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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

Phase Ia clinical trial of SYL040012 for treating elevated intraocular pressure, glaucoma completed

Sylentis, a biopharmaceutical subsidiary of Grupo Zeltia and a pioneer in the research and development of new drugs based on gene silencing (interference RNA, RNAi), has completed Phase Ia of its first clinical trial with SYL040012 in the form of ophthalmic drops to treat elevated intraocular pressure and glaucoma.

7 Jul 2010

Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

Three Rivers Pharmaceuticals, LLC, today received expanded labeling from the U.S. Food and Drug Administration (FDA) to include daily use of INFERGEN (Consensus Interferon) in combination with ribavirin (RBV) for retreatment of chronic hepatitis C patients. The expanded labeling targets hepatitis C patients who need retreatment.

6 Jul 2010

Adeona completes $1 million equity financing and provides update on Zinthionein ZC clinical study

Adeona Pharmaceuticals, Inc., announced today that on July 6, 2010, it completed an equity financing of $1 million with a single institutional investor, Seaside 88, L.P. The financing involved the sale of 1,212,121 registered shares of common stock and no warrants. Enclave Capital served as placement agent and will receive a 7% cash commission and 5-year warrants to acquire 60,606 shares of Adeona at $1.32 per share. The use of proceeds is intended for general corporate purposes.

6 Jul 2010

Nottingham researchers undertake new clinical trial on hearing loss

Researchers at The University of Nottingham are embarking on a clinical trial that will help them to further understand the debilitating condition of hearing loss.

6 Jul 2010

EC approves change in posology of Circadin from 3 weeks to 3 months of treatment

Neurim Pharmaceuticals confirmed today that the European Commission (EC) has approved a change in treatment duration with Circadin from 3 to 13 weeks (3 months). Circadin is indicated for the treatment of primary insomnia in patients who are aged 55 or over.

6 Jul 2010

Synexus expands clinical trial operations in Gydnia, Poland

Synexus, the world's largest multi-national company dedicated to the recruitment and running of clinical trials is expanding its operations in Gydnia, Poland when it moves to new premises later this year. It has also recently increased the capacity of its original centre in Wroclaw by several hundred square metres.

From AES - Accelerated Enrollment Solutions 5 Jul 2010

Clinical Trial News and Research

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

Phase Ia clinical trial of SYL040012 for treating elevated intraocular pressure, glaucoma completed

Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

Adeona completes $1 million equity financing and provides update on Zinthionein ZC clinical study

Nottingham researchers undertake new clinical trial on hearing loss

EC approves change in posology of Circadin from 3 weeks to 3 months of treatment

Synexus expands clinical trial operations in Gydnia, Poland

Expanding research and clinical options for children with cancer

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

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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