Clinical Trial News and Research

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Genzyme provides information on peak sale of alemtuzumab for multiple sclerosis

Genzyme Corporation today provided an extensive briefing on the market potential of alemtuzumab for multiple sclerosis at an event for investors and analysts in New York.

21 Dec 2010

Use of metaphors may help doctors to recruit low-income people for cancer clinical trials

The language that doctors use with low-income, rural patients can help determine whether these patients agree to participate in clinical trials testing new cancer treatments, a new study found.

21 Dec 2010

Biomet Biologics completes enrollment in Recover Kit clinical trial for chronic tennis elbow

Biomet, Inc., a global leader in the manufacture of orthopedic and biotechnology products, announced today that its subsidiary, Biomet Biologics, LLC, has completed the required 230 subject enrollment for its Recover® Kit clinical trial. This clinical trial studies the use of the Recover® Kit device, which produces autologous platelet-rich plasma (PRP) to treat chronic tennis elbow (lateral epicondylitis).

21 Dec 2010

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

Incyte Corporation announced today positive top-line results from COMFORT-I, the pivotal Phase III clinical trial of INCB18424 (also known as INC424) in patients with myelofibrosis (MF) being conducted under a Food and Drug Administration (FDA) Special Protocol Assessment (SPA) Agreement. COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) is a double-blind, placebo-controlled Phase III trial involving 309 patients.

21 Dec 2010

Idera reports positive data from IMO-2125/ribavirin combination Phase 1 trial in null-responder HCV patients

Idera Pharmaceuticals, Inc. announced today preliminary data from a 4-week dose-ranging Phase 1 clinical trial of IMO-2125 in combination with ribavirin in 60 treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. In the trial, treatment with IMO-2125 in combination with ribavirin was well tolerated and achieved substantial decline in virus levels at two days after the first dose of IMO-2125 and after four weeks of treatment.

20 Dec 2010

EMA grants SME designation to PROLOR Biotech

PROLOR Biotech, Inc.,, a clinical stage company developing next generation biobetter therapeutic proteins, today announced that the European Commission and the European Medicines Agency (EMA) has granted PROLOR the designation of "Small and Medium Sized Enterprise" (SME).

20 Dec 2010

Arrowhead launches new company, Ablaris to commercialize novel weight loss technology

Arrowhead Research Corporation today announced that it has executed an exclusive world-wide license on technology developed by Drs. Wadih Arap and Renata Pasqualini at MD Anderson Cancer Center for use in weight loss and obesity-related metabolic conditions, and that it has launched a new company, Ablaris Therapeutics Inc., to commercialize this platform.

20 Dec 2010

Exciting progress made in MS research during 2010

Exciting advances were made in 2010 in virtually every field of MS research. Progress toward finding new therapies for MS is illustrated by the availability of the first oral disease-modifying therapy for MS. Progress was also made toward finding ways to restore function and improving quality of life and specific MS symptoms through exercise, meditation, rehabilitation and medications, including the first therapy specifically approved to treat a symptom of MS (Ampyra).

20 Dec 2010

Cardio3 BioSciences presents positive C3BS-GQR-1 results in patients with acute myocardial infarction

Cardio3 BioSciences, a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today announces positive pre-clinical results from its in-house product candidate C3BS-GQR-1, to treat patients suffering from acute myocardial infarction in order to protect cardiac tissue from damage and direct heart stem cells to mature and restore pump function.

20 Dec 2010

Inspire's denufosol tetrasodium TIGER-1 Phase 3 trial for CF published in AJRCCM

Inspire Pharmaceuticals, Inc. announced today that the results from its first Phase 3 clinical trial with denufosol tetrasodium for cystic fibrosis (CF), TIGER-1, have been published in the peer-reviewed publication, American Journal of Respiratory and Critical Care Medicine (AJRCCM). Denufosol is an investigational, inhaled, novel ion channel regulator currently in Phase 3 clinical development for the treatment of CF.

20 Dec 2010

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, today reported that it has completed enrolment of its COMPONENT Phase IIb study with vidofludimus, an oral inhibitor of IL-17 release, in rheumatoid arthritis (RA) patients. Data from the trial are expected to be announced in Q2 2011.

20 Dec 2010

RXi's dermal anti-scarring candidate selected to advance into development

RXi Pharmaceuticals Corporation, a recognized leader in RNAi-based therapeutic discovery and development, today announced the selection of its first RNAi therapeutic product candidate to advance into development.

20 Dec 2010

CF patients with normal to mildly impaired lung function may benefit from new investigational drug

Cystic fibrosis patients with normal to mildly impaired lung function may benefit from a new investigational drug designed to help prevent formation of the sticky mucus that is a hallmark of the disease, according to researchers involved in a phase 3 clinical trial of the drug.

19 Dec 2010

BioClinica board authorizes $2.0 million share repurchase program

BioClinica®, Inc.,, a global provider of clinical trial management services, announced that its Board of Directors has authorized a share repurchase program of up to $2.0 million of the Company's common stock over the next 18 months.

From Clario 17 Dec 2010

Early intervention can improve core symptoms of ASD in young children: Study

In a study recently published in the Journal of Child Psychology and Psychiatry (Epub ahead of print), researchers from the Kennedy Krieger Institute found that early intervention can improve the core symptoms of autism spectrum disorders in very young children.

17 Dec 2010

FDA's decision on Avastin will take away choice for many patients, says Breastcancer.org

Dr. Marisa Weiss, president and founder of Breastcancer.org and a breast oncologist in the Philadelphia area submitted a letter to the U.S. Food and Drug Administration prior to the Oncology Drug Advisory Committee (ODAC) meeting to review data for Avastin's use in metastatic HER2-negative breast cancer. In light of today's news that the FDA has recommended removing Avastin's approval to treat breast cancer, Breastcancer.org is making public Dr. Weiss' ODAC letter in its entirety.

17 Dec 2010

MDA awards Repligen $1.4M for research of new compound with therapeutic potential for SMA

The Muscular Dystrophy Association today announced it has awarded $1.4 million in new research funding to the biopharmaceutical firm Repligen of Waltham, Mass., to complete the preclinical work needed to begin human clinical trials of a promising therapeutic compound for spinal muscular atrophy (SMA).

17 Dec 2010

FDA recommends removal of breast cancer indication from Avastin label

The U.S. Food and Drug Administration announced today that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

17 Dec 2010

FDA clears Novavax's Phase I clinical trial to evaluate new RSV vaccine candidate

Novavax, Inc. announced today that the company's Phase I clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection has been cleared by the U.S. Food and Drug Administration (FDA) and is no longer on clinical hold. In November, the company reported that it had received a question from the FDA regarding chemistry, manufacturing and controls (CMC) that has now been resolved.

16 Dec 2010

GSK to deploy BioClinica's Trident IWR system across Phase I-IV clinical trials

BioClinica®, Inc.,, a global provider of clinical trial management services, today announced that GlaxoSmithKline LLC ("GSK") has signed a multi-year enterprise technology agreement to deploy BioClinica's Trident IWR (Interactive Web Response) system across its Phase I-IV clinical trials.

From Clario 16 Dec 2010

Clinical Trial News and Research

Genzyme provides information on peak sale of alemtuzumab for multiple sclerosis

Use of metaphors may help doctors to recruit low-income people for cancer clinical trials

Biomet Biologics completes enrollment in Recover Kit clinical trial for chronic tennis elbow

Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

Idera reports positive data from IMO-2125/ribavirin combination Phase 1 trial in null-responder HCV patients

EMA grants SME designation to PROLOR Biotech

Arrowhead launches new company, Ablaris to commercialize novel weight loss technology

Exciting progress made in MS research during 2010

Cardio3 BioSciences presents positive C3BS-GQR-1 results in patients with acute myocardial infarction

Inspire's denufosol tetrasodium TIGER-1 Phase 3 trial for CF published in AJRCCM

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

RXi's dermal anti-scarring candidate selected to advance into development

CF patients with normal to mildly impaired lung function may benefit from new investigational drug

BioClinica board authorizes $2.0 million share repurchase program

Early intervention can improve core symptoms of ASD in young children: Study

FDA's decision on Avastin will take away choice for many patients, says Breastcancer.org

MDA awards Repligen $1.4M for research of new compound with therapeutic potential for SMA

FDA recommends removal of breast cancer indication from Avastin label

FDA clears Novavax's Phase I clinical trial to evaluate new RSV vaccine candidate

GSK to deploy BioClinica's Trident IWR system across Phase I-IV clinical trials

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