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Argos commences dosing in Arcelis personalized immunotherapy Phase 2b clinical trial for HIV

Argos Therapeutics today announced that it has initiated dosing of patients in a Phase 2b clinical trial of its Arcelis™ personalized immunotherapy for the treatment of HIV patients, AGS-004.

30 Nov 2010

FDA approves Inspire to begin STAR clinical trial to evaluate UAS therapy for OSA

Inspire Medical Systems, a leading developer of neuro-stimulation therapies for the treatment of obstructive sleep apnea (OSA), announced today that the company has received approval from the U.S. Food and Drug Administration (FDA) to begin its STAR pivotal clinical trial. The STAR trial (Stimulation Therapy for Apnea Reduction), is a multi-center study that will evaluate both the safety and effectiveness of Inspire Upper Airway Stimulation (UAS) therapy in patients with moderate to severe obstructive sleep apnea (OSA).

30 Nov 2010

Neuraltus reports positive results from NP001 Phase 1 study for ALS

Neuraltus Pharmaceuticals, a privately held biopharmaceutical company dedicated to developing and commercializing high-impact therapeutics that address critical unmet medical needs, primarily for the treatment of neurodegenerative diseases, announced today top-line results from the Company's Phase 1 clinical study of NP001 for the treatment of Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's disease).

30 Nov 2010

Intellikine and MMRC commence INK128 Phase I trial in multiple myeloma

Intellikine, a leader in the development of small molecule drugs targeting the PI3K/mTOR pathway, and the Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a phase I trial of INK128, a novel, orally-available small molecule kinase inhibitor of the TORC1 and TORC2 complexes, in patients with multiple myeloma.

30 Nov 2010

Zogenix completes enrollment in ZX002 Phase 3 study for moderate to severe pain

Zogenix, Inc. today announced completion of enrollment in its open-label Phase 3 safety study (Study 802) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate to severe pain in patients requiring around-the-clock opioid therapy for an extended period of time.

30 Nov 2010

Cyrenaic announces results of CYR-101 Phase IIa clinical trial for schizophrenia

Cyrenaic Pharmaceuticals Inc. a private drug development company focused on the treatment of CNS disorders, today announced Phase IIa clinical results for CYR-101, its novel investigational drug for the treatment of schizophrenia. The results from the study showed that the drug alleviated the symptoms of the disease, including the negative and cognitive symptoms.

30 Nov 2010

Keryx announces positive top-line results from Zerenex Phase 3 study for hyperphosphatemia

Keryx Biopharmaceuticals, Inc. today announced positive top-line results from the Phase 3 short-term efficacy study component of its Phase 3 registration program of Zerenex (ferric citrate), the Company's ferric iron-based phosphate binder for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease on dialysis.

30 Nov 2010

Pharmasset commences combination study of PSI-7977 and PSI-938 nucleotide analogs in HCV

Pharmasset, Inc. announced today that dosing has begun in Part 2 of a Phase 1 study. This is the first clinical study combining a purine (PSI-938) and a pyrimidine (PSI-7977) nucleotide analog for HCV, and is designed to evaluate once daily doses of PSI-7977 and PSI-938 in patients with HCV who have not been treated previously.

30 Nov 2010

ImmunoGen initiates IMGN901 Phase I/II clinical trial in SCLC patients

ImmunoGen, Inc., a biotechnology company that develops antibody-based anticancer products using its Targeted Antibody Payload (TAP) technology, today announced the initiation of a randomized Phase I/II clinical trial to evaluate its proprietary product candidate, IMGN901 (lorvotuzumab mertansine), for first-line treatment of small-cell lung cancer (SCLC) in patients with extensive disease.

30 Nov 2010

Cytheris' combinational therapy demonstrates possible therapeutic strategy for PML

Cytheris SA, a clinical-stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the publication of a case study report based on successful treatment of Progressive Multifocal Leukoencephalopathy (PML) with combination therapy consisting of two investigational agents, Cytheris' recombinant human interleukin-7 (CYT107) and CMX001, an investigational, oral broad-spectrum antiviral drug (Chimerix, Research Triangle Park, NC) in the Journal of Antimicrobial Chemotherapy.

30 Nov 2010

ARIAD to present clinical data on ponatinib for CML at ASH Annual Meeting

ARIAD Pharmaceuticals, Inc. today announced that updated clinical data from a fully enrolled Phase 1 trial of its investigational, pan-BCR-ABL inhibitor, ponatinib, will be presented at the 52nd Annual Meeting of the American Society of Hematology being held in Orlando, Florida, December 4-7, 2010.

30 Nov 2010

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

Drug Trial News

Argos commences dosing in Arcelis personalized immunotherapy Phase 2b clinical trial for HIV

FDA approves Inspire to begin STAR clinical trial to evaluate UAS therapy for OSA

Neuraltus reports positive results from NP001 Phase 1 study for ALS

Intellikine and MMRC commence INK128 Phase I trial in multiple myeloma

Zogenix completes enrollment in ZX002 Phase 3 study for moderate to severe pain

Cyrenaic announces results of CYR-101 Phase IIa clinical trial for schizophrenia

Keryx announces positive top-line results from Zerenex Phase 3 study for hyperphosphatemia

Pharmasset commences combination study of PSI-7977 and PSI-938 nucleotide analogs in HCV

ImmunoGen initiates IMGN901 Phase I/II clinical trial in SCLC patients

Cytheris' combinational therapy demonstrates possible therapeutic strategy for PML

ARIAD to present clinical data on ponatinib for CML at ASH Annual Meeting

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

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