Nastech Considers Spinning Out its RNAi Operations
Nastech Pharmaceuticals is considering spinning out its RNAi drugs business from its other operations, RNAi News has learned.
Speaking last week in San Francisco at Beyond Genome 2007, Nastech President and CEO Steven Quay said that a significant portion of the investment community has been hesitant to embrace RNAi as a therapeutic modality given its early-stage status.
As such, the company is considering splitting its RNAi business from its core operations in order to give Wall Street the option of investing in either technology.
Quay declined to comment further on the possible move, but a company spokesman told RNAi News in an e-mail this week that Nastech is weighing the possibility of “separating the ‘businesses’ structurally to allow the company the flexibility to follow any of a number of business/strategic options.
“At this point, no decision has been made as to which of several options may be implemented or when,” the spokesman added. “The company’s decision will be guided by the option that would provide the greatest increase in shareholder value.”
Nastech’s talk of spinning out its RNAi unit comes just months after CytRx spun out its RNAi drug operations into RXi Pharmaceuticals in order to gain better traction in the marketplace (see RNAi News, 1/11/2007).
NIH Finds UTMB Research Falsified Research, Signs Exclusion Agreement
The National Institutes of Health said last week that it has determined that a former surgical resident in the department of surgery at the University of Texas Medical Branch at Galveston falsified research in RNAi-based, NIH-funded experiments.
According to the NIH, Carlos Murillo had received grants from the National Institute of Diabetes and Digestive and Kidney Diseases to use siRNAs to ameliorate dextran-induced colonic toxicity in mice.
Murillo “altered the concentrations of dextran solution fed to mice to induce colonic inflammation, by intentionally including little or no dextran in the drinking water of siRNA treated mice, so that the animals that received siRNA would have few or no colonic lesions,” the NIH said.
The NIH said that Murillo has voluntarily accepted a three-year agreement under which any institution that submits an application for US Public Health Service research support for a project involving Murillo must also submit a plan for supervision of his duties to the funding agency for approval.
Additionally, Murillo has agreed to ensure that a copy of the supervisory plan is also submitted to the NIH’s Office of Research Integrity and that he will not participate in any such research until such a supervision plan is submitted, the NIH said.
Murillo has also agreed to exclude himself from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. Finally, he has agreed to request retraction of the abstract entitled “Inhibition of Phosphoinositol 3-kinase Using Anti-p85 siRNA Attenuates Dextran-Sulfate-Induced Inflammatory Bowel Disease,” which appeared in Gastroenterology in 2004.
Alnylam Begins Experimental Infection Study of RSV Drug
Alnylam Pharmaceuticals said this week that it has initiated a phase II experimental infection study of its respiratory syncytial virus treatment ALN-RSV01.
The phase II trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and anti-viral activity of ALN-RSV01 administered to approximately 90 healthy adult volunteers experimentally inoculated with RSV, Alnylam said.
The study will evaluate the incidence of infection, measures of viral load, and occurrence of clinical symptoms, the company added. ALN-RSV01 will be administered both before and after inoculation with RSV, and the drug, virus, and placebo will all be administered intranasally. Data from this trial are expected toward the end of the year.
Alnylam is also currently enrolling patients in a phase I study to examine an inhalable form of ALN-RSV01, which is expected to be the version of the drug submitted for regulatory approval.
Agilent to Manufacture siRNA for Intradigm Clinical Trial
Intradigm said this week that it has signed a deal under which the active siRNA in its preclinical cancer drug ICS-283 will be manufactured by Agilent Technologies.
Under terms of the agreement, Agilent will provide to Intradigm the siRNA manufactured under current Good Manufacturing Practice standards.
Intradigm expects to begin phase I testing of the RNAi drug next year.
VWR to Rep for RNAx's siRNA, shRNA Services in Europe
RNAx said this week that VWR will serve as a sales representative for its RNAi services in Europe.
Under the multi-year, co-exclusive agreement, researchers in Europe will be able to access automated siRNA and shRNA validation services at RNAx via their local VWR specialist service representative.
Financial terms of the agreement were not released.
Amaxa to Oversee EU-Funded Effort to Develop Primary Cell Transfection Device
Amaxa said last week that it will coordinate a European collaboration of eight partners to develop devices for ultra high-throughput transfection of primary cells.
The partnership was issued more than €2.75 million ($3.7 million) in funding from the European Commission and will use Amaxa’s Nucleofector technology, the company said.
Amaxa said the development project, termed Modest-EU, is expected to last three years and includes Deutsches Rheumaforschungszentrum, RNAx, Protobios, Fotec, HTP High Tech Plastics, Dominion Pharmakine, and Prevas.