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Aegerion Pharmaceuticals’ MTP-I Phase III trial published in Atherosclerosis online supplement

ACR Image Metrix, a global imaging contract research organization (CRO) with expertise in imaging trial design, techniques and data extraction, is pleased to announce a Phase III trial, conducted for Aegerion Pharmaceuticals, Inc., was published as an abstract in the online supplement of Atherosclerosis and presented at the 78th European Atherosclerosis Society Congress, which took place June 20-23, 2010, in Hamburg, Germany.

6 Oct 2010

Rochester General Hospital Research Institute awarded $7M for Prevnar 13 study of ear infections in children

The Rochester General Hospital Research Institute has been awarded a $7.1 million grant to study the effectiveness of a new vaccine on the bacteria that cause ear infections in children. Michael E. Pichichero MD, Director of the Research Institute, has been named Principal Investigator of the five year study which will follow children who receive the Prevnar 13 vaccine. The vaccine is manufactured by Pfizer Vaccine Research of Collegeville, Pennsylvania which is funding the grant.

6 Oct 2010

IDMC recommends early termination of Phase 3 intramuscular depot aripiprazole trial

Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) announced today that an independent data monitoring committee (IDMC) has recommended the early termination of its Phase 3, 52-week, placebo-controlled, intramuscular depot aripiprazole trial.

6 Oct 2010

Lixte, NCI collaborate for clinical evaluation of LB-100 compound

Lixte Biotechnology Holdings announced today that the National Cancer Institute Experimental Therapeutics (NExT) Program Senior Advisory Committee (SAC), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), National Institutes of Health (NIH), signed a NExT Material Transfer Agreement formalizing a collaboration with Lixte Biotechnology Holdings, Inc. for clinical evaluation of LB-100, one of Lixte's lead anti-cancer compounds.

6 Oct 2010

Liquidia commences dosing in LIQ-001 Phase 1 trial for seasonal influenza

Liquidia Technologies, a privately held nanotechnology company developing particle-based vaccines and therapeutics, today announced the initiation of human dosing of its lead vaccine product candidate, LIQ-001, in a Phase 1 clinical trial. LIQ-001, the first in a pipeline of PRINT® vaccines, is being developed as a seasonal influenza vaccine for enhanced protection in the elderly and represents the company's migration from proof of concept to the clinical application of PRINT technology.

5 Oct 2010

ISTO announces completion of enrollment in NuQu Phase I clinical study for discogenic back pain

ISTO Technologies, Inc., an orthobiologics company with a cell-based platform for cartilage regeneration, announced today the completion of patient enrollment in the Phase I clinical study for NuQu™, an injectable formulation of juvenile chondrocytes designed for the treatment of discogenic back pain. The study included 15 patients enrolled at two clinical sites. All patients enrolled in the trial suffered from persistent discogenic back pain and disability despite undergoing previous traditional conservative therapy.

5 Oct 2010

Archimedes publishes FPNS clinical study results in Pain journal

Archimedes Pharma US Inc. today announced publication of results from a pivotal clinical study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain (BTCP).

5 Oct 2010

Preclinical data of Enzon's PEG-SN38 in pediatric neuroblastoma published in Clinical Cancer Research

Enzon Pharmaceuticals, Inc. today announced the publication of preclinical data demonstrating that PEG-SN38 (EZN-2208), the Company's novel PEGylated DNA topoisomerase I inhibitor, led to significantly greater tumor regression as compared to CPT-11 (irinotecan) in both in vitro and in vivo models of pediatric neuroblastoma.

5 Oct 2010

ImmunoCellular Therapeutics to present ICT-107 clinical data at World Stem Cell Summit

ImmunoCellular Therapeutics, a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that the company's clinical data from ICT-107 will be featured in two oral sessions at the World Stem Cell Summit, which is being held October 4-6 in Detroit, MI.

5 Oct 2010

Neuraltus achieves last patient out for NP001, NP002 studies

Neuraltus Pharmaceuticals, a privately held biopharmaceutical company dedicated to developing and commercializing high-impact therapeutics that address critical unmet needs, primarily in the treatment of neurodegenerative diseases, announced today the Company has achieved last patient out in two studies: a Phase 1 clinical study of NP001 in patients with Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's disease) and a Phase 1/2 clinical study of NP002 in patients with L-dopa-induced dyskinesias (muscle movement disorders).

5 Oct 2010

Merck Serono to present Erbitux data at ESMO Congress

Merck Serono, a division of Merck KGaA, Darmstadt, Germany announces today that it will be presenting new data from several studies of Erbitux (cetuximab) in a range of solid tumor types including the first Phase II data in breast and prostate cancers. These data will be presented at the forthcoming 35th European Society for Medical Oncology Congress (ESMO) in Milan, October 8-12, 2010.

5 Oct 2010

BioSante to present LibiGel clinical trial update at NAMS Annual Meeting

BioSante Pharmaceuticals, Inc. today announced that it will present a LibiGel clinical trial update at the 21st Annual Meeting of The North American Menopause Society (NAMS) being held from October 6-9, 2010 at the Sheraton Chicago Hotel & Towers in Chicago, Illinois.

5 Oct 2010

Amgen announces PRIME '203' and '181' Phase 3 trial results

Amgen today announced that results from the PRIME '203' and '181' pivotal Phase 3 trials evaluating Vectibix (panitumumab) in combination with chemotherapy (FOLFOX or FOLFIRI) as a first and second-line treatment for metastatic colorectal cancer (mCRC), respectively, were published online in the Journal of Clinical Oncology.

5 Oct 2010

Seattle Genetics to present SGN-75 phase I data at ESMO Congress

Seattle Genetics, Inc. today announced that preliminary data from a phase I study of SGN-75 in relapsed and refractory non-Hodgkin lymphoma and metastatic renal cell carcinoma will be presented during a poster session at the 35th European Society for Medical Oncology (ESMO) Congress being held October 8-12, 2010 in Milan, Italy.

5 Oct 2010

CrystalGenomics to present Phase I MAD study data at Arrowhead Summit

CrystalGenomics, Inc. and CG Pharmaceuticals, Inc. a drug discovery and development biopharmaceutical company, has announced that Dr. William Schmidt, its Vice President of Clinical Development, has been invited to present a talk on Development of CG100649, Tissue-selective Dual Inhibitor of COX-2 and Carbonic Anhydrase for Treatment of Osteoarthritis at Arrowhead's upcoming 4th Annual Pain Therapeutics Summit, to be held on October 4-5, 2010 in Philadelphia.

5 Oct 2010

Celldex Therapeutics presents initial clinical data on CDX-1401 cancer vaccine candidate at iSBTc meeting

Celldex Therapeutics, Inc. today announced that the Company presented initial clinical data on CDX-1401 at the 25th Annual Meeting of the International Society of Biological Therapy of Cancer (iSBTc) in Washington, DC. CDX-1401 is a novel antibody-based targeted cancer vaccine candidate being evaluated as a treatment for patients with melanoma and other cancers that are known to express the tumor antigen NY-ESO-1.

5 Oct 2010

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Onconova Therapeutics, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon- (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

5 Oct 2010

Enzo commences clinical trial of Optiquel for chronic non-infectious uveitis

Enzo Biochem, Inc., announced today that, following filing of a investigational new drug (IND) application with the FDA, its Enzo Therapeutics division is commencing a clinical trial of Optiquel™ , the Company's proprietary oral therapeutic for chronic non-infectious uveitis. The trial is designed as a randomized, double-masked, placebo-controlled study with a long-term follow-up and is being conducted by the National Institute of Health's National Eye Institute (NEI).

4 Oct 2010

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Onconova Therapeutics®, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon™ (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

4 Oct 2010

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.

4 Oct 2010

Drug Trial News

Aegerion Pharmaceuticals’ MTP-I Phase III trial published in Atherosclerosis online supplement

Rochester General Hospital Research Institute awarded $7M for Prevnar 13 study of ear infections in children

IDMC recommends early termination of Phase 3 intramuscular depot aripiprazole trial

Lixte, NCI collaborate for clinical evaluation of LB-100 compound

Liquidia commences dosing in LIQ-001 Phase 1 trial for seasonal influenza

ISTO announces completion of enrollment in NuQu Phase I clinical study for discogenic back pain

Archimedes publishes FPNS clinical study results in Pain journal

Preclinical data of Enzon's PEG-SN38 in pediatric neuroblastoma published in Clinical Cancer Research

ImmunoCellular Therapeutics to present ICT-107 clinical data at World Stem Cell Summit

Neuraltus achieves last patient out for NP001, NP002 studies

Merck Serono to present Erbitux data at ESMO Congress

BioSante to present LibiGel clinical trial update at NAMS Annual Meeting

Amgen announces PRIME '203' and '181' Phase 3 trial results

Seattle Genetics to present SGN-75 phase I data at ESMO Congress

CrystalGenomics to present Phase I MAD study data at Arrowhead Summit

Celldex Therapeutics presents initial clinical data on CDX-1401 cancer vaccine candidate at iSBTc meeting

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Enzo commences clinical trial of Optiquel for chronic non-infectious uveitis

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

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