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GlobeImmune Expands GI-5005-02 Phase 2b Trial to Include Additional Treatment Naïve IL28B T/T Subjects with Chronic Genotype 1 HCV
Date: October 28, 2010
Client: GlobeImmune Inc.
Summary: LOUISVILLE, Colo., October 28, 2010 – GlobeImmune Inc. today announced the expansion of its Phase 2b clinical trial of GI-5005, an investigational Tarmogen product for the treatment of hepatitis C virus (HCV) infection. The Company previously reported data demonstrating a 60% improvement in sustained virologic response (SVR) in chronically infected HCV patients with the hardest-to-treat IL28B T/T genotype when GI-5005 was added to standard of care (SOC) versus SOC alone (60% vs. 0% SVR). The Company plans to enroll 40 additional subjects with the IL28B T/T genotype. Approximately 20% of chronically infected HCV patients have the IL28B T/T genotype and those patients are least likely to respond to treatment with SOC. Data from the additional 40 subjects will allow for more precise powering of pivotal clinical trials.
Sanofi-Aventis Completes $10 Million Equity Investment in Regulus Therapeutics
Date: October 28, 2010
Client: Regulus Therapeutics Inc.
Summary: La Jolla, Calif., October 28, 2010 – Regulus Therapeutics Inc. announced today that the Company has received a $10 million equity investment from sanofi-aventis in connection with the landmark alliance the two companies entered into on June 21, 2010. The equity investment by sanofi-aventis further strengthens the balance sheet of Regulus, and with this investment sanofi-aventis becomes the third investor in Regulus, along with its founding companies Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY) and Isis Pharmaceuticals, Inc. (Nasdaq:ISIS).
Amira Pharmaceuticals Announces Initiation of Phase I Clinical Trial for AM152, A Novel LPA1 Antagonist
Date: October 28, 2010
Client: Amira Pharmaceuticals, Inc.
Summary: San Diego, CA - October 28, 2010 -- Amira Pharmaceuticals, Inc. announced today that it has initiated a Phase 1 clinical study with AM152, a novel LPA1 antagonist, in normal, healthy subjects.
Argos Therapeutics to Present a Corporate Overview, Prospects of its Arcelis™ Immunotherapy and Clinical Developments at 2010 Mid-Atlantic Bio
Date: October 28, 2010
Client: Argos Therapeutics
Summary: DURHAM, N.C., Oct. 28 /PRNewswire/ -- Argos Therapeutics today announced that Jeff Abbey, the company's president and chief executive officer, will present a corporate overview, prospects of its Arcelis™ immunotherapy and clinical developments at the 2010 Mid-Atlantic Bio conference in Bethesda, Md. at 9 a.m. EDT on Friday, Oct. 29, 2010. The conference will take place at the Bethesda North Marriott Hotel & Conference Center.
GENFIT Selected by Windhover for the 2011 'Top Biopharma Projects To Watch'
Date: October 25, 2010
Client: GENFIT
Summary: LILLE, France and CAMBRIDGE, Mass., Oct. 25 /PRNewswire/ -- GENFIT (Alternext: ALGFT; ISIN: FR0004163111), a biopharmaceutical company at the forefront of drug discovery and development, focusing on the early diagnosis and preventive treatment of cardiometabolic and associated disorders, today announced that it has been selected by Windhover as one of the "Top Biopharma Projects To Watch" in 2011 in the cardiovascular/metabolic category. This announcement is part of the conference event organized by Elsevier Business Intelligence and Windhover Conferences taking place in Boston from November 2-4, 2010, where GENFIT will be presenting its latest scientific achievements.
FDA Issues Complete Response Letter for Lorcaserin New Drug Application
Date: October 23, 2010
Client: Arena Pharmaceuticals, Inc.
Summary: SAN DIEGO and WOODCLIFF LAKE, N.J., Oct. 23, 2010 /PRNewswire via COMTEX News Network/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding Arena's New Drug Application (NDA) for lorcaserin. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, >/= 30) or patients who are overweight (BMI >/= 27) and have at least one weight-related co-morbid condition.
Miami Dolphins' Running Back Ricky Williams Discusses SPO Wellness™ on 770AM ESPN Radio
Date: October 21, 2010
Client: SPO Wellness
Summary: Ricky Williams talks about the upcoming SPO Wellness™ product line, his passion for health and wellness, the importance of maintaining a healthy lifestyle and discusses his current football season.
Arena Pharmaceuticals Announces Phase 1 Results for APD916 for Narcolepsy with Cataplexy
Date: October 20 ,2010
Client: Arena Pharmaceuticals, Inc.
Summary: SAN DIEGO, Oct. 20, 2010 /PRNewswire via COMTEX News Network/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) 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.
S*BIO’s JAK2 Inhibitor SB1518 Granted Orphan Drug Designation by European Commission (EC) for the Treatment of Myelofibrosis (MF)
Date: October 18, 2010
Client: S*BIO Pte Ltd
Summary: SINGAPORE, Oct. 18 /PRNewswire/ -- S*BIO Pte Ltd today announced that the European Commission (EC) has granted orphan drug designation to SB1518, its potent and orally active JAK2 inhibitor for the treatment of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF). SB1518 has also received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of the same disorder.
MedAssurant and WellCare Expand Relationship with Integrated Solution Suite
Date: October 18, 2010
Client: MedAssurant Inc.
Summary: BOWIE, Md., and TAMPA, Fl.– October 18, 2010 – MedAssurant Inc. a leading provider of data-driven health care solutions, and WellCare Health Plans, Inc., (NYSE: WCG) a leading provider of managed care services for government-sponsored health care programs, today announced their expanded relationship through WellCare’s implementation of MedAssurant’s integrated solution suite.
Argos Therapeutics to Present Overview of its Arcelis™ Dendritic Cell-based Immunotherapy, Participate in Panel Discussion at Inaugural Cancer Immunotherapy Conference
Date: October 18, 2010
Client: Argos Therapeutics
Summary: DURHAM, N.C. – Oct. 18, 2010 – Argos Therapeutics today announced that Jeff Abbey, the company’s president and chief executive officer, will present an overview of its Arcelis™ dendritic cell-based immunotherapy at 3:30 p.m. EDT on Oct. 21 at the inaugural Cancer Immunotherapy Conference in New York.
Stem Cell Research Perseveres in the Midst of Funding Crisis
Date: October 15, 2010
Client: Cellular Dynamics International
Summary: The recent legal wrangling regarding the use or prohibition of the use of federal funds in scientific research utilizing human embryonic stem cells (hESCs) has generated significant uncertainty in the stem cell research community and is very unfortunate. The ruling places current hESC research in jeopardy and casts a cloud over future projects.
AVI BioPharma's Investigational Drug Candidate AVI-4658 Demonstrates Broadly Favorable Profile of Safety and Tolerability, New Dystrophin Expression, Stable Clinical Performance and Inflammatory Modulation in the Treatment of Duchenne Muscular Dystrophy
Date: October 15, 2010
Client: AVI BioPharma, Inc
Summary: AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today announced that data from the recently completed trial of AVI-4658, the Company's investigational drug candidate for the treatment of Duchenne muscular dystrophy (DMD), demonstrated a broadly favorable therapeutic profile with promising safety, biological and exploratory clinical performance assessments that supports rapid advancement of the program into the next phase of clinical development. The data from AVI's Study 28, the completed Phase 1b/2 clinical trial conducted in the U.K., were presented at the 15th International Congress of the World Muscle Society.
AbD Serotec Selected as Preferred Supplier for Custom Monoclonal Antibody Generation by Research Councils UK for UK Research
Date: October 14, 2
Client: MorphoSys AG
Summary: MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that its research and diagnostic antibodies unit AbD Serotec has signed a two year contract for the supply of custom monoclonal antibodies with Research Councils UK Shared Services Centre Limited (RCUK SSC Ltd). RCUK SSC Ltd has been set up by the seven Research Councils of the UK (RCUK) to provide centralized services to the Research Councils and their institutes in various areas including procurement.
MorphoSys and Proteros Biostructures Receive Research Grant to Develop New Technology Platform for Structure-Based Engineering of Antibodies
Date: October 12, 2010
Client: MorphoSys AG
Summary: MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and Proteros Biostructures announced today that they have been awarded a grant by the German Federal Ministry of Education and Research, BMBF. The funding of approximately EUR 850,000 supports both companies in establishing a new technology platform for efficient structural characterization of antibody-antigen-complexes. MorphoSys will provide relevant antigen and antibody molecules, Proteros will provide advanced x-ray technology and computational chemistry know-how. The high resolution access to antibody-antigen-complex structures is expected to allow a faster and more efficient engineering of therapeutic antibodies. The program is part of Munich's biotechnology initiative "m4 - Personalized Medicine and Targeted Therapies - A New Dimension in Drug Development in the Munich Region", which this year received Leading-Edge Cluster status in a German government funding competition.
CureVac presents convincing data from the first ever Phase I/IIa clinical study with a mRNA based vaccine
Date: October 4, 2010
Client: CureVac GmbH
Summary: Tuebingen (Germany), October 4, 2010. CureVac GmbH, the mRNA vaccine company, announced today first data from an open-label phase I/IIa clinical trial of its mRNA vaccine CV9103 in patients with hormone-refractory prostate cancer with rising PSA and existing metastasis in the vast majority of patients. The trial was designed to assess safety and toxicity of CV9103 as well as its ability to induce antigen specific humoral and cellular immune responses in cancer patients. The results suggest that CV9103 is safe, well tolerated and biologically active. Over 70% of the study patients responded to at least one antigen out of the four antigens in CV9103. The trial evaluated a five dose regime of CV9103 delivered via intradermal injection in 44 patients.

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