Clinical Trial News and Research

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MACH II clinical trial results revealed

Abiomed Inc., a leading provider of breakthrough heart support technologies, today announced new clinical data from Academic Medical Center’s (AMC) three-year follow-up results from patients in the Impella 2.5 arm of the MACH II trial, revealing improved left ventricular function, cardiac output and quality of life.

24 Sep 2009

Advanced Biohealing announces growth strategy to expand its product line

Advanced BioHealing, Inc. (ABH), a leader in commercializing the promise of regenerative medicine, announced a strategic growth plan designed to continue the transformation of this former start-up into the leading international regenerative medicine company.

24 Sep 2009

Oxygen Biotherapeutics to commence Phase II-b trial of Oxycyte in treating traumatic brain injury

Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBO) today announced that the company has received approval from Israel's Ministry of Health to begin a Phase II-b, dose escalation, clinical trial in that country for use of Oxycyte(R) in traumatic brain injury (TBI). Oxycyte is the Company's perfluorocarbon (PFC) therapeutic oxygen carrier.

23 Sep 2009

Results of Phase 3 CRYSTAL study of mCRC patients announced

The retrospective CRYSTAL analysis was conducted as a result of an effort to increase the tissue ascertainment rate to determine the K-ras status of patients’ tumors. The analysis included extended patient follow up of nearly 1.5 years and doubled the tissue ascertainment rate from 45% to 89%. These data are an update from the overall survival results from CRYSTAL that were published in the April 2009 issue of the New England Journal of Medicine.

23 Sep 2009

FDA accepts Sangamo's IND for repeat-dosing in Phase 1 clinical trial of SB-728-T ZFN-based therapeutic

Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today that the US Food and Drug Administration (FDA) has reviewed and accepted an Investigational New Drug (IND) application to initiate an open-label, repeat-dosing Phase 1 clinical trial (SB-728-T-902) of the company's ZFN-based therapeutic, SB-728-T. A single dose Phase 1 clinical study of SB-728-T was initiated in February 2009 and is ongoing at the University of Pennsylvania.

23 Sep 2009

Pluristem commences dosing in Phase I clinical trial for the treatment of critical limb ischemia

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; DAX: PJT) today announced the dosing of the first patient in the U.S. with its placenta-derived stem cell product, PLX-PAD, the Company’s leading candidate, in a Phase I clinical trial for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

23 Sep 2009

New drug test promises to yield quick and effective response for cancer therapy

A group of scientists from Hamburg may have taken a big step towards more effective cancer drug development, Europe's largest cancer congress, ECCO 15 - ESMO 34 [1], heard today (Wednesday 23 September). Dr Ilona Schonn, Director of Cell Culture Research at Indivumed GmbH, told the conference that they had developed a preclinical drug test platform that would enable researchers to analyse tumour tissue for individual patient drug responses on the molecular level.

23 Sep 2009

Sorafenib with chemotherapy for breast cancer patients had a 74% percent improvement in the time they lived

One of the first of a series of trials to investigate the use of sorafenib - a targeted anti-cancer drug - for the treatment of advanced breast cancer has found that if it is combined with the chemotherapy drug, capecitabine, it makes a significant difference to the time women live without their disease worsening.

23 Sep 2009

Phase 1b interim clinical trial results of IMO-2055, Tarceva and Avast combination announced

Idera Pharmaceuticals (Nasdaq: IDRA) today presented interim data from a phase 1b, single arm clinical trial evaluating IMO-2055, an agonist of Toll-like Receptor (TLR) 9, in combination with Tarceva® and Avastin® in patients with non-small cell lung cancer (NSCLC).

23 Sep 2009

Bioelectronics files for pre-marketing clearance for its ActiPatch® Therapy products

BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, announced that it filed today with the U.S. Government's Food and Drug Administration for 510(K) pre-marketing clearance for its ActiPatch® Therapy products.

23 Sep 2009

Medifacts awarded a $1.9M contract to provide cardiac safety services

MEDIFACTS INTERNATIONAL, INC., one of the largest global providers of noninvasive cardiac diagnostic services, today announced the award of a $1.9 million contract with a Global pharmaceutical company to provide comprehensive cardiac safety and efficacy services for a large late stage clinical trial.

23 Sep 2009

Drug trial for OSI-906 begins

TGen Clinical Research Services at Scottsdale Healthcare today announced the start of a clinical trial for a drug designed to combat adrenocortical carcinoma (ACC), a rare but deadly cancer that attacks the adrenal glands.

23 Sep 2009

Exercise counseling and fitness center training effective for type 2 diabetic patients

Physical therapist-directed exercise counseling combined with fitness center-based exercise training can improve muscular strength and exercise capacity in people with type 2 diabetes, with outcomes similar to those of supervised exercise, according to a randomized clinical trial published in the September issue of Physical Therapy, the scientific journal of the American Physical Therapy Association (APTA).

23 Sep 2009

Bio-Path Holdings to develop liposome tumor targeting technology

Bio-Path Holdings, Inc. (OTCBB: BPTH), a publicly traded biotechnology company with drug development operations in Houston, Texas, announced today the Company has executed an exclusive license with The University of Texas M. D. Anderson Cancer Center to develop liposome tumor targeting technology. Bio-Path is currently developing a neutral-lipid based liposome delivery technology for nucleic acid cancer drugs (including antisense and siRNA molecules).

23 Sep 2009

Results of OASIS clinical trial reported by Cardiovascular Systems

Two-year follow-up of patients in the first-ever prospective, multi-center clinical trial evaluating a plaque removal product show promising results after treatment with the Diamondback 360® PAD System, a minimally invasive catheter system that removes hardened plaque to restore blood flow in arteries.

23 Sep 2009

Biotime's new subsidiary to focus on clinical development and marketing therapeutic stem cell products in China

BioTime, Inc. (OTCBB:BTIM) announced today that it will organize a new subsidiary, BioTime Asia, Limited, for the purpose of clinically developing and marketing therapeutic stem cell products in the People’s Republic of China, and marketing stem cell research products in China and other countries in Asia.

23 Sep 2009

Transoma Medical commences enrollment in its COMPLIANCE atrial fibrillation clinical trial

Transoma Medical, Inc., manufacturer of Sleuth AT™, the only wireless, automated implantable cardiac monitoring system with programmable and frequent electrocardiogram (ECG) sampling, announced today the first enrollment and implant in the COMPLIANCE trial, a long-term study to compare external event recorders with implantable monitors in patients who have been prescribed catheter ablation therapy for atrial fibrillation (AF) at risk of post-procedure AF recurrence.

23 Sep 2009

Patient recruitment completed for crucial glioblastoma study

MagForce Nanotechnologies AG (FWB:MF6) has successfully completed patient recruitment for its study on recurrent glioblastoma, which is of critical importance for demonstrating the efficacy of its proprietary Nano-Cancer® therapy.

23 Sep 2009

BioMarin commences PEG-PAL Phase 2 clinical trial for phenylketonuria

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the first patient has initiated treatment in the Phase 2 clinical study of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment of phenylketonuria (PKU). Initial top-line results are expected in mid-2010.

23 Sep 2009

StemCells to take part in international networking event

StemCells, Inc. (NASDAQ:STEM) announced today its participation in the 2009 World Stem Cell Summit to be held September 21 – 23 in Baltimore, Maryland.

22 Sep 2009

Clinical Trial News and Research

MACH II clinical trial results revealed

Advanced Biohealing announces growth strategy to expand its product line

Oxygen Biotherapeutics to commence Phase II-b trial of Oxycyte in treating traumatic brain injury

Results of Phase 3 CRYSTAL study of mCRC patients announced

FDA accepts Sangamo's IND for repeat-dosing in Phase 1 clinical trial of SB-728-T ZFN-based therapeutic

Pluristem commences dosing in Phase I clinical trial for the treatment of critical limb ischemia

New drug test promises to yield quick and effective response for cancer therapy

Sorafenib with chemotherapy for breast cancer patients had a 74% percent improvement in the time they lived

Phase 1b interim clinical trial results of IMO-2055, Tarceva and Avast combination announced

Bioelectronics files for pre-marketing clearance for its ActiPatch® Therapy products

Medifacts awarded a $1.9M contract to provide cardiac safety services

Drug trial for OSI-906 begins

Exercise counseling and fitness center training effective for type 2 diabetic patients

Bio-Path Holdings to develop liposome tumor targeting technology

Results of OASIS clinical trial reported by Cardiovascular Systems

Biotime's new subsidiary to focus on clinical development and marketing therapeutic stem cell products in China

Transoma Medical commences enrollment in its COMPLIANCE atrial fibrillation clinical trial

Patient recruitment completed for crucial glioblastoma study

BioMarin commences PEG-PAL Phase 2 clinical trial for phenylketonuria

StemCells to take part in international networking event

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