Here’s a roundup of recent clinical trial and scientific study news:
- Intraoperative defibrillator testing under scrutiny
Biotronik SE & Co. KG announced today the start of the NORDIC ICD clinical trial. NORDIC ICD is an international, multicenter clinical study to evaluate whether ICD implantation without an intraoperative defibrillation test is noninferior to ICD implantation with intraoperative DF testing, regarding the long-term treatment efficacy of all spontaneous ventricular tachyarrhythmia episodes. The primary endpoint is the average efficacy of the first ICD shock for all true ventricular tachyarrhythmias of a patient in the observational period. More than 580 patients will be enrolled. NORDIC ICD will be limited to the use of Biotronik’s Lumax 540/340 ICD families and newer generations, with the capability of high energy defibrillation output.
The first implantable cardioverter defibrillator patients were enrolled by its coordinating clinical investigator, Prof. Dr. Dietmar Bänsch at the University Hospital of Rostock and the investigator Dr. Stefan Kuster at the DRK Hospital of Mölln/Ratzeburg. "Even though there is minimal data supporting routine intraoperative defibrillation testing, and no international guidelines that substantiate this practice, a clinical routine established decades ago is difficult to change. Trials such as NORDIC ICD are necessary to develop a solid evidence base that may alter clinical practice." Johan Brandt of Skane University Hospital in Sweden said in prepared remarks. Brandt developed the study protocol with Bänsch.
- Phase 2 Lymphoseek data published in Annals of Surgical Oncology
Neoprobe Corp. (AMEX:NEOP) announced that results from a Phase II study of Lymphoseek (Tilmanocept) have been published online in the Annals of Surgical Oncology and demonstrate the tracing agent’s ability to identify tumor-draining lymph nodes in breast cancer and melanoma patients. The publication of the multi-center clinical results was announced yesterday after market close by Dr. Stanley Leong, Chief of Cutaneous Oncology and Associate Director of the Melanoma Program at the Center for Melanoma Research and Treatment, California Pacific Medical Center. Dr. Leong was the lead author of the study.
- Otonomy touts OTO-104 hearing loss study results
Otonomy Inc. announced positive results for the company’s lead product candidate, OTO-104, in multiple preclinical models of hearing loss. Data demonstrated that a single intratympanic injection of OTO-104, a sustained release gel formulation of the corticosteroid dexamethasone, provided significant protection against both noise-induced and chemotherapy-induced hearing loss when administered prior to trauma. The treatment was also shown to promote recovery from noise-induced hearing loss when administered several days following trauma. These findings were presented at this week’s 34th MidWinter Meeting of the Association for Research in Otolaryngology.
- Biomoda completes patient enrollment for pilot study
Cancer diagnostics company Biomoda, Inc. (OTC:BMOD) announced that it has completed patient enrollment and sample collection for the pilot study to determine the clinical sensitivity and specificity of its CyPath diagnostic assay for the early detection of lung cancer. The pilot study consisted of two cohorts: a high-risk group of military veterans who smoked more than 20 “pack years” and a smaller positive control group made up of patients diagnosed with lung cancer who have not started treatment. Currently for investigational use only, the CyPath labeling solution binds to cancer cells and causes them to fluoresce under specific frequencies of light. Biomoda is seeking Food & Drug Administration approval of its diagnostic technology as a Class III medical device.
- NxStage touts Freedom study data
NxStage Medical Inc. (NSDQ:NXTM), a leading manufacturer of innovative dialysis products, today announced the latest interim results from its ongoing FREEDOM study which show an increase in overall quality of life benefits, significant improvement in overall sleep quality and a marked improvement in Restless Legs Syndrome symptoms experienced by patients after 12 months of daily home hemodialysis with the NxStage System One. The study results were presented during the Annual Dialysis Conference in Phoenix, Arizona. The ongoing FREEDOM study is the largest study of its kind to measure the clinical and economic benefits of daily home hemodialysis treatment, as compared to conventional, thrice-weekly in-center hemodialysis treatment for patients requiring dialysis therapy.