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.  The data compare very favorably to similar studies performed with melanoma drugs approved over the past few years, and indicate that further improvements to the SivaRods therapeutic regime can be developed in future studies. 

Several aspects of this study set it apart from previously published work in the photothermal therapy field. First, the study used the aggressive, metastatic, and very challenging B16-F10 murine melanoma tumor model in immune-competent C57 mice. Previous work has used human breast tumor models in nude mice, a model know to be more responsive to many cancer therapies. Second, the SivaRods photothermal therapy approach eliminates the use of lasers, a significant factor for both safety and simplicity of treatment. Third, the dosing of both the SivaRods polymer coated nanorods and the infrared light was very low compared to published studies – a factor attributable to the extremely high efficiency of conversion of light into heat by the nanorods. Siva also recently filed a Pre-Submission document with the FDA outlining Siva’s planned route to market as a Class 3 PMA medical device. The Pre-Submission process includes a meeting with the FDA over the next few months to review next steps and development plans.

“Previously published work in the field of photothermal therapy has used relatively simple animal cancer models, with slow growing tumors and low metastatic index. In the present study, we used a very aggressive murine melanoma model in immune-competent mice – a much more challenging test for our therapy,” said Len Pagliaro, PhD, CEO of Siva. “Given the positive results and information gathered from this first efficacy study, we’re planning a follow-on study which we anticipate will yield extremely strong efficacy data.”

A report summarizing the results of this study is available upon request; please contact info@sivatherapeutics.com for a copy.

About Siva Therapeutics Inc

Siva Therapeutics Inc is an early stage biotechnology company developing a device photothermal cancer therapy which uses heat to irreversibly damage solid tumor tissue. The heat is delivered to tumors by infrared light that is absorbed by gold nanorods (‘SivaRods™’) and re-emitted as heat. The size, shape, and surface chemistry of the nanaorods target the leaky vasculature of solid tumors, and the selective thermal sensitivity of tumor tissue enables the therapy to deliver clean margins. Siva therapy promises to be extremely safe, effective, and competitive in cost relative to surgery, chemotherapy, and radiation for cancer treatment. For more information please visit: www.sivatherapeutics.com.

Media Contact: info@sivatherapeutics.com.

PDF version of this article:  July 10, 2013 – Siva Therapeutics Completes Efficacy Study in Melanoma Model and Files FDA Pre-Submission