Clinical Trial News and Research

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FDA approves City of Hope's neural stem cell-based therapy study for recurrent high-grade gliomas

City of Hope researchers received approval from the U.S. Food and Drug Administration (FDA) to conduct the first-in-human study of a neural stem cell-based therapy targeting recurrent high-grade gliomas, the most aggressive type of brain tumor. Karen S. Aboody, M.D., associate professor in City of Hope's Department of Neurosciences, leads the research team that developed this treatment strategy. Jana Portnow, M.D., assistant professor and assistant director of the Brain Tumor Program at City of Hope, is the principal investigator for the clinical trial.

9 Jun 2010

Covance opens state-of-the-art biorepository facility at Greenfield

Covance Inc., a leading provider of drug development services, announced today that it has opened a state-of-the-art biorepository facility at its Greenfield, Indiana location. The 20,000-square-foot building is dedicated to long-term storage of clinical trial specimens. The facility is able to store a wide-range of specimens, including plasma, serum, whole blood, DNA, PBMC, and tissue.

9 Jun 2010

Helix BioPharma reports Phase II clinical results of Topical Interferon Alpha-2b for ano-genital warts

Helix BioPharma Corp. today announced results from the Phase II clinical trial assessing the efficacy and safety of Topical Interferon Alpha-2b cream for the treatment of ano-genital warts (AGW).

9 Jun 2010

PharmaMar commences Aplidin Phase III registration trial for multiple myeloma

PharmaMar SA today announced that a registration trial in relapsed/refractory multiple myeloma patients has been initiated with Aplidin(R) (plitidepsin) in combination with dexamethasone versus dexamethasone alone.

9 Jun 2010

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Sucampo Pharmaceuticals, Inc. and Abbott today announced that a pivotal phase 3 clinical trial of lubiprostone for chronic idiopathic constipation (CIC) in Japanese patients met its primary endpoint with statistical significance and demonstrated a safety profile consistent with previously reported clinical lubiprostone data.

9 Jun 2010

Argos presents positive AGS-003 Phase 2 data for newly diagnosed advanced renal cell carcinoma at ASCO

Argos Therapeutics today 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). The data were discussed June 7 in a poster session at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO), held in Chicago, IL.

8 Jun 2010

HPV-positive tumor status is strong prognostic factor for head, neck cancer

Oropharyngeal cancer patients whose tumors in the upper part of the throat test positively for the human papillomavirus (HPV) have better overall survival than patients with HPV-negative disease, researchers from The University of Texas MD Anderson Cancer Center report in a study published in The New England Journal of Medicine.

8 Jun 2010

Aerovance reports top-line results from Aerovant Phase 2b clinical trial for eosinophilic asthma

Aerovance Inc. today announced top-line results from its Phase 2b clinical trial that show the inhaled dry powder formulation of Aerovant (pitrakinra inhalation powder) is effective in a pre-defined subset of patients with eosinophilic asthma.

8 Jun 2010

GTx reports positive results from toremifene Phase III clinical trial

GTx, Inc. announced today that in the Phase III clinical trial evaluating toremifene 80 mg for the reduction of fractures and treatment of other estrogen deficiency side effects in men with prostate cancer on androgen deprivation therapy (ADT), toremifene treatment demonstrated an improved benefit/risk ratio in men less than 80 years of age. The data were presented yesterday at the 2010 Annual Meeting of the American Society of Clinical Oncology in Chicago.

8 Jun 2010

Idera reports preliminary results from IMO-3100 Phase 1 clinical trial for autoimmune, inflammatory diseases

Idera Pharmaceuticals, Inc. today announced preliminary results from a Phase 1 clinical trial of IMO-3100, its lead Toll-like Receptor (TLR) 7 and TLR9 antagonist drug candidate for potential applications in autoimmune and inflammatory diseases. In this trial, healthy subjects in five dosage cohorts received single doses of IMO-3100 from 0.04 to 0.64 mg/kg. IMO-3100 was well tolerated at all dose levels.

8 Jun 2010

Protalix BioTherapeutics reports positive results from PRX-105 Phase I clinical trial

Protalix BioTherapeutics, Inc. announced today the completion of its phase I clinical trial of PRX-105, a plant cell expressed pegylated recombinant human acetylcholinesterase in development for biodefense indications. The trial established the pharmacokinetics of the protein and demonstrated that single dose, intravenous administration of PRX-105 is safe and well tolerated.

8 Jun 2010

$UC-MSCT improves symptoms, biochemical values in patients with severe refractory SLE: Study$

UC-MSCT improves symptoms, biochemical values in patients with severe refractory SLE: Study

A new study shows that umbilical cord mesenchymal stem cell transplant may improve symptoms and biochemical values in patients with severe refractory systemic lupus erythematosus.

8 Jun 2010

Researchers compare clinical outcome of patients with smaller and larger AAAs after EVAR

Patients with abdominal aortic aneurysms of less than 5.5 cm have no significant differences in clinical outcomes after endovascular repair than those with larger AAAs according to data from a five-year prospective clinical trial setting. The researchers maintain their recommendation that small aneurysms should not be treated surgically.

8 Jun 2010

TMI announces development of new clinical imaging system

With the results of the clinical trial at Duke University Medical Center completed, and the pending publication of the results, TMI is pleased to announce the development of their new clinical imaging system.

8 Jun 2010

$Hana Biosciences reports complete data from Marqibo Phase 2 RALLY trial for relapsed/refractory adult ALL$

Hana Biosciences reports complete data from Marqibo Phase 2 RALLY trial for relapsed/refractory adult ALL

Hana Biosciences Inc.,, today announced complete data from its pivotal, Phase 2 RALLY clinical trial for Marqibo® (vincristine sulfate liposome injection) for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). Results from the RALLY trial demonstrated compelling evidence of single-agent, anti-leukemic activity in an advanced, heavily pre-treated, adult ALL population.

8 Jun 2010

Polaris' ADI-PEG 20 novel anticancer drug inhibits growth of metastatic melanoma cells: Study

Physicians attending the annual meeting of the American Society of Clinical Oncology (ASCO) presented evidence that pegylated arginine deiminase (ADI-PEG 20), a novel anticancer drug that targets ASS(-) tumors, and which is being developed and manufactured by Polaris Group, was effective in inhibiting the growth of metastatic melanoma cells.

8 Jun 2010

GTx presents quality of life results from Ostarine Phase IIb study in cancer cachexia patients at ASCO 2010

GTx, Inc. today presented additional results from the Ostarine™ Phase IIb study demonstrating an improvement in quality of life (fatigue and anorexia) in cancer patients with muscle wasting (cancer cachexia) who demonstrated improvement in functional performance as measured by stair climb. Ostarine (GTx-024) is GTx's lead selective androgen receptor modulator (SARM) which the company is developing for the treatment of cancer cachexia.

8 Jun 2010

Threshold Pharmaceuticals presents results of TH-302 Phase 1/2 trials in solid tumors at ASCO

Threshold Pharmaceuticals, Inc. today announced results from Phase 1/2 clinical trials in various solid tumors related to its hypoxia-activated prodrug, TH-302. The results were presented during the American Society for Clinical Oncology (ASCO) Annual Meeting being held in Chicago, IL.

8 Jun 2010

PET imaging with flurpiridaz F 18 better than technetium-99m sestamibi SPECT for CAD detection

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced preliminary data from a single site participating in the multicenter Phase 2 clinical trial that showed that Positron Emission Tomography (PET) imaging with its novel investigational agent flurpiridaz F 18 injection (formerly known as BMS747158) provided better image quality than technetium-99m sestamibi single photon emission computed tomography (SPECT), the current standard for the non-invasive detection of coronary artery disease (CAD).

8 Jun 2010

First clinical data for ImmunoGen's IMGN388 anticancer compound presented at ASCO Annual Meeting

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the presentation of the first clinical data for the Company's IMGN388 anticancer compound at the 2010 Annual Meeting of the American Society of Clinical Oncology being held in Chicago, IL.

8 Jun 2010

Clinical Trial News and Research

FDA approves City of Hope's neural stem cell-based therapy study for recurrent high-grade gliomas

Covance opens state-of-the-art biorepository facility at Greenfield

Helix BioPharma reports Phase II clinical results of Topical Interferon Alpha-2b for ano-genital warts

PharmaMar commences Aplidin Phase III registration trial for multiple myeloma

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Argos presents positive AGS-003 Phase 2 data for newly diagnosed advanced renal cell carcinoma at ASCO

HPV-positive tumor status is strong prognostic factor for head, neck cancer

Aerovance reports top-line results from Aerovant Phase 2b clinical trial for eosinophilic asthma

GTx reports positive results from toremifene Phase III clinical trial

Idera reports preliminary results from IMO-3100 Phase 1 clinical trial for autoimmune, inflammatory diseases

Protalix BioTherapeutics reports positive results from PRX-105 Phase I clinical trial

UC-MSCT improves symptoms, biochemical values in patients with severe refractory SLE: Study

Researchers compare clinical outcome of patients with smaller and larger AAAs after EVAR

TMI announces development of new clinical imaging system

Hana Biosciences reports complete data from Marqibo Phase 2 RALLY trial for relapsed/refractory adult ALL

Polaris' ADI-PEG 20 novel anticancer drug inhibits growth of metastatic melanoma cells: Study

GTx presents quality of life results from Ostarine Phase IIb study in cancer cachexia patients at ASCO 2010

Threshold Pharmaceuticals presents results of TH-302 Phase 1/2 trials in solid tumors at ASCO

PET imaging with flurpiridaz F 18 better than technetium-99m sestamibi SPECT for CAD detection

First clinical data for ImmunoGen's IMGN388 anticancer compound presented at ASCO Annual Meeting

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