Clinical Trial News and Research

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CASI files application with CFDA to conduct ENMD-2076 Phase 2 trial in fibrolamellar carcinoma patients

CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that it has filed an application with China's Food and Drug Administration to conduct a Phase 2 clinical trial in fibrolamellar carcinoma (FLC) patients in China for its proprietary drug candidate, ENMD-2076.

4 Jun 2015

Experimental Zephyr endobronchial valve provides good result in emphysema patient at UAB

In late March, physicians at the University of Alabama at Birmingham carefully threaded a one-way valve the size of a black-eyed pea into the lower lobe of Dennis Bullock's left lung. Bullock, a 67-year-old emphysema patient, was the fourth person at UAB to receive the experimental Zephyr endobronchial valve.

4 Jun 2015

Breast surgery for low-grade ductal carcinoma in-situ may not change patients' survival rate

In a study published in JAMA Surgery on June 3, researchers from Brigham and Women's Hospital report that breast surgery performed at or shortly after a diagnosis of low-grade ductal carcinoma in-situ (DCIS) did not significantly change patients' survival rate.

4 Jun 2015

New study suggests that IDH1 gene may be prognostic marker for anaplastic astrocytoma

New findings suggest that a gene called IDH1 might be prognostic marker for a rare form of brain cancer. Patients in this study who had a mutated IDH gene lived an average of 7.9 years after diagnosis versus 2.8 years for patients with unaltered IDH.

4 Jun 2015

Study: Intravenous nutrition source may significantly reduce toxicity of platinum-based cancer drugs

A single dose of an FDA-approved intravenous nutrition source may be able to significantly reduce the toxicity and increase the bioavailability of platinum-based cancer drugs, according to a study by Carnegie Mellon University biologists published in Scientific Reports.

3 Jun 2015

Ardelyx signs termination agreement with AstraZeneca, regains rights to portfolio of NHE3 inhibitors

Ardelyx, Inc., a clinical-stage biopharmaceutical company focused on cardio-renal, gastrointestinal and metabolic diseases, today announced that it has entered into a termination agreement with AstraZeneca, such that all the rights to Ardelyx's portfolio of NHE3 inhibitors, including Ardelyx's lead product candidate, tenapanor, are returned to Ardelyx.

3 Jun 2015

Women who suffer from fibromyalgia benefit from hyperbaric oxygen therapy

Women who suffer from fibromyalgia benefit from a treatment regimen in a hyperbaric oxygen chamber, according to researchers at Rice University and institutes in Israel.

3 Jun 2015

BioCision, CCT to develop ThawSTAR automated cell thawing system for treatment of diabetic foot ulcers

BioCision, LLC, a leader in advanced technology to improve biological sample handling and standardization, today announced that it will collaborate with Celgene Cellular Therapeutics (CCT) (a subsidiary of Celgene Corporation), to accelerate the development of a cell thawing solution based on BioCision’s proprietary ThawSTARÔ technology for the 6 mL injectable vial that CCT has chosen to store PDA-002, a cryopreserved, allogeneic cell therapy currently in clinical development to treat diabetic foot ulcers in patients with peripheral arterial disease.

3 Jun 2015

ProBioGen initiates clinical trials of Ebola vaccine using AGE1.CR.pIX cell line

Complex biologics development and manufacturing specialist ProBioGen today announced that an investigational vaccine against Ebola virus disease, produced on its proprietary, continuous muscovy duck AGE1.CR.pIX cell line, has proceeded into clinical trials at the Jenner Institute, Oxford University, UK.

3 Jun 2015

Nivolumab and pembrolizumab therapies continue to show promise against advanced melanomas

Results of two clinical trials reported at the American Society for Clinical Oncology Annual Meeting 2015 show continued promise of immune therapies nivolumab and pembrolizumab against advanced melanomas, specifically in the context of PD1 signaling that some tumors use to avoid immune system attack. Dr. Rene Gonzalez, MD, investigator at the University of Colorado Cancer Center and director of the Melanoma Research Clinics at the CU School of Health, is an author of both studies.

2 Jun 2015

Celltrion receives approval for infliximab biosimilar antibody from Brazil's ANVISA

Hospira, Inc., a global leader in biosimilars, today announced that its partner, Celltrion – a global biopharmaceutical company – has received approval from ANVISA – the National Health Surveillance Agency in Brazil – for Remsima (infliximab), the first biosimilar monoclonal antibody approved for use in Brazil.

2 Jun 2015

ASCO 2015: Berg presents data from BPM 31510 Phase Ib trial for solid tumors

Berg, a biopharmaceutical company committed to uncovering health solutions through a data-driven, biological approach, presented clinical research from its trials using its cancer drug BPM 31510 on Phase Ib solid tumors and preclinical data on triple negative breast cancer, at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), May 29 – June 2 in Chicago.

2 Jun 2015

Apatorsen added to first-line chemotherapy benefits metastatic bladder cancer patients

OncoGenex Pharmaceuticals, Inc. announced that results from an exploratory analysis of the Phase 2 Borealis-1 trial showed that metastatic bladder cancer patients with poor prognostic features benefited from apatorsen 600mg added to first-line chemotherapy compared to chemotherapy alone.

2 Jun 2015

NW Bio releases promising new data on DCVax-Direct Phase I trial for inoperable solid tumors

Northwest Biotherapeutics, a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, over the weekend in Chicago released promising new data on their Phase I trial of DCVax-Direct for direct injection into all types of inoperable solid tumors.

2 Jun 2015

Vitamin D and calcium supplements may not help relieve menopausal symptoms, reveals study

Women who took vitamin D and calcium supplements had the same number of menopausal symptoms as women who did not take the supplements, according to a study published today in Maturitas, the official journal of the European Menopause and Andropause Society.

2 Jun 2015

ASCO 2015: Novartis presents data on Zykadia and Tafinlar studies for non-small cell lung cancer

Novartis today announced new data from two Phase II studies of Zykadia (ceritinib), as well as one Phase II study of Tafinlar® (dabrafenib) in combination with Mekinist (trametinib) in certain patients with non-small cell lung cancer.

2 Jun 2015

Boehringer Ingelheim presents afatinib LUX-Lung 8 trial data at ASCO 2015

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy.

2 Jun 2015

Talimogene laherparepvec treatment shows durable clinical responses in advanced-stage melanoma patients

Research led by Howard L. Kaufman, MD, FACS, associate director for clinical science and chief surgical officer at Rutgers Cancer Institute of New Jersey and colleagues, shows advanced-stage melanoma patients have significant improvement in durable response rate and a trend toward improved survival when treated with a genetically-modified form of a herpes virus, whose native form causes the common cold sore.

2 Jun 2015

VBL Therapeutics reports positive results from VB-111 Phase 1/2a study in recurrent platinum-resistant Müllerian cancer

VBL Therapeutics, a late-stage clinical biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced positive interim results from an investigator-initiated, Phase 1/2a trial of multiple dose VB-111 in recurrent platinum-resistant Müllerian (ovarian) cancer.

2 Jun 2015

Novartis CTL019 CAR T cell therapy demonstrates potential to treat B-cell lymphomas

Novartis is highlighting data from an ongoing Phase II clinical study of CTL019, an investigational chimeric antigen receptor (CAR) T cell therapy, that indicate its potential in the treatment of specific types of hard-to-treat non-Hodgkin lymphoma.

2 Jun 2015

Clinical Trial News and Research

CASI files application with CFDA to conduct ENMD-2076 Phase 2 trial in fibrolamellar carcinoma patients

Experimental Zephyr endobronchial valve provides good result in emphysema patient at UAB

Breast surgery for low-grade ductal carcinoma in-situ may not change patients' survival rate

New study suggests that IDH1 gene may be prognostic marker for anaplastic astrocytoma

Study: Intravenous nutrition source may significantly reduce toxicity of platinum-based cancer drugs

Ardelyx signs termination agreement with AstraZeneca, regains rights to portfolio of NHE3 inhibitors

Women who suffer from fibromyalgia benefit from hyperbaric oxygen therapy

BioCision, CCT to develop ThawSTAR automated cell thawing system for treatment of diabetic foot ulcers

ProBioGen initiates clinical trials of Ebola vaccine using AGE1.CR.pIX cell line

Nivolumab and pembrolizumab therapies continue to show promise against advanced melanomas

Celltrion receives approval for infliximab biosimilar antibody from Brazil's ANVISA

ASCO 2015: Berg presents data from BPM 31510 Phase Ib trial for solid tumors

Apatorsen added to first-line chemotherapy benefits metastatic bladder cancer patients

NW Bio releases promising new data on DCVax-Direct Phase I trial for inoperable solid tumors

Vitamin D and calcium supplements may not help relieve menopausal symptoms, reveals study

ASCO 2015: Novartis presents data on Zykadia and Tafinlar studies for non-small cell lung cancer

Boehringer Ingelheim presents afatinib LUX-Lung 8 trial data at ASCO 2015

Talimogene laherparepvec treatment shows durable clinical responses in advanced-stage melanoma patients

VBL Therapeutics reports positive results from VB-111 Phase 1/2a study in recurrent platinum-resistant Müllerian cancer

Novartis CTL019 CAR T cell therapy demonstrates potential to treat B-cell lymphomas

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