Here’s a roundup of recent clinical trial news:
- Accuray touts CyberKnife prostate cancer radiosurgery results
Accuray Inc. (NSDQ:ARAY), a developer of radiosurgery devices, announced the first published five-year outcomes on low risk prostate cancer patients treated with the CyberKnife® Robotic Radiosurgery System. The multi-center study, published in the Jan. 10, issue of Radiation Oncology, found that 93 percent of patients had no recurrence of their cancer at a median follow-up of five years, a rate that compares favorably to results obtained with other treatment modalities, including surgery and conventional radiation therapy.
- Individuals with partial hearing loss may benefit from hybrid cochlear implant
Hearing loss can affect anyone, at any time. But it can be especially frightening for someone who suddenly starts to lose his hearing during adulthood. Tom Groves, 77, first noticed his diminishing hearing when he was in his early 40s. He was unable to hold conversations with large groups of people; found it nearly impossible to socialize in high-background noise environments like restaurants; and couldn’t enjoy radio, TV and movies unless they were captioned. Now, Groves is hearing much better than he has in 30 years, thanks to an experimental hybrid cochlear implant.
- Apollo Endosurgery demonstrates functionality of the OverStitch cndoscopic suturing system in bariatric repairs and GI therappy
Apollo Endosurgery Inc. announced preliminary results from their GEMINI suturing registry. These results confirm the procedure enabling capability of their newly-launched OverStitch™ Endoscopic Suturing System in a variety of clinical cases in the esophagus, stomach and colon.
A unique device that mimics the way physicians deploy sutures by hand, the OverStitch system enables full-thickness endoscopic suturing on a flexible platform — delivering a surgical standard of care through the flexible endoscope.
- Sequenom CMM commences pivotal clinical validation study for its SensiGene Trisomy 21 laboratory developed test
Sequenom Inc. (NSDQ:SQNM) today announced that the company’s wholly-owned reference laboratory, the Sequenom Center for Molecular Medicine (Sequenom CMM), has authorized commencement of a pivotal clinical validation study. This validation study is designed to evaluate the clinical performance of the SensiGene T21 Laboratory Developed Test (LDT) for the detection of an overabundance in maternal blood of chromosome 21, which is associated with fetal chromosome 21 aneuploidy. Testing of the clinical specimens will be performed at the Sequenom CMM facility in San Diego.
- Cardium’s Excellagen Matrix clinical study results accepted for publication
Cardium Therapeutics (NYSE:CXM) today reported that data from the company’s Matrix Phase 2b clinical study has been accepted for publication in the journal, Wound Repair and Regeneration and provided an update on plans for commercialization of its Excellagen formulated collagen topical wound dressing. The clinical paper now accepted for publication is titled, “Formulated Collagen Gel Accelerates Healing Rate Immediately after Application in Patients with Diabetic Neuropathic Foot Ulcers”, and was authored by nine investigators who participated in the Matrix study and Cardium researchers and is expected to be published in early 2011.
- New research reveals unexpected biological pathway in glaucoma
In a study published today in the Proceedings of the National Academy of Sciences, a team of researchers from the Kennedy Krieger Institute and four collaborating institutions, identified a new and unexpected biological pathway that appears to contribute to the development of glaucoma and its resulting vision loss. Prior research has suggested that the optic nerve head, the point where the cables that carry information from the eye to the brain first exit the eye, plays a role in glaucoma. In this study, researchers report a series of findings that offer novel insights into cellular and molecular mechanisms operating at the optic nerve head in two mouse models of glaucoma.
- Metabolomics provides insight into pathogenesis of dilated cardiomyopathy
Metabolon Inc. announced the publication of “Metabolomic Distinction and Insights into the Pathogenesis of Human Primary Dilated Cardiomyopathy”, in the European Journal of Clinical Investigation. Metabolon’s non-targeted biochemical profiling (metabolomics) platform was used to identify biochemical biomarkers of primary dilated cardiomyopathy (DCM) and potential therapeutic targets for DCM. The study was carried out by Metabolon scientists in collaboration with A. J. Marin and colleagues from The University of Texas Health Science Center and Texas Heart Institute at Houston.
- Boston Scientific completes enrollment in clinical trial evaluating next-generation nitinol stent to treat iliac artery disease
Boston Scientific Corp. (NYSE:BSX) announced that it has completed enrollment in the ORION clinical trial, which is designed to evaluate the Company’s EPIC™ Self-Expanding Nitinol Stent System for the treatment of iliac artery disease, a form of peripheral artery disease associated with severe leg pain caused by insufficient blood flow to the muscles (claudication). The trial will examine rates of device- and/or procedure-related major adverse events and patency rates at nine months in 125 patients at 28 sites in the United States.
- Safety and efficacy of OrbusNeich’s Genous stent demonstrated in high-risk patients with known contraindications for dual antiplatelet therapy
Data from patients who are considered high-risk due to underlying clinical conditions and who cannot be treated with drug eluting stents (DES) and the accompanying requirement of long-term dual antiplatelet therapy (DAPT) showed positive safety and short- and long-term clinical outcomes following treatment with OrbusNeich’s Genous Stent, according to a study published online in EuroIntervention (published-ahead-of-print, August 2010).
- Gore reports first patient treated using Gore C3 delivery system for Gore Excluder AAA Endoprosthesis
W. L. Gore & Associates today reported the first clinical uses of the GORE® C3 Delivery System to deploy the GORE® EXCLUDER® AAA Endoprosthesis as a minimally invasive treatment for patients suffering from an abdominal aortic aneurysm (AAA). The device received approval from the Food & Drug Administration in Jan. 2011. The first procedures were successfully performed by vascular surgeons and interventionalists at medical centers of excellence around the U.S. this week. This game-changing new technology represents a leap forward in medical innovation by allowing physicians to position the device to the specific anatomy of each individual patient.