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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

Three-year clinical results of Medtronic's Resolute Zotarolimus-Eluting Coronary Stent released

New clinical data released today at a major meeting of interventional cardiologists show strong and sustained efficacy and safety of the Resolute® Zotarolimus-Eluting Coronary Stent from Medtronic, Inc. (NYSE: MDT) in long-term patient follow-up.

22 Sep 2009

New sirolimus-eluting stent shows greater neointimal suppression than PES

A new type of sirolimus-eluting stent (SES) successfully showed significantly greater neointimal suppression than the paclitaxel-eluting stent (PES) with greater vessel wall integrity surrounding the stent, confirming the finding of superiority of the SES over the PES stent for the trial's primary endpoint of in-stent late loss.

22 Sep 2009

IRSF announces funding of new clinical study with disease-modifying therapy treatment for Rett syndrome

Today, the International Rett Syndrome Foundation announced that it will provide $200,000 in 2009 to support a newly proposed clinical trial with a growth-factor based treatment for Rett Syndrome. The study will be carried out by a team of clinical trials specialists at the Boston Children's Hospital, led by Dr. Omar Khwaja MD, PhD and will be the first potentially disease modifying therapy ever to be tested in Rett syndrome patients.

22 Sep 2009

Edwards Lifesciences updates on its SAPIEN valve clinical programs

Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, today announced new clinical data demonstrating 100 percent freedom from structural deterioration of the Edwards SAPIEN valve at 18 months, as well as positive midterm patient outcomes resulting from the application of learnings from earlier clinical programs.

22 Sep 2009

Clinical Trial News and Research

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

Three-year clinical results of Medtronic's Resolute Zotarolimus-Eluting Coronary Stent released

New sirolimus-eluting stent shows greater neointimal suppression than PES

IRSF announces funding of new clinical study with disease-modifying therapy treatment for Rett syndrome

Edwards Lifesciences updates on its SAPIEN valve clinical programs

Achieving and maintaining ISO 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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