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All News Consumer Pharma New Drugs Pipeline Clinical Trials

March 2008

March 3

Alexza's AZ-104 (Staccato Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache Pro-Pharmaceuticals Davanat Extends Median Survival 6.7 Months for End-Stage Colorectal Cancer Patients After All Other Treatments Failed Renovo Announces Results of Latest Phase 2 Studies of Juvista (Human Recombinant TGFbeta3) Publication in Clinical Cancer Research Confirms Ability of Peregrine's Bavituximab to Target Tumor Blood Vessels with Excellent Specificity GTx Announces Additional Top Line Phase III Data Demonstrating Toremifene Citrate 80 mg Reduced Hot Flashes in Men with Prostate Cancer on Androgen Deprivation Therapy HUYA Bioscience Int'l Announces Clinical Trial Milestones in China for Promising New Anti-Arrhythmic Compound; Data Supports Desirable Safety Profile LifeCycle Pharma Announces Positive Top-line Results of Phase II Clinical Trial of LCP-Tacro for the Prevention of Organ Rejection after Kidney Transplantation Array BioPharma Announces Positive Phase 2 Top-Line Results in Inflammatory Pain Clinical Trial PhytoMedical's Latest Anti-Cancer Compounds Kill Human Colon Cancer Cells Dendreon Publishes Manuscript on CD54 as a Surrogate Marker of Antigen Presenting Cell Activation

March 4

Inovio Biomedical to Present New Data from Melanoma Immunotherapy Clinical Trial at DNA Vaccines Forum 2008 Sunesis Pharmaceuticals to Present Interim Phase 2 Data for SNS-595 at the 39th Annual Meeting on Women's Cancer Sirtris Pharmaceuticals' SRT501 Slows Retinal Ganglion Cell Loss During Optic Neuritis in a Preclinical Model of Multiple Sclerosis Advaxis Scientists Publish Research of Listeria Monocytogenes-Based Vaccine for Prostate Cancer in Latest Edition of Cancer Immunology & Immunotherapy Lifetime Probability of Needing a Stem Cell Transplant is Much Higher Than Previously Reported, Data Shows International symposium reports on the use of antivirals in patients with H5N1 Panacos Announces Discovery of Bevirimat Patient Response Predictors UCB: Early Data on Cimzia from the WELCOME Study Show Efficacy in Infliximab-Refractory Crohn's Disease Patients

March 10

Palatin Technologies, Inc. Reports Positive Results of a Phase I Clinical Study With PL-3994 for the Treatment of Congestive Heart Failure Keryx Biopharmaceuticals Announces that SUN-MICRO Phase 3 Clinical Trial Fails to Meet Primary Efficacy Endpoint Sunesis Pharmaceuticals Reports Positive Interim Data for SNS-595 Single-Agent Activity in Platinum-Resistant Ovarian Cancer Sirtris Pharmaceuticals Collaborator Presents Neuroprotective Data for Oral Drug Candidate SRT501 at North American Neuro-Ophthalmology Society Meeting Genzyme Announces Presentation of New Positive Data on Carticel GSK Cervical Cancer Candidate Vaccine Cervarix Demonstrates Long-Term Protection for More Than Six Years Anavex 7-1037 Reduces Rate of Cancer Tumor Growth 69% in Preclinical Studies, Compared to Currently Marketed Drug Dacarbazine Showing no Measurable Activity Complete ANX-530 Safety Data to be Published in the 2008 Proceedings of the American Society of Clinical Oncology Independent Physician Surveys Show if Approved, MF101 Could Become First-Line Treatment for Menopause Symptoms Clinical Data on Lenocta, a Protein Tyrosine Phosphatase Inhibitor in Development at VioQuest Pharmaceuticals, Accepted for Oral Presentation at ASCO Potential Brain Cancer Drug for Children May Damage Bones Alseres Pharmaceuticals Presents Inosine and Dopamine Transporter (DAT) Blocker Preclinical Data at the American Society for Experimental NeuroTherapeutics (ASENT) Conference

March 11

I-Flow Leads Infection Prevention Trend by Using Silver with Antimicrobial Properties in Medical Devices Femara helps protect against return of breast cancer even when treatment starts several years after completing tamoxifen therapy Genitope Corporation to Suspend Development of MyVax Personalized Immunotherapy Halozyme Therapeutics Presents Favorable New Safety and Pharmacokinetic Data on rHuPH20 Enzyme Produced Via New Manufacturing Process at European Federation for Pharmaceutical Sciences Inovio Biomedical's Electroporation Delivery Technology Demonstrates Safety and Positive Clinical Responses with Melanoma DNA Immunotherapy Peregrine Pharmaceuticals Announces Positive Data From Cotara Brain Cancer Trials Oculus Innovative Sciences to Announce Additional Phase II Data and Data from Two Recent International Studies at DFCon 08 Nymox Releases Further Results from Latest U.S. Study of NX-1207 for Benign Prostatic Hyperplasia Oxogeme Reports Positive Primate Ocular Tolerance and Penetration Data with Topical Formulation of Zybrestat for Ophthalmology Raven Announces RAV12 Phase 1/2a Study Results To Be Presented at ASCO Nymox Releases Further Results from Latest U.S. Study of NX-1207 for Benign Prostatic Hyperplasia

March 13

Publication of Clinical Results Underscores Velcade (Bortezomib) For Injection Based Therapy As a Standard of Care In Newly Diagnosed Multiple Myeloma Patients Amicus Therapeutics Presents Positive Data from Phase 2 Clinical Trial of Plicera for Gaucher Disease Cambria Biosciences' Chemical Genetics Platform is Featured in Nature Article Describing a New Pharmaceutical Mode of Action MacroChem Announces Presentation of Pexiganan Phase 3 Study Results for Topical Treatment of Diabetic Foot Infection Teva Provides Update on Glatiramer Acetate 40mg for Amyotrophic Lateral Sclerosis Researchers Find Cause of Severe Allergic Reaction to Cancer Drug Amicus Therapeutics Presents Data from Clinical Ex Vivo Response Study and Phase 1 Studies of AT2220 Oncolytics Biotech Inc. Collaborators to Present Reovirus Research at AACR Annual Meeting

March 17

Akesis Pharmaceuticals Provides Preliminary Data from Phase IIa Trial of AKP-020 for Type 2 Diabetes Sepracor Presents Safety Data on Omnaris AQ and Omnaris HFA Nasal Sprays at American Academy of Allergy Asthma and Immunology (AAAAI) Baxter Presents Latest Clinical Trial Results of Gammagard Liquid Administered Subcutaneously Medarex Announces Presentations at Annual Meeting of the American Association for Cancer Research Cardiome Announces Positive Interim Phase 2b Results for Oral Vernakalant and Engages Merrill Lynch as Strategic Advisor Medivation's Dimebon Stabilizes Behavioral Symptoms in Alzheimer's Disease Patients, Resulting in Reduced Caregiver Distress Valeant Pharmaceuticals Reports Encouraging Phase IIb Results at Treatment Week 12 for Taribavirin New Data Show Advair Reduces Asthma-Related Hospitalization and Emergency Department Visits Fludarabine, Mitoxantrone and Zevalin Produces 96% Complete Remission Rate in First-Line Treatment of Patients with Follicular Non-Hodgkin's Lymphoma New Trial Presented at AAAAI Reports that the Growth of Children 2-5 Years Old with Year-Round Allergic Rhinitis Continued According to Normal Age-Adjusted Distribution Over a 6-Month Treatment with Nasacort AQ Hepatitis C Virus DNA Vaccine Shows Safety When Delivered by Inovio Biomedical's Electroporation Delivery System in Phase I/II Clinical Study at Karolinska University Hospital GSK Data Suggests Efficacy of Advair and Serevent is Not Impacted by Genetic Profile Greer's Sublingual-Oral Immunotherapy Clinical Trials Supporting the Safety of Home-Administered Treatment Published in the Annals of Allergy, Asthma and Immunology Study Analyzed Long-Term Symbicort Use in Children With Persistent Asthma New Localized Cancer Treatment for Advanced Retinoblastoma Saves Children From Having Eyes Removed, Restores Vision in Some Cases Study Shows Privigen 10% Liquid Immunoglobulin Preparation for Intravenous Use, Is an Effective Replacement Therapy in Patients with Primary Immune Deficiencies NanoBio Corporation Successfully Completes Phase 2b Study in Herpes Labialis Oculus Innovative Sciences Announces Positive Results From Three Abstracts Evaluating the Use of Microcyn Technology in Diabetic Foot Ulcers Oncolytics Biotech Inc. Announces Publication of Research on Immune Response to Reolysin During a Phase I Clinical Trial Scientists Identify New Leads for Treating Parasitic Worm Disease MediGene Achieves Excellent Efficacy Data of EndoTAG-1 in Clinical Phase II Trial in Pancreatic Carcinoma Nuvelo Announces Phase 2 Sonoma-3 Trial Did Not Meet Target Product Profile and Discontinues Alfimeprase Development

March 18

VioQuest Pharmaceuticals Announces Presentations at Annual Meeting of the American Association for Cancer Research Hollis-Eden Pharmaceuticals Reports Positive Preliminary Data from Ongoing Phase I/II Clinical Trial with Triolex in Obese Insulin Resistant Subjects Micromet Announces Presentation of Five Posters Related to Its Proprietary BiTE Antibody Platform at Annual Meeting of American Association for Cancer Research NPS Reports Successful Gattex Extension Study Ardea Biosciences Reports Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating up to 2.0 Log Reduction in Plasma Viral Load iCo Therapeutics iCo-009 (Oral Amphotericin B) Published in Leading Drug Delivery Journal CeraShield Coated Endotracheal Tubes Provide up to 21 Days of Protection against Bacterial Colonization in Preclinical Testing NovaBay Pharmaceuticals (NBY) Publishes on the Design of New Class of Antimicrobial Compounds It Named Aganocides BioNumerik Pharmaceuticals and ASKA Pharmaceutical Co. Announce Results from Phase III Clinical Trial of Tavocept Study Compares Bronchodilatory Effects of Symbicort and Advair in Adults With Asthma C1-Esterase Inhibitor Concentrate Rapidly Relieves Abdominal and Facial Attacks in Patients with Hereditary Angioedema, According to Pivotal Study Lipid Sciences' HDL Mimetic Peptide Demonstrates Significant Anti-Atherosclerosis Effect in a Key Animal Model Data Presented at International Psoriasis Meeting Support Potential New Role for Biologic Treatment Etanercept in Management of Childhood Psoriasis Leading Rheumatologists Agree Clinical Remission a Key Goal in Rheumatoid Arthritis 960-Patient Study Demonstrates Zero Blood Stream Infection In Patients Treated With Angiotech's Novel 5-FU Central Venous Catheter Lev Presents Results of Phase III Study Supporting Safety and Efficacy of Cinryze (C1 inhibitor) as Prophylactic Therapy for HAE Orexo's Product NLA Nasal Spray Shows Excellent Local Tolerability in Patients with Rhinitis Peptimmune Completes Phase I Study with a Novel Peptide Copolymer for the Treatment of Multiple Sclerosis

March 24

MAP Pharmaceuticals Reports Positive Results From Comparative Pharmacokinetic Trial for its Pediatric Asthma Product Candidate Spectrum Pharmaceuticals Presents Data on SPI-1620, a Novel Adjunct to Cancer Therapy, at the 6th International Symposium on Targeted Anticancer Therapies Sangamo BioSciences and Sigma-Aldrich Announce Publication of Study Demonstrating Zinc Finger Technology for Rapid Generation of 'Knock-Out' Cell Lines Baraclude (entecavir) Data Continue to Demonstrate Low Incidence of Resistance Through Five Years of Treatment in Nucleoside-naive Chronic Hepatitis B Patients Accentia Biopharmaceuticals to Announce Top-Line SinuNase Phase 3 Clinical Trial Results Later Today AVAX to Present Results of Phase I-II Study of MVax at 2008 Meeting of the American Society of Clinical Oncology (ASCO) Revised: Challenging the Norm May Lead to New Therapy for Type 2 Diabetes

March 25

Oxford Biomedica Report Encouraging New Phase II Trial Results with Trovax in Prostate Cancer Accentia Biopharmaceuticals Announces Results on Primary Endpoint in Clinical Study of SinuNase Lavage Chelsea Therapeutics Reports Significant Efficacy of CH-4051 in Reduction of Collagen-Induced Arthritis in Animal Model Anacor Pharmaceuticals Announces Positive Results from Phase 2a Clinical Trial of AN2728 in Psoriasis Patients EPIX Pharmaceuticals to Present Phase 2a Alzheimer's Data at Keystone Symposia Circulation Publishes Data Showing Kynapid (Vernakalant Hydrochloride) Injection Rapidly Converted Short-Duration Atrial Fibrillation to Sinus Rhythm Researchers Report Neublastin Virtually Restores Complete Long-term Sensory Motor Function in Preclinical Studies ExonHit's EHT 0202 Counters Scopolamine's Detrimental Effects on Cognition in Humans Nastech Pharmaceutical Company Inc. to Present RNAi Data Yale and Asuragen Scientists Show That a microRNA Can Reduce Lung Cancer Growth Strong Trend of Effectiveness Indicated in Lipid Sciences' First in Man Clinical Trial of HDL Selective Delipidation

March 26

Cancer Researchers at Manhattan-based St. Vincent's Comprehensive Cancer Center Discover Genes That Can Determine How Patients Respond to Pre-Leukemia Drug Nventa Announces Positive Interim Immunological Data From HspE7 Phase 1 Cervical Dysplasia Trial Cerus Announces Major Presence at Upcoming International Society of Blood Transfusion Conference Levitra Therapy Suitable for Men With High Cholesterol Eric J. Topol, M.D., to Present Late-Breaking Lecture About Advancements in Genomics of Cardiovascular Disease at ACC's 57th Annual Scientific Session Cerus Announces Major Presence at Upcoming International Society of Blood Transfusion Conference Rexinoid Developed by NuRx Pharmaceuticals Shows Promise in Prevention, Treatment of Lung, Breast Cancer, Paper in Clinical Cancer Research Reports CytRx to Present Stroke Recovery Data at the Sixth International Workshop on The Molecular Biology of Stress Responses Best Practice Database: Complimentary Excerpt of Scientific Publications Strategy Study Nature Publishes Study by Santaris Pharma Scientists and Collaborators: LNA-mediated microRNA Silencing in Non-human Primates

March 27

ImmuneRegen BioSciences Releases Study Results Showing Homspera Stimulates Adult Stem Cell Activity Cystic Fibrosis Foundation Announces Positive Early Results for Phase 2 Clinical Trial of VX-770 - an Oral Compound to Treat CF Vertex Announces Positive Results for VX-770, an Oral Investigational Agent That Targets a Defective Protein Responsible for Cystic Fibrosis Vertex Announces Positive Results for VX-770, an Oral Investigational Agent That Targets a Defective Protein Responsible for Cys SGX Pharmaceuticals Provides Update on SGX523 Clinical Trials Stem Cell Research Provides Medical Breakthrough to Repair Heart Cell Damage Created by a Heart Attack Early Research Suggests Umbilical Cord Blood Cell Therapy May Reduce Progression of Alzheimer's Disease Orexo Announces Results Confirming the Clinical Profile of OX17 In Reflux Disease (GERD) Kaiser Permanente Study Shows That a Larger Abdomen in Midlife Increases Risk of Dementia New data presented at European Association of Urology (EAU) Congress in Milan Genfit Shows Encouraging Results in GFT505 First Clinical Trial of Efficacy IntelliPharmaCeutics Announces Successful Completion of a Pilot Clinical Trial for its Abuse and Alcohol Resistant Sustained Release Oxycodone RxGen and Santaris Pharma Use LNA-antimiR Technology to antagonize the liver-expressed microRNA-122 in Non-Human Primates and to Safely Lower Serum Cholesterol

March 31

UCB (BE) - Phase II results for CDP791 in non-small cell lung cancer support further clinical development Angiomax Demonstrated Improved Outcomes in Acute Heart Attack Patients Undergoing Primary Angioplasty Independent of Individual Risk Factors Crestor Outcomes Study Jupiter Closes Early Due To Unequivocal Evidence Of Benefit Update on Achieve: A Study of Merck's Investigational Extended-Release Niacin/Laropiprant (Cordaptive) 12-Month Data From Endeavor IV Show Strong Clinical Efficacy of Medtronic's Drug-Eluting Stent Across All Patient Groups Merck/Schering-Plough Pharmaceuticals Comments on Results of the Enhance Study ANX-201 Demonstrates a Unique Resistance Profile in Preclinical Tests Vertex Pharmaceuticals Announces Acceptance of Late-Breaker Abstract on Telaprevir Gamma Secretase Modulators Show Promise in Alzheimer's Disease Animal Model Efficacy Studies, According to Research Conducted by TorreyPines Therapeutics Synvista Therapeutics Presents New Preclinical Data Demonstrating the Value of Haptoglobin Genotype Testing In Diabetes at ACC Scientific Sessions BRAVE-3 Questions Value of Abciximab in PCI for Heart Attack Phase III Data Showed Taranabant, Merck's Investigational Medicine to Treat Obesity, Led to Statistically Significant Weight Loss Abbott's XIENCE V Drug Eluting Stent Demonstrates Consistent and Positive Clinical Outcomes Out to Two Years Alnylam Presents Pre-clinical Data from Hypercholesterolemia, Liver Cancer, Ebola, and Progressive Multifocal Leukoencephalopathy (PML) Programs at RNAi Keystone Symposium Drug-Eluting Stents Outperform Bare Stents in Heart Attack Endeavor Stent Safety Profile Affirmed in Long-Term Experience Delcath Systems Presents Positive Phase II Data on Delcath PHP System in Treatment of Inoperable Liver Metastases Large Study Gives Nod to Drug-Eluting Stents in Heart Attack MIV Preliminary Nine-Month Human Data Affirms Excellent Safety and Efficacy of VESTAsync Polymer-Free Drug-Eluting Stent Novelos Therapeutics Announces Continued Encouraging Results in Ongoing Phase 2 Ovarian Cancer Trial at Dana-Farber/Harvard Cancer Center Ranolazine Shortens QT Interval and Improves Cardiac Relaxation in Study of Patients With Genetic Sodium Channel Disorder Spirit II Results Support Strength of Boston Scientific's Two Drug-Eluting Stent Platforms Seven Abstracts Featuring Exelixis Compounds Accepted for Presentation at 2008 ASCO Annual Meeting SPIRIT II Explores Long-Term Performance of XIENCE V Stent Abbott's Phase III Studies of Investigational TriLipix (ABT-335), in Combination With Statins, Meets Primary Endpoints on Improving LDL, Triglycerides and HDL Argos Therapeutics Presents Positive Phase 1 Safety Data for its Arcelis Platform in HIV at Keystone Symposia Landmark OnTarget Trial Demonstrates Micardis is Equally Effective as Ramipril, with Fewer Discontinuations, in a Broad High-Risk Cardiovascular Population King Pharmaceuticals Presents Positive Results of CorVue Phase III Clinical Trials at the American College of Cardiology (ACC) Annual Scientific Conference Patients Treated with Merck's Investigational Extended-Release Niacin/Laropiprant (Cordaptive) Reported Significantly Less Flushing Than Patients Treated with Niaspan in Phase III Study New Data Showed Actos (pioglitazone HCl) Prevented Progression of Atherosclerotic Plaque Volume in Patients With Type 2 Diabetes Lotrel, a Single-Pill Combination for Treating High Blood Pressure, Reduced Cardiovascular Events by 20% in High-Risk Patients Repros Reports Interim Safety Results From Ongoing One-Year Open Label Study of Proellex(R) in the Treatment of Uterine Fibroids

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