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Small Phase I trial shows HIV vaccine candidate is most powerful to date

Researchers at the Spanish Superior Scientific Research Council (CSIC) have successfully completed a small Phase I human clinical trial of an HIV vaccine candidate that granted 90 percent of 30 study participants an immunological response against the virus, Gizmag reports.

30 Sep 2011

Microbicide Trials Network stops tenofovir arm of study after findings show drug less effective than anticipated

"The Microbicide Trials Network (MTN), which is funded by the U.S. National Institutes of Health, on Wednesday announced that it decided to stop one arm of a study involving more than 5,000 women in South Africa, Zimbabwe, and Uganda" after "an interim review of the ongoing trial by an independent monitoring board found that the drug tenofovir when used as pre-exposure prophylaxis (PrEP) had less effect in protecting women than anticipated," Science Magazine's "Science Insider" blog reports.

30 Sep 2011

Circadian files IND with FDA for VGX-100 for the treatment of cancer patients with solid tumors

Circadian Technologies Limited (ASX: CIR, OTCQX:CKDXY) is extremely proud to announce that its 100% owned subsidiary, Vegenics Pty Ltd, has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate clinical studies of VGX-100. The first trial (Phase I) will involve the treatment of a variety of different cancer types in patients with late stage cancer.

29 Sep 2011

Positive new data from Otonomy's OTO-104 Phase 1b study on Meniere's disease

Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that researchers presented positive new data from a Phase 1b study of the company's lead product candidate, OTO-104, in patients with Meniere's disease.

29 Sep 2011

Cubist plans to move CB-183,315 into Phase 3 trial for treatment of CDAD

Cubist Pharmaceuticals, Inc. today announced it plans to move CB-183,315, being studied for the treatment of a severe and sometimes life-threatening diarrhea caused by Clostridium difficile known as C. difficile-associated diarrhea, or CDAD, into late-stage trials.

29 Sep 2011

DSMB authorizes ACT to proceed with next set of patients in stem cell clinical trials

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today that the independent Data and Safety Monitoring Board (DSMB) overseeing the Company's two ongoing stem cell clinical trials in the United States authorized ACT to move forward with enrolling and treating the next set of patients in each of the trials.

29 Sep 2011

Cincinnati Children's to conduct first pediatric migraine medicine clinical trial

Cincinnati Children's Hospital Medical Center has received a $12 million grant from the National Institutes of Health to conduct the first clinical trial to determine the medication of choice for preventing migraines in children and teens.

29 Sep 2011

Almirall submits linaclotide MAA to EMA for treatment of IBS-C

Ironwood Pharmaceuticals, Inc. today announced that its European partner Almirall, S.A. submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of irritable bowel syndrome with constipation.

29 Sep 2011

VOICE HIV prevention trial to discontinue use of tenofovir tablets

VOICE, an HIV prevention trial evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women - daily use of one of two different ARV tablets or of a vaginal gel - will be dropping one of the oral tablets from the study.

29 Sep 2011

Enrollment complete in Rexahn's Archexin Phase II trial for metastatic pancreatic cancer

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has completed enrollment for its Phase II clinical trial of Archexin in metastatic pancreatic cancer.

29 Sep 2011

SanBio initiates SB623 Phase 1/2a clinical trial in ischemic stroke

SanBio, Inc. has announced that a patient at Stanford University Medical Center has become the first to be treated with SB623, a novel cell therapy for patients with disability resulting from ischemic stroke.

29 Sep 2011

Halozyme commences HTI-501 clinical trial for cellulite in women

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the diabetes, cancer, dermatology and drug delivery markets, today announced the commencement of a Phase 1/2 clinical trial with HTI-501 (rHuCAT-L) in women with moderate to severe edematous fibrosclerotic panniculopathy (also known as cellulite).

28 Sep 2011

Phase I clinical trials reveal MVA-B preventive vaccine's immune efficiency against HIV

Phase I clinical trials developed by Spanish Superior Scientific Research Council (CSIC) together with Gregorio Mara--n Hospital in Madrid and Cl-nic Hospital in Barcelona, reveals MVA-B preventive vaccine's immune efficiency against Human's immunodeficiency virus (HIV).

28 Sep 2011

Adamas begins ADS-5102 Phase 2/3 clinical trial in Parkinson's disease

Adamas Pharmaceuticals, Inc., a privately held company, announced today that it has initiated a Phase 2/3 clinical trial of its proprietary investigational drug ADS-5102 (amantadine HCl extended release) for the treatment of levodopa induced dyskinesia (LID) in patients with Parkinson's disease.

28 Sep 2011

YM BioSciences begins enrollment in CYT387 Phase II trial for myelofibrosis

YM BioSciences Inc. today announced that it has enrolled the first patients in its multi-center Phase II trial of CYT387 administered twice-daily (BID) for the treatment of myelofibrosis.

28 Sep 2011

Lovastatin appears to be safe, effective for children with neurofibromatosis type 1

Researchers at Children's National Medical Center have found that a cholesterol-lowering statin drug appears to be safe in children with neurofibromatosis type 1 (NF1) and may improve learning disabilities, including verbal and nonverbal memory.

28 Sep 2011

BioLineRx's BL-1020 Phase IIb EAGLE trial data on schizophrenia to be presented at ECSR

BioLineRx, a biopharmaceutical development company, today announced that data from the successfully completed Phase IIb EAGLE study of BL-1020, a first in class GABA-enhanced antipsychotic for the treatment of schizophrenia, will be presented at the 3rd European Conference on Schizophrenia Research (ECSR) held in Berlin, Germany.

28 Sep 2011

MicroDose initiates MDT-637 Phase 1 trial in respiratory syncytial virus

MicroDose Therapeutx, Inc. today announced that the first human subject has been dosed in a Phase 1 clinical trial of MDT-637, MicroDose's inhalable small molecule antiviral fusion inhibitor for the treatment of respiratory syncytial virus.

28 Sep 2011

22nd Century completes enrollment in X-22 Phase II-B smoking cessation study

22nd Century Group, Inc., a company focused on smoking cessation and tobacco harm reduction products, announced today that enrollment of its X-22 Phase II-B clinical trial has been successfully completed; 234 smokers have been randomized in the double-blind, active-controlled, multi-center smoking cessation study.

27 Sep 2011

The Nation examines rise in unregulated drug trials in South America

The Nation examines how a surge in the outsourcing of clinical trials to contract research organizations (CROs) and a resulting increase in the number of trials being conducted in the developing world, where "regulations aren't as onerous, patient recruitment is easier and informed consent is less clearly defined," has led to a rise in unregulated drug trials in South America.

27 Sep 2011

Drug Trial News

Small Phase I trial shows HIV vaccine candidate is most powerful to date

Microbicide Trials Network stops tenofovir arm of study after findings show drug less effective than anticipated

Circadian files IND with FDA for VGX-100 for the treatment of cancer patients with solid tumors

Positive new data from Otonomy's OTO-104 Phase 1b study on Meniere's disease

Cubist plans to move CB-183,315 into Phase 3 trial for treatment of CDAD

DSMB authorizes ACT to proceed with next set of patients in stem cell clinical trials

Cincinnati Children's to conduct first pediatric migraine medicine clinical trial

Almirall submits linaclotide MAA to EMA for treatment of IBS-C

VOICE HIV prevention trial to discontinue use of tenofovir tablets

Enrollment complete in Rexahn's Archexin Phase II trial for metastatic pancreatic cancer

SanBio initiates SB623 Phase 1/2a clinical trial in ischemic stroke

Halozyme commences HTI-501 clinical trial for cellulite in women

Phase I clinical trials reveal MVA-B preventive vaccine's immune efficiency against HIV

Adamas begins ADS-5102 Phase 2/3 clinical trial in Parkinson's disease

YM BioSciences begins enrollment in CYT387 Phase II trial for myelofibrosis

Lovastatin appears to be safe, effective for children with neurofibromatosis type 1

BioLineRx's BL-1020 Phase IIb EAGLE trial data on schizophrenia to be presented at ECSR

MicroDose initiates MDT-637 Phase 1 trial in respiratory syncytial virus

22nd Century completes enrollment in X-22 Phase II-B smoking cessation study

The Nation examines rise in unregulated drug trials in South America

How agentic AI is reshaping laboratory workflows

Fourier 80: bringing benchtop NMR systems to the laboratory

How industrial hygiene flow calibration supports defensible exposure data

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