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Trial collaborators present results from Prime-Boost HIV Vaccine Clinical Trial

Detailed results from the Prime-Boost HIV Vaccine Clinical Trial involving more than 16,000 adult volunteers in Thailand show that an investigational HIV vaccine regimen was safe and modestly effective at reducing the rate of HIV infection compared to placebo.

20 Oct 2009

AstraZeneca and POZEN announce the pivotal data from two POZEN clinical trials

AstraZeneca and POZEN Inc. today announced pivotal data from two POZEN clinical trials that were presented at the American College of Rheumatology (ACR) 2009 Annual Scientific Meeting in Philadelphia, PA.

20 Oct 2009

Cumberland Pharmaceuticals publishes data on its Phase III intravenous ibuprofen study

Cumberland Pharmaceuticals Inc. announced today that its Phase III study on intravenous ibuprofen as a post-operative analgesic was published in Volume 31, Number 9 of the peer-reviewed journal Clinical Therapeutics, distributed in October. The study concludes that patients emerging from orthopedic and abdominal surgeries required less narcotic and experienced less pain with 800 mg of intravenous ibuprofen every six hours compared to morphine alone.

20 Oct 2009

NicOx presents data on its phase 3 naproxcinod study at the ACR meeting

NicOx S.A. announced the presentation of detailed 26-week efficacy, safety and tolerability data from the second pivotal phase 3 study for naproxcinod (the 302 study) yesterday, at the American College of Rheumatology (ACR) and Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in Philadelphia, Pennsylvania.

20 Oct 2009

Rexahn Pharmaceuticals announces positive results from Phase IIa Serdaxin clinical study

Rexahn Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on developing multi-indication therapeutics in CNS and oncology, today announced top-line results from a Phase IIa clinical study of Serdaxin™, its major depressive disorder (MDD) drug candidate.

20 Oct 2009

Optimer Pharmaceuticals to present additional data on fidaxomicin at the 47th IDSA meeting

Optimer Pharmaceuticals, Inc. announced that additional data related to fidaxomicin, the Company's lead developmental product candidate for the treatment of Clostridium difficile infection, will be presented at the 47th Annual Meeting of the Infectious Disease Society of America (IDSA) to be held at The Philadelphia Convention Center in Philadelphia, Pennsylvania October 29 through November 1, 2009.

20 Oct 2009

Human Genome Sciences and GlaxoSmithKline to present Phase 3 trial results of BENLYSTA

Human Genome Sciences, Inc. and GlaxoSmithKline PLC (GSK) today announced the full presentation of results from BLISS-52, the first of two pivotal Phase 3 trials of BENLYSTA™ (belimumab) in seropositive patients with systemic lupus erythematosus (SLE).

20 Oct 2009

Celgene Corporation updates on Phase II study evaluating apremilast in psoriatic arthritis patients

Celgene Corporation announced that updated results of a phase II, multi-center, randomized, double-blind, placebo-controlled, three-arm study of apremilast in adult patients with psoriatic arthritis (CC-10004-PSA-001) were presented today at the American College of Rheumatology (ACR) 2009 annual meeting in Philadelphia, PA.

20 Oct 2009

Jennerex' JX-594 granted European Orphan Drug Designation for the treatment of hepatocellular carcinoma

Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), a clinical stage biotherapeutics company developing a proprietary breakthrough product class of targeted oncolytic virus therapeutics, today announced that the European Medicines Agency (EMEA) has granted Orphan Drug Designation to Jennerex's product JX-594 for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. JX-594 is expected to enter a Phase 3 pivotal trial in the second half of 2010.

20 Oct 2009

Interim results from Phase 1 CAL-101 trial for chronic lymphocytic leukemia

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 the presentation of interim results from the ongoing Phase 1 trial evaluating CAL-101, an oral delta-selective PI3K inhibitor, demonstrating promising clinical responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

20 Oct 2009

Positive results from Transave's Phase II ARIKACE clinical trials

Transave Inc., today reported additional positive clinical trial results on its lead investigational drug, ARIKACE(TM) (liposomal amikacin for inhalation), an antibiotic that aims to treat chronic lung infections.

20 Oct 2009

UCB reports on the outcome of Cimzia and MTX treatment for rheumatoid arthritis

UCB today announced data that showed rapid and sustained improvements in ACR20, physical function, pain and fatigue of rheumatoid arthritis (RA) as early as the first week, and inhibition of progression of structural joint damage (seen at week 24) following treatment with Cimzia (certolizumab pegol), together with methotrexate (MTX), was sustained up to 100 weeks.

19 Oct 2009

Alnara Pharmaceuticals’ announces results of its international Phase 3 study of liprotamase

Alnara Pharmaceuticals, a pharmaceutical company developing novel, non-systemic orally delivered protein therapeutics for the treatment of metabolic diseases, today announced results from an international, Phase 3 open-label, long-term safety study demonstrating the safety and nutritional benefits of liprotamase, a novel pancreatic enzyme replacement therapy (PERT) for patients with cystic fibrosis (CF).

19 Oct 2009

Philippines and Malaysian regulatory agencies approve Celsion’s Phase III Thermodox trial

Celsion Corporation announced today that it has received approval from the regulatory agencis in the Philippines and Malaysia for its Pivotal Phase III primary liver cancer Clinical Trial Application.

19 Oct 2009

Amarin selects Medpace as CRO for its Phase 3 AMR101 MARINE clinical study

Amarin Corporation plc today announced that it has executed an agreement with Medpace, Inc. (‘Medpace’), a leading Contract Research Organization (CRO) with expertise in conducting clinical trials in cardiovascular and metabolic disease, to engage their services in the execution of its Phase 3 clinical trials with AMR101 in patients with very high triglyceride levels (the AMR101 MARINE Study) and mixed dyslipidemia.

19 Oct 2009

New data on Phase 3 SIMPONI clinical trials for rheumatoid arthritis

New long-term data from two pivotal, Phase 3 clinical trials showed that patients with active rheumatoid arthritis (RA) receiving SIMPONI(TM) (golimumab) every four weeks achieved sustained improvements in signs and symptoms and physical function response through one year. These new data were presented today at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting.

19 Oct 2009

Positive results from Trubion Pharmaceuticals' Phase 2B study of TRU-015 for rheumatoid arthritis

Trubion Pharmaceuticals, Inc. today announced favorable safety and efficacy data following administration of a second course (R2) of re-treatment with 800 mg of TRU-015 for rheumatoid arthritis (RA). These data are the latest results from the ongoing open-label re-treatment portion of the Phase 2b (15002) RA study of TRU-015. Pfizer Inc. and Trubion are collaborating on the development of TRU-015 for the treatment of autoimmune and inflammatory diseases, including RA.

19 Oct 2009

Schering-Plough to present data on boceprevir at the AASLD 2009 Annual Meeting

Schering-Plough announced that data on boceprevir, an investigational hepatitis C virus (HCV) protease inhibitor, will be reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3.

19 Oct 2009

Ardea Biosciences reports results of RDEA594 Phase 2a study for hyperuricemia and gout

Ardea Biosciences, Inc. announced additional positive results from the completed first cohort of an ongoing Phase 2a, proof-of-concept study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout.

19 Oct 2009

Phase 3 clinical trial of macimorelin (AEZS-130) to be completed by AEterna Zentaris

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that it has initiated activities intended to complete the clinical development of the growth hormone secretagogue (GHS) / ghrelin agonist compound macimorelin (AEZS-130) which could be the first oral diagnostic test approved for growth hormone deficiency (GHD). Macimorelin is the International Non-proprietary Name (INN) designated for the compound by the World Health Organization (WHO).

19 Oct 2009

Drug Trial News

Trial collaborators present results from Prime-Boost HIV Vaccine Clinical Trial

AstraZeneca and POZEN announce the pivotal data from two POZEN clinical trials

Cumberland Pharmaceuticals publishes data on its Phase III intravenous ibuprofen study

NicOx presents data on its phase 3 naproxcinod study at the ACR meeting

Rexahn Pharmaceuticals announces positive results from Phase IIa Serdaxin clinical study

Optimer Pharmaceuticals to present additional data on fidaxomicin at the 47th IDSA meeting

Human Genome Sciences and GlaxoSmithKline to present Phase 3 trial results of BENLYSTA

Celgene Corporation updates on Phase II study evaluating apremilast in psoriatic arthritis patients

Jennerex' JX-594 granted European Orphan Drug Designation for the treatment of hepatocellular carcinoma

Interim results from Phase 1 CAL-101 trial for chronic lymphocytic leukemia

Positive results from Transave's Phase II ARIKACE clinical trials

UCB reports on the outcome of Cimzia and MTX treatment for rheumatoid arthritis

Alnara Pharmaceuticals’ announces results of its international Phase 3 study of liprotamase

Philippines and Malaysian regulatory agencies approve Celsion’s Phase III Thermodox trial

Amarin selects Medpace as CRO for its Phase 3 AMR101 MARINE clinical study

New data on Phase 3 SIMPONI clinical trials for rheumatoid arthritis

Positive results from Trubion Pharmaceuticals' Phase 2B study of TRU-015 for rheumatoid arthritis

Schering-Plough to present data on boceprevir at the AASLD 2009 Annual Meeting

Ardea Biosciences reports results of RDEA594 Phase 2a study for hyperuricemia and gout

Phase 3 clinical trial of macimorelin (AEZS-130) to be completed by AEterna Zentaris

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