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Clinical Trials
ITN type 1 diabetes study identifies subset of patients with strong response to therapy PDF Print E-mail
Saturday, 17 August 2013 21:01

WA, Seattle (August 15, 2013) – Primary results from a new clinical trial show that patients with type 1 diabetes treated with the monoclonal antibody teplizumab (MacroGenics, Inc.) exhibit greater preservation of C-peptide, a biomarker of islet cell function, compared to controls. Further analyses identified a discrete subset of the treatment group that demonstrated especially robust responses ("responders"), suggesting that these patients could be identified prior to treatment. The trial, entitled "Autoimmunity-Blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes" (AbATE), was conducted by the Immune Tolerance Network (ITN). The results are available online and will be published in the November issue of the journal Diabetes.

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Studies show drug combinations effective for melanoma PDF Print E-mail
Sunday, 30 September 2012 00:45

Promising new data from trials aimed at delaying resistance to BRAF inhibitors

Vienna, Austria, 29 September 2012 –- Promising new data on drug combinations to treat metastatic melanoma are presented at the ESMO 2012 Congress of the European Society for Medical Oncology in Vienna.

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Rancho Cordova firm clears regulatory hurdle in China PDF Print E-mail
Thursday, 12 April 2012 14:04

Rancho Cordova-based medical equipment firm ThermoGenesis Corp. said today that China's State Food and Drug Administration has approved registration of the company's BioArchive system.

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Response Rate High For Some Patients With Metastatic Melanoma Treated With Vemurafenib PDF Print E-mail
Saturday, 17 March 2012 19:29

TAMPA, Fla. (March 16, 2012) - An international team of researchers from the United States and Australia, including researchers at Moffitt Cancer Center in Tampa, Fla., have found that the oral BRAF inhibitor vemurafenib (PLX4032) when tested in a phase II clinical trial offered a high rate of response in patients with previously treated metastatic melanoma and who had the BRAF mutation. More than 50 percent of the patients in the trial had positive, prolonged responses and a median survival of almost 16 months.

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BioSante axes 25% of workforce after big miss in female libido gel trials PDF Print E-mail
Tuesday, 31 January 2012 23:10

BioSante Pharmaceuticals alerted investors this morning to its plan to move forward after the colossal failure of its late-stage trials for its female libido gel last month. To save cash, the company said it's cutting 21 full-time employees or contractors, about a quarter of its total workforce, and is hunting for in-licensing, merger and acquisition deals.

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Drug improves survival of colorectal cancer patients, trial results show PDF Print E-mail
Tuesday, 17 January 2012 22:27

ROCHESTER, Minn. — An investigational drug called regorafenib slowed the progression of tumors and lengthened the lives of patients with metastatic colorectal cancer, an international phase III clinical trial found. The findings were presented today at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology in San Francisco by Mayo Clinic oncologist Axel Grothey, M.D., principal investigator of the trial in the United States.

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Ariad Says Leukemia Drug’s Positive Response May Boost FDA Approval Chance PDF Print E-mail
Tuesday, 13 December 2011 05:48

Ariad Pharmaceuticals Inc. (ARIA)’s experimental drug ponatinib spurred a positive response in 47 percent of chronic myeloid leukemia patients, a pivotal study the company said may help the medicine gain approval as a new therapy for people without treatment options.

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B cell receptor inhibitor causes chronic lymphocytic leukemia remission PDF Print E-mail
Monday, 12 December 2011 05:30

PCI-32765 applies molecularly aimed attack to disease usually treated with chemotherapy combinations

SAN DIEGO - A new, targeted approach to treating chronic lymphocytic leukemia has produced durable remissions in a Phase I/II clinical trial for patients with relapsed or resistant disease, investigators report at the 53rd Annual Meeting of the American Society of Hematology.

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Novel ALS drug slows symptom progression, reduces mortality in phase 2 trial PDF Print E-mail
Monday, 21 November 2011 06:58

Treatment with dexpramipexole – a novel drug believed to prevent dysfunction of mitochondria, the subcellular structures that provide most of a cell's energy – appears to slow symptom progression in the neurodegenerative disease amyotrophic lateral sclerosis (ALS). Promising results of a phase 2 trial of dexpramipexole are receiving advance online publication in Nature Medicine. Some preliminary results of the study were presented at the 2009 International Symposium on ALS/MND and the 2010 American Academy of Neurology annual meeting.

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Landmark Study Shows that Adding Rivaroxaban to Standard Antiplatelet Therapy Significantly Reduced Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome PDF Print E-mail
Tuesday, 15 November 2011 06:43

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Rivaroxaban Used in Combination with Standard Therapy Reduced Cardiovascular Death by Over 30%

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that adding oral rivaroxaban to standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint of cardiovascular-related deaths, heart attacks or strokes in patients with acute coronary syndrome (ACS) compared to those receiving standard therapy alone. Results from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 trial presented today at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine also showed that rivaroxaban significantly increased rates of major bleeding, but did not create an excess risk of fatal bleeding over standard therapy alone.

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Studies show advances in gastrointestinal cancer treatments PDF Print E-mail
Sunday, 30 September 2012 00:47

Phase III data reported at ESMO 2012

VIENNA, Austria, 29 September 2012 –- New trial data showing improvements in the treatment of esophageal and gastrointestinal cancers were released today at the ESMO 2012 Congress of the European Society for Medical Oncology in Vienna.

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Sorafenib does not extend overall survival as third or fourth line therapy in lung cancer PDF Print E-mail
Sunday, 30 September 2012 00:42

Phase III MISSION trial - EGFR status may help select patients who will benefit most

Vienna, Austria, 29 September 2012 – Treatment with the drug sorafenib as a third or fourth line therapy does not result in improved overall survival among patients with advanced non-small cell lung cancer (NSCLC), according to findings released at the ESMO 2012 Congress of the European Society for Medical Oncology in Vienna. However, a post-hoc biomarker analysis of the trial data that was also presented suggests that patients with EGFR-mutant tumors may benefit.

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Tokai Pharmaceuticals' galeterone well-tolerated in patients with advanced prostate cancer PDF Print E-mail
Sunday, 01 April 2012 04:40

Phase 1 data presented at AACR Annual Meeting 2012; Study showed no dose limiting toxicities with galeterone; Preliminary efficacy data reported

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SciClone to discontinue development of SCV-07 oral mucositis trial PDF Print E-mail
Wednesday, 07 March 2012 06:21

http://www.sciclone.com/wp-content/themes/sciclone/images/sciclone_home_logo.gifSciClone Pharmaceuticals, Inc., a specialty pharmaceutical company, has announced the results from a pre-planned interim analysis of the phase II b trial of SCV-07 in patients with oral mucositis (OM) indicate that the trial would not meet the pre-specified efficacy endpoints. After conferring with the study's independent Data Monitoring Committee (DMC), the company has decided to discontinue development of SCV-07 in this indication.

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Pfizer writes off $725M Dimebon pact after final Phase III failure PDF Print E-mail
Tuesday, 17 January 2012 23:11

The last flickering hope that Medivation's Dimebon could help Alzheimer's disease patients has just been extinguished. The biotech announced this morning that a 12-month study of the drug failed to register significant improvements for patients, mirroring two shorter Phase III studies in which Dimebon failed to outperform a sugar pill. Pfizer took the opportunity to bow out of its partnership, writing off its $225 million upfront and $500 million milestone program for what proved to be another embarrassing pipeline failure.

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AstraZeneca Setbacks May Force Change in Drug Development PDF Print E-mail
Wednesday, 21 December 2011 07:45

http://www.bloomberg.com/image/iMcj1flIYO5k.jpgAstraZeneca Plc (AZN), the U.K.’s second- biggest drugmaker, may need to change its drug development strategy after setbacks with experimental treatments for cancer and depression, analysts said.

A medicine called olaparib won’t move to the next stage of clinical trials to treat a type of ovarian cancer and a second advanced study of another drug for patients with major depressive disorder failed to meet the main goal, AstraZeneca said in statement today. As a result, AstraZeneca will take a charge of $381.5 million in the fourth quarter.

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Pfizer’s Failed Blood Cancer Drug Shows New Benefits in Study PDF Print E-mail
Tuesday, 13 December 2011 05:37

Dec. 10 (Bloomberg) -- Pfizer Inc.’s blood-cancer drug Mylotarg, pulled from the market last year after it was linked to deaths, helped a different group of patients, a study found.

Patients newly diagnosed with acute myeloid leukemia who received Mylotarg with chemotherapy lived for 25 months after treatment, compared with 15 months for those given chemotherapy alone, according to the study released today at the American Society of Hematology meeting in San Diego. Mylotarg had previously been used in patients ages 60 and older only after their cancer had returned.

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Clinical trial for muscular dystrophy demonstrates safety of customized gene therapy PDF Print E-mail
Thursday, 01 December 2011 05:37

CHAPEL HILL, N.C. – Researchers at the University of North Carolina at Chapel Hill have shown that it is safe to cut and paste together different viruses in an effort to create the ultimate vehicle for gene therapy. In a phase I clinical trial, the investigators found no side effects from using a "chimeric" virus to deliver replacement genes for an essential muscle protein in patients with muscular dystrophy.

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Pfizer-Bristol Drug Doesn’t Cut Clots After Hospital Stays PDF Print E-mail
Tuesday, 15 November 2011 06:51

Pfizer Inc. and Bristol-Myers Squibb Co.’s experimental drug apixaban wasn’t safer or more effective than a standard treatment in stopping blood clots in the legs and lungs of patients after hospitalization, a study found.

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Genzyme Announces Successful Phase III Results for Alemtuzumab (LEMTRADA(TM*)) in Multiple Sclerosis PDF Print E-mail
Tuesday, 15 November 2011 06:31
http://www.genzyme.com/images/common/logo.gifCAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), reports today that the Phase lll CARE-MS ll trial met both of its co-primary endpoints. Relapse rate and sustained accumulation (worsening) of disability (SAD) were significantly reduced in multiple sclerosis patients receiving alemtuzumab (LEMTRADA™) as compared with Rebif® (44 mcg subcutaneous interferon beta-1a). Results for both of these co-primary endpoints were highly statistically significant.
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