Breaking news on Clinical trials
ThromboGenics Presents Positive Pooled Results From The MIVI-TRUST Phase III Program published
Tue, 07 Sep 2010 00:00:00 PDT
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, cardiovascular disease and cancer, announces that the pooled results from the successful microplasmin MIVI-TRUST Phase III program were presented today at the EURETINA (European Society of Retina Specialists) Congress in Paris, France...
Road-Map Agreed For Confirmatory Trials Of Promising Microbicide published
Mon, 06 Sep 2010 04:00:00 PDT
Two further clinical trials are planned to confirm a vaginal gel which has shown potential in reducing the risk of HIV. The results of the first trial of the gel, which were announced in July at the XVIII International AIDS Conference in Vienna, must be confirmed before the product can be made available for general use...
Gynecologic Cancer Patients Should Consider Clinical Trials published
Mon, 06 Sep 2010 02:00:00 PDT
For the estimated 83,000 women who will be diagnosed with a gynecologic cancer in 2010, participation in clinical trials offers an opportunity both to ensure that future patients benefit from the most up-to-date treatments and increased survival rates and to potentially improve the health of current patients...
Successful Completion Of First Clinical Trials On Potent New Hepatitis C Drug published
Mon, 06 Sep 2010 01:00:00 PDT
The first clinical trials on a new investigational drug being developed to treat infections caused by Hepatitis C virus have been successfully completed...
Depression Significantly Improved By Non-Invasive Therapy published
Mon, 06 Sep 2010 00:00:00 PDT
Major depression is a common and disabling brain condition marked not only by the presence of depressed mood but also by its effects on sleep, energy, decision-making, memory and thoughts of death or of suicide. Major depression affects 15 million adults in the U.S...
Merck's Cladribine Tablets For Multiple Sclerosis Approved In Australia published
Sun, 05 Sep 2010 01:00:00 PDT
Merck KGaA announced that the Australian Therapeutic Goods Administration (TGA) has approved Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS)(1). Cladribine Tablets will be registered in Australia under the trade name Movectro®...
HeartWare Receives Second Patient Allotment Under Continued Access Protocol For Pivotal U.S. Bridge-To-Transplant Clinical Trial published
Sat, 04 Sep 2010 01:00:00 PDT
HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S...
Optimer Pharmaceuticals Announces Presentations Of Additional Fidaxomicin Phase 3 Data At Upcoming ICAAC Annual Meeting published
Fri, 03 Sep 2010 04:00:00 PDT
Results from studies related to Optimer Pharmaceuticals, Inc.'s (Nasdaq: OPTR) lead developmental product candidate, fidaxomicin, will be presented at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) to be held at the Boston Convention and Exhibition Center in Boston on September 12-15, 2010...
Transdel Pharmaceuticals Presents Phase 3 Study Data On Ketotransdel® At World Pain Congress In Montreal, Canada published
Fri, 03 Sep 2010 02:00:00 PDT
Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, announced the final data set from its Phase 3 study of Ketotransdel® (TDLP-110) at the 13th World Congress on Pain in Montreal, Canada...
Soligenix Announces Publication Of Article Identifying Domains Within The Ricin Toxin A Subunit As Targets Of Protective Antibodies published
Fri, 03 Sep 2010 02:00:00 PDT
Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced the publication of an article online in Vaccine. The article describes the systematic identification of neutralizing and non-neutralizing B-cell epitopes on ricin toxin's enzymatic A subunit (RTA)...
Inhibitex Successfully Completes Phase 1a Trial Of INX-189 published
Fri, 03 Sep 2010 02:00:00 PDT
Inhibitex, Inc. (Nasdaq: INHX), announced that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo...
Halozyme Begins Phase 2 Clinical Trials With Insulin Analogs Lispro And Aspart With RHuPH20 In Type 1 And Type 2 Diabetes published
Fri, 03 Sep 2010 02:00:00 PDT
Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced the initiation of two Phase 2 Ultrafast Insulin treatment studies that utilize its rHuPH20 hyaluronidase enzyme (PH20) in combination with the two leading commercially available mealtime analogs: insulin aspart, the active ingredient in NovoLog®, and insulin lispro, the active ingredient in Humalog®...
Eisai Announces The Start Of The First Clinical Study Of Ban2401, A Novel Monoclonal Antibody Targeting Neurotoxic Protofibrils published
Thu, 02 Sep 2010 04:00:00 PDT
Eisai Co., Ltd. (Headquarters: Tokyo, Japan, President & CEO: Haruo Naito, "Eisai") announced today the start of the first patient enrolled clinical study with BAN2401, a novel monoclonal antibody that is being developed as a potential next-generation therapeutic treatment for Alzheimer's disease...
Trial To Test Experimental Drug For Advanced Pancreatic Cancer published
Thu, 02 Sep 2010 04:00:00 PDT
Cancer Research UK's Drug Development Office has launched a clinical trial* to test an experimental drug in patients with advanced (Stage IV) pancreatic cancer - one of the most difficult cancers to treat. Around 60 patients with advanced pancreatic cancer will be recruited for the first Phase I/IIclinical trial of a drug called MK-0752** in this disease...
Roche Provides Update On FDA Application For T-DM1 published
Thu, 02 Sep 2010 03:00:00 PDT
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the company's trastuzumab-DM1 (T-DM1) Biologics License Application (BLA). As planned Roche will continue with its ongoing Phase III EMILIA registration study...
QRxPharma Announces Interim Analysis Of Final Pivotal Phase 3 Study For MoxDuo®IR published
Thu, 02 Sep 2010 02:00:00 PDT
QRxPharma (ASX: QRX and OTCQX: QRXPY) announced a successful interim analysis of its final MoxDuo IR pivotal Phase 3 study required for New Drug Application (NDA) submission. The analysis indicated the planned sample size of 140 patients has greater than 90% power to detect differences of analgesic effect, indicating there is no need to enrol additional patients...
Agensys, An Affiliate Of Astellas, Announces Initiation Of Phase I Clinical Trial Of AGS-16M8F For Renal Cancer published
Thu, 02 Sep 2010 02:00:00 PDT
Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., announced that they have initiated a Phase I clinical trial of AGS-16M8F an antibody-drug conjugate (ADC) that is being developed for the treatment of metastatic renal cancer. An ADC uses the specific binding properties of an antibody to target a toxin in tumor cells, resulting in selective tumor cell killing...
Proprietary Zinc/Phytase Formulation Improved Botulinum Toxin A Results published
Thu, 02 Sep 2010 02:00:00 PDT
A recent study conducted by oculoplastic surgeon Charles Soparkar, M.D., Ph.D. (The Methodist Hospital, Houston, TX) utilizing a patent-pending formulation of zinc and phytase (trademarked as ZYTAZE™), demonstrated that increasing zinc levels by oral administration for 4 days prior to a planned injection of botulinum toxin improved efficacy and/or duration in 41 of 44 patients tested (93%)...
ReVision's Fenretinide (RT-101) Reduced Incidence Of Choroidal Neovascularization By More Than 50 Percent In Patients With Geographic Atrophy published
Thu, 02 Sep 2010 02:00:00 PDT
ReVision Therapeutics Inc. announced that data from a Phase 2b trial show that fenretinide (RT-101) reduced the incidence of choroidal neovascularization (CNV, wet age related macular degeneration) by about 50 percent in patients with geographic atrophy (GA), the most advanced form of dry age related macular degeneration (AMD). The data, presented Monday by Alexander M. Eaton, M.D...
Microplasmin Meets Primary Endpoint In Second Phase III Trial In VMA, Confirms Positive Findings Of First Trial published
Thu, 02 Sep 2010 02:00:00 PDT
ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer announces that its second Phase III trial evaluating microplasmin for the non-surgical treatment of vitreomacular adhesion (VMA) has met its primary endpoint...
Lytix Biopharma AS Announces Approval By Hungarian Authorities To Start Phase IIa Clinical Trial With LytixarTM In Gram Positive Skin Infections published
Wed, 01 Sep 2010 06:00:00 PDT
The Norwegian pharmaceutical company Lytix Biopharma AS today announces the approval in Hungary to commence a Phase IIa clinical trial with LytixarTM (LTX-109) treatment of skin infections caused by Gram positive bacteria...
Glenmark Announces The Discovery Of A Novel Chemical Entity 'GRC 17536', A TRPA1 Receptor Antagonist, A Potential First-in-Class Molecule Globally published
Wed, 01 Sep 2010 02:00:00 PDT
Glenmark Pharmaceuticals announced the discovery of a Novel Chemical Entity(NCE) 'GRC 17536'. The new NCE program is targeting TRPA1 receptor antagonists for pain and respiratory disorders...
Bionovo Receives Positive Guidance From FDA On Menerba® published
Wed, 01 Sep 2010 02:00:00 PDT
Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced that it has received positive guidance from the U.S. Food and Drug Administration (FDA) regarding the Company's Chemistry, Manufacturing and Controls (CMC) plan for its lead drug candidate Menerba®. The FDA indicated its agreement with Bionovo's plan...
BioMarin Receives Orphan Drug Designation From The FDA For BMN-701 For The Treatment Of Pompe Disease published
Wed, 01 Sep 2010 02:00:00 PDT
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for BMN-701, a novel fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in development for the treatment of Pompe disease...
MS Activity Varies With The Seasons published
Tue, 31 Aug 2010 02:00:00 PDT
A new US study that compared brain scans of people with multiple sclerosis to weather data over a two year period found that disease activity varied with the seasons, with spring and summer months showing predominantly the highest rates of activity, but with increased temperature and solar activity also showing a strong link...
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