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Sepracor announces preliminary results from OMNARIS HFA Phase III study for seasonal allergic rhinitis

Sepracor Inc. announced today the preliminary results of a large-scale, 671-patient Phase III study of OMNARIS® (ciclesonide) HFA, an aerosol nasal formulation of ciclesonide, for the treatment of seasonal allergic rhinitis (SAR) in adult and adolescent patients. In this study, OMNARIS HFA met its primary efficacy endpoint by demonstrating a statistically significant reduction versus placebo in the reflective total nasal symptom score averaged over a two-week treatment period.

1 Jul 2010

Evotec commences EVT 101 proof-of-concept Phase II study in treatment-resistant depression

Evotec AG today announced the start of the proof-of-concept Phase II study in treatment-resistant depression with its NR2B subtype selective NMDA receptor antagonist EVT 101. This clinical development is part of an alliance between Evotec and Roche.

1 Jul 2010

CBio achieves recruitment milestone in XToll clinical trial

Australian drug development company CBio Limited today announced the achievement of a recruitment milestone in its clinical trial of XToll, the potential new-generation drug therapy which could provide safer and more effective treatment of autoimmune diseases such as rheumatoid arthritis.

1 Jul 2010

Biospherics acquires worldwide patent rights to Dtagatose from UKRF

Spherix Incorporated, an innovator in biotechnology for therapy in diabetes, metabolic syndrome, and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that its wholly-owned subsidiary, Biospherics Incorporated, has signed a license agreement with the University of Kentucky Research Foundation (UKRF).

1 Jul 2010

XOMA reaches enrollment goal of 325 patients for Phase 2b clinical trial of XOMA 052

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced that it has reached the enrollment goal of 325 patients for its Phase 2b dose-ranging clinical trial of XOMA 052, and that it expects patient enrollment to close in July 2010, with top-line results available in the first quarter of 2011. XOMA 052 is a therapeutic antibody candidate that inhibits the pro-inflammatory cytokine interleukin-1 beta (IL-1 beta) which drives the inflammatory cause of Type 2 diabetes.

1 Jul 2010

Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

Eisai Inc. announced today preliminary results from a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection versus either a low-dose chemotherapy agent or supportive care in elderly patients with acute myeloid leukemia (AML), a life-threatening cancer of the blood that generally occurs in older adults.

1 Jul 2010

Threshold Pharmaceuticals initiates Phase 2 clinical trial of TH-302 in patients with first line pancreatic cancer

Threshold Pharmaceuticals, Inc. today announced that it has initiated a multi-center, randomized, controlled, crossover Phase 2 clinical trial of TH-302 in combination with gemcitabine in patients with first line pancreatic cancer. TH-302 is a proprietary tumor selective Hypoxia-Activated Prodrug that specifically targets tumor hypoxia.

1 Jul 2010

Cubist commences enrollment in Phase 2 study of CXA-201 for complicated intra-abdominal infections

Cubist Pharmaceuticals, Inc., a leading acute care therapeutics company, today announced the enrollment of the first patient in a Phase 2 study with CXA-201. This multicenter, double-blind, randomized, study will compare the safety and efficacy of intravenous CXA-201 with an active comparator in patients with complicated intra-abdominal Infections (cIAI). This international study is expected to enroll 120 patients.

1 Jul 2010

SuperGen encouraged by Eisai's intent to file Dacogen sNDA for new indication

SuperGen, Inc., a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that Eisai Inc. today released information regarding a randomized Phase III clinical trial of Dacogen® (decitabine) for Injection in elderly patients with acute myeloid leukemia (AML). The comparator in this trial was low-dose cytarabine, a chemotherapy agent, or supportive care.

30 Jun 2010

Calistoga Pharmaceuticals closes $40 million Series C financing

Calistoga Pharmaceuticals, Inc., the leader in the development of isoform-selective phosphatidylinositol 3 kinase (PI3K) inhibitors for the treatment of cancer and inflammatory diseases, today announced it has closed a $40 million Series C financing. The financing was led by Quogue Capital, LLC along with existing investors Alta Partners, Amgen Ventures, Frazier Healthcare and Three Arch Partners and new investor Latterell Venture Partners.

30 Jun 2010

Chelsea completes enrollment in Northera Phase III Study 301 for neurogenic orthostatic hypotension

Chelsea Therapeutics International, Ltd. has successfully reached its target enrollment of 150 patients in its Northera™ (Droxidopa) pivotal Phase III Study 301 for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH). Results from the trial are expected in September 2010 and the full registration program is on track to initiate a new drug application (NDA) in the first half of 2011.

30 Jun 2010

BioSante reports positive results from Phase II study of Pill-Plus "triple hormone" oral contraceptive

BioSante Pharmaceuticals, Inc. announced today positive results in a Phase II study of the Pill-Plus "triple hormone" oral contraceptive (OC). Results showed an increase in the frequency of sexual activity (p< 0.05) and reduced frequency of rejection of initiation of sexual activity by partner (p< 0.05).

30 Jun 2010

Transition commences dosing in TT-301 Phase 1 clinical study for rheumatoid arthritis, ICH, TBI

Transition Therapeutics Inc. announced today that the first patient has been dosed with drug candidate TT-301 in a Phase 1 clinical study. TT-301 is a small molecule compound that has demonstrated efficacy in preclinical models of rheumatoid arthritis, intracerebral haemorrhage and traumatic brain injury.

30 Jun 2010

Data published in Cancer Research demonstrates proof of concept for Mirna's tumor suppressor miRNAs

Mirna Therapeutics announced today publication of new results in the journal Cancer Research demonstrating proof of concept that the systemic delivery of tumor suppressor microRNAs (miRNA) inhibits tumor growth by restoring the proper regulatory pathways required for cell cycle arrest and apoptosis.

30 Jun 2010

European Congress of Nephrology unveils results of various clinical trials

The 47th ERA-EDTA/DGfN congress in Munich has been the setting for a wide range of new clinical data. The results of the following clinical trials were presented at "Late-Breaking Clinical Trials Sessions."

30 Jun 2010

Vimpat provides long-term additional partial-onset seizure control when added to broad range of AEDs

New long term data showed that Vimpat- (lacosamide) C-V provided sustained reduction in seizure frequency for up to five years when used as an add-on treatment for uncontrolled partial onset seizures in adults with epilepsy. In addition post-hoc exploratory analyses showed that adjunctive lacosamide treatment reduced partial-onset seizure frequency and improved responder rates when added to a broad range of antiepileptic drugs (AEDs) including both traditional sodium channel-blocking agents and those that act on non-sodium channel-targets.

30 Jun 2010

Cubist Phase 2 trial for efficacy of CXA-101 in complicated urinary tract infections meets objectives

Cubist Pharmaceuticals, Inc., a leading acute care therapeutics company, today announced that the recently-completed Phase 2 study of CXA-101, a novel cephalosporin, compared to ceftazidime for the treatment of complicated urinary tract infections (cUTI) in adults met its study objectives.

30 Jun 2010

Aeolus AEOL 10150 study confirms ability to rescue skin from deleterious effects of CEES

Aeolus Pharmaceuticals, Inc. reported that researchers from National Jewish Health and the University of Colorado Anschutz Medical Campus have completed studies demonstrating that AEOL 10150 provides statistically significant protection of the skin in the 2-chloroethyl-ethylsulfide (CEES; half mustard) model of mustard gas exposure in mice and in a human cell culture model.

30 Jun 2010

Sirnaomics receives NIH SBIR grants to advance siRNA therapeutics for critical human diseases

Sirnaomics, Inc. announced today that the company has received two SBIR (Small Business Innovation Research) grants from National Cancer Institute (NCI) and National Institute of Allergy and Infectious Diseases (NIAID), of National Institute of Health (NIH). Sirnaomics, Inc., a biopharmaceutical company founded in early 2007, is dedicated to developing RNA interference (RNAi) therapeutics for treatment of critical human diseases.

30 Jun 2010

Ph II data of perifosine + capecitabine in metastatic CRC to be presented at gastrointestinal cancer congress

Keryx Biopharmaceuticals, Inc. today announced that abstract O-0017, entitled "Subset Analysis of 5-FU Refractory Patients from a Randomized Ph II Study of Perifosine + Capecitabine (P-CAP) vs. Placebo + Capecitabine (CAP) in Patients with 2nd or 3rd Line Metastatic CRC" has been selected for oral presentation at the upcoming 12th World Congress on Gastrointestinal Cancer, to be held in Barcelona, Spain from June 30 - July 2, 2010.

30 Jun 2010

Drug Trial News

Sepracor announces preliminary results from OMNARIS HFA Phase III study for seasonal allergic rhinitis

Evotec commences EVT 101 proof-of-concept Phase II study in treatment-resistant depression

CBio achieves recruitment milestone in XToll clinical trial

Biospherics acquires worldwide patent rights to Dtagatose from UKRF

XOMA reaches enrollment goal of 325 patients for Phase 2b clinical trial of XOMA 052

Eisai reports preliminary results from Dacogen for Injection Phase III study in AML

Threshold Pharmaceuticals initiates Phase 2 clinical trial of TH-302 in patients with first line pancreatic cancer

Cubist commences enrollment in Phase 2 study of CXA-201 for complicated intra-abdominal infections

SuperGen encouraged by Eisai's intent to file Dacogen sNDA for new indication

Calistoga Pharmaceuticals closes $40 million Series C financing

Chelsea completes enrollment in Northera Phase III Study 301 for neurogenic orthostatic hypotension

BioSante reports positive results from Phase II study of Pill-Plus "triple hormone" oral contraceptive

Transition commences dosing in TT-301 Phase 1 clinical study for rheumatoid arthritis, ICH, TBI

Data published in Cancer Research demonstrates proof of concept for Mirna's tumor suppressor miRNAs

European Congress of Nephrology unveils results of various clinical trials

Vimpat provides long-term additional partial-onset seizure control when added to broad range of AEDs

Cubist Phase 2 trial for efficacy of CXA-101 in complicated urinary tract infections meets objectives

Aeolus AEOL 10150 study confirms ability to rescue skin from deleterious effects of CEES

Sirnaomics receives NIH SBIR grants to advance siRNA therapeutics for critical human diseases

Ph II data of perifosine + capecitabine in metastatic CRC to be presented at gastrointestinal cancer congress

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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