Theorem Clinical Research

Clinical Intelligence

VolitionRx begins first ovarian cancer detection study

Thursday, January 22, 2015 02:39 PM

VolitionRx, a Belgium-based life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, has signed an agreement to commence a pilot ovarian cancer study in collaboration with Singapore General Hospital (SGH). Blood and tissue samples collected from 40 patients will be assessed to establish the feasibility of VolitionRx's proprietary NuQ assays in detecting ovarian cancer. If this test proves to be accurate, it could offer hope as an early-stage screening tool.

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Quest Diagnostics

Celator Pharmaceuticals receives FDA Fast Track for CPX-351 for AML

Thursday, January 22, 2015 01:54 PM

The FDA granted Fast Track designation for Celator Pharmaceuticals’ CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary acute myeloid leukemia (AML).

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TapImmune reports positive immune responses in phase I cancer trial

Friday, January 16, 2015 01:08 PM

TapImmune, an immunotherapy company, has reported the completion of data analysis from all 21 evaluable patients treated in a phase I clinical trial. In addition, the recent financing provides immediate, short term and long term access to the capital required to execute its exclusive option to license these very promising peptides and to progress its on-going clinical program into phase II trials.

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Biotronik announces first enrollments in new thromboembolic events study

Friday, January 16, 2015 01:03 PM

Biotronik, a manufacturer of cardiovascular medical technology, has announced the first enrollments in its prospective, multi-center, international Reduce-TE Pilot study (Reduction of AF Ablation Induced Thrombo-Embolic Incidence). The study will assess the ability of the advanced irrigated ablation catheter AlCath Flux eXtra Gold to reduce the incidence of silent microemboli (SME). SME are a complication associated with catheter ablation of the pulmonary veins, a common treatment for atrial fibrillation (AF). The Biotronik ablation catheter features a GoldTip and a 3-D irrigation system which study investigators believe can diminish the number of SME via optimized cooling, thereby improving patient safety.

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FDA approves VBLOC vagal blocking therapy for obesity

Friday, January 16, 2015 12:52 PM

The FDA has approved medical device company EnteroMedics’ VBLOC vagal blocking therapy, delivered via the Maestro System, for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years.

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Inovio Pharmaceuticals HIV immunotherapy shows vital characteristics

Thursday, January 8, 2015 02:28 PM

Inovio Pharmaceuticals has reported results from a 12-patient, phase I study of Inovio's HIV immunotherapy, PENNVAX-B, in HIV-infected patients revealed that immune response characteristics generated by the immunotherapy were similar to those observed in HIV-infected individuals who without treatment do not progress to further stages of the disease.

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Johnson & Johnson begins phase I clinical trial of Ebola vaccine regimen

Thursday, January 8, 2015 02:19 PM

Johnson & Johnson has begun a phase I, first-in-human clinical trial of a preventive Ebola vaccine in development at its Janssen Pharmaceutical Companies. The trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Pediatrics. Recruitment in the trial is underway, and the first volunteers have received their initial vaccine dose. Enrollment is expected to be completed by the end of January.

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FDA grants Soligenix Fast Track designation for SGX301 for lymphoma

Thursday, January 8, 2015 02:12 PM

Soligenix, a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, has announced that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received Fast Track designation from the FDA.

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The CenterWatch Monthly, January 2015

Monday, January 5, 2015 07:00 AM

U.S. watching EMA’s adaptive licensing pilot

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ClinicalRM tests convalescent plasma therapy for Ebola treatment

Monday, December 15, 2014 01:24 PM

Clinical Research Management (ClinicalRM), a full-service CRO with headquarters in Ohio, has announced that the clinical trial evaluating the safety and efficacy of Ebola convalescent plasma (ECP) for the treatment of Ebola virus disease (EVD) in Liberia has commenced. The first donor survivors at the ELWA Hospital 2 unit in Monrovia, Liberia have undergone plasmapheresis. The donated convalescent plasma was transferred to a Liberian patient with EVD in an effort to help them combat this disease. The ClinicalRM trial is being funded through a grant from the Bill & Melinda Gates Foundation.

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March 30

Icon, Carnegie Mellon partner to research ways to improve study patients' understanding of Informed Consent

Veeva launches OpenKey, partner program to unlock difficult access to, restrictions on customer reference data

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The CenterWatch Monthly


Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly


Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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