Theorem Clinical Research

Clinical Intelligence

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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Quest Diagnostics

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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FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer

Monday, December 15, 2014 12:50 PM

The FDA has expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).

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Anergis starts phase II trial with birch pollen allergy vaccine AllerT

Monday, December 15, 2014 08:00 AM

Anergis, a Swiss-based company developing proprietary ultra-fast allergy vaccines, has begun a phase II trial designed to finalize the dose selection for the phase III study of AllerT. AllerT is Anergis´ lead vaccine against birch pollen allergy that originated from the company´s proprietary Contiguous Overlapping Peptide (COP) platform. COPs are pharmaceutical-grade, long-peptide immunotherapeutics designed for an ultra-fast, safe and long-lasting treatment of allergy patients.

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March 2

Huntingdon Life Sciences-Harlan prepares for rebranding and U.S. expansion to compete with early phase CROs Covance, CRL

Patients' increased sharing of clinical trial experiences through social media can help sponsors improve outcomes, enrollment

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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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