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Phase 2 CUBICIN study for prosthetic joint infections meets primary endpoint

Cubist Pharmaceuticals, Inc., a leading acute care therapeutics company, today announced that its Phase 2 safety study of CUBICIN (daptomycin for injection) in the treatment of prosthetic joint infections caused by certain Gram positive pathogens met its study objectives. This study was a first-of-its-kind randomized controlled Phase 2 trial studying anti-infective therapy in the setting of 2-stage surgery for the replacement of infected prosthetic hip or knee joints.

19 Jul 2010

Phase II data on Genetic Immunity's DermaVir vaccine to be presented at XVIII International AIDS Conference

Genetic Immunity, a US/Hungarian biopharmaceutical company developing nanomedicine-based immunotherapies for HIV/AIDS and other chronic diseases, is releasing Phase II data on the Company's novel DermaVir therapeutic vaccine for HIV/AIDS during the XVIII International AIDS Conference this week in Vienna, Austria. DermaVir, the first dendritic cell-targeting topical HIV vaccine candidate, employs nanotechnology to induce multi-faceted and long-lived immune responses capable of eliminating HIV infected cells.

19 Jul 2010

ViroStatics to present VS411 Phase II dose-ranging trial data at International AIDS Conference in Vienna

ViroStatics, a US/Italian biopharmaceutical company developing innovative immunotherapies for HIV/AIDS and other chronic diseases, is releasing Phase II data from a randomized, dose-ranging trial of VS411, the Company's novel combination product for treating HIV/AIDS, during the XVII International AIDS Conference this week in Vienna, Austria.

19 Jul 2010

FIT Biotech to present results of FIT-06 Phase II clinical trial at XVIII International AIDS 2010 Conference

FIT Biotech, a privately held biotechnology company developing novel, proprietary immunotherapies for HIV/AIDS and other viral diseases, announced results today from a Phase II clinical trial. The company's immunomodulator FIT-06 showed unprecedented long-term reductions in viral load (approximately 0.5 log) and statistically significant CD4 cell count increases in HIV-infected, previously untreated patients. The effect lasted longer than two years in the absence of any anti-retroviral therapy.

19 Jul 2010

Pacific Shore releases clinical trial results for Burner Balm lip balm

Pacific Shore Holdings, Inc., today announced the release of the highly anticipated clinical trial results for Burner Balm lip balm. According to lead clinical investigator, Dr. David E. Toomey, who has orchestrated a multitude of clinical trials for some of the top pharmaceutical manufacturers in the United States, "Over a twelve week period, 120 study participants who were overweight participated in the study. The Burner Balm group lost an average of 7 to 9 pounds versus the placebo group who lost an average of 1.43 to 1.64 pounds in the 12 week period.

17 Jul 2010

Amgen granted FDA priority review designation for denosumab BLA

Amgen today announced that the U.S. Food and Drug Administration (FDA) has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone metastases to reduce skeletal related events (SREs) in patients with cancer.

17 Jul 2010

VIVUS disappointed with FDA Advisory Committee's vote on QNEXA for obesity treatment

VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted against the following question: "Based on the current available data, do you believe the overall benefit-risk assessment of PHEN/TPM (QNEXA) is favorable to support its approval for the treatment of obesity in individuals with a BMI > 30 kg/m2 or > 27 kg/m2 with weight-related co-morbidities?" The three co-morbidities included hypertension, diabetes and dyslipidemia.

16 Jul 2010

JDD publishes long-term efficacy and tolerability study of PyratineXR Moisturizing Lotion

The June 2010 issue of Journal of Drugs in Dermatology (JDD), a full-color, peer-reviewed publication serving the dermatology community, features a study on the long-term efficacy and tolerability of the active ingredient in PyratineXR™.

16 Jul 2010

Noscira presents results of Nypta Phase IIa clinical trial for AD at ICAD 2010

Noscira, the Grupo Zeltia (ZEL.MC) subsidiary specialized in researching and developing drugs for treating neurodegenerative diseases, presented the results of a Phase IIa clinical trial of Nypta(R) (Tideglusib) on Alzheimer's disease (AD) at the International Conference on Alzheimer's Disease (ICAD), held in Honolulu (Hawaii) from July 10-15, 2010.

16 Jul 2010

QR Pharma to present positive clinical data from mechanism of action study in MCI at ICAD 2010

QR Pharma, Inc., a developer of novel drugs to treat Alzheimer's disease (AD), is presenting a poster today on positive clinical data from its recent mechanism of action study in mild cognitive impaired (MCI) patients at the International Congress on Alzheimer's Disease (ICAD 2010).

15 Jul 2010

Positive microplasmin Phase II trial results published in journal Retina

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that positive microplasmin Phase II trial results, evaluating the product for the nonsurgical treatment of vitreomacular adhesion, have been published in the July/August issue of the journal Retina.

15 Jul 2010

Scientists comment on two clinical trials that use Rituximab to treat small-vessel vasculitis

Two UNC School of Medicine faculty authored an editorial in the July 15, 2010 New England Journal of Medicine commenting on results from two clinical trials using the drug Rituximab to treat small-vessel vasculitis, a rare autoimmune disease.

15 Jul 2010

PPMD to provide grant to clinical sites participating in Phase 2 study of ACE-031

Patricia A. Furlong, Founding President and CEO of Parent Project Muscular Dystrophy, the largest non-profit organization in the United States focused on finding a cure for Duchenne muscular dystrophy, announced that PPMD will provide a grant to clinical sites participating in Acceleron Pharma's Phase 2 clinical study of ACE-031. These grants will help patients' families cover travel costs to and from the study site, and hotel rooms and meals during study visits.

15 Jul 2010

Two patents issued for GlycoMimetics lead drug candidate, related compounds

GlycoMimetics, Inc., a clinical-stage biotechnology company developing a new class of glycobiology-based therapies for a broad range of indications, today announced that the U. S. Patent and Trademark Office has issued two patents covering the company's lead drug candidate and related compounds. One patent, US number 7,728,117, specifically covers GMI-1070, the Company's drug candidate now in clinical trials of patients with vaso-occlusive crisis of sickle cell disease. The second patent, US number 7,741,312, contains claims covering a family of molecules that includes and extends beyond GMI-1070.

15 Jul 2010

Enrollment complete in Nabi's first NicVAX Phase III clinical trial for nicotine addiction

Nabi Biopharmaceuticals announced today that it has completed enrollment in the first Phase III clinical trial of NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse.

15 Jul 2010

Aeterna Zentaris' partner Keryx receives FDA orphan-drug designation for perifosine in neuroblastoma

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that its partner, Keryx Biopharmaceuticals, Inc., has been granted orphan-drug designation by the U.S. Food and Drug Administration for perifosine, Aeterna Zentaris' novel, potentially first-in-class, oral Akt inhibitor, for the treatment of neuroblastoma.

15 Jul 2010

Aastrom commences extension study for control patients from Phase 2 IMPACT-DCM clinical trial

Aastrom Biosciences, Inc., the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced the initiation of an extension study for control patients from the company's ongoing open-label Phase 2 IMPACT-DCM clinical trial in patients with dilated cardiomyopathy (DCM).

14 Jul 2010

Phase 1/2 clinical study of bepotastine besilate nasal spray initiated for seasonal allergic rhinitis

ISTA Pharmaceuticals, Inc., today announced it has initiated a Phase 1/2 clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. The randomized, placebo-controlled, parallel-group study will evaluate the safety and efficacy of three concentrations of bepotastine besilate, dosed twice daily, in an Environmental Exposure Chamber model of allergic rhinitis caused by natural exposure to seasonal allergens.

14 Jul 2010

Presidio Pharmaceuticals completes Phase 1a clinical trial of PPI-461 in healthy subjects

Presidio Pharmaceuticals, Inc. announced today the successful completion of a Phase 1a clinical trial of PPI-461, its lead HCV NS5A inhibitor, in healthy subjects. This first-in-human trial evaluated four single doses of PPI-461, followed by a five-day, once-a-day treatment regimen with PPI-461 at the highest tested dose.

14 Jul 2010

Supernus initiates SPN812 Phase IIa clinical trial for ADHD in adults

Supernus Pharmaceuticals, Inc. today announced the initiation of a Phase IIa U.S. clinical trial of its product candidate SPN812 for the treatment of ADHD in adults. The trial is a proof-of-concept, randomized, double-blind, placebo-controlled study in healthy adults aged 18 to 64, inclusive, with ADHD. Supernus expects to enroll 50 subjects in the study at 5 sites across the United States.

14 Jul 2010

Drug Trial News

Phase 2 CUBICIN study for prosthetic joint infections meets primary endpoint

Phase II data on Genetic Immunity's DermaVir vaccine to be presented at XVIII International AIDS Conference

ViroStatics to present VS411 Phase II dose-ranging trial data at International AIDS Conference in Vienna

FIT Biotech to present results of FIT-06 Phase II clinical trial at XVIII International AIDS 2010 Conference

Pacific Shore releases clinical trial results for Burner Balm lip balm

Amgen granted FDA priority review designation for denosumab BLA

VIVUS disappointed with FDA Advisory Committee's vote on QNEXA for obesity treatment

JDD publishes long-term efficacy and tolerability study of PyratineXR Moisturizing Lotion

Noscira presents results of Nypta Phase IIa clinical trial for AD at ICAD 2010

QR Pharma to present positive clinical data from mechanism of action study in MCI at ICAD 2010

Positive microplasmin Phase II trial results published in journal Retina

Scientists comment on two clinical trials that use Rituximab to treat small-vessel vasculitis

PPMD to provide grant to clinical sites participating in Phase 2 study of ACE-031

Two patents issued for GlycoMimetics lead drug candidate, related compounds

Enrollment complete in Nabi's first NicVAX Phase III clinical trial for nicotine addiction

Aeterna Zentaris' partner Keryx receives FDA orphan-drug designation for perifosine in neuroblastoma

Aastrom commences extension study for control patients from Phase 2 IMPACT-DCM clinical trial

Phase 1/2 clinical study of bepotastine besilate nasal spray initiated for seasonal allergic rhinitis

Presidio Pharmaceuticals completes Phase 1a clinical trial of PPI-461 in healthy subjects

Supernus initiates SPN812 Phase IIa clinical trial for ADHD in adults

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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