Current Status of a Clinical Trial

We have FDA approval to commence a human trial in patients with head and neck cancer. This trial will be limited to those patients who have a reoccurrence of prior disease and / or who have failed other therapies. This trial will not include other types of cancers. We will post information with the contacts for the physicians who can enroll patients at a later date. We do not enroll patients in the trial; this is done by the physician at the hospitals where the trial will be conducted. Please visit our web site in the future for the posting of further details.

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.

These AuroShell™ particles are injected 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 our therapy is 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 destroy nearly all solid tumors, we will conduct our first clinical trial in patients with head and neck cancer.

We currently intend to commence a human trial for the treatment of head and neck cancers in 2008. 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.