination with a lower dose, suggesting dose-related activity...Additional results showed that patients receiving the vaccine without cyclophosphamide were capable of producing antigen-specific immune responses

The positive clinical effects of the twice-daily dose of the drug relative to placebo were observed in a variety of standard psoriasis assessment parameters, with the responses accumulating over the 24 weeks...Sophiris Bio Inc., of La Jolla, Calif., released top-line data from the 12-month follow-up of patients receiving PRX302 for the treatment of benign prostatic hyperplasia in a Phase IIb study

There also were consistent trends toward reduction in pain scores and the incidence of nausea and vomiting in patients receiving Caldolor, and no safety concerns were observed during the study...Imprimis Pharmaceuticals Inc., of Solana Beach, Calif., said it started a clinical trial testing Impracor, a topical cream designed to deliver ketoprofen

Celgene International Sàrl, of Boudry, Switzerland, a subsidiary of Celgene Corp., said its Phase III PALACE-2 and PALACE-3 studies of apremilast in psoriatic arthritis demonstrated statistical significance for the primary endpoint of ACR20 at week 16 in patients receiving both 20-mg and 30-mg doses...Laboratorios del Dr. Esteve SA, of Barcelona, Spain, published data from three Phase I trials of S1RA E-52862 in the British Journal of Clinical Pharmacology, showing a favorable safety and

Net proceeds from the offering will be funneled into clinical development of cancer candidates IPI-145 and retaspimycin...Net proceeds of about $361.9 million will support clinical trials, research and development and other corporate purposes...The funds will be used as working capital to support clinical development of the company's products, including therapies for men's health, female sexual health and respiratory disorders.

Agenus Inc., of Lexington, Mass., said clinical data from a Phase I trial of a Prophage Series vaccine (HSPPC-96, vitespen) to treat patients with recurrent glioblastoma multiforme (GBM) were published online by Clinical Cancer Research...Patients receiving the naloxone spray achieved the study's primary endpoint with a statistically significant reduction in time spent per week binge eating compared with patients on placebo

A second immune reconstitution product, Cytovir ADV, for the treatment of adenovirus infection in pediatric patients receiving bone marrow donations, is due to start a Phase I/II trial later this year at Great Ormond Street Hospital in London...Funds also will support clinical work on a second product, a small molecule to be investigated as a possible treatment for a complication of chronic kidney disease.

Osiris Therapeutics Inc., of Columbia, Md., said interim one-year results from its 220-patient Phase II trial testing Prochymal (remestemcel-L) in patients experiencing first-time acute myocardial infarction showed that those receiving Prochymal had significantly less cardiac hypertrophy, as measured by cardiac MRI, compared to patients receiving placebo (p < 0.05...Protalix BioTherapeutics Inc., of Carmiel, Israel, reported clinical data for taliglucerase alfa showing that at 36 months, patients

However, a secondary endpoint of objective response rate showed statistically significant benefit for patients receiving belinostat...Patients receiving a treatment regimen that included belinostat had 43.2 percent objective response rate, compared to those receiving the comparator regimen

Patients receiving lorcaserin lost 4.5 percent to 5 percent of their initial body weight, compared to 1.5 percent for those on placebo...The greatest improvements in lung function were observed in patients receiving 600 mg of VX-809, the highest dose evaluated, plus Kalydeco

While the trial was not powered for statistical significance related to efficacy, patients receiving intravenous infusions of KB001 tended to have better clinical outcomes, with 33.3 percent of patients receiving the 3 mg/kg dose and 42 percent of patients receiving the 10 mg/kg dose alive at day 28 and free of Pa infection, compared to 20 percent of patients in the placebo group

Treatment involved the patient receiving five injections in the cervical (upper back) region of the spinal cord, in addition to the 10 he received previously in the lumbar region of the spine, for a total of 15 injections...The subject was treated at the clinical site and has fully recovered, the company said

The response was 56 percent in patients receiving 200 mg CCX354 once daily, compared to 44 percent in patients receiving 100 mg twice daily and 30 percent in patients receiving placebo

At the American Society of Clinical Oncology meeting in Chicago, Advaxis reported preliminary Phase II data on Indian women with recurrent/refractory cervical cancer who failed cytotoxic therapy, with results showing that the tolerability of ADXS-HPV compared favorably with single-agent and combination chemotherapies. (See BioWorld Today, June 6, 2012...Alnylam also initiated a Phase II trial with ALN-TTR02 to evaluate clinical activity, safety and tolerability of multiple once-monthly doses of ALN

Encouraging clinical activity, including partial responses, was observed in colorectal, lung and gastric cancer patients receiving fruquintinib

Of the 89 evaluable patients, the objective response rates were 73 percent for patients receiving combination therapy, with 36 percent achieving a complete response, compared to 51 percent for patients receiving the Revlimid monotherapy, with 13 percent achieving a complete response