Current Clinical Trial Status

We have FDA authorization to commence an investigational pilot study in patients with refractory head and neck cancer. This trial will be limited to those patients who have a recurrence of prior disease and / or who have failed other therapies. This trial will not include other types of cancers. Participation in this investigational clinical trial may only be determined by a study site clinical investigator. Contact information will be posted shortly for those interested in participating.

AuroLase™ Therapy combines the unique physical and optical properties of AuroShell™ particles with a near infrared laser source to thermally destroy cancer cells without significant damage to surrounding tissue.

AuroShell™ particles are administered intravenously and specifically collect in the tumor through the associated leaky vasculature (the Enhanced Permeability and Retention effect, or EPR). After the particles accumulate in a tumor, the area is illuminated with a near-infrared laser at wavelengths chosen to allow the maximum penetration of light through tissue. Unlike solid metals and other materials, AuroShell™ particles are designed to specifically absorb this wavelength, converting the laser light into heat. This results in the rapid destruction of the tumor along its irregular boundaries.

Preclinical studies have shown that AuroLase™ Therapy is safe and highly effective.

We have also performed extensive safety testing of AuroShell™ particles in animal studies. Long-term studies have not indicated any toxicity or effect on the immune system. Accordingly, we believe AuroLase™ Therapy will have a significant safety advantage over traditional chemotherapy and ionizing radiation.

While AuroLase™ Therapy can be used to treat nearly all solid tumors, we will conduct our first clinical trial in patients with refractory head and neck cancer. This trial is currently enrolling patients.

Other cancer applications will be developed after these initial trials.

The potential benefits of AuroLase™ therapy include:

(i) the precise elimination of irregularly shaped or invasive solid tumors;
(ii) the potential treatment of otherwise non-resectable tumors;
(iii) a minimally invasive therapy that avoids significant damage to surrounding healthy tissue and preserves critical structures; and
(iv) a biocompatible material with no evidence of systemic toxicity.

Additionally, our therapeutic device may be used in combination with, and could increase the effectiveness of standard chemotherapy and radiation.