Clinical Trial News and Research

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Access provides update on new formulation of anti-inflammatory drug amlexanox

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided an update on a new formulation of the anti-inflammatory drug amlexanox, called LexaGard™, for the treatment of inflammatory and ulcerative conditions of the esophagus.

8 Apr 2014

PDS launches new data sharing platform to improve lives of cancer patients

Project Data Sphere, LLC (PDS), an independent not-for-profit initiative of the CEO Roundtable on Cancer's Life Sciences Consortium (LSC), announced today the launch of a new data sharing platform (www.ProjectDataSphere.org), with the goal of advancing research to improve the lives of cancer patients and their families around the world.

8 Apr 2014

MicroBiome Therapeutics to present clinical trial data of NM504 in type 2 diabetes, prediabetes at ICE/ENDO 2014

MicroBiome Therapeutics LLC, today announced that data from the company's clinical trial of microbiome modulator NM504 in development for type 2 diabetes and prediabetes has been accepted for a Poster Preview Presentation at ICE/ENDO 2014, the joint meeting of the International Society of Endocrinology and The Endocrine Society.

8 Apr 2014

Alkermes announces results from phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia

Alkermes plc today announced positive topline results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. Patients treated once monthly with either 441 mg or 882 mg of aripiprazole lauroxil demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12, compared to placebo (p<0.001 aripiprazole lauroxil 441 mg, p<0.001 aripiprazole lauroxil 882 mg), which was the prespecified primary endpoint in the study. Based on the positive results from this phase 3 study, Alkermes plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2014.

8 Apr 2014

Ambit initiates QUANTUM-R Phase 3 clinical trial of quizartinib in FLT3-ITD positive AML patients

Ambit Biosciences, a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced the initiation of the QUANTUM-R Phase 3 clinical trial comparing quizartinib as monotherapy to chemotherapy regimens in relapsed/refractory acute myeloid leukemia (AML) patients with the FMS-like tyrosine kinase-3 (FLT3)-ITD mutation.

8 Apr 2014

DelMar presents pre-clinical study data that evaluates activity of VAL-083 in drug-resistant NSCLC

DelMar Pharmaceuticals, Inc. (OTCQB: DMPI) ("DelMar") today announced the presentation of new data in a poster entitled, "In vivo efficacy of VAL-083 in the treatment of non-small cell lung cancer." DelMar's data was presented on Sunday, April 6, 2014 during the Novel Cytotoxic Strategies Session at the 105th Annual Meeting of the American Association for Cancer Research (AACR) in San Diego.

8 Apr 2014

SU2C and Farrah Fawcett announce formation of research team dedicated to HPV-related cancers

Stand Up To Cancer (SU2C) and the Farrah Fawcett Foundation, along with the American Association for Cancer Research (AACR), SU2C's Scientific Partner, announced the formation of a research team dedicated to HPV-related cancers during a press event today at the AACR Annual Meeting 2014, held here April 5-9.

8 Apr 2014

PatientsLikeMe collaborates with Genentech to develop innovative ways of researching patients' real-world experience with disease, treatment

PatientsLikeMe announced today a five-year agreement with Genentech, a member of the Roche Group, to explore use of PatientsLikeMe's global online patient network to develop innovative ways of researching patients' real-world experience with disease and treatment.

8 Apr 2014

Combination therapy with MEK and BRAF inhibitors for anaplastic thyroid cancer proves effective

Researchers from the Jacks Laboratory at MIT's Koch Institute for Integrative Cancer Research (KI) have developed and characterized a genetically engineered mouse that successfully models progression from papillary thyroid cancer, which has an excellent prognosis, to anaplastic thyroid cancer (ATC), a highly lethal disease.

8 Apr 2014

I-SPY 2 trial qualifies neratinib for HER2-positive breast cancer

In an innovative clinical trial led by UC San Francisco, the experimental drug neratinib along with standard chemotherapy was found to be a beneficial treatment for some women with newly diagnosed, high-risk breast cancer.

8 Apr 2014

6 months of hormonal treatment in addition to radiotherapy improves outcome for prostate cancer

Vienna, Austria: Men with prostate cancer that is small and confined to the prostate gland but that is at risk of growing and spreading, do better if they are treated with radiotherapy combined with androgen deprivation therapy, which lowers their levels of the male hormone, testosterone, according to new research.

7 Apr 2014

Ambit initiates Phase 2 study of quizartinib in acute myeloid leukemia patients

Ambit Biosciences, a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced the initiation of the Phase 2 cohort of the MD Anderson Cancer Center-sponsored Phase 1/2 study of quizartinib in combination with either 5-azacitidine or low dose cytarabine for previously untreated FLT3-ITD positive acute myeloid leukemia (AML) patients age 60 or older, or FLT3-ITD positive AML patients 18 years of age or older in first relapse.

7 Apr 2014

Merck KGaA initiates Phase 3 START2 study of MUC1 antigen-specific cancer immunotherapy tecemotide

Oncothyreon Inc. today announced that Merck KGaA, Darmstadt, Germany, has initiated the international Phase 3 START2 study, which is designed to assess the efficacy and safety of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC).

7 Apr 2014

GI Dynamics establishes reimbursement coverage for EndoBarrier Therapy for treatment of type 2 diabetes, obesity

GI Dynamics, Inc. today announced that Clalit Health Services, Israel's largest and one of the world's largest health maintenance organization, has established a reimbursement coverage policy for EndoBarrier Therapy, an endoscopically-delivered device therapy approved for the treatment of type 2 diabetes and obesity.

7 Apr 2014

Deciphera Pharmaceuticals initiates Phase 1 clinical trial of pan-RAF inhibitor LY3009120

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7 Apr 2014

Study shows PET imaging monitors prostate cancer progression without need for so many biopsies

Your body's cells have two major interconnected energy sources: the lipid metabolism and the glucose metabolism. Most cancers feed themselves by metabolizing glucose, and thus can be seen in Positron Emission Topography (PET) scans that detect radiolabeled glucose.

7 Apr 2014

Genetic screening of cancer can help doctors customize treatments in patients with melanoma

Genetic screening of cancer can help doctors customize treatments so that patients with melanoma have the best chance of beating it, according to the results of a clinical trial by researchers at the University of Pittsburgh Cancer Institute (UPCI), a partner with UPMC CancerCenter.

7 Apr 2014

Transgenomic to provide genetic testing services for Raptor’s clinical trial

Transgenomic, Inc., a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through diagnostic tests as well as clinical and research services, today announced an agreement with Raptor Pharmaceuticals Inc. to provide genetic testing services for Raptor's clinical trial (RP103-MITO-001) evaluating RP103 as a potential treatment for Leigh syndrome and other inherited mitochondrial disorders.

4 Apr 2014

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Astellas Pharma Inc. and Medivation Inc. today announced the submission of a variation to amend the European Marketing Authorization Application for XTANDI® (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.

4 Apr 2014

Aortic valve replacement now possible without open-heart surgery

Loyola University Medical Center is the first hospital in Illinois to implant a newly approved aortic heart valve device that does not require open surgery.

From Medtronic 4 Apr 2014

Clinical Trial News and Research

Access provides update on new formulation of anti-inflammatory drug amlexanox

PDS launches new data sharing platform to improve lives of cancer patients

MicroBiome Therapeutics to present clinical trial data of NM504 in type 2 diabetes, prediabetes at ICE/ENDO 2014

Alkermes announces results from phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia

Ambit initiates QUANTUM-R Phase 3 clinical trial of quizartinib in FLT3-ITD positive AML patients

DelMar presents pre-clinical study data that evaluates activity of VAL-083 in drug-resistant NSCLC

SU2C and Farrah Fawcett announce formation of research team dedicated to HPV-related cancers

PatientsLikeMe collaborates with Genentech to develop innovative ways of researching patients' real-world experience with disease, treatment

Combination therapy with MEK and BRAF inhibitors for anaplastic thyroid cancer proves effective

I-SPY 2 trial qualifies neratinib for HER2-positive breast cancer

6 months of hormonal treatment in addition to radiotherapy improves outcome for prostate cancer

Ambit initiates Phase 2 study of quizartinib in acute myeloid leukemia patients

Merck KGaA initiates Phase 3 START2 study of MUC1 antigen-specific cancer immunotherapy tecemotide

GI Dynamics establishes reimbursement coverage for EndoBarrier Therapy for treatment of type 2 diabetes, obesity

Deciphera Pharmaceuticals initiates Phase 1 clinical trial of pan-RAF inhibitor LY3009120

Study shows PET imaging monitors prostate cancer progression without need for so many biopsies

Genetic screening of cancer can help doctors customize treatments in patients with melanoma

Transgenomic to provide genetic testing services for Raptor’s clinical trial

Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Aortic valve replacement now possible without open-heart surgery

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