Targeted Hyperthermia Treatment Accepted for Full Characterization at the Frederick National Laboratory for Cancer Research
Siva Therapeutics in partnership with NanoHybrids have teamed to develop and manufacture gold nanoparticles for treating cancer with hyperthermia. The nanoparticle treatment was submitted to the Frederick National Laboratory for Cancer Research and has passed the first stages in the Nanotechnology Characterization Laboratory, which helps pave the way for regulatory review of nanotechnologies intended for cancer therapies and diagnostics.
FNL’s Nanotechnology Characterization Laboratory (NCL) – a partnership with the U.S. Food and Drug Administration and the National Institute of Standards and Technology – is a world leader in the characterization of therapeutic nanoparticles, which helps pave the way for regulatory review of nanotechnologies intended for cancer therapies and diagnostics.
The NCL uses a three-tiered assay cascade to thoroughly characterize each nanomaterial strategy submitted to the lab for physical and chemical attributes, in vitro biological properties, and in vivo compatibility through preclinical toxicology, pharmacology, and efficacy studies. Through an application process, NCL offers preclinical characterization services to investigators nationwide who have developed promising nanotechnology-based cancer treatments. NCL’s assay cascade takes about a year to complete.
Siva delivered a pilot-scale batch of SivaRods™ precision gold nanorods, manufactured by partner company NanoHybrids, Inc. to the NCL early in 2017. “We are pleased that our partnership with Siva continues to progress and build value for both companies,” stated Kimberly Homan, PhD,CTO of NanoHybrids. “Through the NCL process, we are building support for the clinical translation of Siva’s promising technology.”
“The NCL Assay Cascade Program is the premier program in the world for bringing nanomaterials through critical preclinical stages and facilitating regulatory review,” said Len Pagliaro, PhD, CEO of Siva. “We are very pleased at having successfully passed through the first stages of the program, a step which validates the manufacturing capabilities of our partners at NanoHybrids, Inc., and the commercial potential of SivaRods for Targeted Hyperthermia. The scientific, technical, and regulatory resources of the NCL are greatly strengthening Siva’s next steps toward the clinic.”