In addition to standard clinical efficacy measures, biological endpoints also will be evaluated to help understand the specific activity of the therapeutic in this disease...Local nasal symptoms, including nasal stuffiness, were common and generally brief, and no vaccine-related serious adverse events occurred

The interim data suggested a correlation between dose-related variations in levels of inflammatory serum markers and measurable clinical response in patients treated with BPX-101...Clinical responses were evident within the first 12 weeks of treatment, in both low and mid-dose cohorts...Phase I results showed six of 16 evaluable patients experienced stabilization of disease for a median of 34.9 weeks and no dose-limiting toxicity or serious adverse events were found

AIC246 was generally very well tolerated, with no serious adverse events reported, he added...While much of the $75 million raised in the recent financing will be used for clinical trials, the funds also will go toward research activities, he said

Clinical Data Inc., of Newton, Mass., said results of two Phase I studies showed Stedivaze (apadenoson), a selective agonist of the adenosine A2A receptor subtype, was safe and well tolerated in patients with asthma and chronic obstructive pulmonary disease...SCV-07 also was found to be safe and well tolerated with no dose-related serious adverse events reported...The primary efficacy endpoint will be based on clinical response observed within four hours after dosing

Evotec AG, of Hamburg, Germany, completed the clinical part of the first Phase I trial of its NR2B-selective NMDA receptor antagonist EVT 103, showing that the compound was safe and well tolerated, with excellent bioavailability and only a minimal effect of food in the kinetic profile...Data showed that no serious adverse side effects of LIM-0705 or tacrolimus were noted, while a pharmacokinetic analysis revealed that LIM-0705 favorably altered tacrolimus tissue distribution in a majority of

The compound was well tolerated, with no serious adverse events and with similar number of adverse events across treatment groups, and pharmacokinetic parameters were consistent with expectations...Synta anticipates initiating one or more clinical trials in the second half of this year, with further details announced over the coming months. (See BioWorld Today, March 2, 2009

Biotie Therapies Corp., of Turku, Finland, reported positive top-line data from a clinical study with the VAP-1 antibody in rheumatoid arthritis, with BTT-1023 showing itself to be well tolerated and with signals of therapeutic activity...Seven patients received a single dose of photosensitizer Amphinex plus bleomycin, with all treated tumors disappearing within a few weeks and no drug-related serious adverse events

The IMPACT-DCM trial hit a couple of rough spots last year, when it was twice placed on clinical hold following reports of a serious adverse event...Proceeds will provide additional capital to fund clinical trials

The percentage of patients reporting adverse events and serious adverse events was similar across treatment arms, with the most frequent adverse event, COPD exacerbation, occurring in 9.2 percent, 7.4 percent and 12.4 percent in the aclidinium 200-mcg, 400-mcg and placebo groups, respectively...In addition, the trial will assess the drug's safety and tolerability and will follow duration of clinical symptoms and global functionality

Thallion will retain primary responsibility for the conduct of the clinical program, whereas LFB Biotechnologies will be responsible for the manufacture and supply of Shigamabs for both clinical study and commercial sale...No serious adverse events were experienced in any of the 50 healthy volunteers that have received the drug

There were no serious adverse events, but eight patients reported a rash, and Anadys' stock (NASDAQ:ANDS) slipped 34 cents, or 11.56 percent, to close at $2.60...This is the fifth clinical study to be initiated on STA-9090, a synthetic, small molecule Hsp90 inhibitor with a novel chemical structure

Overall, the incidence of adverse events (96 percent denosumab, 97 percent Zometa) and serious adverse events (44 percent denosumab, 46 percent Zometa) was consistent with what has previously been reported for these two agents...Secondary clinical endpoints showed the duration of episode from the first prodromal symptoms to healing to be significantly decreased (p=0.0062), the percentage of patients with abortive episode (episode not progressing to vesicular lesion) to be increased (p=0.045) and

Cetrorelix was well tolerated, and there were no relevant differences to placebo with regard to both clinical adverse events or changes in laboratory parameters with the exception of the anticipated hormonal changes...No serious adverse events were reported...UCB SA, of Brussels, Belgium, said results of two new studies supported the use of the intravenous formulation of the antiepileptic drug (AED) Vimpat for patients requiring add-on therapy in clinical settings where oral AED therapy is temporarily

Those data were published in the Journal of Clinical Oncology...Twelve weeks into therapy, most patients showed a clinical response and more than half were in clinical remission

The safety profile was comparable to placebo and no drug-related serious adverse events were reported...ChemoCentryx Inc., of Mountain View, Calif., reported Phase II/III data from its PROTECT-1 (Prospective Randomized Oral Therapy Evaluation in Crohn's disease Trial) study showing that Traficet-EN (CCX282-B) in patients with moderate to severe Crohn's disease demonstrated clinical efficacy with a favorable safety and tolerability profile

PTK 0796, a compound from Boston-based Paratek Pharmaceuticals Inc., also has shown a 98 percent clinical success rate in cSSSI...PolyMedix recently completed a Phase Ib trial showing that PMX-60056 completely reversed the anticoagulant effects of heparin and normalized blood clotting time in patients in less than 10 minutes, with no serious adverse events reported...Proceeds will be used to complete clinical development of lead product Ontaril in perianal fistulas and preparation for a market launch

PolyMedix Inc., of Radnor, Pa., completed a second successful clinical study of its anticoagulant reversing agent, PMX-60056...No serious adverse events occurred

pSivida Corp., of Watertown, Mass., said results of a second pancreatic clinical trial showed that 100 percent, or all six patients, experienced stabilization in tumor growth after receiving BrachySil (P32 BioSilicon), a brachytherapy treatment for inoperable pancreatic cancer...No device-related serious adverse events were experienced at the elevated levels, and independent dosimetry experts have concluded from the data that 400 Gy is the optimum dose

No drug-related serious adverse events were reported...Results were published in the Journal of Clinical Oncology