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Drug to reverse immunological decline in aging

UCSF researchers have identified an existing medication that restores key elements of the immune system that, when out of balance, lead to a steady decline in immunity and health as people age.

14 Dec 2010

Top-line results from Inhibitex's FV-100 Phase II clinical trial for treatment of shingles

Inhibitex, Inc. today reported top-line safety and efficacy data from its Phase II clinical trial of FV-100, an oral antiviral compound being developed to treat herpes zoster, more commonly referred to as shingles. The study was the first clinical trial to assess the antiviral activity of FV-100, included 350 shingles patients and compared two once-daily doses of FV-100 (200 mg and 400 mg) to an active control, valacyclovir, one of the most commonly-used antiviral drugs to treat shingles.

14 Dec 2010

Capstone presents AZX100 Phase 2a trial results for keloid and trocar site scarring

Capstone Therapeutics announced today twelve-month results from its two AZX100 Phase 2a pilot clinical trials in keloid scarring and seven-month interim results of its ongoing AZX100 Phase 2a pilot clinical trial in surgical (trocar site) scarring.

14 Dec 2010

FDA to review Lantheus' DEFINITY sNDA for use in stress echocardiography

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental New Drug Application (sNDA) for DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension for use in stress echocardiography.

14 Dec 2010

Lilly suspends tasisulam global Phase III study in metastatic melanoma

Eli Lilly and Company announced today that it has suspended its global Phase III study evaluating tasisulam, an investigational, small-molecule anti-cancer compound, as a second-line treatment for those with unresectable or metastatic melanoma.

13 Dec 2010

PREZISTA/ritonavir once-daily dosing for HIV-1 receives FDA approval for treatment in no DRV RAM adults

Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., announced today that the U.S. Food and Drug Administration (FDA) has approved a revision to the dosing recommendation to include once-daily dosing of PREZISTA® (darunavir) tablets in combination with ritonavir for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adult patients with no darunavir resistance-associated mutations (DRV RAMs).

13 Dec 2010

Intercell to stop further development of Travelers' Diarrhea Vaccine Patch

Intercell AG announced today preliminary clinical results on its investigational Travelers' Diarrhea (TD) Vaccine Patch program and the decision not to pursue further the development of this vaccine candidate. The decision was made following the receipt of results of its randomized and placebo-controlled Phase III study (ELT301) with 2036 travelers from Europe to Mexico and Guatemala as well as the pilot efficacy Phase II trial (ELT209) with 723 travelers from Europe to India.

13 Dec 2010

Bionovo reports positive Menerba clinical program meeting with FDA

Bionovo, Inc., a pharmaceutical company focused on the discovery and development of innovative treatments for women's health and cancer, today announced that it had received the minutes from the U.S. Food and Drug Administration's (FDA) Clinical Guidance meeting that took place on November 8, 2010. In that meeting, the FDA agreed with the Company's proposed overall clinical development plan.

13 Dec 2010

New positive data on Generex Oral-lyn published in Diabetes, Obesity and Metabolism

Generex Biotechnology Corporation announced today that the peer-reviewed scientific journal Diabetes, Obesity and Metabolism has published new positive data in respect of Generex Oral-lyn™, the Company's proprietary buccal insulin spray product.

13 Dec 2010

Vical's Vaxfectin adjuvant boosts immune response of DNA-based vaccines against cancer

Vical Incorporated announced today that the company's Vaxfectin® adjuvant has significantly boosted the immune response of DNA-based vaccines against a range of pathogens and cancer in preclinical models from rodents to non-human primates. Vaxfectin® has demonstrated similar effects with protein- and peptide-based vaccines in preclinical models.

13 Dec 2010

GeparQuinto study data on bevacizumab plus chemotherapy in early breast cancer to be presented at 33rd CTRC-AACR

Results of the GeparQuinto study, randomized Phase III efficacy data on the use of bevacizumab plus chemotherapy to treat women with early breast cancer will be presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium.

13 Dec 2010

Syndax reports promising results from entinostat preclinical studies in breast cancer

Syndax Pharmaceuticals, Inc., a clinical-stage epigenetics oncology company, announces results from two preclinical studies on entinostat, an orally bioavailable, highly selective, class I histone deacetylase (HDAC) inhibitor, in animal models of breast cancer. The data are being presented as oral poster discussions at the San Antonio Breast Cancer Symposium December 8 through December 12 in San Antonio Texas.

13 Dec 2010

Xeloda may reduce recurrence of faster growing breast cancers: Study

Joyce O'Shaughnessy, M.D., medical director and co-chair of the Breast Cancer Research Committee, US Oncology Research, and medical oncologist with Texas Oncology-Baylor Sammons Cancer Center, presented her study findings today at the 33rd Annual San Antonio Breast Cancer Symposium (SABCS), an international scientific symposium for interaction and exchange among basic scientists and clinicians in breast cancer

13 Dec 2010

Boehringer Ingelheim reports positive results from afatinib phase IIb/III LUX-Lung 1 trial in advanced NSCLC

Boehringer Ingelheim Pharmaceuticals, Inc. announced that new data from a subgroup analysis of the phase IIb/III LUX-Lung 1 trial show that afatinib (BIBW 2992) reached a four-fold extension (4.4 months vs. 1.0 month for placebo) in progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients most likely to have an epidermal growth factor receptor (EGFR) mutation. The updated LUX-Lung 1 data will be presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

13 Dec 2010

Novelos NOV-002 demonstrates positive results in Phase 2 neoadjuvant breast cancer trial

Novelos Therapeutics, Inc., a biopharmaceutical company developing therapeutics to treat cancer, announced that today a poster highlighting positive results in a Phase 2 trial of NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu negative invasive breast cancer is being presented by the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine at the AACR Breast Cancer Symposium in San Antonio, TX.

13 Dec 2010

Argos' AGS-004 shows feasibility in in vitro models to generate DC from viremic patients

Argos Therapeutics announced today that its Arcelis HIV immunotherapy, AGS-004, showed feasibility in in vitro models to generate fully functional dendritic cells (DC) from viremic patients.

13 Dec 2010

Researchers present Phase III study of neoadjuvant therapy with trastuzumab and lapatinib for early breast cancer

Researchers presented Phase III efficacy data from the GeparQuinto study, a head-to-head comparison of neoadjuvant lapatinib and trastuzumab in combination with chemotherapy for patients with early breast cancer, at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held Dec. 8-12.

13 Dec 2010

Positive preliminary results from tivozanib-paclitaxel combination Phase 1b trial in metastatic breast cancer

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced preliminary results from an ongoing Phase 1b clinical trial evaluating the company's lead product candidate, tivozanib, a highly potent and selective inhibitor of VEGF receptors 1, 2, and 3, in combination with paclitaxel (Taxol®), a standard chemotherapy regimen, in patients with metastatic breast cancer.

10 Dec 2010

Pfizer withdraws Thelin for treatment of PAH, discontinues global clinical studies

Pfizer Inc. announced today that, in the interest of patient safety, it is voluntarily withdrawing Thelin® (sitaxentan) for the treatment of pulmonary arterial hypertension (PAH) in regions where it is approved (the European Union, Canada and Australia). In addition, Pfizer is discontinuing clinical studies of Thelin worldwide.

10 Dec 2010

Arena initiates dosing in APD811 Phase 1 clinical trial for pulmonary arterial hypertension

Arena Pharmaceuticals, Inc. announced today the initiation of dosing in a Phase 1 clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin receptor for the treatment of pulmonary arterial hypertension, or PAH.

10 Dec 2010

Drug Trial News

Drug to reverse immunological decline in aging

Top-line results from Inhibitex's FV-100 Phase II clinical trial for treatment of shingles

Capstone presents AZX100 Phase 2a trial results for keloid and trocar site scarring

FDA to review Lantheus' DEFINITY sNDA for use in stress echocardiography

Lilly suspends tasisulam global Phase III study in metastatic melanoma

PREZISTA/ritonavir once-daily dosing for HIV-1 receives FDA approval for treatment in no DRV RAM adults

Intercell to stop further development of Travelers' Diarrhea Vaccine Patch

Bionovo reports positive Menerba clinical program meeting with FDA

New positive data on Generex Oral-lyn published in Diabetes, Obesity and Metabolism

Vical's Vaxfectin adjuvant boosts immune response of DNA-based vaccines against cancer

GeparQuinto study data on bevacizumab plus chemotherapy in early breast cancer to be presented at 33rd CTRC-AACR

Syndax reports promising results from entinostat preclinical studies in breast cancer

Xeloda may reduce recurrence of faster growing breast cancers: Study

Boehringer Ingelheim reports positive results from afatinib phase IIb/III LUX-Lung 1 trial in advanced NSCLC

Novelos NOV-002 demonstrates positive results in Phase 2 neoadjuvant breast cancer trial

Argos' AGS-004 shows feasibility in in vitro models to generate DC from viremic patients

Researchers present Phase III study of neoadjuvant therapy with trastuzumab and lapatinib for early breast cancer

Positive preliminary results from tivozanib-paclitaxel combination Phase 1b trial in metastatic breast cancer

Pfizer withdraws Thelin for treatment of PAH, discontinues global clinical studies

Arena initiates dosing in APD811 Phase 1 clinical trial for pulmonary arterial hypertension

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