Clinical Trial News and Research

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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

Harvard stem cell scientists discover potential treatment for amyotrophic lateral sclerosis

Harvard stem cell scientists have discovered that a recently approved medication for epilepsy may possibly be a meaningful treatment for amyotrophic lateral sclerosis (ALS)-Lou Gehrig's disease, a uniformly fatal neurodegenerative disorder. The researchers are now collaborating with Massachusetts General Hospital to design an initial clinical trial testing the safety of the treatment in ALS patients.

4 Apr 2014

FDA clears Omeros' OMS721 IND for inhibition of complement‑mediated TMAs

Omeros Corporation today announced that its Investigational New Drug Application (IND) to evaluate OMS721 for the inhibition of complement‑mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration.

3 Apr 2014

BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

BioDelivery Sciences International, Inc. announced today the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy.

3 Apr 2014

Janssen begins Phase 3 OPTIMIST trials for treatment of chronic Genotype 1 HCV infection

Janssen R&D Ireland (Janssen) announced today that two Phase 3 trials are recruiting patients to examine the efficacy and safety of the NS3/4A protease inhibitor simeprevir in combination with the nucleotide inhibitor sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in treatment-naive and treatment-experienced patients with and without cirrhosis.

3 Apr 2014

CardioCell receives IND approval for Phase IIa clinical study of itMSC therapy to treat heart failure

CardioCell LLC has just received the FDA's investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than 1 million hospitalizations annually.

3 Apr 2014

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

Gilead Sciences, Inc. today announced topline results from a Phase 3 clinical trial (Study GS-US-334-0118) in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin (RBV) for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection.

3 Apr 2014

BronchoGen genomic test meets primary endpoint in AEGIS-2 clinical trial

Allegro Diagnostics Corp. today announced that the AEGIS-2 clinical trial has met its primary endpoint, demonstrating that the BronchoGen genomic test improves the accuracy of lung cancer diagnosis when used in combination with bronchoscopy.

3 Apr 2014

FDA grants Fast Track designations for IV and oral formulations of Tetraphase's eravacycline

Tetraphase Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company's lead antibiotic candidate, eravacycline.

3 Apr 2014

Sanaria receives 2014 Vaccine Industry Excellence Award for "Best Prophylactic Vaccine"

Sanaria received the 2014 Vaccine Industry Excellence Award for the "Best Prophylactic Vaccine" at a ceremony held March 25 in Washington DC during the 14th World Vaccine Congress.

3 Apr 2014

Kessler Foundation receives grant to study effect of speed of processing training on cognitive performance in MS

Kessler Foundation received a four-year $750,000 grant from the National Multiple Sclerosis Society to conduct a randomized controlled trial of speed of processing training to improve cognition in multiple sclerosis (MS).

3 Apr 2014

FDA allows CryoLife to begin PerClot clinical trial in the U.S.

CryoLife, Inc., a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has received approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration.

2 Apr 2014

Clinical Trial News and Research

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

Harvard stem cell scientists discover potential treatment for amyotrophic lateral sclerosis

FDA clears Omeros' OMS721 IND for inhibition of complement‑mediated TMAs

BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

Janssen begins Phase 3 OPTIMIST trials for treatment of chronic Genotype 1 HCV infection

CardioCell receives IND approval for Phase IIa clinical study of itMSC therapy to treat heart failure

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

BronchoGen genomic test meets primary endpoint in AEGIS-2 clinical trial

FDA grants Fast Track designations for IV and oral formulations of Tetraphase's eravacycline

Sanaria receives 2014 Vaccine Industry Excellence Award for "Best Prophylactic Vaccine"

Kessler Foundation receives grant to study effect of speed of processing training on cognitive performance in MS

FDA allows CryoLife to begin PerClot clinical trial in the U.S.

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