Clinical

Genetic Analysis Systems Enter the Clinical Mainstream

Like many other diagnostic regimes that were previously restricted to large specialty laboratories, genetic analysis is entering the clinical mainstream. Smaller, simpler analyzer systems are now suitable and affordable for hospital or large physicians group labs, while some genetic test kits are becoming available for primary point of care locations such as clinics and physician offices.<...

Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs

IRVING, Texas--(BUSINESS WIRE)--Jul 11, 2007 - The Journal of theAmerican Society of Clinical Oncology has published the earlyresults of a clinical study conducted by Dr. Siu-Fun Wong, and hercolleagues, which concluded that the topical gel, Regenecare(R),caused a statistically significant reduction in the pain anditching of a rash that results from the use of anti-cancer drugsknown as EGFR...

Large Geographic Differences in EpiPen Prescriptions in the U.S., From the Journal of Allergy and Clinical Immunology

MILWAUKEE, July 11, 2007 /PRNewswire/ -- A new study suggestsstrong variation in the occurrence of anaphylaxis between thenorthern and southern U.S. Anaphylaxis is a severe allergicreaction that can be fatal without treatment with epinephrine. Thestriking north-south differences in EpiPen prescribing, a marker ofanaphylaxis risk, currently are without explanation. Theinvestigators hypoth...

Sygnis Pharma AG announces date for presentation of clinical results

HEIDELBERG, Germany, 11 July 2007 – On 23 July SYGNIS PharmaAG will present the results of the clinical phase IIa study forAX200 (AXIS-study). AX200, a compound for the treatment of stroke, is the mostadvanced drug candidate in SYGNIS’ product pipeline. Theprimary aim of the study is to show safety and tolerability ofAX200 in acute stroke patients. The results of the AXIS-stud...

Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis

HORSHAM, Pa.--(BUSINESS WIRE)--Jul 11, 2007 - Neose Technologies,Inc. (Nasdaq GM:NTEC) today announced that two poster presentationswere presented with its collaborative partner, Novo Nordisk A/S,relating to GlycoPEGylated recombinant Factor VIIa at the XXIstCongress of the International Society on Thrombosis and Haemostasisin Geneva, Switzerland. The data presented demonstrates thatGlycoPE...

Clinical Data Suggest Decreased Bleeding Risk in People With Severe Hemophilia A While Maintaining Factor VIII Levels Above One Percent

Results Highlighted in Oral Presentation at International Symposiumof Thrombosis and Haemostasis GENEVA, July 10, 2007 /PRNewswire-FirstCall/ -- BaxterHealthcare Corporation today announced the presentation of findingsfrom the ADAPT (Analysis of Data from ADVATE(R) Prospective Trials)study program database showing a statistically significantrelationship between the duration of time spent...

Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis

LEVERKUSEN, Germany - Biofrontera AG (DSE: B8F) announces todaythat it has received very positive results in the dose finding partof its phase IIb/III clinical trial started in autumn 2006. BF-200ALA, a gel that combines the active substance 5-aminolevulinic acid(ALA) with the nanoemulsion BF-200, was strongly and significantlysuperior to placebo in the treatment of actinic keratosis. BF-...

Halozyme Therapeutics' Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society

- Co-Injection of rHuPH20 with Humira Estimated to Increase theMaximal Steady State Subcutaneous Bioavailability from 64% to 100%- SAN DIEGO, July 09, 2007 /PRNewswire-FirstCall/ -- HalozymeTherapeutics, Inc. , a biopharmaceutical company developing andcommercializing recombinant human enzymes, today announced thatfinal results of the Enhanze(TM) Technology clinical trialdemonstrating im...

Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease

DENVER--(BUSINESS WIRE)--Jul 10, 2007 - Corgenix MedicalCorporation (OTC BB: CONX) and the Company's clinical collaboratorsreported new clinical data demonstrating a significant correlationbetween serum levels of the Company's patented AtherOx(TM)bio-markers and cardiovascular disease. The data was presented atthe XXIst Congress of the International Society on Thrombosis andHemostasis (ISTH...

AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease

PORTLAND, Ore.--(BUSINESS WIRE)--Jul 10, 2007 - AVI BioPharma, Inc.(Nasdaq:AVII) announced today that its partner Cook Medical hascompleted target patient enrollment and released six-monthfollow-up data from a Phase II clinical trial known as Appraisal.The trial, currently being held in Germany, was designed to studythe effect of the Neugene(R) antisense drug Resten-MP(TM), whenused in conj...

Protox Announces Positive Clinical Data from Prostate Cancer Study

VANCOUVER, British Columbia, July 10, 2007 /CNW/ - ProtoxTherapeutics Inc. (TSX-V:PRX) today announced positivetop-line results from its Phase 1 clinical trial evaluating PRX302 in patients with localized, recurrent prostate cancerfollowing radiation failure. The trial results indicate thatPRX302 is safe and well tolerated and shows promising signsof therapeutic activity following a s...

Gene Therapy Eradicates Pancreatic Cancer in Preclinical Trial Targeting System's Success in Mouse Model Reported in Cancer Cell

HOUSTON, July 9, 2007 - A molecularly engineeredtherapy selectively embeds a gene in pancreatic cancer that shrinksor eradicates tumors, inhibits metastasis, and prolongs survivalwith virtually no toxicity, researchers from The University ofTexas M. D. Anderson Cancer Center report in the July 9 edition ofCancer Cell. "This vehicle, or vector, is so targeted and robust in itscanc...

AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis

AM Pharma Continues Its Success with Positive Phase IIa ClinicalTrial Results First clinical Results Confirm Potential New Application of KeyProduct in AM-Pharma's Pipeline BUNNIK, The Netherlands, July 9, 2007-AM-Pharma B.V., thebiopharmaceutical company developing novel therapeutics to treatinfectious and inflammatory diseases, today announced the positiveclinical results of its...

YM BioSciences Announces Preclinical Data Confirming Nimotuzumab Binds to the EGF Receptor and Potentiates Radiotherapy

MISSISSAUGA, ON, July 09, 2007 /PRNewswire-FirstCall/ - YMBioSciences Inc. , an oncology company that identifies, developsand commercializes differentiated products for patients worldwide,today announced that a study presented by investigators from KinkiUniversity School of Medicine and Kyoto University at the 11thmeeting of The Japanese Association for Molecular Target Therapy ofCancer...

Cougar Biotechnology Announces Presentation of Positive CB7630 Clinical Data at ESMO Conference

LOS ANGELES--(BUSINESS WIRE)--July 8, 2007 - Cougar Biotechnology,Inc. (OTCBB:CGRB) today announced that positive Phase I and PhaseII data on the Company's prostate cancer drug candidate CB7630(abiraterone acetate) were presented at the European Society forMedical Oncology (ESMO) Conference, which is currently taking placein Lugano, Switzerland. The data were presented in two oral andposter...

TransPharma Medical Announces Positive Results of Phase I Clinical Trials for Transdermal Delivery of hPTH (1-34) for Osteoporosis Treatment

LOD, Israel--(BUSINESS WIRE)--Jul 9, 2007 - TransPharma MedicalLtd., a specialty pharmaceutical company focused on the developmentand commercialization of drug products utilizing a proprietaryactive transdermal drug delivery technology, announced todaypromising results of its phase I clinical trials demonstrating thesafety and pharmacokinetic profile of its ViaDerm-hPTH (1-34)product for th...

Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings

NEWTON, Mass.--(BUSINESS WIRE)--Jul 9, 2007 - Pro-Pharmaceuticals,Inc. (Amex: PRW), a company "Advancing Drugs ThroughGlycoscience(R)", today updated the progress of its Phase IIclinical trial for first-line treatment of metastatic, unresectablecolorectal cancer patients who are unable to tolerate irinotecanand/or oxaliplatin, and its Phase II clinical trial for first-linetreatment of bilia...

MediGene Announces Cancer-Fighting Virus Shows Promise in Early Clinical Trial

MARTINSRIED/MUNICH, Germany, July 9, 2007-A virus that has beenspecifically designed by scientists to be safe to normal tissue butdeadly to cancer is showing early promise in a preliminary study,researchers said today at the ESMO Conference Lugano (ECLU),Switzerland. The virus, called NV1020, is a type of herpes simplex virusmodified so that it selectively replicates in virus cells...

Response Genetics Announces Publication of a Phase III Clinical Trial Demonstrating That Low Levels of ERCC-1 Help to Predict Likelihood of Response to Cisplatin-Based Therapy in Lung Cancer

- First prospective biomarker trial in non-small cell lung cancer - LOS ANGELES, July 09, 2007 /PRNewswire-FirstCall/ -- ResponseGenetics, Inc. today announced that positive Phase III clinicaldata published in the July 1 issue of the Journal of ClinicalOncology suggests that low expression of the biomarkerExcision-Repair Cross-Complementing 1 (ERCC-1) in patient biopsieswith advanced non-...

Avexa's Apricitabine Clinical Trial Update

MELBOURNE, Australia--(BUSINESS WIRE)--Jul 5, 2007 - Australianbiotechnology company Avexa (ASX:AVX) announced today thecompletion of apricitabine's controlled, double blinded phase whichrepresents the first 24 week segment of its Phase IIb trial.Patients have now progressed into the open-label section of thetrial (weeks 24 to 48) and will continue to receive 800mgapricitabine twice a day a...

Suven Life Sciences Presenting Pre-clinical data of their NCE’s SUVN-502 and SUVN-507at International Brain Research Organization (IBRO) 2007 World Congress of Neuroscience

HYDERABAD, India, July 5th, 2007 – Several datapresentations from Suven’s portfolio of investigationalneuroscience compounds will be presented at International Brain Research Organisation (IBRO) 2007 WorldCongress of Neuroscience to be held at Melbourne, Australia duringJuly 12-17, 2007. Scientists from Suven Discovery Research will be presenting newdata for 4 p...

Genzyme Announces Results of Clinical Trial of Hylastan

CAMBRIDGE, Mass., July 05, 2007 /PRNewswire-FirstCall/ --Genzyme Corp. today announced top-line results from a pivotal studyinvestigating the safety and efficacy of hylastan in treating painin patients with osteoarthritis (OA) of the knee. Hylastan is beingdeveloped within Genzyme's program to introduce aviscosupplementation product that can be delivered through a singleknee injection. T...

Clinical Data From Nymox BPH Drug To Be Presented at American Urological Association Meeting

HASBROUCK HEIGHTS, N.J.--(BUSINESS WIRE)--Jul 3, 2007 - NymoxPharmaceutical Corporation (NASDAQ: NYMX) today announced thatfurther clinical results from the Company's studies of NX-1207 forbenign prostatic hyperplasia (BPH) will be presented at the NewEngland Section of the American Urological Association Meeting inBoston in September. The paper is authored by leading clinicalresearch inves...

From Clinical Cancer Research: Rethinking Therapeutic Cancer Vaccine Trials

PHILADELPHIA, July 3, 2007-- Ongoing therapeutic cancer vaccinetrials have yet to show evidence of vaccines spurring apatient’s immune system to shrink tumors -- yet patients whoreceive these vaccines in trials tend to live longer and respondbetter to subsequent treatment. In the July 1 issue of ClinicalCancer Research, a journal of the American Association for CancerResearch, a te...

ENDEAVOR IV Clinical Trial Meets Primary Endpoint

MINNEAPOLIS--(BUSINESS WIRE)--Jul 2, 2007 - Medtronic, Inc.,(NYSE:MDT) today announced that a review of data from the ENDEAVORIV Clinical Trial indicates that the trial has met its primary,non-inferiority endpoint. The ENDEAVOR IV Clinical Trial is a randomized, single-blindtrial evaluating the safety and efficacy of the Endeavor(TM) DrugEluting Coronary Stent as compared to the TAXUS Pac...

Advanced Life Sciences Announces Supplemental Efficacy Data from First Pivotal Phase 3 Pneumonia Clinical Trial

Provides Update to Timeline for Second Pivotal Phase 3 Trial CL-05 CHICAGO, July 02, 2007 /PRNewswire-FirstCall/ -- Advanced LifeSciences Holdings, Inc. , today announced the confirmation ofsupplemental efficacy data from Trial CL-06, the first of twopivotal Phase 3 clinical trials designed to assess the safety andeffectiveness of cethromycin, a novel once-a-day antibiotic, forthe treatme...

Alkermes Announces Positive Results from Phase 1/2 Clinical Study of ALKS 29

Company to Proceed with Development Program for Oral Compoundsto Treat Alcohol Dependence CAMBRIDGE, Mass.--(BUSINESS WIRE)--July 2, 2007--Alkermes, Inc.(Nasdaq: ALKS) today announced positive preliminary results from aclinical trial of ALKS 29 in alcohol dependent patients. Based onthese results, the company plans to move forward with itsdevelopment program for oral product...

Cytokinetics Reports Additional Clinical Trials Data for Ispinesib

SOUTH SAN FRANCISCO, CA June 28, 2007 - Cytokinetics,Incorporated (Nasdaq: CYTK) announced results from the analyses ofthree Phase II clinical trials of ispinesib administered asmonotherapy, one in patients with hepatocellular cancer, one inpatients with melanoma, and one in patients with hormone-refractoryprostate cancer. I...

European Society for Medical Oncology (ESMO) Presents Data from the Clinical Trial of MediGene's Cancer-Killing Virus in Press Conference

* Presentation of efficacy trends from ongoing phase I/II trialof oncolytic HSV * Poster selected by ESMO for presentation inpress conference MARTINSRIED, Germany, June 29, 2007.--The biotech companyMediGene AG (Frankfurt, Prime Standard: MDG) announces that a casereport from the ongoing clinical trial of MediGene's cancer killingvirus will be presented in a press conferen...

Biotec Pharmacon Announces Preliminary Results from the Sloan-Kettering Clinical Study

TROMSØ, Norway, June 29, 2007-Preliminary results fromthe immunotherapeutic cancer study at Memorial Sloan-KetteringCancer Center show a very good safety profile for SBG. Furthermore,encouraging responses on cancer development have been observedamong several patients that have been treated with SBG incombination with the monoclonal antibody against neuroblastoma. In line wit...

Based on Up to 6 Years of Follow-Up, Biovest Announces Favorable Interim Blinded Data for Fast-Tracked Pivotal Phase 3 Clinical Trial of BiovaxID Anti-Cancer Vaccine for Non-Hodgkin's Lymphoma

WORCESTER, Mass.--(BUSINESS WIRE)--Jun 28, 2007 - BiovestInternational, Inc. (OTCBB: BVTI), a majority owned subsidiary ofAccentia Biopharmaceuticals, Inc. (NASDAQ:ABPI), announced on June27, 2007 blinded interim data from the start of its fast-trackedpivotal Phase 3 clinical trial of BiovaxID(TM) for Non-Hodgkin'slymphoma (NHL) from September 2000 through June 2006. This interimblinded dat...

ZIO-101 (Darinaparsin) Interim Phase II and Preclinical Data Presented at International Myeloma Workshop

KOS, Greece--(BUSINESS WIRE)--Jun 28, 2007 - ZIOPHARM Oncology,Inc. (NASDAQ: ZIOP), announced today the presentation of twoposters at the XIth Annual International Myeloma Workshop beingheld in Kos, Greece from June 25-28th, 2007. The meeting highlightsimportant advances made in the biology and treatment of multiplemyeloma. ZIOPHARM is presenting darinaparsin (ZIO-101) geneexpression profil...

Progenics and Wyeth Announce Positive Results from Three-Month Clinical-Extension Study of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Patients with Advanced Illness

TARRYTOWN, N.Y. & MADISON, N.J.--(BUSINESS WIRE)--Jun 28, 2007- Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) and WyethPharmaceuticals, a division of Wyeth (NYSE: WYE), today announcedpositive results from a three-month open-label extension study ofsubcutaneous methylnaltrexone for the treatment of opioid-inducedconstipation (OIC) in patients with advanced illness. The resultsare sched...

Cytochroma Reports Positive Phase I Clinical Data for CTA018 Injection

MARKHAM, ON, June 28, 2007 /PRNewswire/ - Cytochroma Inc.announced today positive data from a Phase I clinical trial ofCTA018 Injection. The initial top-line results from this trialshowed that CTA018 was safe and well tolerated. Complete studyresults are expected in August 2007. The recently completed Phase I trial was an open label,placebo-controlled, randomized study of CTA018 In...

Accentia Biopharmaceuticals Announces Favorable Interim Blinded Data on SinuNase in Its Fast-Tracked Pivotal Phase 3 Clinical Trial for Chronic Sinusitis

TAMPA, Fla.--(BUSINESS WIRE)--Jun 28, 2007 - AccentiaBiopharmaceuticals, Inc. (NASDAQ: ABPI) announced on Wednesday,June 27 at the Jefferies Healthcare Conference that its interimanalysis of the blinded data on the first fifty patients in theFast-Tracked Phase 3 clinical study of SinuNase(TM), at 8 weekspost-randomization, has demonstrated substantial improvement inresolution of one or both...

Clinical Trial Suggests Bone Marrow Stem Cells Are Useful for Spinal Cord Injury; PrimeCell Therapeutics Provided Pre-Clinical Study

SYDNEY, Australia--(BUSINESS WIRE)--Jun 27, 2007 - PrimeCell(TM)Therapeutics LLC (http://www.primecelltherapeutics.com) todayannounced that it provided research support and pre-clinicalstudies for a clinical trial to assess the safety, feasibility andefficacy of implanting autologous bone marrow stem cells intospinal cord injury (SCI) patients. Dr. Luis Geffner presented a preliminary rep...

Lupus Foundation of America Statement on Results for Clinical Study of CellCept Released by Aspreva Pharmaceutical Company

Statement by Sandra C. Raymond, President & CEO of the LupusFoundation of America, Inc. WASHINGTON, June 27, 2007 /PRNewswire-USNewswire/ -- The LupusFoundation of America, Inc. and more than 1.5 million Americanswith lupus have been awaiting the preliminary findings of the PhaseIII clinical trials for CellCept(R), a potential treatment forlupus kidney disease being tested by Aspreva...

Two Phase III clinical trials on corifollitropin alfa (Org 36286) reach randomization target

OSS, the Netherlands, June 27, 2007-Organon, the humanhealthcare business unit of Akzo Nobel, announced today that twoout of three Phase III clinical trials with corifollitropin alfa(Org 36286), a new long-acting fertility hormone, have reachedtheir randomization target. Corifollitropin alfa is a new recombinant fertility hormone. It isthe first of a new class of gonadotropi...

CytRx Reports Promising Data from Its Open-Label Extension Clinical Trial of Arimoclomol in ALS

LOS ANGELES--(BUSINESS WIRE)--Jun 27, 2007 - CytRx Corporation(NASDAQ:CYTR), a biopharmaceutical company engaged in thedevelopment and commercialization of human therapeutics, todayannounced promising data from the six-month, open-label extensionof its completed Phase IIa clinical trial with arimoclomol in ALSvolunteers. While the clinical trial was not placebo-controlled,arimoclomol at a 1...

ACE-011 Improves Multiple Myeloma Bone Disease in a Preclinical Model

KOS, Greece--(BUSINESS WIRE)--Jun 26, 2007 - Acceleron Pharma,Inc., a biopharmaceutical company developing therapeutics for thetreatment of musculoskeletal, metabolic and cancer-relateddiseases, today announced results demonstrating that ACE-011, anovel anabolic bone agent for the treatment of bone loss, preservedbone mass and architecture in a murine model of multiple myeloma.Multiple myel...