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Chelsea reports top-line data from Phase III NORTHERA extension study in NOH

Chelsea Therapeutics International, Ltd. reported new 12-month data from Study 303, a safety extension study from its Phase III NORTHERA™ (droxidopa) registration program in symptomatic neurogenic orthostatic hypotension (NOH). Preliminary, top-line results demonstrate Northera provides clinically meaningful and durable symptomatic improvements in patients with NOH throughout a one-year observation period.

20 Jan 2011

ZIOPHARM's darinaparsin receives EMA COMP orphan drug designation for treatment of peripheral T-cell lymphoma

ZIOPHARM Oncology, Inc., announced today that The Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) adopted a positive opinion for darinaparsin (Zinapar™ or ZIO-101) designation as an orphan medicinal product for the treatment of peripheral T-cell lymphoma (PTCL).

20 Jan 2011

Merck provides additional information about DSMB recommendations for vorapaxar TRA-2P study

Merck reported today that investigators in the TRA-2P study of vorapaxar have been provided with additional information about the recommendations of the Data and Safety Monitoring Board (DSMB) regarding the TRA-2P study. The additional information was sent yesterday in a communication to investigators from the Operations Committee of the TRA-2P study of vorapaxar. Vorapaxar is one of Merck's investigational cardiovascular medicines.

20 Jan 2011

FOLOTYN Phase 2 peripheral T-cell lymphoma study results published in Journal of Clinical Oncology

Allos Therapeutics, Inc. today announced that the Journal of Clinical Oncology has published data from the Company's pivotal Phase 2 PROPEL study demonstrating clinical activity of FOLOTYN® (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

20 Jan 2011

Pervasis pursues matrix-embedded endothelial cell-based therapy to target and regulate cell stroma

Pervasis Therapeutics, Inc. today announced that the company is pursuing a matrix-embedded endothelial cell-based therapy (PVS-30200) to target and regulate cell stroma (the tumor environment or "ecosystem" that is comprised of various supporting cell types distinct from cancer cells) in order to prevent key processes that play a role in advancing solid tumor growth and metastasis.

20 Jan 2011

Koronis' KP-1461 drug causes extra mutations to occur in HIV genome in HIV-infected patients

Recently published Phase 2a clinical trial results show that the frequency of specific, drug-induced mutations in the HIV genome can be significantly increased by administering KP-1461, a drug being developed by Koronis Pharmaceuticals based on its novel Viral Decay Acceleration (VDA) drug mechanism.

20 Jan 2011

4SC initiates dosing in resminostat Phase I/II SHORE study for KRAS-mutant colorectal cancer

4SC AG, a drug discovery and development company, today announced that the first patient has been dosed in the Phase I/II SHORE study with the oral pan-histone deacetylase (HDAC) inhibitor resminostat as a second-line treatment for patients with advanced and metastatic colorectal KRAS-mutant cancer.

20 Jan 2011

Apricus Bio's MycoVa demonstrates 'non-inferiority' for treatment of onychomycosis compared to Loceryl

Apricus Biosciences, Inc. today announced that an additional analysis conducted on behalf of the Company has shown that MycoVa™ has successfully demonstrated 'non-inferiority' for the treatment of onychomycosis (commonly referred to as nail fungus), compared to the current standard of care in Europe for topical therapy, Loceryl®.

20 Jan 2011

FDA establishes PDUFA date for ADVENTRX's Exelbine NDA review

ADVENTRX Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine (ANX-530) New Drug Application (NDA).

20 Jan 2011

GSK and Prosensa commence GSK2402968 Phase III study in DMD

GlaxoSmithKline and Prosensa today announced that the first patient has commenced treatment in the Phase III clinical study investigating GSK2402968, in ambulant boys with Duchenne Muscular Dystrophy (DMD), who have a dystrophin gene mutation amenable to an exon 51 skip (up to 13% of boys with DMD). Commencement of this study confirms previously announced plans to progress this asset into Phase III.

20 Jan 2011

Biomarin commences BMN 701 Phase 1/2 trial for treatment of Pompe disease

BioMarin Pharmaceutical Inc. announced today that it has initiated a Phase 1/2 trial for BMN 701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase in development for the treatment of Pompe disease.

20 Jan 2011

Positive top-line results from TC-5619 Phase 2 trial in patients with schizophrenia

Targacept, Inc. today announced positive top-line results from a Phase 2 clinical proof of concept trial to assess TC-5619 as an augmentation therapy to improve cognition in patients with schizophrenia.

20 Jan 2011

Geron commences enrollment in imetelstat Phase 2 clinical trial in essential thrombocythemia

Geron Corporation today announced enrollment of the first patient in a Phase 2 clinical trial to evaluate the activity of the company's telomerase inhibitor drug, imetelstat (GRN163L), in patients with essential thrombocythemia (ET).

19 Jan 2011

Pluristem completes parallel scientific advisory process with EMA and FDA for PLX-PAD clinical development

Pluristem Therapeutics, Inc. today announced the successful completion of a parallel scientific advisory process with the European Medical Agencies (EMA) and the U.S. Food and Drug Administration (FDA) regarding the Company's planned clinical development program for PLX-PAD.

19 Jan 2011

Ridaforolimus achieves primary endpoint in Phase 3 trial for metastatic soft-tissue and bone sarcomas

ARIAD Pharmaceuticals, Inc., today announced top-line data showing that ridaforolimus, an investigational oral mTOR inhibitor, met the primary endpoint of improved progression-free survival (PFS) compared to placebo in the Phase 3 SUCCEED trial conducted in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy.

19 Jan 2011

New long-term survival data from OPUS, CRYSTAL studies demonstrate strong tumor shrinkage of Erbitux

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today highlighted a further analysis of the large randomized Phase II OPUS study demonstrating an association between early tumor shrinkage and long-term median overall survival (OS) of more than 2 years for patients with KRAS wild-type metastatic colorectal cancer (mCRC) treated with Erbitux® (cetuximab) plus FOLFOX standard chemotherapy.

19 Jan 2011

RG7204 Phase III study shows significant survival benefit in patients with metastatic melanoma

Genentech, a member of the Roche Group, today announced that BRIM3, a Phase III clinical study of RG7204, met its co-primary endpoints showing a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma.

19 Jan 2011

Arrowhead increases ownership in Calando's outstanding equity to 79%

Arrowhead Research Corporation today announced that it has invested $1 million in its majority owned subsidiary, Calando Pharmaceuticals, and converted approximately $8M of Calando debt to Arrowhead into equity. Arrowhead now owns approximately 79% of Calando's outstanding equity.

19 Jan 2011

Positive results from PLX4032 Phase 3 Trial in patients with metastatic melanoma

Plexxikon today announced positive data from an interim analysis of the BRIM3 trial, a large multi-center Phase 3 clinical study of PLX4032 in patients with previously untreated metastatic melanoma with the BRAF mutation. Patients treated with PLX4032 had an improved overall survival compared to patients treated with dacarbazine, the current standard of care.

19 Jan 2011

UMMS begins MBL-HCV1 Phase 2 trial to prevent hepatitis C virus infection in liver transplant patients

Following a successful Phase 1 study for safety, researchers at MassBiologics of the University of Massachusetts Medical School today announced the beginning of a Phase 2 clinical trial testing the ability of a human monoclonal antibody they developed to prevent hepatitis C virus infection of a donor liver in transplant patients.

19 Jan 2011

Drug Trial News

Chelsea reports top-line data from Phase III NORTHERA extension study in NOH

ZIOPHARM's darinaparsin receives EMA COMP orphan drug designation for treatment of peripheral T-cell lymphoma

Merck provides additional information about DSMB recommendations for vorapaxar TRA-2P study

FOLOTYN Phase 2 peripheral T-cell lymphoma study results published in Journal of Clinical Oncology

Pervasis pursues matrix-embedded endothelial cell-based therapy to target and regulate cell stroma

Koronis' KP-1461 drug causes extra mutations to occur in HIV genome in HIV-infected patients

4SC initiates dosing in resminostat Phase I/II SHORE study for KRAS-mutant colorectal cancer

Apricus Bio's MycoVa demonstrates 'non-inferiority' for treatment of onychomycosis compared to Loceryl

FDA establishes PDUFA date for ADVENTRX's Exelbine NDA review

GSK and Prosensa commence GSK2402968 Phase III study in DMD

Biomarin commences BMN 701 Phase 1/2 trial for treatment of Pompe disease

Positive top-line results from TC-5619 Phase 2 trial in patients with schizophrenia

Geron commences enrollment in imetelstat Phase 2 clinical trial in essential thrombocythemia

Pluristem completes parallel scientific advisory process with EMA and FDA for PLX-PAD clinical development

Ridaforolimus achieves primary endpoint in Phase 3 trial for metastatic soft-tissue and bone sarcomas

New long-term survival data from OPUS, CRYSTAL studies demonstrate strong tumor shrinkage of Erbitux

RG7204 Phase III study shows significant survival benefit in patients with metastatic melanoma

Arrowhead increases ownership in Calando's outstanding equity to 79%

Positive results from PLX4032 Phase 3 Trial in patients with metastatic melanoma

UMMS begins MBL-HCV1 Phase 2 trial to prevent hepatitis C virus infection in liver transplant patients

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