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Amicus Therapeutics presents additional data from Amigal Phase 2 extension study for Fabry disease

Amicus Therapeutics announced today additional positive preliminary data from its ongoing Phase 2 extension study of its investigational drug Amigal™ (migalastat HCl) for Fabry disease at the Lysosomal Disease Network WORLD Symposium in Miami, Florida.

11 Feb 2010

PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

PARI Pharma has enrolled the first patient in its Phase 2b clinical trial studying inhaled liposomal cyclosporine A (L-CsA) delivered via a customized Investigational eFlow Nebulizer System. The multinational study is investigating the safety and efficacy of PARI's L-CsA formulation. In previous clinical trials, reactions from physicians and lung transplant recipients to PARI's drug-device combination were encouraging.

11 Feb 2010

3SBio submits application for Phase I clinical trial of NuPIAO to the Chinese SFDA

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a Phase I clinical trial for NuPIAO to the Chinese State Food and Drug Administration (SFDA).

11 Feb 2010

YM Biosciences to present JAK1/2 inhibiting small molecule and vascular disrupting agent data at Cancer Conference

YM BioSciences Inc., is presenting posters on its JAK1/2 inhibiting small molecule (CYT387) and on its novel vascular disrupting agent (CYT997) at the Lorne Cancer Conference in Lorne, Victoria, Australia. CYT387 is an oral JAK1/2 inhibitor, originating from the seminal discovery of JAK1 and JAK2 kinases by Dr. Andrew Wilks, the founder of Cytopia Limited, now YM Australia. CYT997 is an orally-available agent with dual mechanisms of vascular disruption and cytotoxicity and has the potential to be broadly active against a range of tumor types.

11 Feb 2010

Biodel's VIAject insulin Phase 3 study results to be presented at international diabetes conference in Basel

Biodel, Inc. announced today that its chief executive officer, Dr. Sol Steiner, will present results from the company’s two Phase 3 studies with VIAject® ultra-rapid-acting recombinant human insulin in a platform presentation at the 3rd International Conference on Advanced Technologies and Treatments for Diabetes in Basel, Switzerland, on Friday, February 12, 2010, at 1pm central European time.

11 Feb 2010

4SC AG announces the first treatment in Phase I clinical study of 4SC-205

4SC AG a drug discovery and development company focused on autoimmune and cancer indications, today announced the first treatment in a Phase I study evaluating 4SC-205, an oral Eg5 kinesin spindle protein inhibitor, in patients with solid tumours or malignant lymphomas.

11 Feb 2010

Micromet outlines the design of registration study for blinatumomab in ALL

At its annual investor R&D Day today, Micromet, Inc. (Nasdaq: MITI) outlined the design of a registration study for the Company's lead product candidate blinatumomab in acute lymphocytic leukemia (ALL), highlighted clinical data demonstrating the breadth of blinatumomab's activity in B-cell non-Hodgkin's lymphomas and announced plans to expand clinical development of blinatumomab in the U.S.

11 Feb 2010

MUHC commences clinical trial of Exsulin for type 1 diabetes

A clinical trial of Exsulin, an innovative new treatment that targets the underlying cause of type 1 diabetes, has begun at the McGill University Health Centre (MUHC). Under the direction of Dr. George Tsoukas of the MUHC and the McGill University Faculty of Medicine, the study will assess the effectiveness of Exsulin.

11 Feb 2010

QRxPharma announces the initiation of second pivotal Phase 3 registration trial of MoxDuo IR

QRxPharma Limited announced today initiation of its second pivotal Phase 3 registration trial (Study 009) to evaluate analgesic efficacy and safety of MoxDuo™IR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone.

11 Feb 2010

Raptor Pharmaceutical to present DR Cysteamine trial data at Lysosomal Disease Network Symposium

Raptor Pharmaceutical Corp., today announced the presentation of cystinosis data at the Annual Lysosomal Disease Network WORLD Symposium 2010, being held February 10-12 in Miami, Florida. Biomarker data from a Phase IIb pilot study of Raptor's proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") will be the subject of a poster titled, "Correlation of Plasma Cysteamine and WBC Cystine Levels at Steady State in Patients Treated with Cysteamine Bitartrate." The results will also be published in an upcoming issue of the journal Molecular Genetics and Metabolism.

10 Feb 2010

DMC recommends Celsion to continue its Phase III ThermoDox clinical trial for primary liver cancer

Celsion Corporation announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox® clinical trial ("HEAT" trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.

10 Feb 2010

Genzyme and Isis Pharmaceuticals: Phase 3 mipomersen study in heFH patients meets primary endpoint

Genzyme Corp. and Isis Pharmaceuticals Inc. today announced that the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) met its primary endpoint with a highly statistically significant 28 percent reduction in LDL-cholesterol after 26 weeks of treatment, compared with an increase of 5 percent for placebo.

10 Feb 2010

Positive results from Naurex's Phase I clinical trial of GLYX-13 reported

Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders based on its novel glycine site functional partial agonist (GFPA) NMDA receptor modulators, today reported positive top-line results from its Phase I clinical trial of lead compound GLYX-13.

10 Feb 2010

Alexza Pharmaceuticals announces development and commercialization collaboration with Biovail Laboratories International

Alexza Pharmaceuticals, Inc. announced today that it has established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to develop and commercialize AZ-004 (Staccato® loxapine) in the U.S. and Canada. AZ-004 is Alexza's lead program, based on the company's proprietary technology, the Staccato system. Alexza submitted its New Drug Application (NDA) for Staccato loxapine in December 2009. Alexza is seeking regulatory approval to market AZ-004, an inhalation product candidate developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.

10 Feb 2010

DMC recommends JV to continue enrolling patients in Phase III clinical trial of StemEx

The Gamida Cell-Teva Joint Venture (JV) announced today that the Data Monitoring Committee (DMC) has independently reviewed preliminary data from the pivotal registration, Phase III clinical trial of StemEx (called ExCell) and has recommended that the JV continue to enroll patients in this study.

10 Feb 2010

QR Pharma commences clinical trial of Posiphen in early stage AD patients

QR Pharma, Inc. , a developer of novel drugs to treat Alzheimer’s disease, announced today that it began a clinical trial of its lead compound, Posiphen, in early stage AD patients.

10 Feb 2010

Concomitant use of dexlansoprazole and other PPIs with Plavix: TGRD U.S. initiates trial

Takeda Global Research & Development Center, Inc., U.S., (TGRD U.S.) announced today that it has initiated a trial to study how dexlansoprazole and several other proton pump inhibitors (PPIs) affect the pharmacokinetics and pharmacodynamics of Plavix (clopidogrel bisulfate) in healthy subjects. Takeda has been evaluating all published data and communications from the U.S. Food and Drug Administration (FDA) regarding the potential risks associated with concomitant use of clopidogrel and PPIs.

10 Feb 2010

Johns Hopkins Hospital initiates Phase I trial with Neogenix's NPC-1C

Neogenix Oncology, Inc. (Neogenix) announced today that the Johns Hopkins Hospital has initiated a Phase I trial with the company’s first therapeutic antibody, NPC-1C, in patients with late stage pancreatic or colorectal cancer.

10 Feb 2010

TI commences Phase IIa clinical trial for its lead molecule in CDH

Trigemina, Inc. (TI), a Mountain View based startup, has begun a Phase IIa clinical trial for its lead molecule in Chronic Daily Headache (CDH) in collaboration with Dr. Egilius Spierings at MedVadis Research Corporation located outside of Boston.

10 Feb 2010

Palatin Technologies completes first cohort dosing in bremelanotide trial for sexual dysfunction

Palatin Technologies, Inc. today announced the completion of first cohort dosing in a placebo-controlled, multiple dose study of bremelanotide, its experimental treatment for sexual dysfunction. The primary endpoint in this double-blind safety study is evaluation of blood pressure effects of subcutaneous bremelanotide in men between 45 and 65 years old. The study will also evaluate consistency of plasma exposure of bremelanotide given as repeated subcutaneous injections.

10 Feb 2010

Drug Trial News

Amicus Therapeutics presents additional data from Amigal Phase 2 extension study for Fabry disease

PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

3SBio submits application for Phase I clinical trial of NuPIAO to the Chinese SFDA

YM Biosciences to present JAK1/2 inhibiting small molecule and vascular disrupting agent data at Cancer Conference

Biodel's VIAject insulin Phase 3 study results to be presented at international diabetes conference in Basel

4SC AG announces the first treatment in Phase I clinical study of 4SC-205

Micromet outlines the design of registration study for blinatumomab in ALL

MUHC commences clinical trial of Exsulin for type 1 diabetes

QRxPharma announces the initiation of second pivotal Phase 3 registration trial of MoxDuo IR

Raptor Pharmaceutical to present DR Cysteamine trial data at Lysosomal Disease Network Symposium

DMC recommends Celsion to continue its Phase III ThermoDox clinical trial for primary liver cancer

Genzyme and Isis Pharmaceuticals: Phase 3 mipomersen study in heFH patients meets primary endpoint

Positive results from Naurex's Phase I clinical trial of GLYX-13 reported

Alexza Pharmaceuticals announces development and commercialization collaboration with Biovail Laboratories International

DMC recommends JV to continue enrolling patients in Phase III clinical trial of StemEx

QR Pharma commences clinical trial of Posiphen in early stage AD patients

Concomitant use of dexlansoprazole and other PPIs with Plavix: TGRD U.S. initiates trial

Johns Hopkins Hospital initiates Phase I trial with Neogenix's NPC-1C

TI commences Phase IIa clinical trial for its lead molecule in CDH

Palatin Technologies completes first cohort dosing in bremelanotide trial for sexual dysfunction

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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