Overcoming Challenges in Manufacturing Scale-Up of Plasmonic Gold Nanorods: Bringing Photothermal Therapy to the Clinic.

Siva Therapeutics is developing a simple, safe, and effective adjunct cancer treatment termed Targeted Hyperthermia™, which generates therapeutic heat emanating from within solid tumors using systemically injected precision gold nanorods and an infrared light engine – technology termed photothermal therapy. Heat has several beneficial effects for solid tumors, including selective induction of apoptosis in cancer cells, stimulation of the immune system, inactivation of cancer stem cells, and increased perfusion resulting in improved drug efficacy. Targeted Hyperthermia provides precision heating of tumors with minimal collateral damage, using SivaRods™ polymer-coated gold nanorods and a SivaLum™ infrared light engine, and it promises to be a valuable adjunct to current drug therapies. While awareness of the therapeutic value of hyperthermia has been in the cancer community for many decades, implementing practical, safe, and cost effective hyperthermic therapies has been challenging. Nanotechnology has provided key tools for targeting heat to tumors, and photohermal therapy, in particular, has demonstrated efficacy, both in animal models, and now in the clinic. A critical hurdle for photothermal therapy has been scaling up manufacture of nanoparticles to pilot batch size, while maintaining plasmonic properties and uniformity of the material. Siva has accomplished pilot scale manufacturing, and is currently undertaking full characterization of this material through a grant from the Nanotechnology Characterization Laboratory (https://ncl.cancer.gov/), which is supported by the National Cancer Institute, the FDA, and NIST. Additionally, Siva is developing a second generation LED-based infrared light engine with the ability to illuminate regions of ~10 cm in diameter with high intensity infrared light to excite nanorods that have concentrated in tumors. Together, these advances have made nanotechnology-enabled photothermal therapy more practical, safe, and cost-effective than was previously possible.

Overcoming Challenges in Manufacturing Scale-Up of Plasmonic Gold Nanorods: Bringing Photothermal Therapy to the Clinic.

Siva’s Targeted Hyperthermia™ Treatment Accepted for Full Characterization at the Frederick National Laboratory for Cancer Research

AUSTIN, TEXAS, July 18, 2017 – Siva Therapeutics (“Siva”) is pleased to announce that its Targeted Hyperthermia™ technology has successfully passed through the first stages of nanoparticle characterization at the Frederick National Laboratory (FNL) for Cancer Research in Frederick, Md.

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.
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Siva Therapeutics Publishes in the Journal of Nanomaterials

BOULDER, COLORADO, August 7, 2014 – Siva Therapeutics has had a manuscript accepted for publication in the Journal of Nanomaterials.  The forthcoming paper, entitled “Photothermal therapy using gold nanorods and near-infrared light in a murine melanoma model increases survival and decreases tumor volume” by Mary Popp and colleagues, describes Siva’s approach to photothermal monotherapy for melanoma, using the aggressive B16F10 mouse melanoma model.  The study also describes the tissue and gel models used to develop and calibrate the photothermal therapy approach.

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Siva Therapeutics Initiates Research Collaboration with SomaLogic Inc.

BOULDER, COLORADO, March 18, 2014 – Siva Therapeutics (“Siva”) has initiated a research collaboration with SomaLogic, Inc. (Boulder, CO). The initial focus of the collaboration is to determine the ability of SomaLogic’s SOMAmer® (Slow-off Rate Modified Aptamer) reagents to actively target gold nanorods to solid tumors. Continue reading “Siva Therapeutics Initiates Research Collaboration with SomaLogic Inc.”

Siva Therapeutics Initiates Research Collaboration with Plexxikon Inc.

PlexxikonBOULDER, COLORADO, January 23, 2014 – Siva Therapeutics Inc (‘Siva’) has initiated a research collaboration with Plexxikon Inc., of Berkeley, California. The focus of the collaboration is to evaluate the potential for synergistic effects between Zelboraf®, a cancer treatment approved for BRAF V600E mutation-positive metastatic melanoma discovered and co-developed by Plexxikon, and SivaRods™ photothermal therapy. Continue reading “Siva Therapeutics Initiates Research Collaboration with Plexxikon Inc.”

Siva Therapeutics Completes Efficacy Study in Melanoma Model and Files FDA Pre-Submission

BOULDER, COLORADO, July 10, 2013 – Siva Therapeutics Inc (‘Siva’) has generated very positive efficacy results in a challenging mouse melanoma model, using SivaRods™ photothermal therapy. In the study, significant decreases in tumor volume and increased survival, relative to control animals, were seen.  Continue reading “Siva Therapeutics Completes Efficacy Study in Melanoma Model and Files FDA Pre-Submission”

Siva Therapeutics Closes Angel Financing Round, Moves into New Facilities

BOULDER, COLORADO, December 3, 2012 –Siva Therapeutics has closed an initial angel financing round; this funding, together with a recent $350,000 grant from Breakout Labs, has enabled Siva to expand operations and to undertake a new series of studies on its nanotechnology enabled photothermal therapy. With this financing in place, Siva has hired a Bioengineer Continue reading “Siva Therapeutics Closes Angel Financing Round, Moves into New Facilities”