Archive for the 'Clinical Trials' Category

Argos Therapeutics Presents Positive Phase 2 Data For Arcelis(TM) Dendritic Cell-based Immunotherapy

Argos TherapeuticsArgos Therapeutics has announced the presentation of positive interim data from a Phase 2 trial that evaluated the clinical activity, safety and immune response of AGS-003 treatment, given in combination with sunitinib, in patients with newly diagnosed advanced renal cell carcinoma (RCC). AGS-003 is a product of the Company’s Arcelis™ technology, and is a personalized, RNA-loaded, dendritic cell-based immunotherapy that is individualized to each patient’s unique tumor.

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Bayer drug shows promise in breast tumors

Bayer’s cancer pill Nexavar shows promise in treating breast tumors, the second-most common form of cancer. Nexavar, when combined with standard chemotherapy Xeloda, helped keep tumors in check for a longer time than that in a control group of patients receiving Xeloda only, according to Bayer. Nexavar is one of Bayer’s most promising drugs and is sold as a liver and kidney cancer treatment in more than 70 countries. Bayer is also pursuing the approval of the drug for use against lung tumors.

ImmunoCellular’s Cancer Vaccine Demonstrates Immune Response Against Brain Cancer

ImmunoCellular Therapeutics, Ltd. has presented preliminary, promising clinical data from a Phase I trial, evaluating ICT-107, the company’s dendritic cell-based cancer vaccine product candidate for the treatment of glioblastoma. ICT-107 was well tolerated, and no significant adverse events were reported. The Phase I clinical trial of ICT-107 was conducted to evaluate the safety and tolerability of the cancer vaccine in patients with glioblastoma, the most common and malignant type of brain cancer. The trial enrolled 19 patients and was conducted at Cedars-Sinai Medical Center.

Blood Scanner That Detects Even Faint Indicators Of Cancer Developed By Stanford Researchers

A team led by Stanford University researchers has developed a prototype blood scanner that can find cancer markers in the bloodstream in early stages of the disease, potentially allowing for earlier treatment and dramatically improved chances of survival. The system based on MagArray biodetection chips can find cancer-associated proteins in a blood serum sample in less than an hour. This could be especially helpful for lung cancer, ovarian cancer and pancreatic cancer, because those cancers are hidden in the body

FDA delays Genesense approval

GentaThe FDA has decided to postpone the approval for Genesense (oblimersen sodium) due to the lack of adequate data available for the drug. The drug is used in relapsed or refractory chronic lymphocytic leukemia. The Center for Drug Evaluation and Research (CDER) and the FDA agreed that the drug achieved the primary endpoint in the pivotal trial, drug maker Genta said. CDER has asked the company to come up with confirmatory evidence for the drug.

Oncothyreon files INDA for advanced cancer treatment compound

OncothyreonOncothyreon has filed an INDA with the FDA for PX-866, a small molecule phosphatidylinositol-3-kinase (PI-3-kinase) inhibitor for the treatment of advanced cancers. The compound has been shown to have good single agent in vivo antitumor activity and works well in combination with other agents in a number of human tumor models, the company said. Following FDA review, the company plans to initiate a Phase I clinical trial.

ACT II study shows substantial tumor-specific immune response

Celldex LogoData presented by Celldex Therapeutics, a wholly-owned subsidiary of AVANT Immunotherapeutics, from its Phase 2 ACT II study in glioblastoma multiforme (GBM) indicated that temozolomide, the standard chemotherapy agent for this disease, may potentiate the effect of AVANT’s vaccine candidate, CDX-110. All patients vaccinated with CDX-110 in the Phase 2a ACT II extension study showed a tumor-specific immune response, a significant improvement over previous vaccines and over CDX-110 alone.

Novartis commences Phase III trial for ASA404

Novartis Inc has initiated the Phase III trial for its non-small cell lung cancer drug, ASA404, designed to selectively reduce blood supply to tumors. The randomized, double-blind, placebo-controlled, multicenter study, named ATTRACT-1, is designed to evaluate ASA404 in combination with paclitaxel and carboplatin as first-line treatment for locally advanced or metastatic non-small cell lung cancer.

Novartis kidney cancer drug shows promise

Novartis logoSwiss company Novartis AG has reported that an independent data monitoring committee stopped a major trial of an investigational drug after interim results showed significantly better survival rates in kidney-cancer patients taking the therapy.Novartis was in Phase III of clinical trials, but the independent committee stopped the trial, involving some 400 patients in a dozen countries, because the study met its primary endpoint. Researchers say the targeted therapy could have promise for people with late-stage renal-cell cancer. Researchers are also evaluating the drug’s use in neuroendocrine tumors, lymphoma and other cancers.

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