The company expects to begin testing the compound in a single- and multiple-dose escalation study in healthy volunteers for safety, tolerability and inhibition of mechanism-related biomarkers...Results of the final study are intended to supplement the company's existing clinical database of more than 4,000 patients to form the basis of a new drug application submission in early 2009 for Glinsuna (mitiglinide) and a fixed-dose combination product, Metgluna, which combines Glinsuna and metformin

The study also will measure the effect of Soliris on other clinical manifestations of PNH, including blood transfusion requirements, thromboses and kidney function...The clinical trial is being conducted in collaboration with Summit, N.J.-based Celgene Corp...under a clinical research agreement whereby Celgene supplies Revlimid to study participants

The Phase I study is an open-label, dose-escalation trial in patients with nonresectable or metastatic solid tumors, and the primary objectives are to evaluate the safety and tolerability of CALAA-01 in humans...Clinical Data Inc., of Newton, Mass., initiated the second of its two pivotal trials of Vilazodone, the company's drug candidate for depression...Data obtained from the first Phase II/III clinical trial yielded promising efficacy results on the study endpoints

Calistoga Pharmaceuticals Inc., of Seattle, said it has initiated a Phase I clinical trial of CAL-101, an orally available small molecule that inhibits an important intracellular signaling component known as phosphoinositide-3 kinase (PI3K) delta...Inovio Biomedical Corp., of San Diego, said that interim data from its first-in-man Phase I clinical trial showed that a DNA-based immunotherapy (plasmid IL-12) against metastatic melanoma was safe and also produced durable local and systemic tumor

Penwest reported last month that a Phase IIa clinical trial of nalbuphine ER failed to meet its primary endpoint of the sum of pain intensity differences between baseline and day 21...The randomized, double-blind, placebo-controlled, dose-escalation Phase IIa trial evaluated the analgesic efficacy of nalbuphine ER in 138 patients with chronic pain secondary to osteoarthritis of the knee or hip

Algeta ASA, of Oslo, Norway, said it soon will begin clinical development of Alpharadin in hormone-refractory prostate cancer patients...As a result, the company will be extending the dose escalation portion of the study longer than originally planned

Hana Biosciences, of South San Francisco, has completed patient enrollment in its Phase I dose-escalation clinical trial of Alocrest (vinorelbine liposomes injection, Optisome...MorphoSys had submitted the clinical trial application in December...The multicenter clinical trial is being conducted in the Republic of Georgia

AGI Dermatics, of Freeport, N.Y., said clinical research indicates that the ability of bicyclic monoterpene diols (BMTds) to reduce collagenase MMP-1 secretion and increase collagen production is dependent on the TNF-alpha signaling in the fibrolasts...The open-label, dose-escalation study will evaluate safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and dosing

The 35-patient, open-label, dose-escalation study will assess safety and tolerability as well as clinical measures such as urine flow rate, sodium excretion rate and plasma cGMP levels

BioVascular's European Phase Ib dose-escalation study of BVI-007, a compound that acts to reduce platelet production without affecting platelet function, is expected to be completed in late spring, Parrish said...acted as co-managers for the offering.

The company plans to begin an open-label, single-arm, dose-escalation Phase I trial in solid tumors...New data showed the drug also significantly improved secondary endpoints including clinical outcomes such as tender and swollen joints, the clinician's global assessment, a subgroup analysis of complete responders and quality of life

The open-label, sequential dose escalation study will evaluate the combination of AV-951 and temsirolimus in patients with metastatic renal cell carcinoma...Preliminary clinical results demonstrated an excellent safety profile and evidence of efficacy in the alleviation of symptoms, the company said, adding that it plans to file for a Phase III trial in the next few months

The Phase I study of Lipoxen's first product to enter clinical trials is being conducted in 12 healthy volunteers at the Federal State Center of Endocrinology in Moscow...The firm said it will start a randomized, placebo-controlled, dose-escalation, single-center Phase I study in about 30 healthy adults males in the first quarter of 2008

The double-blind, dose-escalation trial will test both single and multiple doses of BI-204 administered either intravenously or subcutaneously...The trial is a randomized, double-blind placebo-controlled multicenter clinical study that will be conducted internationally and involve about 500 patients with general SLE

Adventrx Pharmaceuticals Inc., of San Diego, said safety results from its marketing-enabling bioequivalence clinical study of ANX-530 (vinorelbine emulsion) demonstrated a statistically significant reduction in injection site reactions when compared with Navelbine (vinorelbine tartrate...The objective of the 60-patient study is to assess clinical efficacy of an oral capsule formulation of iclaprim as step-down therapy in comparison with IV vancomycin, with the primary endpoint measured by the

Emergent BioSolutions Inc., of Rockville, Md., said a final analysis from a recently completed, randomized, placebo-controlled, blinded Phase II clinical study showed that 97 percent of children developed an immune response after receiving a single-dose of the firm's drinkable typhoid vaccine candidate...Medarex plans to initiate a 40-patient, open-label, dose-escalation, multidose Phase I trial in clear cell renal cell carcinoma

The study also will measure the effect of Soliris on other clinical manifestations of PNH, including blood transfusion requirements, thromboses and kidney function...The dose-escalation study in up to 30 adult patients with advanced cancer will investigate the safety and preliminary efficacy of CNDO101

Clinical Data Inc., of Newton, Mass., said it started a long-term safety study ahead of schedule for vilazodone, a treatment for depression that acts both as a selective serotonin reuptake inhibitor (SSRI) and a 5-HT1A partial agonist...The open-label, dose-escalation study will enroll up to 105 patients

Preliminary clinical activity observed in most subjects, including: reduction in spleen size of 33 percent to 100 percent in five of six patients evaluated...The Phase I dose-escalation portion of the trial has been completed and the maximum tolerated dose was determined to be 1.3 mg/m2 of bortezomib, 20 mg of dexamethasone and 10 mg/m2 of romidepsin