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PhaseBio initiates Glymera Phase 1/2a clinical trial in patients with Type 2 diabetes

PhaseBio Pharmaceuticals, Inc., a privately held, clinical-stage biotechnology company developing drugs to treat diabetes, metabolic disease and cardiovascular disease, announced today that it has begun Phase 1/2a clinical testing with its lead compound, Glymera(PB1023), in patients with Type 2 diabetes.

1 Dec 2010

Elorac's naloxone lotion receives FDA Orphan Drug Designation for pruritus associated with mycosis fungoides

Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders announced that it has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for its naloxone lotion for the topical treatment of pruritus accompanying cutaneous t-cell lymphoma (CTCL, also known as mycosis fungoides).

1 Dec 2010

ACT files IND application to initiate Phase I/II study for Dry AMD

Advanced Cell Technology, Inc. announced today that it has filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using human embryonic stem cell (hESC) derived retinal pigment epithelial (RPE) cells to treat patients with Dry Age-Related Macular Degeneration (Dry AMD).

30 Nov 2010

Ikaria initiates enrollment in LUCASSIN Phase III trial for HRS Type 1

Ikaria, Inc. announced that it has enrolled the first patients in its pivotal Phase III trial for LUCASSIN® (terlipressin). The multi-center, randomized, placebo-controlled, double-blind trial is known as the REVERSE Trial.

30 Nov 2010

Argos commences dosing in Arcelis personalized immunotherapy Phase 2b clinical trial for HIV

Argos Therapeutics today announced that it has initiated dosing of patients in a Phase 2b clinical trial of its Arcelis™ personalized immunotherapy for the treatment of HIV patients, AGS-004.

30 Nov 2010

FDA approves Inspire to begin STAR clinical trial to evaluate UAS therapy for OSA

Inspire Medical Systems, a leading developer of neuro-stimulation therapies for the treatment of obstructive sleep apnea (OSA), announced today that the company has received approval from the U.S. Food and Drug Administration (FDA) to begin its STAR pivotal clinical trial. The STAR trial (Stimulation Therapy for Apnea Reduction), is a multi-center study that will evaluate both the safety and effectiveness of Inspire Upper Airway Stimulation (UAS) therapy in patients with moderate to severe obstructive sleep apnea (OSA).

30 Nov 2010

Cyrenaic announces results of CYR-101 Phase IIa clinical trial for schizophrenia

Cyrenaic Pharmaceuticals Inc. a private drug development company focused on the treatment of CNS disorders, today announced Phase IIa clinical results for CYR-101, its novel investigational drug for the treatment of schizophrenia. The results from the study showed that the drug alleviated the symptoms of the disease, including the negative and cognitive symptoms.

30 Nov 2010

Spinal Modulation's Dorsal Root Ganglion Stimulation Pilot Clinical Trial results to be presented at 14th NANS

SPINAL MODULATION, Inc., a privately held medical device company focused on developing devices to treat chronic pain, today announced that the results of its prospective, multicenter Dorsal Root Ganglion (DRG) Stimulation Clinical Trial will be presented by David Caraway, MD, PhD, Timothy Deer, MD and Robert Levy, MD, PhD at the 14th Annual North American Neuromodulation Society (NANS) meeting.

30 Nov 2010

ImmunoGen initiates IMGN901 Phase I/II clinical trial in SCLC patients

ImmunoGen, Inc., a biotechnology company that develops antibody-based anticancer products using its Targeted Antibody Payload (TAP) technology, today announced the initiation of a randomized Phase I/II clinical trial to evaluate its proprietary product candidate, IMGN901 (lorvotuzumab mertansine), for first-line treatment of small-cell lung cancer (SCLC) in patients with extensive disease.

30 Nov 2010

Aegerion third quarter net loss increases to $6.2 million

Aegerion Pharmaceuticals, Inc., an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat severe lipid disorders, announced its financial results and business highlights for the third quarter ended September 30, 2010.

30 Nov 2010

DATATRAK applauds Cosmo Pharmaceuticals for positive top-line results from budesonide MMX

DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today publically congratulated its sponsor partner Cosmo Pharmaceuticals S.p.A. who last week announced positive top-line results from their second pivotal Phase III clinical study which was conducted in the EU utilizing DATATRAK's unified eClinical product suite and services team to evaluate the safety and efficacy of budesonide MMX for the induction of remission of mild or moderate ulcerative colitis.

30 Nov 2010

GeoVax supports Bionor's Phase 2b trial of therapeutic HIV/AIDS vaccine

GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical company developing human vaccines for HIV/AIDS (HIV-1, Human Immunodeficiency Virus), announced it was pleased to learn of the partial success observed in the recently completed Phase 2b trial of a therapeutic HIV/AIDS vaccine produced by Bionor Immuno AS of Oslo, Norway.

30 Nov 2010

Resverlogix files new patent for dosing combinations of RVX-208, statin therapeutics

Resverlogix Corp. is pleased to announce today that it has filed additional new patent protection based on novel findings derived from its recently completed ASSERT Phase 2 clinical trial.

30 Nov 2010

Researchers conduct real-time metabolic imaging in human patient with prostate tumor

A UCSF research collaboration with GE Healthcare has produced the first results in humans of a new technology that promises to rapidly assess the presence and aggressiveness of prostate tumors in real time, by imaging the tumor's metabolism.

30 Nov 2010

Long-term phase 3 trial confirms safety of lubiprostone in Japanese patients with chronic idiopathic constipation

Sucampo Pharmaceuticals, Inc. and Abbott today announced positive top-line data from a 48-week phase 3 long-term safety and efficacy clinical trial of lubiprostone in Japanese patients with chronic idiopathic constipation (CIC). The trial demonstrated that lubiprostone was safe and well-tolerated.

30 Nov 2010

FDA approves Axiron topical solution CIII for testosterone replacement therapy in men

Acrux , a drug delivery company that develops and commercializes patented pharmaceutical products for global markets, and Eli Lilly Company today announced that the United States Food and Drug Administration (FDA) has approved the Axiron® topical solution CIII for testosterone replacement therapy in men. Axiron is the first testosterone topical solution approved for application via an underarm applicator.

29 Nov 2010

SuperSonic Imagine receives €19 million from historical investors

SuperSonic Imagine's historical investors, Edmond de Rothschild Investment Partners, Auriga Partners, Crédit Agricole Private Equity, NBGI Ventures, BioAm (managed by CDC Entreprises), Wellington Partners and IXO Private Equity, reiterated their strong support through a combined investment of €19 million in this round.

29 Nov 2010

FDA approves Merit's phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere Microspheres

The Food and Drug Administration (FDA) has approved Merit Medical Systems, Inc.'s phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere™ Microspheres (hqTACE) for delivery of doxorubicin. The clinical trial will involve U.S. and international interventional radiologists who treat patients with localized, unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer.

29 Nov 2010

Hemispherx requests FDA time extension for Ampligen NDA data resubmission

Hemispherx Biopharma, Inc., announced that the Company has requested an extension of time in which to resubmit data to its NDA for Ampligen®, an experimental therapeutic, to treat CFS.

29 Nov 2010

Micell initiates enrollment in DESSOLVE I clinical trial of MiStent DES

Micell Technologies,™ Inc. today announced it has enrolled at Mercy Hospital in Auckland, New Zealand, the first patient in DESSOLVE I (DES with Sirolimus and a bioabsorbable pOLymer for the treatment of patients with de noVo lEsions in the native coronary arteries), a first-in-human clinical trial of the company's investigational MiStent™ Drug Eluting Coronary Stent System (MiStent DES).

29 Nov 2010

Clinical Trial News and Research

PhaseBio initiates Glymera Phase 1/2a clinical trial in patients with Type 2 diabetes

Elorac's naloxone lotion receives FDA Orphan Drug Designation for pruritus associated with mycosis fungoides

ACT files IND application to initiate Phase I/II study for Dry AMD

Ikaria initiates enrollment in LUCASSIN Phase III trial for HRS Type 1

Argos commences dosing in Arcelis personalized immunotherapy Phase 2b clinical trial for HIV

FDA approves Inspire to begin STAR clinical trial to evaluate UAS therapy for OSA

Cyrenaic announces results of CYR-101 Phase IIa clinical trial for schizophrenia

Spinal Modulation's Dorsal Root Ganglion Stimulation Pilot Clinical Trial results to be presented at 14th NANS

ImmunoGen initiates IMGN901 Phase I/II clinical trial in SCLC patients

Aegerion third quarter net loss increases to $6.2 million

DATATRAK applauds Cosmo Pharmaceuticals for positive top-line results from budesonide MMX

GeoVax supports Bionor's Phase 2b trial of therapeutic HIV/AIDS vaccine

Resverlogix files new patent for dosing combinations of RVX-208, statin therapeutics

Researchers conduct real-time metabolic imaging in human patient with prostate tumor

Long-term phase 3 trial confirms safety of lubiprostone in Japanese patients with chronic idiopathic constipation

FDA approves Axiron topical solution CIII for testosterone replacement therapy in men

SuperSonic Imagine receives €19 million from historical investors

FDA approves Merit's phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere Microspheres

Hemispherx requests FDA time extension for Ampligen NDA data resubmission

Micell initiates enrollment in DESSOLVE I clinical trial of MiStent DES

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