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Study shows why candidate vaccine used in HVTN 505 clinical trial not protective against HIV infection

A study by researchers at the National Institute of Allergy and Infectious Diseases and Duke University helps explain why the candidate vaccine used in the HVTN 505 clinical trial was not protective against HIV infection despite robustly inducing anti-HIV antibodies: the vaccine stimulated antibodies that recognized HIV as well as microbes commonly found in the intestinal tract, part of the body's microbiome.

31 Jul 2015

Daiichi Sankyo, Plexxikon’s Phase 1 trial shows PLX3397 induced prolonged tumor regression in TGCT patients

Daiichi Sankyo Europe and Plexxikon Inc., a member of the Daiichi Sankyo Group, announced today that The New England Journal of Medicine published clinical trial results demonstrating that the investigational drug, PLX3397, an oral targeted CSF-1R inhibitor, induced prolonged tumor regressions in most patients with tenosynovial giant cell tumor, a rare, locally aggressive neoplasm of the joint or tendon sheath.

31 Jul 2015

NEJM publishes positive clinical results from Phase 2 clinical study of volanesorsen

Isis Pharmaceuticals, Inc., the leader in RNA-targeted therapeutics, and Akcea Therapeutics, its wholly owned subsidiary, announced today that The New England Journal of Medicine (NEJM) has published positive clinical results from a Phase 2 clinical study evaluating volanesorsen (formerly ISIS-APOCIII Rx) in patients with very high to severely high triglycerides.

30 Jul 2015

Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections.

30 Jul 2015

LixiLan-O Phase III clinical trial meets primary endpoint in patients with type 2 diabetes

Sanofi announced today that the LixiLan-O Phase III clinical trial met its primary objective in patients with type 2 diabetes treated with metformin. The fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide, a GLP-1 RA, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months) compared with lixisenatide and compared with insulin glargine 100 units/mL.

29 Jul 2015

Consumption of B-GOS prebiotic has positive effect on gut microbiota, immune systems of elderly people

Clasado Biosciences Limited, the producers and suppliers of the second generation prebiotic Bimuno, a unique trans-galactooligosaccharide, and the Department of Food and Nutritional Sciences, The University of Reading, UK, today announce the results of human research demonstrating the positive effects of an advanced prebiotic on the immune system of the elderly.

29 Jul 2015

Moerae announces initiation of second MMI-0100 Phase 1 clinical trial for pulmonary disorders

Moerae Matrix Inc. announced today the initiation of its second Phase 1 clinical trial with MMI-0100, a first-in-class inhibitor of MAPKAP kinase 2 (MK2) that is being developed for pulmonary disorders characterized by inflammation and fibrosis. The study, conducted in the United Kingdom, is a double-blind, two-way cross-over design lipopolysaccharide (LPS) challenge study further evaluating the safety and tolerability of MMI-0100 when given via inhalation to healthy subjects who smoke.

29 Jul 2015

Researchers establish safety, dosing of new drug for treating blood cancers

Researchers at University of California, San Diego School of Medicine have established the safety and dosing of a new drug for treating blood cancers. The findings are published online July 27 in The Lancet Haematology.

29 Jul 2015

Research brief provides clinical validation of LOXO-101 Phase 1 trial for treatment of TRK fusion cancer

The University of Colorado Cancer Center and Loxo Oncology, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of targeted cancer therapies, today announced the publication of a research brief in the online edition of the journal Cancer Discovery, describing the first patient with a tropomyosin receptor kinase fusion cancer enrolled in the Phase 1 dose escalation trial of LOXO-101, the only selective TRK inhibitor in clinical development.

28 Jul 2015

Research brief describes enrollment of first patient with TRK fusion cancer in LOXO-101 Phase 1 trial

The University of Colorado Cancer Center and Loxo Oncology, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of targeted cancer therapies, today announced the publication of a research brief in the online edition of the journal Cancer Discovery, describing the first patient with a tropomyosin receptor kinase (TRK) fusion cancer enrolled in the Phase 1 dose escalation trial of LOXO-101, the only selective TRK inhibitor in clinical development.

28 Jul 2015

Eddingpharm plans to begin Phase 1 study for BRINAVESS in China

Cardiome Pharma Corp. today announced that its Chinese development and commercialization partner, Eddingpharm, plans to initiate a Phase 1 study for BRINAVESSTM to support regulatory approval in China. The study will be conducted in healthy volunteers.

24 Jul 2015

Omeros' OMS721 granted FDA Fast Track designation for treatment of atypical hemolytic uremic syndrome

Omeros Corporation today announced that the U.S. Food and Drug Administration granted Fast Track designation to OMS721 for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system.

23 Jul 2015

Phase 3 SUMIT study: Selumetinib fails to meet primary endpoint in patients with metastatic uveal melanoma

AstraZeneca today announced that the Phase 3 SUMIT study of selumetinib in combination with dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib.

23 Jul 2015

New TCR therapy demonstrates encouraging clinical responses in patients with multiple myeloma

Results from a clinical trial investigating a new T cell receptor (TCR) therapy that uses a person's own immune system to recognize and destroy cancer cells demonstrated a clinical response in 80 percent of multiple myeloma patients with advanced disease after undergoing autologous stem cell transplants (ASCT).

22 Jul 2015

GUMC physician leads new national clinical trial for melanoma treatment

A Georgetown University Medical Center physician renowned for his research in melanoma will lead a new national clinical trial involving novel treatments for the disease. The study compares the sequencing of two groups of drugs -- both effective in treating melanoma.

22 Jul 2015

New phase III cancer treatment trial opens for patient with advanced melanoma

A new phase III cancer treatment trial has opened for patient enrollment that examines two treatments that work in completely different ways yet have both been shown in previous clinical trials to be effective in treating patients with advanced melanoma, the ECOG-ACRIN Cancer Research Group announced today.

22 Jul 2015

InnaVirVax presents positive results of IVVAC-3S/P1 study at International AIDS Society Conference

InnaVirVax, a biopharmaceutical company specialized in research and development of therapeutic and diagnostic solutions for major infectious and chronic diseases, today announced the overall results of its Phase I/IIa clinical study of its VAC-3S immunotherapy, which is currently in development.

22 Jul 2015

Elderberry supplement can provide protection from cold, flu-like symptoms following long-haul flights

The negative health effects of international air travel are well documented but now it seems that the common elderberry can provide some relief.

22 Jul 2015

Adaptimmune’s NY-ESO-1 TCR-engineered T-cell therapy mediates sustained antitumor effects in multiple myeloma patients

Adaptimmune Therapeutics plc, a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, today announced that data from its Phase I/II study of its affinity enhanced T-cell receptor therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published in Nature Medicine.

22 Jul 2015

Early antiretroviral treatment prevents AIDS- and non-AIDS-related diseases in HIV-infected people

Starting antiretroviral therapy early not only prevents serious AIDS-related diseases, but also prevents the onset of cancer, cardiovascular disease, and other non-AIDS-related diseases in HIV-infected people, according to a new analysis of data from the Strategic Timing of AntiRetroviral Treatment (START) study, the first large-scale randomized clinical trial to establish that earlier antiretroviral treatment benefits all HIV-infected individuals.

22 Jul 2015

Drug Trial News

Study shows why candidate vaccine used in HVTN 505 clinical trial not protective against HIV infection

Daiichi Sankyo, Plexxikon’s Phase 1 trial shows PLX3397 induced prolonged tumor regression in TGCT patients

NEJM publishes positive clinical results from Phase 2 clinical study of volanesorsen

Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

LixiLan-O Phase III clinical trial meets primary endpoint in patients with type 2 diabetes

Consumption of B-GOS prebiotic has positive effect on gut microbiota, immune systems of elderly people

Moerae announces initiation of second MMI-0100 Phase 1 clinical trial for pulmonary disorders

Researchers establish safety, dosing of new drug for treating blood cancers

Research brief provides clinical validation of LOXO-101 Phase 1 trial for treatment of TRK fusion cancer

Research brief describes enrollment of first patient with TRK fusion cancer in LOXO-101 Phase 1 trial

Eddingpharm plans to begin Phase 1 study for BRINAVESS in China

Omeros' OMS721 granted FDA Fast Track designation for treatment of atypical hemolytic uremic syndrome

Phase 3 SUMIT study: Selumetinib fails to meet primary endpoint in patients with metastatic uveal melanoma

New TCR therapy demonstrates encouraging clinical responses in patients with multiple myeloma

GUMC physician leads new national clinical trial for melanoma treatment

New phase III cancer treatment trial opens for patient with advanced melanoma

InnaVirVax presents positive results of IVVAC-3S/P1 study at International AIDS Society Conference

Elderberry supplement can provide protection from cold, flu-like symptoms following long-haul flights

Adaptimmune’s NY-ESO-1 TCR-engineered T-cell therapy mediates sustained antitumor effects in multiple myeloma patients

Early antiretroviral treatment prevents AIDS- and non-AIDS-related diseases in HIV-infected people

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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