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Interim progress from Phase III TeloVac study of GV1001 vaccine announced

KAEL-GemVax, a leading oncology vaccine company, today announced, through its subsidiary GemVax A.S, encouraging interim progress from the UK-based Phase III TeloVac study of its anti-telomerase therapeutic cancer vaccine GV1001 in pancreatic cancer. The company also strongly believes GV1001 has major "blockbuster" potential as a universal therapeutic cancer vaccine and is developing a strong pipeline for other indications, including lung and liver cancer and melanoma.

12 Jul 2010

Report shows experimental trials have higher risk for bias

A Johns Hopkins review of nearly 150 randomized controlled trials on children - all published in well-regarded medical journals - reveals that 40 to 60 percent of the studies either failed to take steps to minimize risk for bias or to at least properly describe those measures.

12 Jul 2010

bitop's Ectoin allergy nasal spray reduces symptoms of acute allergic rhinitis in two-week crossover study

bitop AG, a biotech company specializing in the development of Ectoin®-containing medical devices, reports that Ectoin allergy nasal spray has been shown to significantly reduce symptoms of acute allergic rhinitis in a two-week observational, randomized, comparative crossover study with 50 patients suffering from acute allergic rhinitis. Based on this study, bitop performed a clinical trial on eyes drops and nasal spray in humans using an environmental exposure chamber (EEC) model.

12 Jul 2010

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Biogen Idec and Swedish Orphan Biovitrum today announced that they plan to advance the companies' long-lasting, fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) into a registrational clinical trial in people with hemophilia A. The decision to advance the program is based on promising data from a Phase 1/2a open-label, cross-over, multi-center, dose-escalation study that evaluated the safety and pharmacokinetics of an intravenous injection of rFVIIIFc in 16 previously-treated patients with severe hemophilia A.

12 Jul 2010

Mesoblast schedules formal meeting with FDA to discuss proposed Phase 3 clinical trial program

Australian regenerative medicine company, Mesoblast Limited, today announced that based on positive results from its bone marrow transplant clinical trial conducted at the University of Texas MD Anderson Cancer Center, a formal meeting has been scheduled with the United States Food and Drug Administration to discuss a proposed Phase 3 clinical trial program.

12 Jul 2010

Simple, routine test for detecting subtle onset of diabetes and prediabetes

Having discovered a dramatic increase of an easy-to-detect enzyme in the red blood cells of people with diabetes and prediabetes, Johns Hopkins scientists say the discovery could lead to a simple, routine test for detecting the subtle onset of the disease, before symptoms or complications occur and in time to reverse its course.

9 Jul 2010

Screening for HPV genotypes 16 and 18 helps detect cervical pre-cancer missed by Pap test

Roche today announced that data from the ATHENA (Addressing THE Need for Advanced HPV Diagnostics) U.S. registration trial of over 47,000 women demonstrate that two human papillomavirus genotypes, HPV 16 and HPV 18, can identify those women with cervical pre-cancer missed by cytologic examination with a Papanicolau (Pap) test.

From Roche Sequencing and Life Science 9 Jul 2010

First patient enrolled in Boston Scientific's MultiSENSE clinical trial

Boston Scientific Corporation today announced enrollment of the first patient in its MultiSENSE clinical trial. The trial is designed to evaluate multiple physiologic sensors in the Company's COGNIS cardiac resynchronization therapy defibrillators. Boston Scientific plans to use the trial data to help develop a clinical alert that identifies the early onset of worsening heart failure.

8 Jul 2010

NOSCAR completes first NOTES transoral and transvaginal gallbladder removal in U.S. human trial

The Natural Orifice Surgery Consortium for Assessment and Research- (NOSCAR-), a joint effort of the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), announces the completion of the first transoral and transvaginal cholecystectomies (gallbladder removal) using Natural Orifice Translumenal Endoscopic Surgery- (NOTES-) in a multicenter human trial in the United States.

From Evident Corporation - Life Sciences 8 Jul 2010

Study of latest in clinical data technology applied to Phase II clinical trial in South Africa

Last week, at the fourth annual Clinical Trials in Emerging Economies conference, Margaret Ann Snowden, Director of Biostatistics and Data Management at Aeras Global TB Vaccine Foundation, and Daragh Ryan of Cmed Technology, presented a case study of the application of the latest in clinical data technology to a large Phase II clinical trial in South Africa. The presentation provided an update on how effective technology can be in promoting the development of affordable vaccine regimens for the prevention of tuberculosis (TB) worldwide.

8 Jul 2010

Landmark study compares oral and transvaginal NOTES to traditional laparoscopy

As part of the only U.S. prospective multicenter clinical trial to compare natural orifice translumenal endoscopic surgery to laparoscopy, surgeons at the University of California, San Diego School of Medicine have performed the trial's first oral gallbladder removal. This landmark study will evaluate whether or not NOTES is safe and as effective as traditional laparoscopic surgery.

8 Jul 2010

BioMimetic reports final study results comparing Augment Bone Graft to autograft in foot, ankle fusion surgery

BioMimetic Therapeutics will report today the final, one year results of its North American Pivotal Study comparing Augment Bone Graft to autograft in foot and ankle fusion surgery. The presentation of the data by Dr. Timothy Daniels, associate professor of orthopedic surgery at the University of Toronto and St. Michaels Hospital, will take place at the American Orthopaedic Foot and Ankle Society (AOFAS) summer meeting.

8 Jul 2010

SurModics licenses biodegradable polymer implant technology to Clinuvel

SurModics, Inc., a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced today that it has entered into a license agreement with Clinuvel Pharmaceuticals Limited of Melbourne, Australia. Under the agreement, the Company's SurModics Pharmaceuticals unit has licensed certain of its biodegradable polymer implant technology to Clinuvel for the treatment of sun-induced skin disorders. Terms of the agreement were not disclosed.

8 Jul 2010

Cardiac Concepts initiates enrollment in European trial of RespiCardia System for CSA

Cardiac Concepts, Inc., a developer of medical devices to treat Heart Failure patients who experience breathing disturbances during sleep, announced today enrollment of the first European patients in a Pilot Clinical Trial. The purpose of the Pilot Study is to understand the respiratory and cardiac benefits of the RespiCardia™ System when treating a breathing disorder known as Central Sleep Apnea (CSA) in Heart Failure patients.

8 Jul 2010

NOXXON to commence multiple ascending dose study of MCP-1 targeting anti-inflammatory Spiegelmer NOX-E36

NOXXON Pharma AG announced today that it has permission to commence a multiple ascending dose study of its Monocyte Chemoattractant Protein-1 (MCP-1) targeting anti-inflammatory Spiegelmer®, NOX-E36. NOXXON plans to develop NOX-E36 for the treatment of diabetic nephropathy and other diabetes related complications.

7 Jul 2010

Invision Sally Jobe introduces SBU technology for early detection of breast cancer

Invision Sally Jobe is among the first diagnostic imaging networks in the nation to offer a new breast ultrasound technology for the early detection of cancer. Screening Breast Ultrasound is a highly effective technology developed to complement mammography in women with radiologically dense breasts and other risk factors.

7 Jul 2010

Capstone Therapeutics to continue AZX100 Phase 2a trial in dermal scarring to planned 12-month endpoints

Capstone Therapeutics announced today it has completed a limited analysis of a subset of data from its ongoing AZX100 Phase 2a clinical trial in trocar site scarring following arthroscopic shoulder surgery. Based on this analysis, the clinical trial will continue to its planned 12-month endpoints.

7 Jul 2010

Aastrom to pursue Phase 3 CLI clinical program through FDA SPA process

Aastrom Biosciences, Inc., the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that the company will pursue a Phase 3 clinical program for its autologous cell therapy for the treatment of critical limb ischemia (CLI) through the U.S. Food and Drug Administration's special protocol assessment (SPA) process. Aastrom is currently completing a Phase 2b clinical trial of its cell therapy in patients with CLI and recently met with FDA officials to discuss plans for the Phase 3 program.

7 Jul 2010

Debiopharm's achievement of Phase I milestone in Debio 0932 trial triggers $3M milestone payment to Curis

Curis, Inc. announced today that its licensee Debiopharm S.A. has treated the fifth patient in its ongoing Phase I clinical trial for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305. Under the terms of the August 2009 license agreement between Curis and Debiopharm, Curis will receive a $3 million milestone payment from Debiopharm for the achievement of this development objective.

7 Jul 2010

FDA accepts DBV Technologies' IND for clinical study of VIASKIN for desensitization to peanut allergy

DBV Technologies (DBV), a biotech company specializing in food allergy with innovative products for diagnosis and treatment, announced today the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application. DBV Technologies will begin clinical investigation of its lead food allergy desensitization candidate, VIASKIN® PEANUT, for the desensitization to peanut allergy. The Company expects to commence recruitment of peanut allergy patients at several medical centers in the U.S. this month.

7 Jul 2010

Clinical Trial News and Research

Interim progress from Phase III TeloVac study of GV1001 vaccine announced

Report shows experimental trials have higher risk for bias

bitop's Ectoin allergy nasal spray reduces symptoms of acute allergic rhinitis in two-week crossover study

Biogen Idec, Swedish Orphan Biovitrum announce advancement of rFVIIIFc into registrational study

Mesoblast schedules formal meeting with FDA to discuss proposed Phase 3 clinical trial program

Simple, routine test for detecting subtle onset of diabetes and prediabetes

Screening for HPV genotypes 16 and 18 helps detect cervical pre-cancer missed by Pap test

First patient enrolled in Boston Scientific's MultiSENSE clinical trial

NOSCAR completes first NOTES transoral and transvaginal gallbladder removal in U.S. human trial

Study of latest in clinical data technology applied to Phase II clinical trial in South Africa

Landmark study compares oral and transvaginal NOTES to traditional laparoscopy

BioMimetic reports final study results comparing Augment Bone Graft to autograft in foot, ankle fusion surgery

SurModics licenses biodegradable polymer implant technology to Clinuvel

Cardiac Concepts initiates enrollment in European trial of RespiCardia System for CSA

NOXXON to commence multiple ascending dose study of MCP-1 targeting anti-inflammatory Spiegelmer NOX-E36

Invision Sally Jobe introduces SBU technology for early detection of breast cancer

Capstone Therapeutics to continue AZX100 Phase 2a trial in dermal scarring to planned 12-month endpoints

Aastrom to pursue Phase 3 CLI clinical program through FDA SPA process

Debiopharm's achievement of Phase I milestone in Debio 0932 trial triggers $3M milestone payment to Curis

FDA accepts DBV Technologies' IND for clinical study of VIASKIN for desensitization to peanut allergy

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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