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Biotie Therapies commences clinical trial with its phosphodiesterase 4 inhibitor ELB353

Biotie has started a clinical trial with its phosphodiesterase 4 (PDE4) inhibitor ELB353, having received the prerequisite regulatory and ethical clearances for the clinical trial application.

14 Sep 2009

Phase 1 trial results of Achaogen's ACHN-490 announced at ICAAC meeting

Achaogen, a clinical stage biopharmaceutical company addressing the issue of multi-drug resistant bacterial infections through the discovery and development of innovative, broad-spectrum antibiotics, today announced the results of a Phase 1 trial and preclinical data on its lead drug candidate ACHN-490 at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Annual Meeting in San Francisco, CA.

14 Sep 2009

Phase 2b clinical trial results of Dextofisopam to treat irritable bowel syndrome announced

Pharmos Corporation (Pink Sheets: PARS) announced today the results of its Phase 2b Dextofisopam clinical trial to evaluate safety and efficacy of the compound in irritable bowel syndrome.

14 Sep 2009

Clinical studies reveal treatment with pirfenidone is safe and well-tolerated

InterMune, Inc. (Nasdaq: ITMN) today announced that the results of a comprehensive review of safety data from four clinical studies were presented at the 2009 European Respiratory Society Annual Congress in Vienna, Austria by Dr. Ulrich Costabel of the Ruhrlandklinik, Essen, Germany.

14 Sep 2009

Results from Keryx' KRX-0401 Phase 2 study to be presented at the International Kidney Cancer Symposium

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that Phase 2 data of KRX-0401 (perifosine), the Company's PI3K/Akt pathway inhibitor for cancer, as a single agent in the treatment of advanced metastatic renal cell cancer, has been selected for oral presentation at the Eighth International Kidney Cancer Symposium, to be held in Chicago from September 25-26, 2009.

14 Sep 2009

Cytrx initiates tamibarotene and TRISENOX combination dose escalation study

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics, today announced the initiation of a dose escalation study with its oncology drug candidate tamibarotene combined with TRISENOX® (arsenic trioxide) injection (marketed by Cephalon, Inc.) in patients with relapsed acute promyelocytic leukemia (APL).

14 Sep 2009

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

Altair announces positive Phase I results for AIR645 in treating asthma

Altair Therapeutics, Inc., a privately-held, biopharmaceutical company developing novel therapeutics for respiratory diseases, today announced positive results from a phase I multiple dose safety and pharmacokinetic study of its lead product, once-weekly inhaled AIR645 in healthy adults and mild asthmatics.

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

Enobia Pharma's clinical study of ENB-0040 for treating hypophosphatasia provides positive results

Enobia Pharma today announced positive data from a clinical study of ENB-0040, a bone targeted enzyme replacement therapy, under investigation for the treatment of hypophosphatasia (HPP). After six months of treatment with ENB-0040, four of five severely affected patients showed marked improvements in bone mineralization, correction of skeletal defects, better respiratory function, including weaning from assisted ventilation, and cognitive and motor development.

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

ARIAD to complete its Phase 3 SUCCEED trial following DMS recommendation

ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced that the independent Data Monitoring Committee (DMC) of the Phase 3 SUCCEED trial has completed the first interim efficacy analysis as specified by the study protocol and has recommended that the randomized, placebo-controlled trial of oral ridaforolimus in patients with metastatic sarcomas continue to full patient enrollment and completion.

14 Sep 2009

Data from Phase 1 and Phase 2a studies of inhaled liposomal ciprofloxacin to be presented at ERS Congress

Aradigm Corporation (OTCBB: ARDM) ("Aradigm") today announced it is presenting data from its Phase 1 and Phase 2a studies at the ERS Annual Congress in Vienna, Austria, September 12-16, 2009.

14 Sep 2009

Final results of SAPHRIS clinical study released

Schering-Plough Corporation today reported final results of a SAPHRIS(R) (asenapine) long-term schizophrenia relapse prevention clinical study.

14 Sep 2009

Patient enrollment for Phase 3 clinical trials of VEGF Trap-Eye completed

Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced the completion of patient enrollment in two randomized, double-masked, Phase 3 clinical trials evaluating VEGF Trap-Eye in the treatment of the neovascular form of age-related macular degeneration (wet AMD).

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

Phase 3 results of TARGET 1 and TARGET 2 clinical trials released

Salix Pharmaceuticals, Ltd. today announced the successful outcome of two Phase 3, randomized, double-blind, placebo-controlled, multicenter trials, TARGET 1 and TARGET 2, designed to evaluate the efficacy and safety of rifaximin 550 mg TID in the treatment of patients with non-constipation irritable bowel syndrome (non-C IBS).

14 Sep 2009

Drug Trial News

Biotie Therapies commences clinical trial with its phosphodiesterase 4 inhibitor ELB353

Phase 1 trial results of Achaogen's ACHN-490 announced at ICAAC meeting

Phase 2b clinical trial results of Dextofisopam to treat irritable bowel syndrome announced

Clinical studies reveal treatment with pirfenidone is safe and well-tolerated

Results from Keryx' KRX-0401 Phase 2 study to be presented at the International Kidney Cancer Symposium

Cytrx initiates tamibarotene and TRISENOX combination dose escalation study

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

Altair announces positive Phase I results for AIR645 in treating asthma

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

Enobia Pharma's clinical study of ENB-0040 for treating hypophosphatasia provides positive results

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

ARIAD to complete its Phase 3 SUCCEED trial following DMS recommendation

Data from Phase 1 and Phase 2a studies of inhaled liposomal ciprofloxacin to be presented at ERS Congress

Final results of SAPHRIS clinical study released

Patient enrollment for Phase 3 clinical trials of VEGF Trap-Eye completed

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

Phase 3 results of TARGET 1 and TARGET 2 clinical trials released

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