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Quark initiates dosing NAION patients in QPI-1007 Phase I study for ocular neuroprotection

Quark Pharmaceuticals, Inc., a pharmaceutical company engaged in the discovery and development of RNAi-based therapeutics, today announced it has dosed the first patient with recent onset of non-arteritic anterior ischemic optic neuropathy (NAION) in its ongoing Phase I study of QPI-1007, the Company's proprietary synthetic siRNA drug candidate for ocular neuroprotection.

21 Oct 2010

Agensys and Seattle Genetics initiate ASG-5ME phase I clinical trial for castration-resistant prostate cancer

Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., and Seattle Genetics, Inc. today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of castration-resistant prostate cancer. ASG-5ME is an antibody-drug conjugate (ADC) targeting the SLC44A4 antigen and is being co-developed by both companies for the treatment of solid tumors.

21 Oct 2010

Aastrom submits SPA for Phase 3 clinical development program in critical limb ischemia to FDA

Aastrom Biosciences, Inc., a leading developer of expanded autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) a special protocol assessment (SPA) describing the company's proposed Phase 3 clinical development program in critical limb ischemia (CLI).

21 Oct 2010

DMC concludes Protege Phase 3 clinical trial for type 1 diabetes lacks efficacy

MacroGenics, Inc. and Eli Lilly and Company today announced that the Protege Data Monitoring Committee (DMC), composed of independent experts in the fields of diabetes and biostatistics, has completed a planned analysis of one-year safety and efficacy data of the Protege Phase 3 clinical trial of teplizumab, an investigational biologic under development for the treatment of individuals with recent-onset type 1 diabetes.

21 Oct 2010

Genzyme third quarter revenue increases to $1.0 billion

Genzyme Corp. today reported third-quarter earnings growth driven by increased shipments of Cerezyme® (imiglucerase for injection). Patients in the United States began returning to normal dosing levels last month, and patients globally are expected to be able to do so this quarter. Earnings growth in the third quarter was also driven by strong revenue from Lumizyme™ (alglucosidase alfa) and cost reduction measures.

21 Oct 2010

Alexion announces results of eculizumab two open-label Phase 2 studies for aHUS treatment

Alexion Pharmaceuticals, Inc. today announced that its two open-label Phase 2 studies investigating eculizumab (Soliris) as a treatment for patients with atypical Hemolytic Uremic Syndrome (aHUS) have met the primary and key secondary endpoints with high clinical and statistical significance, in interim analyses.

21 Oct 2010

Genzyme reports results of Clolar combination Phase 3 trial in adult AML

Genzyme Corporation announced results today from its CLASSIC I phase 3 trial comparing Clolar® (clofarabine) in combination with the chemotherapy agent cytarabine (ara-c) to cytarabine plus placebo in relapsed-refractory adult acute myeloid leukemia (AML).

21 Oct 2010

IRB approves CEL-SCI’s Multikine Phase III clinical trial for head and neck cancer

CEL-SCI Corporation announced today it has received approval from seven hospital Institutional Review Boards in India to begin enrollment of subjects for a Phase III clinical trial of Multikine, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer.

21 Oct 2010

Arena reports results of APD916 Phase 1 clinical trial for narcolepsy with cataplexy

Arena Pharmaceuticals, Inc. announced today results from a Phase 1 clinical trial of APD916, a novel drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy with cataplexy.

20 Oct 2010

Rockwell Medical announces design of Phase III development program for Soluble Ferric Pyrophosphate

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron-deficiency anemia, announced today the design of its Phase III development program for Soluble Ferric Pyrophosphate (SFP) as a continuous iron replacement therapeutic.

20 Oct 2010

Aradigm reports positive data from DRCFI, ARD-3150 Phase 2b bronchiectasis study

Aradigm Corporation today announced positive top line data from its recently concluded 6-month Phase 2b study (ORBIT-2) with Aradigm's once-daily dual release ciprofloxacin for inhalation (DRCFI, ARD-3150) in patients with non-cystic fibrosis bronchiectasis.

20 Oct 2010

European Commission grants Ipsen's OBI-1 orphan drug status for treatment of hemophilia

Ipsen announced today that the European Commission has granted orphan drug status for OBI-1 for the treatment of hemophilia. Expected to enter pivotal clinical trials before the end of this year, OBI-1 is designed to treat individuals with hemophilia who have developed inhibitory antibodies (inhibitors) against human Factor VIII (hFVIII).

20 Oct 2010

LANL's researcher to implement first human trial of mosaic HIV vaccine candidate

Los Alamos National Laboratory researcher Bette Korber is part of an international team of investigators working to design and implement the first human trial of a mosaic HIV vaccine candidate. The vaccine represents a novel strategy for fighting the virus that causes AIDS by attempting to address one of the most daunting challenges in HIV vaccine design: the virus's extensive genetic diversity.

20 Oct 2010

Neuralstem updates Phase I human clinical trial of spinal cord stem cells for ALS

Neuralstem, Inc. updated the progress of its ongoing Phase I human clinical trial of the company's spinal cord stem cells in the treatment of ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease) at Emory University in Atlanta, Georgia.

20 Oct 2010

NIAID announces four new contracts for clinical trials to address problem of antimicrobial resistance

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today announced four new contracts for large-scale clinical trials that address the problem of antimicrobial resistance.

20 Oct 2010

MannKind begins MKC1106-MT Phase 2 trial for advanced melanoma

MannKind Corporation today announced the first patient has been dosed in a phase 2 clinical trial of the novel, investigational cancer vaccine MKC1106-MT. As a part of MannKind's cancer immunotherapy program, this phase 2 study will evaluate the safety, tolerability, immune response and clinical response of MKC1106-MT in patients with advanced melanoma.

20 Oct 2010

Ceregene commences enrollment in CERE-120 Phase 2b study for Parkinson's disease

Ceregene, Inc., a biopharmaceutical company, announced today that enrollment has begun in a new double-blind sham surgery-controlled Phase 2b study evaluating CERE-120 in Parkinson's disease patients. CERE-120 is a gene therapy product that delivers the neurotrophic factor neurturin to degenerating or dying dopamine neurons. Data from the first Phase 2 clinical trial of CERE-120 are being published later this year in Lancet Neurology (to appear online October 21, 2010).

20 Oct 2010

BioMarin announces BMN-111 program for treatment of achondroplasia

BioMarin Pharmaceutical Inc. today announced its program for BMN-111, a peptide therapeutic for the treatment of achondroplasia. BioMarin plans to file an IND in the fourth quarter of 2011 and to initiate a Phase 1 clinical trial by the first quarter of 2012.

19 Oct 2010

Rexahn announces publication of 3-aryl-1-isoquinolinamines preclinical data

Rexahn Pharmaceuticals, Inc. a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced the publication of new preclinical data on the development of 3-aryl-1-isoquinolinamines in the European Journal & Medicinal Chemistry.

19 Oct 2010

Acorda announces data of GGF2 preclinical studies for focal ischemic stroke

Acorda Therapeutics, Inc, today announced that data from preclinical studies show that Glial Growth Factor 2 (GGF2) promoted functional recovery following a permanent focal ischemic stroke.

19 Oct 2010

Drug Trial News

Quark initiates dosing NAION patients in QPI-1007 Phase I study for ocular neuroprotection

Agensys and Seattle Genetics initiate ASG-5ME phase I clinical trial for castration-resistant prostate cancer

Aastrom submits SPA for Phase 3 clinical development program in critical limb ischemia to FDA

DMC concludes Protege Phase 3 clinical trial for type 1 diabetes lacks efficacy

Genzyme third quarter revenue increases to $1.0 billion

Alexion announces results of eculizumab two open-label Phase 2 studies for aHUS treatment

Genzyme reports results of Clolar combination Phase 3 trial in adult AML

IRB approves CEL-SCI’s Multikine Phase III clinical trial for head and neck cancer

Arena reports results of APD916 Phase 1 clinical trial for narcolepsy with cataplexy

Rockwell Medical announces design of Phase III development program for Soluble Ferric Pyrophosphate

Aradigm reports positive data from DRCFI, ARD-3150 Phase 2b bronchiectasis study

European Commission grants Ipsen's OBI-1 orphan drug status for treatment of hemophilia

LANL's researcher to implement first human trial of mosaic HIV vaccine candidate

Neuralstem updates Phase I human clinical trial of spinal cord stem cells for ALS

NIAID announces four new contracts for clinical trials to address problem of antimicrobial resistance

MannKind begins MKC1106-MT Phase 2 trial for advanced melanoma

Ceregene commences enrollment in CERE-120 Phase 2b study for Parkinson's disease

BioMarin announces BMN-111 program for treatment of achondroplasia

Rexahn announces publication of 3-aryl-1-isoquinolinamines preclinical data

Acorda announces data of GGF2 preclinical studies for focal ischemic stroke

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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