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FDA removes clinical hold for Amicus' AT2220 IND for treatment of Pompe disease

Amicus Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the AT2220 (1-deoxynojirimycin HCI) Investigational New Drug Application (IND). AT2220 is a pharmacological chaperone in development as a treatment for Pompe disease.

9 Mar 2011

Unique gene therapy to combat Parkinson's disease

Physicians at Rush University Medical Center are testing a unique gene therapy product called CERE-120 to evaluate if its use can improve the symptoms of Parkinson's disease. Rush is one of 11 sites in the U.S. and the only site in Illinois enrolling patients into the new, double-blinded trial.

9 Mar 2011

Novartis QAB149 receives FDA Pulmonary-Allergy Advisory Committee approval for COPD

An advisory committee recommended today that the Food and Drug Administration (FDA) approve QAB149 (indacaterol) 75 mcg in the US as a once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

9 Mar 2011

Treatment with sildenafil significantly reduces RP in patients with scleroderma

Researchers in Europe reported that treatment with modified-release sildenafil significantly reduced the frequency of attacks of Raynaud's phenomenon in patients with limited cutaneous systemic sclerosis, also known as scleroderma.

8 Mar 2011

Plexxikon commences PLX3397 Phase 2 trial in patients with Hodgkin lymphoma

Plexxikon today announced that it has treated the first patient in a Phase 2 clinical trial in Hodgkin lymphoma with PLX3397. This novel agent is an oral, selective inhibitor that down-modulates two key cell types that are thought to mediate the progression of Hodgkin lymphoma tumors — macrophages and mast cells.

8 Mar 2011

Conflicts of interest overlooked in drug trial reviews: Study

A new study shows that researchers who review large sets of drug trials for medical journals – also known as meta analysis - often ignore financial conflicts that might affect the evidence and thereby conclusions.

8 Mar 2011

Recent rituximab trial with TNF inhibitors reports no new safety risks in patients with RA

A recent trial of rituximab in combination with a tumor necrosis factor inhibitor and methotrexate in patients with active rheumatoid arthritis found the safety profile to be consistent with other RA trials with TNF inhibitors.

8 Mar 2011

Compugen reports positive results from CGEN-25068 in animal model to treat certain disease conditions

Compugen Ltd. announced today positive animal model results for CGEN-25068, a novel peptide predicted and selected in silico to block a specific protein-protein interaction known to play an important role in various immune-related disease conditions.

8 Mar 2011

BMY to present new Phase II data on investigational hepatitis C compounds at ILC

New Phase II data on multiple Bristol-Myers Squibb Company investigational hepatitis C compounds will be presented at The International Liver Congress, the 46th annual meeting of the European Association for the Study of the Liver in Berlin, Germany, from March 30 to April 2.

8 Mar 2011

Fumaric acid salts may protect against Multiple Sclerosis

Fumaric acid salts have been in use against severe psoriasis for a long time. About ten years ago, researchers in Bochum speculated that they may also have a favourable effect on Multiple Sclerosis as a result of their TH2 polarizing mechanisms.

8 Mar 2011

New clinical trial to assess antiretroviral treatment in HIV-infected individuals based on CD4 counts

A major new clinical trial seeks to determine whether HIV-infected asymptomatic individuals have less risk of developing AIDS or other serious illness if they begin taking antiretrovirals sooner rather than later, based on their level of CD4+ T-cells.

8 Mar 2011

Top-line results from Repligen RG2417 Phase 2b trial results in patients with bipolar depression

Repligen Corporation announced today results of a Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression.

8 Mar 2011

Inovio initiates VGX-3100 Phase II trial in patients with cervical cancer

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it is initiating a Phase II clinical trial for its VGX-3100 DNA vaccine for cervical dysplasia and cancer caused by human papillomavirus.

7 Mar 2011

USPTO grants patent to Symphogen's Sym004 to treat solid tumors

Symphogen, a private biopharmaceutical company developing superior antibody therapeutics, said the company had been granted a US patent for Sym004 as well as other antibody compositions containing at least two distinct anti-EGFR antibodies having certain binding characteristics.

7 Mar 2011

Duchenne Parent Project awards grant to AMT for DMD gene therapy

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, announced today that the Duchenne Parent Project, based in the Netherlands, has awarded AMT a grant of EUR 145,000 to support the development of AMT-080, AMT's gene therapy for Duchenne Muscular Dystrophy.

7 Mar 2011

Researchers use qMRI to confirm effect of CS treatment in patients with OA

A group of Canadian researchers led by Prof. Jean-Pierre Pelletier, Head of the Osteoarthritis Research Unit at the University of Montreal Hospital Research Centre, published a clinical trial in which they confirm, for the first time using quantitative Magnetic Resonance Imaging, the disease modifying effects of chondroitin sulphate, a symptomatic slow acting drug for osteoarthritis.

5 Mar 2011

Combination therapy may reduce albuminuria in patients with type 2 diabetes: Study

Results from a Phase 2, 8-week dose-ranging study using low doses of atrasentan in patients with diabetic kidney disease were published this week in the Journal of the American Society of Nephrology. The published study results suggest that atrasentan, used in conjunction with renin-angiotensin system inhibitors, may reduce albuminuria (presence of protein in urine) for patients with type 2 diabetes.

5 Mar 2011

Pfizer's ORAL Sync Phase 3 study of tofacitinib in moderate-to-severe RA meets primary endpoints

Pfizer Inc. today announced that the ORAL Sync Phase 3 study of tofacitinib, formerly known as tasocitinib, an investigational, novel, oral JAK inhibitor, being studied in moderate-to-severe rheumatoid arthritis, met its primary endpoints by showing statistically significant changes versus placebo in reducing signs and symptoms of RA, as measured by ACR20 response rates at six months; in improving physical function, as measured by mean change in HAQ DI at three months; and in reaching DAS28-4 <2.6 at six months.

5 Mar 2011

Pediatrician unveils latest findings of IMPAACT HIV/AIDS study during 2011 CROI

A clinical study of anti-HIV/AIDS medicines in the developing world is on the verge of turning "the whole treatment world on its head," according to Dartmouth pediatrician Paul Palumbo.

4 Mar 2011

Nevirapine reduces HIV transmission risk from mother to breastfeeding infants by 75%

Giving breastfeeding infants of HIV-infected mothers a daily dose of the antiretroviral drug nevirapine for six months halved the risk of HIV transmission to the infants at age 6 months compared with giving infants the drug daily for six weeks, according to preliminary clinical trial data presented today.

4 Mar 2011

Drug Trial News

FDA removes clinical hold for Amicus' AT2220 IND for treatment of Pompe disease

Unique gene therapy to combat Parkinson's disease

Novartis QAB149 receives FDA Pulmonary-Allergy Advisory Committee approval for COPD

Treatment with sildenafil significantly reduces RP in patients with scleroderma

Plexxikon commences PLX3397 Phase 2 trial in patients with Hodgkin lymphoma

Conflicts of interest overlooked in drug trial reviews: Study

Recent rituximab trial with TNF inhibitors reports no new safety risks in patients with RA

Compugen reports positive results from CGEN-25068 in animal model to treat certain disease conditions

BMY to present new Phase II data on investigational hepatitis C compounds at ILC

Fumaric acid salts may protect against Multiple Sclerosis

New clinical trial to assess antiretroviral treatment in HIV-infected individuals based on CD4 counts

Top-line results from Repligen RG2417 Phase 2b trial results in patients with bipolar depression

Inovio initiates VGX-3100 Phase II trial in patients with cervical cancer

USPTO grants patent to Symphogen's Sym004 to treat solid tumors

Duchenne Parent Project awards grant to AMT for DMD gene therapy

Researchers use qMRI to confirm effect of CS treatment in patients with OA

Combination therapy may reduce albuminuria in patients with type 2 diabetes: Study

Pfizer's ORAL Sync Phase 3 study of tofacitinib in moderate-to-severe RA meets primary endpoints

Pediatrician unveils latest findings of IMPAACT HIV/AIDS study during 2011 CROI

Nevirapine reduces HIV transmission risk from mother to breastfeeding infants by 75%

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