The funds will support clinical work in multiple sclerosis (MS), inflammatory bowel disease (IBD) and allergic/immune-mediated disorders. (See BioWorld Today, April 8, 2013.) The pricing hits pretty close to the $86.3 million target set when the company filed for its offering only a month ago...A superior safety profile, including reduced cardiovascular side effects, reduced liver toxicity and fewer off-target side effects, could give RPC1063 the edge against Gilenya

In the study, Prevenar 13 showed a favorable safety profile and was generally well tolerated...The results of a separate clinical cardiovascular safety study showed that tedizolid was not associated with heart beat abnormalities at up to six times its effective dose, the maximum dose examined in the study...The results of both studies further supported the safety profile for tedizolid

AG014 comprises oral delivery of an anti-TNF antibody with proven clinical efficacy in IBD, resulting in local efficacy and an improved safety profile over systemic drugs

Tarafenacin also showed the expected dose-efficacy response and confirmed a safety profile seen in earlier studies...Regentis raised $10 million last year in a Series C financing to support clinical studies and commercial launch of GelrinC in Europe. (See BioWorld Today, May 15, 2012

The primary endpoint of the study is the induction of clinical remission at week 12...Data from the Phase I study established that LPCN 1111 exhibited a strong safety profile and pharmacokinetics, which should allow for once-a-day dosing of the next-generation oral testosterone replacement product, Lipocine said...The study is being conducted by more than 60 clinical investigators worldwide, including about 11 sites in Brazil and 24 sites in India

The sphingosine 1-phosphate receptor (S1PC) modulator is expected to go up against marketed S1PC modulator Gilenya (fingolimod), the oral multiple sclerosis (MS) drug sold by Novartis AG, but Receptos is hoping data will confirm a better safety profile for its drug, including reduced cardiovascular side effects, reduced liver toxicity and fewer off-target side effects...Funds will be used to progress the clinical development program for lead candidate, Pracinostat, its oral histone deacetylase

It is the first immune cell clinical trial of its kind in China...A follow-on Phase II trial will include clinical markers of muscle health, levels of utrophin expression and other biomarkers...CALM is investigating the clinical efficacy and safety of Cavatak in Stage IIIc or IV melanoma

The Phase I/II trial showed a significantly slower decline in overall clinical and respiratory function, as measured by the ALS functional rating score (ALSFRS-R) and forced vital capacity (FVC) score, respectively, in the six patients who received an intrathecal injection of the cells in the six months following treatment, as compared to the three months preceding treatment...and additional data reinforced the drug's safety profile in patients treated up to four years

The German Federal State of Saxony and the European Union funded the grant, which supplements a grant awarded by the SAB in August 2011 for the CANVAS clinical trial...Net proceeds of about $12 million will be used to support R&D, acquisition of intellectual property related to complementary drug therapies, clinical trials and other expenses...The first tranche of the Series B closed in June 2012 for $8.6 million.

The ATX-101 global clinical development program has enrolled more than 2,500 total patients, of which more than 1,500 have been treated with ATX-101, the company said...The primary objective was to assess the safety profile of dupilumab

Brickell sees an opportunity in the atopic dermatitis market for a product with a benign safety profile that can be used long term without major side effects...The company is planning to begin clinical studies in the first half of 2014

Two posters feature clinical data of PROSTVAC evaluated as monotherapy or in combination with a radiopharmaceutical...A third poster reviews the safety profile of poxviral vaccines from eight separate trials of PROSTVAC and the immunotherapy CV-301

Advanced Cell Technology Inc. (ACT), of Marlborough, Mass., said its clinical partner, the University of California, Los Angeles (UCLA), received FDA approval for its investigational new drug application...The safety profile of the program remains consistent with what has been seen in the post-menopausal osteoporosis (PMO) program and is not a factor in the decision to not pursue acceleration of fracture healing

The trial will assess safety and clinical benefit of various dose levels of cells...The primary objective is to establish the safety profile of VGX-100, while secondary objectives include determination of anti-tumor activity, biomarker levels and pharmacokinetics...The vaccine was well tolerated, and its safety profile was comparable to other pediatric vaccines

The company has an extensive pipeline of products in clinical development, including HyperAcute Pancreas (algenpantucel-L), HyperAcute Lung (tergenpumatucel-L), HyperAcute Melanoma, HyperAcute Renal and others...The safety profile was favorable, as well...Total gross proceeds from the offering will be $38.2 million. (See BioWorld Today, Jan. 30, 2013.)

Repros Therapeutics Inc., of The Woodlands, Texas, provided a revised date for expected clinical results from the first pivotal trial, ZA-301, of Androxel (enclomiphene) in secondary hypogonadism, with data expected in the third quarter rather than the second quarter...Spectrum Pharmaceuticals Inc., of Henderson, Nev., said data from the BELIEF trial showed belinostat had an acceptable safety profile in patients with relapsed/refractory peripheral T-cell lymphoma, including those who received a

The preliminary analysis showed that BI-505, a human antibody, has a good safety profile and in cohorts where extended therapy was available, 24 percent of the patients had stable disease for at least two months...Those data were presented at the American Society of Clinical Oncology's 2013 Gastrointestinal Cancers Symposium in San Francisco

Ampio plans to start enrolling in a 450-patient clinical trial this quarter...Those data completed the pivotal pharmacokinetic and clinical program for BNX, which BDSI said will enable a new drug application submission in mid-2013...Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong, said it received approval for clinical studies from Chinese regulators to test Benapenem, a carbapenem drug in the class of broad-spectrum beta-lactam antibiotics, with a Phase I program set to start in the first

Secondary endpoints also were met, including the clinical cure rate at end of treatment day 10 to day 14 (88.9 percent) and test of cure at day 21 to day 28 (100 percent...That allows Lorus to initiate a biomarker clinical investigation to further explore the effects of the drug at relevant doses determined in the trial...The complete clinical study report for the interim analysis would be supplied to the FDA during the review within 60 days of the resubmission