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Genzyme and Isis Pharmaceuticals announce phase 3 study data of mipomersen

Genzyme Corp. and Isis Pharmaceuticals Inc. announced that data from the phase 3 study of mipomersen in patients with homozygous familial hypercholesterolemia (hoFH) were presented today at the American Heart Association’s Scientific Sessions.

17 Nov 2009

Alkermes commences phase 2 study of ALKS 33 in patients with alcohol dependence

Alkermes, Inc. today announced the initiation of a phase 2 clinical study of ALKS 33, an investigational oral opioid modulator for the potential treatment of alcohol dependence and other central nervous system disorders. The study will assess the safety and efficacy of multiple doses of ALKS 33 in patients with alcohol dependence and is designed to further define the clinical profile of ALKS 33.

17 Nov 2009

Oncolytics Biotech's REOLYSIN combined with paclitaxel and carboplatin well tolerated for advanced cancers

Oncolytics Biotech Inc. today announced updated results from a Phase I/II U.K. trial (REO 011) of REOLYSIN(R) combined with paclitaxel/carboplatin for patients with advanced cancers in a poster presentation at the 2009 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference being held in Boston, Massachusetts.

17 Nov 2009

Melanoma Institute director to present Phase 2 study data of PV-10 for metastatic melanoma

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced today that Professor John F. Thompson, MD, Professor of Melanoma and Surgical Oncology at the University of Sydney, Director of the Melanoma Institute Australia, and Lead Investigator of the Phase 2 study of PV-10 for Metastatic Melanoma, will be presenting data at the 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers on November 21, 2009 in Berlin, Germany.

17 Nov 2009

YM BioSciences presents preclinical results of its small molecule VDA at the AACR-NCI-EORTC conference

YM BioSciences Inc., a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, announced that preclinical results for CYT997 were presented today in a poster by Cytopia Limited at the 2009 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference in Boston, Massachusetts.

17 Nov 2009

Anacor Pharmaceuticals commences patient dosing in AN3365 Phase I clinical study

Anacor Pharmaceuticals today announced that it has dosed the first patient in a Phase I clinical study for AN3365, a novel boron-based, small-molecule drug candidate in development for the treatment of hospital infections caused by Gram-negative bacteria. The study will evaluate the safety, tolerability and pharmacokinetics of AN3365 in healthy volunteers.

17 Nov 2009

ThromboGenics and BioInvent International present phase I results of novel anti-cancer monoclonal antibody

ThromboGenics NV and BioInvent International AB today announced positive results from a Phase I trial of their novel anti-cancer monoclonal antibody TB-403 in patients with advanced solid tumours. The results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, U.S. TB-403 was well tolerated with no reported dose limiting toxicity. These positive data support progression of TB-403 and further development.

17 Nov 2009

Phase II clinical study to evaluate Nanocort commenced

Galapagos NV announced today that it has started a Phase II clinical study to evaluate Nanocort's effectiveness in treating flares in multiple sclerosis (MS). Nanocort combines less frequent treatment with lower dosage and potentially more effective delivery than other MS flare treatments.

17 Nov 2009

Results of Phase III clinical trials of flibanserin for treatment of HSDD in pre-menopausal women released

Data from pivotal Phase III clinical trials demonstrate that flibanserin 100mg increased the number of satisfying sexual events (SSE) and sexual desire (the co-primary endpoints) while decreasing the distress associated with Hypoactive Sexual Desire Disorder (HSDD).

16 Nov 2009

Sequella broadens the licensed therapeutic indications of its SQ109 lead drug candidate

Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing products to treat life-threatening infectious diseases, today announced that it amended an existing agreement with the National Institutes of Health (NIH) to significantly broaden the licensed therapeutic indications, or "field of use," for Sequella's lead drug candidate, SQ109.

16 Nov 2009

Semafore Pharmaceuticals to present SF1126 Phase I data at the 51st ASH meeting

Researchers are scheduled to present Phase I data relating to Semafore Pharmaceuticals’ lead product candidate, SF1126, as a treatment for patients with relapsed and refractory myeloma during the 51st American Society of Hematology (ASH) Annual Meeting, December 5 - 8, 2009, at the Ernst N. Morial Convention Center in New Orleans, LA.

16 Nov 2009

Seattle Genetics commences phase I clinical trial of SGN-75 ADC for metastatic renal cell carcinoma

Seattle Genetics, Inc. today announced that it has initiated a phase I clinical trial of SGN-75 for metastatic renal cell carcinoma and relapsed and refractory non-Hodgkin lymphoma. SGN-75 is an antibody-drug conjugate (ADC) targeting CD70 that utilizes the company’s proprietary technology.

16 Nov 2009

Interim data from Hollis-Eden Pharmaceuticals' Apoptone Phase I/II clinical trial presented

Hollis-Eden Pharmaceuticals, Inc., today reported preliminary results of its ongoing Phase I/II clinical trial with Apoptone® (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC). Presented at the Molecular Targets and Cancer Therapeutics Conference, which is co-sponsored by the AACR, NCI and EORTC, the poster is titled: "Results of preclinical and clinical Phase I/II open-label dose-ranging trial with HE3235, a synthetic adrenal hormone, in Castrate Resistant Prostate Cancer (CRPC)."

16 Nov 2009

Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

Alkermes, Inc. today announced positive preliminary results from a phase 3 clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence. The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with XR-NTX demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo, as measured by the cumulative distribution of clean urine screens (p<0.0002).

16 Nov 2009

Aradigm commences patient dosage in Phase 2 trial of novel inhaled ciprofloxacin formulation

Aradigm Corporation today announced that the first patient was dosed in a 6-month, multicenter, international Phase 2 clinical trial of a novel version of inhaled ciprofloxacin (ARD-3150) in 40 adult patients with non-cystic fibrosis bronchiectasis.

16 Nov 2009

Findings from post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse announced

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse-. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.

16 Nov 2009

Aspirin doses have beneficial effects for patients with heart diorders: Study

On Sunday, November 15, 2009, Florida Atlantic University (FAU) researcher Charles H. Hennekens, M.D., the first Sir Richard Doll Research Professor in the Charles E. Schmidt College of Biomedical Science will present at the American Heart Association's Annual Scientific Sessions meeting in Orlando, FL, the first data in humans to show that all doses of aspirin used in clinical practice increase nitric oxide.

16 Nov 2009

New reversible blood thinner for angioplasty patients not superior over placebo

A new reversible blood thinner for angioplasty patients wasn't superior over placebo for its primary combined endpoint of heart attack, all-cause mortality and need for revascularization, but it reduced mortality and in-stent blood clots, researchers reported in a late-breaking clinical trial presentation at the American Heart Association's Scientific Sessions 2009.

16 Nov 2009

Phase I clinical study for ETC-1002 commenced

Esperion Therapeutics, a privately held biotechnology company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, today announced that the company has initiated a Phase I clinical study for ETC-1002, the company's novel small molecule compound designed to beneficially regulate the levels of plasma lipids and lipoproteins.

16 Nov 2009

Axelar AB to present data from ongoing Phase I/II clinical trial of AXL1717

Axelar AB today announced that promising data from the ongoing Phase I/II clinical trial concerning their lead anticancer product AXL1717, an insulin-like growth factor-1 (IGF-1) receptor inhibitor, will be presented next week at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, Boston, Massachusetts, USA.

13 Nov 2009

Drug Trial News

Genzyme and Isis Pharmaceuticals announce phase 3 study data of mipomersen

Alkermes commences phase 2 study of ALKS 33 in patients with alcohol dependence

Oncolytics Biotech's REOLYSIN combined with paclitaxel and carboplatin well tolerated for advanced cancers

Melanoma Institute director to present Phase 2 study data of PV-10 for metastatic melanoma

YM BioSciences presents preclinical results of its small molecule VDA at the AACR-NCI-EORTC conference

Anacor Pharmaceuticals commences patient dosing in AN3365 Phase I clinical study

ThromboGenics and BioInvent International present phase I results of novel anti-cancer monoclonal antibody

Phase II clinical study to evaluate Nanocort commenced

Results of Phase III clinical trials of flibanserin for treatment of HSDD in pre-menopausal women released

Sequella broadens the licensed therapeutic indications of its SQ109 lead drug candidate

Semafore Pharmaceuticals to present SF1126 Phase I data at the 51st ASH meeting

Seattle Genetics commences phase I clinical trial of SGN-75 ADC for metastatic renal cell carcinoma

Interim data from Hollis-Eden Pharmaceuticals' Apoptone Phase I/II clinical trial presented

Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

Aradigm commences patient dosage in Phase 2 trial of novel inhaled ciprofloxacin formulation

Findings from post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse announced

Aspirin doses have beneficial effects for patients with heart diorders: Study

New reversible blood thinner for angioplasty patients not superior over placebo

Phase I clinical study for ETC-1002 commenced

Axelar AB to present data from ongoing Phase I/II clinical trial of AXL1717

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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