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Celldex commences dosing patients in Phase 1/2 study of its CDX-1401 vaccine candidate

Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the first patient has been dosed in a Phase 1/2 study of its vaccine candidate, CDX-1401, in patients with malignant solid tumors that express NY-ESO-1. CDX-1401 is a fully human monoclonal antibody designed to selectively deliver the NY-ESO-1 antigen to dendritic cells to generate a robust immune response against cancer cells expressing NY-ESO-1.

14 Sep 2009

Zabecor Pharmaceuticals initiates Phase II clinical trial of its Excellair asthma drug

ZaBeCor Pharmaceuticals ("ZaBeCor" or the "Company") announced today the initiation of a Phase II clinical trial for its asthma drug candidate Excellair™, following the successful results of the Company's Phase I clinical trials. ZaBeCor is one of the first companies to deliver siRNA to the lung and one of the first to target asthma with siRNA.

14 Sep 2009

Positive results from Transave's Phase II clinical trial of ARIKACE in non-CF bronchiectasis patients

Transave, Inc., today reported positive results from a Phase II clinical trial in non-cystic fibrosis (CF) bronchiectasis patients for its lead investigational drug, ARIKACE(TM) (liposomal amikacin for inhalation). The Phase II data indicated that ARIKACE, delivered once daily for 28 consecutive days, demonstrated superior clinical benefit compared to placebo as measured by patient and physician reported outcomes and reduction in Pseudomonas aeruginosa density.

14 Sep 2009

Protalix Biotherapeutics reports completion of its Phase III trial of prGCD

Protalix Biotherapeutics, Inc. (NYSE-Amex: PLX), announced the completion of its pivotal Phase III trial for prGCD, the Company’s proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. The trial enrolled a total of 31 patients across Europe, North America, South America, Israel and South Africa. No serious adverse events were reported in this trial.

14 Sep 2009

Phase 1 results of CTP-347 presented

Concert Pharmaceuticals, Inc. announced today the presentation of Phase 1 data on CTP-347, a deuterium-modified analog of paroxetine for the treatment of hot flashes. Concert presented the results during a poster session at the American College of Clinical Pharmacology’s 38th Annual Meeting.

14 Sep 2009

Preliminary results of Phase 2b clinical trial of AZ-104 announced by Alexza Pharmaceuticals

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced preliminary results from its 366 patient Phase 2b clinical trial of AZ-104 (Staccato(R) loxapine) in patients with migraine headache.

14 Sep 2009

ALF, Celsion partner to educate physicians about primary liver cancer treatments

Celsion Corporation (NASDAQ:CLSN) and the American Liver Foundation (ALF) announced today that they have formed a partnership to provide education to physicians and liver patients about the treatment options for hepatocellular carcinoma (commonly referred to as primary liver cancer) and Celsion’s on-going ThermoDox Phase III global HEAT clinical study.

14 Sep 2009

DSG’s eCaseLink EDC software used in Cipher's Phase 3 dermatology study

DSG Inc., an industry leader in clinical trial data collection and management, today announced that Cipher Pharmaceuticals (TSX:DND) is using electronic data capture (EDC) software and data management services from DSG. Cipher is using DSG’s eCaseLink™ for its Phase 3 dermatology study on its new compound for the treatment of severe acne.

14 Sep 2009

Chinese SFDA approves Abbott's XIENCE V drug eluting stent for treating coronary artery disease

Abbott (NYSE: ABT) announced today that the Chinese State Food and Drug Administration (SFDA) has approved its XIENCE V(R) Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease (CAD) - the leading cause of death in China. XIENCE V is the only drug eluting stent to have demonstrated superiority over the TAXUS(R) Paclitaxel-Eluting Coronary Stent System (TAXUS) in the primary endpoints of two randomized, pivotal (phase III) clinical trials.

14 Sep 2009

GTx to continue its toremifene Phase III high grade PIN clinical trial for prevention of prostate cancer

GTx, Inc. (Nasdaq: GTXI), today announced that following a planned safety review, an independent Data Safety Monitoring Board (DSMB) has recommended that the company continue as planned the pivotal Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN), a precancerous lesion of the prostate.

14 Sep 2009

Schizophrenia: A major public health problem

Schizophrenia is a major public health problem. Affecting almost 1% of the world's population, it takes an enormous economic and social toll in addition to the distress, dysfunction, disability and mortality for those afflicted with this disease. Elements of the disease are present from birth, other aspects emerge during developmental years, and the illness becomes fully expressed in early adulthood with long-lasting implications for most patients.

14 Sep 2009

Phase IIa clinical data of EHT 0202 released

Top-line Phase IIa clinical data released today demonstrate that EHT 0202, ExonHit’s lead candidate for the treatment of Alzheimer’s disease, is safe and generally well tolerated in patients and that it could potentially enhance cognition in Alzheimer’s disease patients.

14 Sep 2009

Clinical data emphasizing on efficacy and potency of torezolid to be presented

Trius Therapeutics, Inc. announced today that 13 posters will be presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) supporting the potency, efficacy and safety of torezolid as a potential new antibiotic for the treatment of severe skin infections caused by gram positive bacteria including MRSA.

14 Sep 2009

Phase III clinical trial results of DAR-31 published

Gilead Sciences, Inc. today announced the publication of data from DAR-311 (DORADO), a Phase III clinical trial evaluating the company’s once-daily oral endothelin receptor antagonist (ERA) darusentan as an add-on treatment for resistant hypertension, defined as the failure to achieve blood pressure goal while adhering to full doses of an appropriate three (or more) drug antihypertensive regimen that includes a diuretic.

14 Sep 2009

Data from Phase III clinical trial of TYSABRI presented at ECTRIMS

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced data presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) showing the potential of TYSABRI® (natalizumab) to redefine successful multiple sclerosis (MS) therapy.

14 Sep 2009

Quest Diagnostics' OVA1 ovarian cancer test cleared by the FDA

The U.S. Food and Drug Administration (FDA) today cleared the OVA1(TM) Test, the first blood test that, prior to surgery, can help physicians determine if a woman is at risk for a malignant pelvic mass. OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy.

From Quest Diagnostics 14 Sep 2009

FOCUS 1 and FOCUS 2 clinical trial results released

Forest Laboratories, Inc today presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco new data from a complete analysis of FOCUS 1 and FOCUS 2, two global multicenter Phase III studies of ceftaroline for the treatment of community-acquired pneumonia (CAP) in hospitalized patients.

14 Sep 2009

NIAID conducts human clinical trials of 2009 H1N1 influenza vaccines

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, also is conducting clinical trials of 2009 H1N1 influenza vaccines, produced by Sanofi Pasteur and CSL Limited. The NIAID trials are testing two different dosages (15 micrograms versus 30 micrograms) and evaluating the immune response to one and two doses of these vaccines.

14 Sep 2009

Oral NKTR-118 has low risk for mediating significant drug-drug interactions

Nektar Therapeutics presented clinical study data today demonstrating that the oral tablet formulation of NKTR-118 has favorable systemic bioavailability and a low risk for mediating significant drug-drug interactions.

14 Sep 2009

Phase 2 MS clinical trial data continues to show durable reductions in relapse rate

Genzyme Corporation reported today that four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial continued to show durable reductions in relapse rate and sustained accumulation of disability three years after the majority of patients received their last course of the investigational compound alemtuzumab.

14 Sep 2009

Clinical Trial News and Research

Celldex commences dosing patients in Phase 1/2 study of its CDX-1401 vaccine candidate

Zabecor Pharmaceuticals initiates Phase II clinical trial of its Excellair asthma drug

Positive results from Transave's Phase II clinical trial of ARIKACE in non-CF bronchiectasis patients

Protalix Biotherapeutics reports completion of its Phase III trial of prGCD

Phase 1 results of CTP-347 presented

Preliminary results of Phase 2b clinical trial of AZ-104 announced by Alexza Pharmaceuticals

ALF, Celsion partner to educate physicians about primary liver cancer treatments

DSG’s eCaseLink EDC software used in Cipher's Phase 3 dermatology study

Chinese SFDA approves Abbott's XIENCE V drug eluting stent for treating coronary artery disease

GTx to continue its toremifene Phase III high grade PIN clinical trial for prevention of prostate cancer

Schizophrenia: A major public health problem

Phase IIa clinical data of EHT 0202 released

Clinical data emphasizing on efficacy and potency of torezolid to be presented

Phase III clinical trial results of DAR-31 published

Data from Phase III clinical trial of TYSABRI presented at ECTRIMS

Quest Diagnostics' OVA1 ovarian cancer test cleared by the FDA

FOCUS 1 and FOCUS 2 clinical trial results released

NIAID conducts human clinical trials of 2009 H1N1 influenza vaccines

Oral NKTR-118 has low risk for mediating significant drug-drug interactions

Phase 2 MS clinical trial data continues to show durable reductions in relapse rate

Achieving and maintaining ISO/IEC 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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