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DATATRAK applauds Cosmo Pharmaceuticals for positive top-line results from budesonide MMX

DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today publically congratulated its sponsor partner Cosmo Pharmaceuticals S.p.A. who last week announced positive top-line results from their second pivotal Phase III clinical study which was conducted in the EU utilizing DATATRAK's unified eClinical product suite and services team to evaluate the safety and efficacy of budesonide MMX for the induction of remission of mild or moderate ulcerative colitis.

30 Nov 2010

FG-2216 drug offers new treatment option for kidney disease-related anemia

A new drug called FG-2216 can stimulate production of the hormone erythropoietin (EPO) in dialysis patients—possibly offering a new approach to treatment of kidney disease-related anemia, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN).

30 Nov 2010

GeoVax supports Bionor's Phase 2b trial of therapeutic HIV/AIDS vaccine

GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical company developing human vaccines for HIV/AIDS (HIV-1, Human Immunodeficiency Virus), announced it was pleased to learn of the partial success observed in the recently completed Phase 2b trial of a therapeutic HIV/AIDS vaccine produced by Bionor Immuno AS of Oslo, Norway.

30 Nov 2010

Sanofi Pasteur commences phase II clinical study of vaccine for Clostridium difficile infection prevention

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that it has started its phase II clinical study of a vaccine for primary prevention of Clostridium difficile infection (CDI). The trial starting in the United States is focused on evaluating prevention of the first episode of CDI in at-risk individuals, which includes adults with imminent hospitalization or current or impending residence in a long-term care or rehabilitation facility.

30 Nov 2010

Long-term phase 3 trial confirms safety of lubiprostone in Japanese patients with chronic idiopathic constipation

Sucampo Pharmaceuticals, Inc. and Abbott today announced positive top-line data from a 48-week phase 3 long-term safety and efficacy clinical trial of lubiprostone in Japanese patients with chronic idiopathic constipation (CIC). The trial demonstrated that lubiprostone was safe and well-tolerated.

30 Nov 2010

NIAID scientists confirm antiviral activity of two lead compounds against HPV

Tamir Biotechnology, Inc. announced today that scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID) reported test results confirming two of our lead compounds showed excellent in vitro antiviral activity and no cellular toxicity at dose levels tested for Human Papillomavirus (HPV).

30 Nov 2010

Medivation, Astellas enroll 1,199 patients in MDV3100 Phase 3 AFFIRM study in advanced prostate cancer

Medivation, Inc. and Astellas Pharma Inc. today announced that patient enrollment was completed on November 15, 2010 in the Phase 3 AFFIRM study of the investigational drug MDV3100, a novel, triple-acting oral androgen receptor antagonist, in patients with advanced prostate cancer who have previously been treated with chemotherapy. The companies also announced that clinical development of MDV3100 in Japan has commenced, with the initiation of patient dosing in a Phase 1-2 clinical study.

30 Nov 2010

Array BioPharma to present data on ARRY-520 Phase 1 trial for multiple myeloma at ASH Annual Meeting

Array BioPharma Inc. today announced that it will present data from a Phase 1 trial of KSP inhibitor ARRY-520 in patients with relapsed/refractory multiple myeloma at the 2010 Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida on Saturday, December 4, 2010.

30 Nov 2010

Calistoga to feature data on CAL-101 inhibitor for hematologic malignancies at ASH Annual Meeting

Calistoga Pharmaceuticals, Inc., the leader in the development of delta-isoform-selective phosphatidylinositol 3-kinase (PI3K-delta) inhibitors for the treatment of cancer and inflammatory diseases, today announced the upcoming presentation of clinical and preclinical results supporting the clinical benefit of CAL-101, an oral, PI3K-delta inhibitor, in the treatment of patients with hematologic malignancies.

30 Nov 2010

Hana Biosciences to present Marqibo data for acute lymphoblastic leukemia at ASH Annual Meeting

Hana Biosciences, a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that data regarding Marqibo for treatment of adults with relapsed/refractory acute lymphoblastic leukemia (ALL) will be the subject of two presentations at the 2010 Annual Meeting and Exposition of the American Society of Hematology (ASH) being held in Orlando, Florida from December 4-7, 2010.

30 Nov 2010

Zalicus to highlight A2A agonist oncology programs at ASH Annual Meeting

Zalicus Inc. announced today that preclinical data on its discovery of novel A2A agonist oncology programs for the treatment of multiple myeloma and other B-cell malignancies will be highlighted at the 52nd Annual Meeting of the American Society of Hematology in Orlando, FL on December 4-7, 2010.

29 Nov 2010

FDA approves Merit's phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere Microspheres

The Food and Drug Administration (FDA) has approved Merit Medical Systems, Inc.'s phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere™ Microspheres (hqTACE) for delivery of doxorubicin. The clinical trial will involve U.S. and international interventional radiologists who treat patients with localized, unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer.

29 Nov 2010

Merck announces initial results from ISENTRESS Phase III study in HIV-1

Merck today reported initial results from the Phase III study investigating the efficacy and safety of a treatment regimen including ISENTRESS® (raltegravir) Tablets once daily in treatment-naïve adult patients infected with HIV-1. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults.

29 Nov 2010

Hemispherx requests FDA time extension for Ampligen NDA data resubmission

Hemispherx Biopharma, Inc., announced that the Company has requested an extension of time in which to resubmit data to its NDA for Ampligen®, an experimental therapeutic, to treat CFS.

29 Nov 2010

Positive results from Oncolytics' combination REOLYSIN-docetaxel Phase I trial in advanced cancer

Oncolytics Biotech Inc. announced today that a paper entitled "REO-10: A Phase I Study of Intravenous Reovirus and Docetaxel in Patients with Advanced Cancer," was recently published by Comins et al in the journal Clinical Cancer Research (Clin Cancer Res 16(22):5564-5572).

29 Nov 2010

Amarin reports top-line results from AMR101 Phase 3 trial for treatment of high triglycerides

Amarin Corporation plc, a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported positive, statistically significant top-line results from the MARINE study, its first Phase 3 clinical trial of lead drug candidate AMR101.

29 Nov 2010

Phase 3 trial: TYSABRI improves vision in MS patients

Results recently presented from a study of multiple sclerosis (MS) patients taking TYSABRI (natalizumab) are supported by a Canadian woman's improved vision since starting the therapy.

25 Nov 2010

Neptune, Acasti completes preclinical program comparing CaPre with Lovaza

Neptune Technologies & Bioressources Inc. subsidiary, Acasti Pharma Inc., reports the completion of its preclinical program designed to compare the lipid management effects of Acasti's drug candidate CaPre versus prescription drug Lovaza.

25 Nov 2010

Response to PLX4032 drug short lived in BRAF-mutated metastatic melanoma patients

Researchers with UCLA's Jonsson Comprehensive Cancer Center have found that melanoma patients whose cancers are caused by mutation of the BRAF gene become resistant to a promising targeted treatment through another genetic mutation or the overexpression of a cell surface protein, both driving survival of the cancer and accounting for relapse.

25 Nov 2010

Advaxis initiates ADXS11-001 clinical trial for cervix cancer

Advaxis, Inc., the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, has begun dosing patients in its 110 patient clinical trial of ADXS11-001 for the treatment of cervix cancer in women for whom cytotoxic treatment has failed.

24 Nov 2010

Drug Trial News

DATATRAK applauds Cosmo Pharmaceuticals for positive top-line results from budesonide MMX

FG-2216 drug offers new treatment option for kidney disease-related anemia

GeoVax supports Bionor's Phase 2b trial of therapeutic HIV/AIDS vaccine

Sanofi Pasteur commences phase II clinical study of vaccine for Clostridium difficile infection prevention

Long-term phase 3 trial confirms safety of lubiprostone in Japanese patients with chronic idiopathic constipation

NIAID scientists confirm antiviral activity of two lead compounds against HPV

Medivation, Astellas enroll 1,199 patients in MDV3100 Phase 3 AFFIRM study in advanced prostate cancer

Array BioPharma to present data on ARRY-520 Phase 1 trial for multiple myeloma at ASH Annual Meeting

Calistoga to feature data on CAL-101 inhibitor for hematologic malignancies at ASH Annual Meeting

Hana Biosciences to present Marqibo data for acute lymphoblastic leukemia at ASH Annual Meeting

Zalicus to highlight A2A agonist oncology programs at ASH Annual Meeting

FDA approves Merit's phase 3 clinical trial protocol to treat primary liver cancer with QuadraSphere Microspheres

Merck announces initial results from ISENTRESS Phase III study in HIV-1

Hemispherx requests FDA time extension for Ampligen NDA data resubmission

Positive results from Oncolytics' combination REOLYSIN-docetaxel Phase I trial in advanced cancer

Amarin reports top-line results from AMR101 Phase 3 trial for treatment of high triglycerides

Phase 3 trial: TYSABRI improves vision in MS patients

Neptune, Acasti completes preclinical program comparing CaPre with Lovaza

Response to PLX4032 drug short lived in BRAF-mutated metastatic melanoma patients

Advaxis initiates ADXS11-001 clinical trial for cervix cancer

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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