Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX) announced top-line results from its U.S. Phase II clinical trial to treat cocaine addiction. The data from the trial showed that CPP-109 did not demonstrate statistical significance in the primary endpoint — that a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine-free during the last two weeks of the treatment period (Weeks 11 and 12). The clinical trial did not reveal any unexpected “serious” adverse events.
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Catalyst Pharmaceutical Partners Announces Top-Line Results Of CPP-109 Phase II Trial For Cocaine Addiction
June 1, 2009Cytori Completes Enrollment In First Adipose Stem & Regenerative Cell Therapy Trial For Chronic Heart Disease
May 30, 2009Cytori (NASDAQ:CYTX) completed enrollment in the first study to investigate adipose derived stem and regenerative cells in chronic heart disease. The trial, which has been named the PRECISE study, was carried out at leading cardiology centers in Europe. It specifically enrolled patients suffering from an advanced form of chronic heart disease, known as chronic myocardial ischemia, for which there is no generally accepted treatment.
The trial enrolled 27 patients and was designed as a double-blind, randomized, placebo controlled, dose escalation study. It is unique in that the patients’ own cells were extracted from adipose tissue and processed for delivery at the point of care using Cytori’s Celution System. The cells were then injected back into the patients using the NOGA XP System (Biologics Delivery Systems, Cordis Corp., a Johnson and Johnson company), which identifies and guides cells to damaged regions of the heart.
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Zetiq Reports Success In Clinical Trial Aimed For Early Identification Of Cervical Cancer
May 28, 2009Zetiq, a subsidiary of Bio-Light Ltd. (TASE:BOLT), reports the successful completion of a clinical trial to validate feasibility of early identification of cervical cancer.
The trial was conducted on cervical smears collected from 74 subjects at Meir MC and Macabbi health services in Israel. The collected samples were processed with the advanced liquid based cytology method, and examined using 3 methods: staining with the traditional widely used Pap method, testing to identify the presence of the HPV virus that causes the disease, and staining with the Zetiq method. The analysis of the specimens was conducted by the company’s team as well as by an independent professional.
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NEVO Sirolimus-Eluting Coronary Stent Yields Superior Results To Taxus(R) Liberte(R) Stent In Pivotal Clinical Trial
May 23, 2009At six months, the NEVO™ Sirolimus-eluting Coronary Stent, incorporating RES Technology™, was superior to the Taxus Liberte Stent in reducing tissue growth within the stent that can potentially lead to repeat procedures, in new clinical study results released . In addition, no reports of stent thrombosis were reported in patients treated with NEVO™ through six months.
The results of the NEVO RES I study comparing these two drug-eluting stents were presented during Late Breaking Clinical Trials at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.
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Trial Begins In Case Of Kansas Abortion Provider Tiller
March 27, 2009Opening arguments began on Monday in the criminal case of Kansas abortion provider George Tiller, who is charged with 19 misdemeanor counts of failing to follow a Kansas law regarding later abortion, which requires approval of a second, independent doctor who practices in Kansas and has no financial or legal affiliations with the first doctor, according to the Los Angeles Times. “The doctor must certify that the mother will suffer permanent and irreversible harm, which can include psychological harm, if she carries the baby to term,” according to the Times.
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Clinical Trial Exploring Use Of Cardiac Device In New Groups Of Heart Failure Patients Completes Enrollment Phase
March 22, 2009Medtronic, Inc. (NYSE: MDT) announces completion of the enrollment phase of 1,800 patients in the RAFT clinical trial (Resynchronization/Defibrillation for Ambulatory Heart Failure Trial), which is studying the impact of cardiac resynchronization therapy in mildly symptomatic heart failure patients, or those at risk of worsening heart failure, but not currently indicated under medical guidelines to receive treatment with the device.
“This study is important to guide therapy for heart failure patients with milder heart failure symptoms who have a dilated heart and poor heart function. These patients have a tendency to develop worsening symptoms, to require hospitalization, and they may die prematurely. This study will determine if cardiac resynchronization therapy, when used earlier in the disease, can delay or prevent the progression of heart failure,” said Anthony Tang, M.D., RAFT Nominated Principal Investigator and Adjunct Professor of Medicine, University of Ottawa.
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CyDex Pharmaceuticals Announces Successful Completion Of Phase II Clinical Trial For Budesonide/Azelastine Combination Solution Nasal Spray
February 6, 2009CyDex Pharmaceuticals, Inc. announced that it has successfully completed an early proof-of-concept phase II clinical trial of its Captisol-Enabled budesonide/azelastine nasal spray for seasonal allergic rhinitis (SAR). CyDex has an international PCT patent application pending for this combination nasal spray product.
A Randomized, Double-Blind, Placebo-Controlled, Three-Way Cross-Over Study was conducted in 108 SAR patients to Compare the Relative Efficacy of Captisol-Enabled Budesonide + Azelastine Nasal Spray (Single Solution) and Rhinocort Aqua (Suspension) + Astelin Nasal Spray (Solution) against Placebo Nasal Spray Solution in the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber (EEC).
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Clinical Trial Demonstrates Safety Of Pre-Transplant Expansion Of Umbilical Cord Blood Stem Cells
January 14, 2009Taking blood stem cells collected from an umbilical cord into the lab and expanding their number before transplanting them to replace a patient’s blood supply is as safe as a standard cord blood transplant, researchers reported at the 50th Annual Meeting of the American Society of Hematology.
In a first-of-its-kind randomized clinical trial, researchers at The University of Texas M. D. Anderson Cancer Center are addressing the critical challenge to successful “standard” cord blood transplants for adult patients – low doses of stem cells that lead to longer recovery times, leaving patients more vulnerable to bleeding, infection and transplant failure.
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