Spherix starts patient recruitment in India for phase 3 diabetes trial
Researchers used a new imaging technique to take high quality color photographs of the clinical stages of ocular inflammation in mice, and the technology could help in the monitoring and treatment of diseases of the eye that may cause blindness. The study, “The Clinical Time-Course of Experimental Autoimmune Uveoretinitis Using Topical Endoscopic Fundal Imaging with
Full Post: New imaging technique captures clinical stages of ocular inflammation
Spherix Incorporated reported that patient recruitment for its Phase 3 clinical trial of its potential type 2 diabetes drug, Naturlose, has begun in India. Expectations for India are to provide more than 300 patients spread across 35 sites for the pivotal Phase 3 trial.
“Now that enrollment efforts are underway in India, we believe that the Phase 3 trial will be completed on schedule as reported during the May 2008 Annual Shareholders Meeting. This truly represents a tremendous amount of hard work, both internally and externally, to achieve regulatory approval and patient recruitment in such a short period of time,” said Randy W. Brown, Chief of Operations. Global enrollment is scheduled for completion by the end of the first quarter 2009, and the trial is scheduled to be completed in 2010.
Spherix Incorporated also announced the signing of a contract with Amarex, a Contract Research Organization (CRO) located in Germantown, MD, to oversee the work of two India CROs hired to execute the trial in India.
“It became quite clear that the trial was not executable solely in the United Sates with our known parameters; therefore, India became an obvious, viable solution. I now expect our ultimate deliverable, a new drug application, to be back on schedule,” said Mr. Brown.
Certain statements contained herein are “forward looking” statements as defined in the Private Securities Litigation Reform Act of 1995. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied. Factors that could cause actual results to differ materially from those expressed or implied include, but are not limited to, those discussed in filings by the Company with the Securities and Exchange Commission, including the filing on Form 8-K made on October 10, 2007.
Spherix’s mission is to create value and increase shareholder wealth through innovations that benefit our clients and the human condition. Spherix offers innovations in biotechnology, and provides technical and regulatory consulting services to biotechnology and pharmaceutical companies.
ZOLL Medical Corporation, a manufacturer of resuscitation devices and related software solutions, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and sell the ZOLL R Series Code-Ready clinical defibrillator with a WiFi option that allows wireless communication between the defibrillator and standard hospital networks to help ensure code-readiness and download
Full Post: ZOLL Medical cleared to market defibrillator with WiFi option
SpectraScience, Inc. has announced that it has been awarded U.S. Patent number 7,469,160 for its methods and apparatus for evaluating image focus. Jim Hitchin, SpectraScience’s CEO, commented, “This patent is another important addition to our expanding intellectual property portfolio.” The invention provides methods of focusing an instrument for the acquisition of optical data from a
Full Post: SpectraScience awarded U.S. patent for methods and apparatus for evaluating image focus
Sequella, Inc., a clinical-stage biopharmaceutical company focused on diseases of epidemic potential, announced today that SQ109, its lead drug candidate for the treatment of tuberculosis (TB), was the first drug approved for evaluation in a newly awarded clinical program contract to Dynport Vaccine Company LLC and Quintiles Transnational. The contract, awarded by the National Institute
Full Post: Sequella, Inc. drug compound SQ109 selected for phase 1B clinical trial program
SemBioSys Genetics Inc., a biotechnology company developing protein pharmaceuticals in crop plants, has announced that it has initiated a phase I/II clinical trial of its plant-produced insulin with the first injection of its drug in humans. The trial, taking place in the United Kingdom (UK), will include up to 30 healthy volunteers in a three-arm study
Full Post: SemBioSys begins phase I/II trial of insulin produced in plant seeds
Delcath Systems, Inc. has announced that the first fifty percent (46 of 92) of patients have been enrolled in the Phase III clinical trial treating metastatic cutaneous and ocular melanoma to the liver. The eleven participating cancer centers in this trial continue to evaluate and enroll patients and the Company looks forward to completing enrollment
Full Post: Delcath Systems enrols first fifty percent in trial treating metastatic cutaneous and ocular melanoma to the liver