Clinical Trial News and Research

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Northwest Biotherapeutics resumes enrollment in DCVax Phase II brain cancer clinical trial

Cutting edge, patient-specific vaccine treatments like DCVax® provide for a longer life expectancy along with a better quality of life for brain cancer patients, an improvement over current conventional brain tumor treatments. "The vaccine that I received has extended the median survival of Grade IV brain cancer (GBM) from 14.6 months, with conventional treatment, to over 36 months," stated Bob Gibbs, a 7 year brain cancer survivor, who has defied the odds statistically, thanks to the experimental brain cancer vaccine DCVax®.

25 Jan 2011

ASCO urges physicians, medical schools to improve quality of life for people with cancer

The American Society of Clinical Oncology today called on physicians, medical schools, insurers, and others to help improve quality of life for people with advanced cancer.

25 Jan 2011

Diamyd Medical reports first quarter group total net sales of MSEK 144.5

Diamyd completed screening for US Phase III study in type 1 diabetes. The screening of patients for the US Phase III study, DiaPrevent, was completed, ending the recruitment campaign. More than 310 recently diagnosed type 1 diabetes patients between 10 and 20 years of age had, at the completion of screening, been enrolled in the study and received their first injection of the antigen-based therapy Diamyd® or placebo.

25 Jan 2011

Glioblastoma's molecular flexibility helps resist nearly all treatment efforts

Glioblastoma, the most common and lethal form of brain cancer and the disease that killed Massachusetts Senator Ted Kennedy, resists nearly all treatment efforts, even when attacked simultaneously on several fronts. One explanation can be found in the tumor cells' unexpected flexibility, discovered researchers at the Salk Institute for Biological Studies.

25 Jan 2011

FDA approves IDE Supplement for third patient allotment in HeartWare Ventricular Assist System ADVANCE trial

HeartWare International, Inc., 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. Food and Drug Administration has approved an IDE Supplement that allows HeartWare to enroll a third allotment, of 94 additional patients, in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).

25 Jan 2011

St. Georg Hospital performs two live procedures using Endoscopic Ablation System

CardioFocus announced that two "live cases" using its Endoscopic Ablation System were recently conducted. The first live case was a satellite transmission performed at Centro Cardiologico Monzino in Milan, Italy; broadcast to the 16th Annual Boston Symposium on Atrial Fibrillation in Boston, MA.

25 Jan 2011

ArQule's ARQ 197 Phase 1 clinical trial results in colorectal cancer presented at ASCO 2011

ArQule, Inc. today announced the presentation of Phase 1 results of a clinical trial among patients with metastatic colorectal cancer (CRC) treated with ARQ 197, a selective small molecule inhibitor of the c-MET receptor tyrosine kinase, in combination with irinotecan and cetuximab. ARQ 197 is under development by Daiichi Sankyo Co., Ltd. and ArQule.

24 Jan 2011

Threshold reports positive results from TH-302 Phase 1/2 clinical trial in pancreatic cancer

Threshold Pharmaceuticals, Inc. today announced updated Phase 1/2 clinical trial results related to the Company's clinical stage hypoxia-activated prodrug, TH-302. The results were presented at the ASCO Gastro Intestinal Cancers Symposium that took place in San Francisco from January 20-22, 2011.

24 Jan 2011

Alexza's AZ-004 Phase 3 study in agitated patients with schizophrenia published in British Journal of Psychiatry

Alexza Pharmaceuticals, Inc. announced today that the British Journal of Psychiatry, a publication of the Royal College of Psychiatrists, has published the results of the pivotal Phase 3 study evaluating AZ-004 (inhaled or Staccato® loxapine) for the rapid treatment of agitation in patients with schizophrenia, in its January 2011 edition (198:51-58).

24 Jan 2011

Boston Scientific completes enrollment in comparison trial of SYNERGY Stent to PROMUS Element Stent

Boston Scientific Corporation today announced the completion of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of the Company's fourth-generation SYNERGY™ Coronary Stent. The randomized, single-blind, non-inferiority trial will compare the SYNERGY Stent to the PROMUS Element™ Everolimus-Eluting Coronary Stent in patients with a single de novo native coronary artery lesion.

24 Jan 2011

Methodist DeBakey Heart & Vascular Center chosen for critical percutaneous heart valve study

The Methodist DeBakey Heart & Vascular Center was chosen today as a site for a critical percutaneous heart valve study. As part of the research study, Methodist physicians will replace diseased cardiac valves through a single, tiny puncture hole in the research subject's groin.

24 Jan 2011

Northwest Biotherapeutics resumes enrollment in DCVax Phase II clinical trial for GBM brain cancer

Northwest Biotherapeutics announced today that the Company is resuming enrollment of additional new patients into its ongoing 240-patient, double blind, randomized, placebo controlled Phase II clinical trial of DCVax for Glioblastoma multiforme brain cancer.

24 Jan 2011

Raptor completes enrollment in DR Cysteamine Phase 3 clinical trial in cystinosis

Raptor Pharmaceutical Corp., today announced it has completed enrollment in its Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

24 Jan 2011

Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

Immune Network, a company in the business of development and commercialization of immune therapies, announced today that its newly acquired business, Immunitor, has published interim data from the ongoing Phase IIb imm01 clinical trial of V5 in tuberculosis conducted at its second site in Ukraine.

24 Jan 2011

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration voted unanimously that clinical trial and postmarketing data for gadobutrol injection, a macrocyclic 1.0 molar gadolinium-based contrast agent (GBCA), support approval of the product for proposed use in diagnostic magnetic resonance imaging (MRI) in adults and children.

24 Jan 2011

SuppreMol completes successful pre-IND meeting with U.S. FDA

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).

24 Jan 2011

Scientists ignore relevant drug clinical trials when conducting new research on same topic

The vast majority of already published and relevant clinical trials of a given drug, device or procedure are routinely ignored by scientists conducting new research on the same topic, a new Johns Hopkins study suggests.

24 Jan 2011

CRI, Oncovir sign new investment agreement to produce immunological stimulant

Cancer Research Institute, a U.S. nonprofit organization founded in 1953 to advance the science of tumor immunology and foster the discovery and development of new cancer immunotherapies, announced today that its Cancer Vaccine Acceleration Fund, a joint initiative with the Ludwig Institute for Cancer Research, has completed a new investment agreement with Oncovir, a biotechnology company based in Washington, D.C., to enable the production of the immunological stimulant Hiltonol- (Poly-ICLC).

24 Jan 2011

CVAF completes new investment agreement with Oncovir for production of Hiltonol

Cancer Research Institute, Inc. (CRI), a U.S. nonprofit organization founded in 1953 to advance the science of tumor immunology and foster the discovery and development of new cancer immunotherapies, announced today that its Cancer Vaccine Acceleration Fund (CVAF), a joint initiative with the Ludwig Institute for Cancer Research (LICR), has completed a new investment agreement with Oncovir, Inc., a biotechnology company based in Washington, D.C., to enable the production of the immunological stimulant Hiltonol® (Poly-ICLC).

21 Jan 2011

Additional data from HyperAcute Pancreas cancer immunotherapy Phase 2 trial to be presented at ASCO 2011

NewLink Genetics Corporation today announced that additional data from its Phase 2 clinical trial of the company's investigational HyperAcute® Pancreas cancer immunotherapy will be presented during a poster session at the American Society of Clinical Oncology 2011 Gastrointestinal Cancers Symposium in San Francisco, California.

21 Jan 2011

Clinical Trial News and Research

Northwest Biotherapeutics resumes enrollment in DCVax Phase II brain cancer clinical trial

ASCO urges physicians, medical schools to improve quality of life for people with cancer

Diamyd Medical reports first quarter group total net sales of MSEK 144.5

Glioblastoma's molecular flexibility helps resist nearly all treatment efforts

FDA approves IDE Supplement for third patient allotment in HeartWare Ventricular Assist System ADVANCE trial

St. Georg Hospital performs two live procedures using Endoscopic Ablation System

ArQule's ARQ 197 Phase 1 clinical trial results in colorectal cancer presented at ASCO 2011

Threshold reports positive results from TH-302 Phase 1/2 clinical trial in pancreatic cancer

Alexza's AZ-004 Phase 3 study in agitated patients with schizophrenia published in British Journal of Psychiatry

Boston Scientific completes enrollment in comparison trial of SYNERGY Stent to PROMUS Element Stent

Methodist DeBakey Heart & Vascular Center chosen for critical percutaneous heart valve study

Northwest Biotherapeutics resumes enrollment in DCVax Phase II clinical trial for GBM brain cancer

Raptor completes enrollment in DR Cysteamine Phase 3 clinical trial in cystinosis

Positive interim data from ongoing V5 Phase IIb imm01 trial against tuberculosis

Bayer's gadobutrol injection for CNS imaging receives FDA Advisory Committee approval

SuppreMol completes successful pre-IND meeting with U.S. FDA

Scientists ignore relevant drug clinical trials when conducting new research on same topic

CRI, Oncovir sign new investment agreement to produce immunological stimulant

CVAF completes new investment agreement with Oncovir for production of Hiltonol

Additional data from HyperAcute Pancreas cancer immunotherapy Phase 2 trial to be presented at ASCO 2011

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