Clinical Trial News and Research

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Takeda, Zinfandel enter global licensing agreement for TOMM40 biomarker assay for Alzheimer's disease

Takeda Pharmaceutical Company Limited and Zinfandel Pharmaceuticals, Inc. today announced that they have entered into an exclusive, worldwide licensing agreement regarding Zinfandel's TOMM40 assay as a biomarker for the risk of Alzheimer's disease in high-risk older adults with normal cognition. The companies will study pioglitazone in connection with the TOMM40 biomarker and Alzheimer's disease.

11 Jan 2011

Pro-Pharmaceuticals to begin DAVANAT Phase III development program following FDA approval

Pro-Pharmaceuticals, the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced that on December 17, 2010, Company representatives met with officials from the U.S. Food & Drug Administration to present its Phase III clinical development program for DAVANAT.

11 Jan 2011

World's first drug eluting bioresorbable vascular scaffold receives CE Mark approval

Abbott announced today that it has received CE Mark approval for the world's first drug eluting bioresorbable vascular scaffold (BVS) for the treatment of coronary artery disease. Abbott's BVS device restores blood flow by opening a clogged vessel and providing support to the vessel until the device dissolves within approximately two years, leaving patients with a treated vessel free of a permanent metallic implant. Abbott's BVS device will be commercialized under the brand name ABSORB.

10 Jan 2011

Boston Scientific completes enrollment in Nitinol Stent System trial for treatment of iliac artery disease

Boston Scientific Corporation today announced that it has completed enrollment in the ORION clinical trial, which is designed to evaluate the Company's EPIC™ Self-Expanding Nitinol Stent System for the treatment of iliac artery disease, a form of peripheral artery disease associated with severe leg pain caused by insufficient blood flow to the muscles (claudication).

10 Jan 2011

Vicept reports positive data from V-101 Phase II clinical trial for Type I Rosacea

Vicept Therapeutics, Inc. announced positive study results from a Phase II clinical trial evaluating the dose-response relationship of four concentrations of V-101 cream, a topical cream for the treatment of Type I Rosacea (Erythematotelangiectatic Rosacea). The results demonstrated a statistically significantrebound" or tachyphylaxis was observed.

10 Jan 2011

DATATRAK awarded Phase III device study by new European client

DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced that it has been awarded a Phase III device study by a new European client, a leading global healthcare supplier.

10 Jan 2011

Sangamo completes enrollment in SB-509-901 Phase 2b clinical trial in diabetic neuropathy

Sangamo BioSciences, Inc. announced today that the company completed enrollment of its Phase 2b double-blind, placebo-controlled clinical trial (SB-509-901) in subjects with diabetic neuropathy (DN). The company expects to have efficacy data from this study in the second half of 2011. The company also plans to present the first human clinical data from its Phase 1 trials of SB-728-T in HIV/AIDS in the first quarter of 2011.

10 Jan 2011

FDA grants Exelixis XL184 orphan drug designation for treatment of medullary thyroid cancer

Exelixis, Inc. today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to XL184 for treatment of follicular, medullary, and anaplastic thyroid carcinoma, and metastatic or locally advanced papillary thyroid cancer. A pivotal phase 3 trial of XL184 is ongoing in patients with medullary thyroid cancer (MTC) and the company expects to release top-line phase 3 results in the first-half of 2011 and potentially file a New Drug Application (NDA) for the compound in the second-half of 2011.

10 Jan 2011

LabCorp to market On-Q-ity's circulating tumor cell platform

On-Q-ity, a next-generation oncology diagnostics company developing personalized and predictive tests to improve cancer therapy effectiveness, today announced a strategic alliance with Laboratory Corporation of America Holdings® (LabCorp). LabCorp will market On-Q-ity's novel and proprietary circulating tumor cell (CTC) platform to the biopharma industry to greatly accelerate and improve the cancer drug discovery and development process.

10 Jan 2011

New study finds extending term of exclusive access can lead to higher drug costs in short term

A new study in the January 2011 issue of Health Affairs is the first to calculate the financial and social costs of limiting access to trial data — and finds that extending the term of exclusive access will lead to higher drug costs in the short term but also to more than 200 extra drug approvals and to greater life expectancy in the next several decades.

10 Jan 2011

Quality of life measures most useful for clinical decision-making in trials with QOL as primary outcome

Quality of life measures tend to be most useful for clinical decision-making in trials in which quality of life is the primary outcome, according to a recent study published online January 7 in The Journal of the National Cancer Institute.

10 Jan 2011

Positive results form INX-189 Phase 1b trial against hepatitis C virus

Inhibitex, today reported positive preliminary interim safety and antiviral data from the first two monotherapy cohorts of its ongoing Phase 1b clinical trial of INX-189, an oral NS5b nucleotide inhibitor being developed to treat chronic infections caused by hepatitis C virus.

10 Jan 2011

AFQ056 drug improves symptoms in Fragile X patients: Study

The first drug to treat the underlying disorder instead of the symptoms of Fragile X, the most common cause of inherited intellectual disability, shows some promise according to a new study published in the January issue of Science Translational Medicine.

9 Jan 2011

Synergy's plecanatide Phase II/III trial to begin in second quarter 2011

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, today announced that the next clinical trial of plecanatide to treat chronic idiopathic constipation patients, planned to begin in the second quarter of 2011, has been designed as a Phase II/III trial.

7 Jan 2011

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. today announced the dosing of the first patient in the third phase 3 clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD) in subjects with chronic, non-cancer pain, excluding those taking methadone. The primary endpoint is an overall responder rate based on the change from baseline in the reported frequency of spontaneous bowel movements (SBMs).

7 Jan 2011

BIND Biosciences commences BIND-014 Phase 1 clinical trial in cancer

BIND Biosciences announced today that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of BIND-014 in cancer patients. BIND-014, the first product candidate to enter clinical evaluation from BIND's broad proprietary Medicinal Nanoengineering platform, is a targeted polymeric nanoparticle containing the cytotoxic agent, docetaxel.

7 Jan 2011

Plexxikon, Genentech enter PLX4032 co-promotion agreement

Plexxikon, Inc., announced today that it has signed an agreement with Genentech to co-promote PLX4032 (RG7204) in the United States. PLX4032, an oral, novel kinase inhibitor that targets the oncogenic BRAF mutation, is being tested in late-stage clinical trials for the treatment of metastatic melanoma.

7 Jan 2011

Cell Medica enters EBV-associated cancer research collaboration with CAGT and Baylor College of Medicine

Cell Medica, a leading cellular therapeutics company which develops, manufactures and markets cellular immunotherapy products for the treatment of infectious disease and cancer, is pleased to announce an exclusive license agreement and research collaboration with the Center for Cell and Gene Therapy (CAGT), Baylor College of Medicine (Houston, Texas), for the commercialization of an innovative cell-based treatment for cancers associated with the oncogenic Epstein Barr virus (EBV).

7 Jan 2011

Intrexon Corporation, ZIOPHARM enter partnership to develop, commercialize DNA-based therapeutics

ZIOPHARM Oncology, a small molecule late-stage oncology drug development company, and Intrexon Corporation, a next generation synthetic biology company, announced today a global exclusive channel partnership in oncology where ZIOPHARM will develop and commercialize DNA-based therapeutics using Intrexon's UltraVector Technology.

7 Jan 2011

Regular blood test shows pre-diabetes risk factors, reduces treatment costs

A simpler form of testing individuals with risk factors for diabetes could improve diabetes prevention efforts by substantially increasing the number of individuals who complete testing and learn whether or not they are likely to develop diabetes.

7 Jan 2011

Clinical Trial News and Research

Takeda, Zinfandel enter global licensing agreement for TOMM40 biomarker assay for Alzheimer's disease

Pro-Pharmaceuticals to begin DAVANAT Phase III development program following FDA approval

World's first drug eluting bioresorbable vascular scaffold receives CE Mark approval

Boston Scientific completes enrollment in Nitinol Stent System trial for treatment of iliac artery disease

Vicept reports positive data from V-101 Phase II clinical trial for Type I Rosacea

DATATRAK awarded Phase III device study by new European client

Sangamo completes enrollment in SB-509-901 Phase 2b clinical trial in diabetic neuropathy

FDA grants Exelixis XL184 orphan drug designation for treatment of medullary thyroid cancer

LabCorp to market On-Q-ity's circulating tumor cell platform

New study finds extending term of exclusive access can lead to higher drug costs in short term

Quality of life measures most useful for clinical decision-making in trials with QOL as primary outcome

Positive results form INX-189 Phase 1b trial against hepatitis C virus

AFQ056 drug improves symptoms in Fragile X patients: Study

Synergy's plecanatide Phase II/III trial to begin in second quarter 2011

Sucampo, Takeda initiate dosing in third lubiprostone phase 3 trial for opioid-induced bowel dysfunction

BIND Biosciences commences BIND-014 Phase 1 clinical trial in cancer

Plexxikon, Genentech enter PLX4032 co-promotion agreement

Cell Medica enters EBV-associated cancer research collaboration with CAGT and Baylor College of Medicine

Intrexon Corporation, ZIOPHARM enter partnership to develop, commercialize DNA-based therapeutics

Regular blood test shows pre-diabetes risk factors, reduces treatment costs

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