Clinical Trial News and Research

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SIRO Clinpharm announces alliance with DreamCIS CRO

SIRO Clinpharm, a Contract Research Organization (CRO) with a presence in India, Western and Central Eastern Europe, and the United States today announced its alliance with DreamCIS Inc., a leading CRO based in Seoul, South Korea.

9 Feb 2010

U.S. PSA screening efficacy lower than in ERSPC-Rotterdam due to lower testing sensitivity

Fewer prostate cancers were detected by prostate-specific antigen (PSA) screening in the U.S. than in a European randomized trial because of lower screening sensitivity, according to a new brief communication published online February 8 in the Journal of the National Cancer Institute.

9 Feb 2010

Merck's asthma drug formoterol/mometasone to garner global peak year sales of more than $250M

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, following its expected launch this year for the treatment of asthma, Merck's formoterol/mometasone will garner peak year sales of more than $250 million in the United States, France, Germany, Italy, Spain and the United Kingdom.

9 Feb 2010

FDA accepts Psyadon Pharmaceuticals' ecopipam IND for treatment of LND

Psyadon Pharmaceuticals, Inc. today announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to study ecopipam in patients with Lesch-Nyhan Disease (LND). The first center at which the drug will be evaluated is Emory University under the direction of Dr. Hyder A. Jinnah, MD, PhD. The study is designed to evaluate the safety and tolerability of different doses of ecopipam in adults (group 1), adolescents (group 2) and children (group 3) with LND.

9 Feb 2010

Phase 1 trial of Cerus' INTERCEPT red blood system meets primary endpoint

Cerus Corporation announced today that its Phase 1 trial of red blood cells treated with the INTERCEPT Blood System met its primary endpoint, with preliminary analysis demonstrating that greater than 75 percent of treated cells continued to circulate 24 hours following transfusion. The INTERCEPT red blood cell system is a pathogen inactivation treatment the company is developing to protect against transmission of infectious diseases through red blood cell transfusions. An estimated 70 million units of red blood cells are transfused worldwide each year.

9 Feb 2010

GeoVax Labs provides updates on HIV-1 vaccine trials

GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical company developing human vaccines for diseases caused by HIV-1 (Human Immunodeficiency Virus) and other infectious agents, today provided an update on its vaccine trials progress.

9 Feb 2010

Positive data from Cara Therapeutics' peripherally-restricted kappa opioid agonist Phase II trial

Cara Therapeutics, Inc. today announced positive data in a Phase II proof-of-concept clinical trial of its peripherally-restricted kappa opioid agonist, CR845. The 46 patient Phase II, multi-center, double-blind, placebo-controlled study was conducted at eight hospitals in the United States and evaluated the efficacy and safety of CR845 in women following laparoscopic-assisted hysterectomy.

9 Feb 2010

Dimebon drug associated with improved cognitive function in patients with Huntington's disease

An early stage clinical trial of the experimental drug dimebon (latrepirdine) in people with Huntington's disease appears to be safe and may improve cognition. That is the conclusion of a study published today in the Archives of Neurology.

9 Feb 2010

Kamada commences enrollment in European inhaled AAT clinical trial for alpha-1 antitrypsin deficiency

Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it has enrolled the first patient into its pivotal clinical trial with its new breakthrough compound of inhaled alpha-1 antitrypsin (AAT) delivered by an Investigational eFlow Nebulizer System (PARI Pharma GmbH), in patients with alpha-1 antitrypsin deficiency.

9 Feb 2010

AMRI announces fourth-quarter and full-year 2009 results

AMRI today reported financial and operating results for the fourth quarter and full year ending December 31, 2009.

8 Feb 2010

Sorin Group announces first implant of FDA approved Paradym CRT Model 8750 defibrillator

Sorin Group, a global leader in the treatment of cardiovascular disease, announced today U.S. FDA approval and first implant of its next-generation of cardiac resynchronization therapy defibrillator (CRT-D), Paradym™ CRT Model 8750. Featuring a new, state-of-the-art battery technology, Paradym™ CRT delivers 37 Joules, the highest energy of any implantable cardiac defibrillator (ICD) currently available.

6 Feb 2010

Centerphase Solutions and Mayo Clinic collaborate to speed up clinical trials for new medical treatments

Centerphase has entered into a collaboration with Mayo Clinic to speed the introduction of new medical treatments developed by the biopharmaceutical industry. The Company addressed the root causes historically plaguing the clinical trials process: the lack of a systematic, structured approach for evaluating and optimizing protocols and the tremendous burdens associated with trial start-up administration.

5 Feb 2010

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

BioTime, Inc. today reported recently-released results from an independent study evaluating the use of Hextend® in hemodynamically unstable trauma patients. Hextend (6% Hetastarch in Lactated Electrolyte Injection) is BioTime’s commercially-available blood plasma volume expander used to treat hypovolemia (low blood volume). The study, conducted at the University of Miami Ryder Trauma Center, reported that initial resuscitation with Hextend was associated with no obvious coagulopathy and reduced mortality compared to fluid resuscitation without Hextend.

5 Feb 2010

World Heart consortium awarded $5.6M NIH contract for developing PediaFlow VAD

World Heart Corporation ("WorldHeart") announced today that it was part of a consortium awarded a $5.6 million, 4-year contract by the National Institutes of Health (NIH) to further develop the PediaFlow™ VAD to clinical trial readiness.

5 Feb 2010

NHLBI awarded four contracts to test new devices to help children with congenital heart defects

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, has awarded four contracts totaling $23.6 million to begin preclinical testing of devices to help children born with congenital heart defects or those who develop heart failure.

5 Feb 2010

BioClinica signs three-year, multi-million dollar deal with Cephalon

BioClinica, Inc., a leading global provider of clinical trial services, has signed a three-year, multi-million dollar deal with Cephalon, Inc. for clinical trial technology and support services.

From Clario 5 Feb 2010

Bioheart initiates REGEN Phase I Clinical Trial for testing genetically modified MyoCell in CHF patients

Bioheart, Inc., announced today that the company has commenced work on its REGEN trial, a Phase I Clinical Trial to test genetically modified MyoCell® in patients suffering from Congestive Heart Failure (CHF). Bioheart’s MyoCell® is a regenerative cell therapy that uses myoblasts, or muscle stem cells,that are grown from a patient’s own muscle. MyoCell® has been tested successfully on patients in four clinical trials.

5 Feb 2010

WORLD Symposium: Protalix Biotherapeutics to present data on taliglucerase alfa Phase III Gaucher disease trial

Protalix Biotherapeutics, Inc. today announced that data from its pivotal Phase III trial of taliglucerase alfa in patients with Gaucher disease will be presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2010, February 10-12, 2010 in Miami, Florida.

5 Feb 2010

Lux Biosciences seeks US and European marketing approval for LUVENIQ

Lux Biosciences, Inc. today announced its submission of simultaneous regulatory filings to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking marketing approval for its investigational drug LUVENIQ™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

5 Feb 2010

Lux Biosciences files NDA with FDA and MAA with EMA for approval of voclosporin

Isotechnika Pharma Inc. today announced that its partner, Lux Biosciences, Inc., has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Market Authorization Application (MAA) with the European Medicines Agency (EMA) for voclosporin, under the proposed brand name, LUVENIQ(TM).

4 Feb 2010

Clinical Trial News and Research

SIRO Clinpharm announces alliance with DreamCIS CRO

U.S. PSA screening efficacy lower than in ERSPC-Rotterdam due to lower testing sensitivity

Merck's asthma drug formoterol/mometasone to garner global peak year sales of more than $250M

FDA accepts Psyadon Pharmaceuticals' ecopipam IND for treatment of LND

Phase 1 trial of Cerus' INTERCEPT red blood system meets primary endpoint

GeoVax Labs provides updates on HIV-1 vaccine trials

Positive data from Cara Therapeutics' peripherally-restricted kappa opioid agonist Phase II trial

Dimebon drug associated with improved cognitive function in patients with Huntington's disease

Kamada commences enrollment in European inhaled AAT clinical trial for alpha-1 antitrypsin deficiency

AMRI announces fourth-quarter and full-year 2009 results

Sorin Group announces first implant of FDA approved Paradym CRT Model 8750 defibrillator

Centerphase Solutions and Mayo Clinic collaborate to speed up clinical trials for new medical treatments

BioTime announces results of independent Hextend study in hemodynamically unstable trauma patients

World Heart consortium awarded $5.6M NIH contract for developing PediaFlow VAD

NHLBI awarded four contracts to test new devices to help children with congenital heart defects

BioClinica signs three-year, multi-million dollar deal with Cephalon

Bioheart initiates REGEN Phase I Clinical Trial for testing genetically modified MyoCell in CHF patients

WORLD Symposium: Protalix Biotherapeutics to present data on taliglucerase alfa Phase III Gaucher disease trial

Lux Biosciences seeks US and European marketing approval for LUVENIQ

Lux Biosciences files NDA with FDA and MAA with EMA for approval of voclosporin

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