Pari Nebulizer Used in Phase I Trial of Alnylam RSV Drug
Aerosol delivery system maker Pari said this week that its eFlow electronic nebulizer is being used in a phase I study of Alnylam Pharmaceuticals’ investigational respiratory syncytial virus therapy ALN-RSV01.
Alnylam said last week that it had begun a phase I trial of an inhalable version of ALN-RSV01, which is designed to deliver the therapy directly to the lungs and is the expected formulation for the treatment of naturally infected RSV patients (see RNAi News, 10/12/2006).
Korean Oligo Manufacturer Bioneer Opens US Subsidiary
Korean oligo manufacturer Bioneer has opened a US subsidiary in Alameda, Calif., the Korean biotech company said last week
Bioneer selected the site for its manufacturing facility and distribution center to be near San Francisco’s biotech hub and “for environmental conditions ideally suited” to synthetic oligonucleotide production.
The 22,000-square-foot facility will have the capacity to manufacture 6,000 oligos per day. The firm said capacity will rise with increased demand.
Since its IPO in December 2005, Bioneer has expanded into North America and Europe.
Genta Begins Phase I Trial of Antisense-Based Cancer Therapy
Genta said last week that it has begun a phase I trial of an antisense-based cancer drug, G4460.
According to the company, G4460 targets the oncogene c-myb. “Using an accelerated dosing schedule, this study will evaluate dosing regimens, safety, biologic activity, and down-regulation of c-myb in patients with advanced hematologic cancers,” Genta said.
G4460 has been granted orphan drug designation by the US Food and Drug Administration, the company noted.
Initiation of the phase I study follows a series of setbacks for Genta’s once-promising antisense drug Genasense.
In September, an FDA advisory panel recommended the agency not approve Genasense for CLL, sending shares of the company tumbling (see RNAi News, 9/7/2006). The FDA is not obligated to follow its advisory panels’ recommendations, but usually does.
Previously, Genasense failed to prove effective in phase III testing in its key indication, melanoma. This setback led to the dissolution of a marketing deal between Genta and Sanofi-Aventis.
Bio-Rad Closes Acquisition of Dx QC Firm Blackhawk
Bio-Rad Laboratories this week said it has closed its acquisition of Blackhawk Biosystems, a privately held maker of quality-control products for infectious disease testing.
Bio-Rad CEO Norman Schwartz said he expects this acquisition will help his company expand its online quality control and inter-laboratory peer group comparison.
Financial terms of the acquisition were not disclosed.