Efficacy News and Research

RSS

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

Project ideas needed from worldwide Alzheimer Disease research community

On the 9 June 2010, 119 participants from industry, academia, and related stakeholder communities in the U.S. and Europe joined Alzforum for a Webinar, "Treating Before Symptoms—ADCS Invites Ideas for Clinical Trials in Very Early AD," presented by Alzheimer's Disease Cooperative Study (ADCS) director Paul Aisen, MD.

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

Entomologists to develop genetically engineered bacteria for killing mosquito larvae

Roughly half the world's population still lives in areas at risk of malaria transmission. Even in the United States, 1500 cases of malaria are reported annually on average.

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

ConvaTec presents Vitala Continence Control Device Phase 2 data at 2010 WOCN/WCET joint conference

ConvaTec, a world-leading developer of innovative medical technologies for community and hospital care, today presented data supporting the safety and efficacy of Vitala™, a novel, non-intrusive pouchless ostomy device that provides temporary continence to people with a colostomy. The clinical trial data were presented at the 2010 Joint Conference of the Wound, Ostomy and Continence Nurses Society (WOCN) and World Council of Enterostomal Therapists (WCET), where the new device is being previewed to U.S. and global healthcare professionals.

15 Jun 2010

UCB announces availability of Vimpat oral solution formulation

UCB today announced the availability of an oral solution formulation of Vimpat- (lacosamide) C-V, an antiepileptic drug (AED) for add-on treatment of partial-onset seizures in people with epilepsy age 17 years and older. Vimpat 10 mg/mL solution is now available in U.S. pharmacies.

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

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

Biodel announces schedule for presentations at 70th Scientific Sessions of American Diabetes Association

Biodel Inc. announced today that the following oral and poster presentations describing results from studies of the company's product candidates will be presented during the 70th Scientific Sessions of the American Diabetes Association this month in Orlando, Florida:

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

USPTO issues patent covering methods for enhancing RNA silencing activity of RNAi agents

Silence Therapeutics plc announces the issuance of United States patent 7,732,593, titled Methods and Compositions For Controlling Efficacy of RNA Silencing, by the United States Patent and Trademark Office. The issued patent, which is based on the seminal research of Phillip D. Zamore, Ph.D., Howard Hughes Medical Institute Investigator, the Gretchen Stone Cook Chair of Biomedical Sciences, and Professor of Biochemistry & Molecular Pharmacology at University of Massachusetts Medical School, generally claims methods of enhancing the RNA silencing activity of RNA interference (RNAi) agents through certain structural modifications.

14 Jun 2010

Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that the final analysis of the Phase 3 NExUS (NSCLC research Experience Utilizing Sorafenib) trial evaluating Nexavar® (sorafenib) tablets in patients with advanced non-squamous non-small cell lung cancer (NSCLC) showed that the study did not meet its primary endpoint of improving overall survival in the first-line setting.

14 Jun 2010

Chiasma successfully completes Phase I clinical study of Octreolin

Chiasma, Inc., a privately held biopharma company, announced that it has successfully completed a Phase I clinical study evaluating the safety and pharmacokinetics (PK) of its proprietary product Octreolin, which contains the active ingredient octreotide actetate and is administered orally

14 Jun 2010

$Data from Phase 1 study of FOLOTYN in patients with relapsed or refractory CTCL presented at EHA 2010$

Data from Phase 1 study of FOLOTYN in patients with relapsed or refractory CTCL presented at EHA 2010

Allos Therapeutics, Inc. today announced updated data from its ongoing dose finding Phase 1 study of FOLOTYN (pralatrexate injection) in patients with relapsed or refractory cutaneous T-cell lymphoma, a group of often slow-growing non-Hodgkins lymphomas that primarily manifest in the skin. These data were presented during a poster presentation at the European Hematology Association meeting being held June 10-13, 2010 in Barcelona, Spain.

11 Jun 2010

Phase II study results of riociguat for CTEPH and PAH published online

Bayer HealthCare Pharmaceuticals, Inc. today announced that the study "Riociguat for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension: a phase II study" was published online this week by the European Respiratory Journal. Results of this study to assess the safety, tolerability and the feasibility of individual dose titration of riociguat were previously presented at the 2009 International Conference of the American Thoracic Society.

11 Jun 2010

Phase 2b RESTORE-CLI clinical trial in patients with CLI reaches statistical significance

Richard J. Powell, M.D., section chief of vascular surgery at the Dartmouth-Hitchcock Medical Center in Lebanon, NH and a principal investigator of the U.S. Phase 2b RESTORE-CLI clinical trial sponsored by Aastrom Biosciences, will present the full results from the interim analysis at today's session of the annual meeting of the Society for Vascular Surgery.

11 Jun 2010

Efficacy News and Research

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

Project ideas needed from worldwide Alzheimer Disease research community

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

Entomologists to develop genetically engineered bacteria for killing mosquito larvae

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

ConvaTec presents Vitala Continence Control Device Phase 2 data at 2010 WOCN/WCET joint conference

UCB announces availability of Vimpat oral solution formulation

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

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

Biodel announces schedule for presentations at 70th Scientific Sessions of American Diabetes Association

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

USPTO issues patent covering methods for enhancing RNA silencing activity of RNAi agents

Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

Chiasma successfully completes Phase I clinical study of Octreolin

Data from Phase 1 study of FOLOTYN in patients with relapsed or refractory CTCL presented at EHA 2010

Phase II study results of riociguat for CTEPH and PAH published online

Phase 2b RESTORE-CLI clinical trial in patients with CLI reaches statistical significance

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

Latest News