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Biogen Idec initiates enrollment in Phase II BG-12 combination trial for relapsing-remitting multiple sclerosis

Biogen Idec today announced enrollment of the first patient in a multicenter Phase II clinical trial designed to evaluate its investigational oral therapy BG-12 (dimethyl fumarate) in combination with commonly used first-line treatments in patients with relapsing-remitting multiple sclerosis (RRMS).

15 Jun 2010

Anacor's AN3365 novel systemic antibiotic achieves proof of concept

Anacor Pharmaceuticals today announced that a Joint Research Committee, composed of both GlaxoSmithKline (GSK) and Anacor employees, has determined that AN3365, a novel systemic antibiotic derived from Anacor's boron chemistry platform, has achieved proof of concept as defined under the collaboration agreement between GSK and Anacor.

15 Jun 2010

Positive clinical trial results for Anacor Pharmaceuticals' AN2728 announced

Anacor Pharmaceuticals today announced positive clinical trial results for its lead phosphodiesterase-4 inhibitor, AN2728, a novel topical anti-inflammatory compound derived from Anacor's boron chemistry platform. These results were obtained from a multi-center, Phase 2b, randomized, double-blind, dose-ranging, bilateral trial comparing AN2728 ointment, 0.5% and 2.0%, applied once or twice daily, to vehicle in 145 patients with mild-to-moderate plaque-type psoriasis.

15 Jun 2010

Alexion's Soliris may benefit patients with thrombotic microangiopathy from uncontrolled complement activation

Researchers reported today that Soliris® (eculizumab), a first-in-class terminal complement inhibitor developed by Alexion Pharmaceuticals, Inc., may provide clinical benefits to patients with thrombotic microangiopathy (TMA) resulting from uncontrolled complement activation. TMA, the formation of blood clots in capillaries and small arteries, can lead to life-threatening damage in multiple organs including kidney failure, thrombocytopenia (abnormally low platelet count) and anemia.

15 Jun 2010

Inovio commences immunization in U.S. Phase I clinical trial of SynCon H5N1 influenza DNA vaccine

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has immunized its first subject in a U.S. Phase I clinical trial to evaluate its SynCon™ H5N1 (avian) influenza DNA vaccine, VGX-3400X.

15 Jun 2010

Pieris commences PRS-050 anti-VEGF Anticalin Phase I clinical trial for cancer

Pieris AG announced today the initiation of a Phase I clinical trial in cancer patients for its lead program, PRS-050, an anti-VEGF Anticalin. The trial is an open-label, dose-escalating evaluation of the compound's safety and tolerability in patients with solid tumors. Conducted at three sites in Germany, the trial is underway and patients from the first cohort have been dosed.

15 Jun 2010

First patient treated in multicentre Phase I clinical trial of SCIB1 DNA ImmunoBody vaccine for melanoma

Scancell Holdings Plc,, the developer of therapeutic cancer vaccines, today announces the enrolment and treatment of the first patient in its multicentre Phase I clinical trial of SCIB1, its DNA ImmunoBody® vaccine being developed for the treatment of melanoma. The trial will evaluate the safety and tolerability of SCIB1 in patients with late stage melanoma.

15 Jun 2010

Early administration of tranexamic acid to patients with severe bleeding injuries saves lives

If recently injured patients with serious bleeding were to receive a cheap, widely available and easily administered drug to help their blood to clot, tens of thousands of lives could be saved every year, according to a paper published on-line today by The Lancet.

15 Jun 2010

Aeterna Zentaris to present poster on AEZS-130 growth hormone secretagogue/ghrelin receptor agonist at 92nd ENDO

Aeterna Zentaris Inc. a late-stage drug development company specialized in oncology and endocrine therapy, today announced that a poster on its oral synthetic growth hormone secretagogue/ghrelin receptor agonist, AEZS-130, will be presented at the upcoming 92nd Annual Endocrine Society (ENDO) Meeting and Expo, which will be held June 19 through 22, 2010 at the San Diego Convention Center in San Diego, California.

15 Jun 2010

Micromet's blinatumomab demonstrates potential to change outcome for patients with ALL

Micromet, Inc. today announced the presentation of updated results from a Phase 2 trial of the Company's lead product candidate blinatumomab (MT103) in adult patients with minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL). Results of the analysis demonstrate that a prolonged hematologic relapse free survival was observed in patients treated with blinatumomab.

15 Jun 2010

Trubion announces Pfizer's decision to discontinue development of TRU-015 for RA

Trubion Pharmaceuticals, Inc. today announced Pfizer's decision to discontinue development of TRU-015 (PF-05212374), an investigational drug in Phase 2 evaluation for the treatment of rheumatoid arthritis (RA) developed under the companies' CD20 collaboration. However, Pfizer has confirmed that it will continue to develop SBI-087 (PF-05230895), Trubion's next-generation, humanized, subcutaneous CD20 RA product candidate also in Phase 2 clinical evaluation.

15 Jun 2010

Celator presents new data on CPX-351 liposome injection at European Hematology Association congress

Celator Pharmaceuticals today announced that new data from a preclinical leukemia study in mice demonstrate that its lead product, CPX-351 (Cytarabine:Daunorubicin) Liposome Injection, alone or in combination with clofarabine or azacytidine can improve treatment outcomes compared to the combination of either agent with the conventional (unencapsulated) cytarabine:daunorubicin regimen.

15 Jun 2010

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Genzyme Corporation announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease.

15 Jun 2010

MultiCell retains CDSS to manage MCT-125 Phase IIb clinical trial for PMSF in UK

MultiCell Technologies, Inc. has retained Clinical Development & Support Services, Ltd. (CDSS) of Cheshire, England to manage its planned Phase IIb clinical trial in the United Kingdom for MCT-125, the Company's lead drug candidate for treatment of primary multiple sclerosis-related fatigue (PMSF).

14 Jun 2010

Upsher-Smith commences global USL255 Phase III clinical trial for management of epilepsy

Upsher-Smith Laboratories, Inc. today announced the initiation of a global Phase III clinical trial for USL255 (extended-release topiramate), an internally developed program for the management of epilepsy in adults, using the company's proprietary formulation technology. USL255 is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.

14 Jun 2010

Calistoga Pharmaceuticals presents CAL-101 PI3K inhibitor data at European Hematology Association Congress

Calistoga Pharmaceuticals, Inc., the leader in the development of isoform-selective phosphatidylinositol 3 kinase (PI3K) inhibitors for the treatment of cancer and inflammatory diseases, today presented preclinical and clinical data on CAL-101, the Company's oral, delta selective PI3K inhibitor at the 15th Congress of the European Hematology Association in Barcelona, Spain.

14 Jun 2010

Lantheus Medical Imaging reports new Phase 4 data from DEFINITY study

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced new data from a Phase 4, open-label safety study evaluating the effect of DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension, an echocardiography contrast agent, on pulmonary and systemic artery hemodynamics in patients with either normal or increased baseline pulmonary artery pressure.

14 Jun 2010

Updated Phase 1 trial results of blinatumomab in patients with relapsed NHL presented at EHA 2010

Micromet, Inc. today announced the presentation of updated results from a Phase 1 trial of the Company's lead product candidate blinatumomab (MT103) in patients with relapsed non-Hodgkin's lymphoma. A high objective response rate was maintained among patients treated with blinatumomab using an adapted schedule, comparable to that previously reported in patients receiving constant dosing.

14 Jun 2010

Telormedix initiates Phase I/II clinical study of TMX-101 for treating NMIBC

Telormedix, a clinical stage biopharmaceutical company focused on targeted immunity in the treatment of cancer and other diseases, today announced the start of a Phase I/II clinical study of TMX-101 for the treatment of Non-Muscle Invasive Bladder Cancer. TMX-101 is an immunotherapeutic compound and Telormedix has already recruited the first patients for this clinical study.

14 Jun 2010

Abstract on Phase I/II DIGNITY trial of ThermoDox in RCW Breast Cancer accepted at ASTRO 2010

Celsion Corporation announced today that an abstract on the Phase I/II DIGNITY trial of ThermoDox in Recurrent Chest Wall Breast Cancer has been accepted for a poster session at the 52nd American Society for Radiation Oncology Annual Meeting. The abstract will provide updated clinical results, as well as the rationale and design of the DIGNITY study, which is evaluating ThermoDox in combination with microwave hyperthermia in women with RCW Breast Cancer.

14 Jun 2010

Drug Trial News

Biogen Idec initiates enrollment in Phase II BG-12 combination trial for relapsing-remitting multiple sclerosis

Anacor's AN3365 novel systemic antibiotic achieves proof of concept

Positive clinical trial results for Anacor Pharmaceuticals' AN2728 announced

Alexion's Soliris may benefit patients with thrombotic microangiopathy from uncontrolled complement activation

Inovio commences immunization in U.S. Phase I clinical trial of SynCon H5N1 influenza DNA vaccine

Pieris commences PRS-050 anti-VEGF Anticalin Phase I clinical trial for cancer

First patient treated in multicentre Phase I clinical trial of SCIB1 DNA ImmunoBody vaccine for melanoma

Early administration of tranexamic acid to patients with severe bleeding injuries saves lives

Aeterna Zentaris to present poster on AEZS-130 growth hormone secretagogue/ghrelin receptor agonist at 92nd ENDO

Micromet's blinatumomab demonstrates potential to change outcome for patients with ALL

Trubion announces Pfizer's decision to discontinue development of TRU-015 for RA

Celator presents new data on CPX-351 liposome injection at European Hematology Association congress

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

MultiCell retains CDSS to manage MCT-125 Phase IIb clinical trial for PMSF in UK

Upsher-Smith commences global USL255 Phase III clinical trial for management of epilepsy

Calistoga Pharmaceuticals presents CAL-101 PI3K inhibitor data at European Hematology Association Congress

Lantheus Medical Imaging reports new Phase 4 data from DEFINITY study

Updated Phase 1 trial results of blinatumomab in patients with relapsed NHL presented at EHA 2010

Telormedix initiates Phase I/II clinical study of TMX-101 for treating NMIBC

Abstract on Phase I/II DIGNITY trial of ThermoDox in RCW Breast Cancer accepted at ASTRO 2010

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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