The results will be presented in an oral abstract session at the 2012 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology in San Francisco Jan. 21...Rexahn Pharmaceuticals Inc., of Rockville, Md., received approval from the Hungarian Regulatory Authority and Ethics Committee for its initial clinical trial application to begin a Phase I trial of RX-3117...Patients will be maintained on their CompleoTRT regimen beyond the duration of the 90-day efficacy component of the study

Neovacs SA, of Paris, reported full results for its Phase IIa TNF-K-003 clinical trial with TNF-Kinoid in rheumatoid arthritis (RA), indicating the results confirmed TNF-Kinoid's favorable safety profile, ability to induce antibodies to TNF and trend toward the relief of disease symptoms...multicenter, 70-patient Phase II clinical trial with Fibrocaps – a dry powder topical tissue sealant to stop bleeding after or during surgery – in spinal, peripheral vascular and general surgery resulted in a

Affitech A/S, of Copenhagen, Denmark, said its Russian partner, IBC Generium, submitted a clinical trial application to the Russian Health Authority to begin a Phase Il trial with Affitech's lead monoclonal antibody candidate AT001/r84...Can-Fite BioPharma Ltd., of Petah-Tikva, Israel, said its 18-patient Phase I/II study of CF102 met its objectives, with the drug showing a favorable safety profile in patients with hepatocellular carchoma and Child-Pugh cirrhosis classes A and B. The median overall

Results showed that ATx08-001 monotherapy met the primary objective of demonstrating significant analgesia and showed an excellent safety profile...The primary objective is to establish noninferiority with respect to the proportion of patients who achieve clinical cure 26 to 30 days after treatment begins

It's a great fit with clinical need and best suited to deal with the three major factors associated with myelofibrosis...Rodman and Renshaw's Reni Benjamin commented, "The Phase I/II ASH data adds strength to CYT387's overall clinical profile and increases the value proposition for potential partners...Alnylam Pharmaceuticals Inc., of Cambridge, Mass., reported clinical data from a number of programs

AMAG Pharmaceuticals Inc., of Lexington, Mass., presented new clinical data for Feraheme (ferumoxytol), which is approved for iron deficiency anemia in chronic kidney disease...In a separate presentation, Array reported Phase I and Phase II data showing that ARRY-520, its kinesin spindle protein inhibitor, produced clinical activity in heavily pretreated multiple myeloma patients...CytRx Corp., of Los Angeles, reported results from a Phase II trial demonstrating bafetinib's clinical activity and

Although vanoxerine's mechanism of action remains unproven, the drug's safety profile is a big differentiator, Brown said...acting as co-managers.

The company also said an eight-year update from its Phase I/II trial was published in Clinical Cancer, reporting that vaccination with GV1001 is well tolerated, immunizing the majority of NSCLC patients and establishing durable T-cell memory...Fibrocaps – a dry powder topical fibrin sealant developed from a mixture of fibrinogen and thrombin – also demonstrated a good safety profile

AMAG Pharmaceuticals Inc., of Lexington, Mass., said new data from the FIRST head-to-head study comparing Feraheme (ferumoxytol) for intravenous use to iron sucrose in patients with iron deficiency anemia and chronic kidney disease (CKD) demonstrated overall that ferumoxytol 1.02 g, delivered as two injections of 510 mg within 5±3 days, had a favorable safety profile and comparable efficacy to 1 g of iron sucrose dosed as 100 mg or 200 mg over five to 10 injections given over two to 2.5 weeks

It has produced a number of recent clinical trial failures, including GenVec Inc.'s Phase III trial of TNFerade and AmpiMed Corp.'s Phase II trial of Amplimexon (imexon), as well as established cancer blockbusters like Avastin (bevacizumab, Genentech Inc./Roche AG) and Erbitux (cetuxumab, Eli Lilly and Co...In another interim analysis of 45 patients, HyperAcute Lung had a favorable safety profile

The vaccine for enterovirus 71 had good immunogenicity and a favorable safety profile with no adverse events...In a clinical trial sponsored by The Medicines Co., of Parsippany, N.J., the anticoagulant Angiomax (bivalirudin) showed a 60 percent reduction in major bleeding events compared to heparin when used as an adjunct to catheter-based procedures in patients with severely defective aortic heart valves

DARA BioSciences Inc., of Raleigh, N.C., reported data from a Phase Ib trial showing that DB959, a peroxisome proliferator activated receptor-delta/gamma agonist, had a safety profile comparable to placebo when given as once-daily doses for seven sequential days and was safe and well tolerated throughout the 40-fold dose range tested...Pooled data from 672 patients showed clinical and endoscopic remission for budesonide MMX of 17.7 percent vs. 6.2 percent for placebo (p = 0.0002), while symptom

Neovacs SA, of Paris, announced results in the first 24 rheumatoid arthritis patients included in a Phase IIa study conducted with TNF-Kinoid, which confirmed a good safety profile, its ability to induce an immune response in patients and provided evidence of promising clinical efficacy

The biggest challenge for Benlysta uptake has been the drug's unique clinical profile," Roy said...However, the combination of the drug's safety profile, along with favorable economics to the physician, will drive widespread use of the drug

Merz Pharmaceuticals GmbH, of Frankfurt, Germany, reported clinical data showing that cervical dystonia or blepharospasm patients treated with Xeomin (botulism toxin Type A) experienced long-term sustained efficacy with a favorable safety profile of up to 121 and 88 weeks duration...Xencor will lead all clinical development until that time. (See BioWorld Today, Jan. 10, 2011

The advantage is that bacteria has to mutate at all three sites to become resistant to CEM-101, and Cempra said it has seen no resistance to the compound in its clinical studies to date...CEM-101 is in development as oral and intravenous formulations for community-acquired bacterial pneumonia (CAPB), and data from a recent Phase II study showed that the oral formulation demonstrated comparable efficacy to levofloxacin, the standard of care, with an improved safety profile...Amarantus is developing

Data were published in the Journal of Clinical Oncology...Boston Therapeutics Inc., of Manchester, N.H., said it started the first clinical trial of PAZ320 when added to oral agents or an insulin regimen in patients with Type II diabetes mellitus...Pevion Biotech AG, of Bern, Switzerland, reported the latest results from its ongoing clinical study of volunteers vaccinated with the intramuscular high dose of Candida vaccine PEV7, showing high levels of specific antibodies and a 100 percent mucosal

Under the firms' 2010 deal, Otsuka will contract with Acucela for early clinical development in exchange for an opt-in right to co-develop and co-promote the compound in the U.S...Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, said data from a recently completed clinical trial of LX4211 , a dual inhibitor of the sodium glucose transporters 1 and 2, demonstrated a favorable safety profile and effects on multiple parameters of glycemic control and cardiovascular health in healthy subjects

After about 11,000 injections administered to about 10,000 patients in the U.S., there was no clinical meaningful change in the nature of events expected relative to the clinical trial safety profile...About 40 patients will be enrolled, and the primary endpoint will be clinical benefit rate, as measured by complete response, partial response and stable disease for at least six months