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SciClone initiates phase 2b study of SCV-O7 for oral mucositis

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced the enrollment of the first patient in the company's phase 2b clinical trial of SCV-07 for the prevention of oral mucositis (OM) -- a painful, debilitating, and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer.

11 Jan 2011

ALLOZYNE completes AZ01 Phase IA clinical trial in relapsing remitting multiple sclerosis

ALLOZYNE, Inc. announced today, the completion of its first Phase IA clinical trial in healthy individuals for AZ01, a PEGylated form of human interferon beta-1b which is being developed for the treatment of relapsing remitting multiple sclerosis. The objectives of the Phase IA trial were to assess safety and tolerability profile in addition to defining its pharmacological properties.

11 Jan 2011

Positive results from Allovectin-7 Phase 3 trial in patients with metastatic melanoma

Vical Incorporated today announced a new publication summarizing results from the company's completed trials of Allovectin-7 including systemic responses and an excellent safety profile in patients with metastatic melanoma.

11 Jan 2011

Study supports use of telomerase inhibitors for treatment of childhood cancers

Geron Corporation today announced the publication of preclinical data demonstrating that the company's telomerase inhibitor drug, imetelstat (GRN163L), currently in Phase 2 clinical trials, selectively targets cancer stem cells in pediatric tumors of neural origin.

11 Jan 2011

Cautionary note on measuring perceived pain in research

It is well known that pain is a highly subjective experience. We each have a pain threshold, but this can vary depending on distractions and mood. A paper in the International Journal of Behavioural and Healthcare Research offers a cautionary note on measuring perceived pain in research.

11 Jan 2011

TransPharma reports positive results from ViaDerm-Calcitonin Phase 1 trial for musculoskeletal disorders

TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced today successful results of a Phase I clinical trial of its self-applied ViaDerm-Calcitonin product for the treatment of musculoskeletal disorders such as osteoarthritis and musculoskeletal pain.

11 Jan 2011

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

Clinical Trial News and Research

SciClone initiates phase 2b study of SCV-O7 for oral mucositis

ALLOZYNE completes AZ01 Phase IA clinical trial in relapsing remitting multiple sclerosis

Positive results from Allovectin-7 Phase 3 trial in patients with metastatic melanoma

Study supports use of telomerase inhibitors for treatment of childhood cancers

Cautionary note on measuring perceived pain in research

TransPharma reports positive results from ViaDerm-Calcitonin Phase 1 trial for musculoskeletal disorders

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

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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