NovaRx scientists were the first in the world to demonstrate that blocking a molecule called transforming growth
factor-beta (TGF-β), which is commonly produced by cancer cells, leads to improved antitumor immune
responses. TGF-β allows cancer cells to hide from the body's natural immune system.
When TGF-β is blocked, the immune system can see, find, and destroy the cancer naturally.
In a study published in the scientific journal Proceedings of the National Academy of Sciences. NovaRx scientists showed the Company's technologies were able to completely eradicate rapidly growing tumors in an animal model. They later extended this finding to the treatment of patients with brain and lung cancers.
NovaRx's patented platform technologies, vaccine therapies, can potentially be developed for most kinds of cancer. Although the Company's current clinical trials are for the treatment of advanced non-small cell lung cancer, the majority of other forms of cancer are also characterized by TGF-&beta. immunosuppression. Should the viability of this technology be proven in a pivotal Phase III trial, there could be many other therapeutic vaccines developed by NovaRx in the future to treat other types of cancer.
NovaRx's lead product candidate is Lucanix® , a cell-based therapeutic vaccine
for patients with non-small cell lung cancer (NSCLC). In contrast to conventional
cancer therapies, where systemic chemotherapeutic drugs nonspecifically kill normal
cells as well as tumor cells, Lucanix® induces a patient's immune system to
specifically target the cancer.
Lucanix® consists of four NSCLC cell lines gene-modified to block the secretion
of TGF-β. The vaccine was tested in a Phase II clinical trial. In the trial,
advanced stage NSCLC patients (stages IIIB and IV) who had received zero to five
prior chemotherapies, demonstrated a one-year survival of 61% and a two-year
survival of 41%, and a median survival of 16 months.
The United States Food Drug Administration granted NovaRx Fast-Track and Special Protocol Assessment approval for the Phase III Lucanix® trial. The trial commenced in August of 2008 and NSCLC patients are currently being treated in the trial globally.
Lucanix® is currently under clinical investigation but has not been approved for use in the United States. Canada. Europe or elsewhere. The product has not been proved to be safe or effective, and any claims of safety and effectiveness can be made only after regulatory review of the Phase Ill data and approval of the labeled claims.
Although NovaRx's current clinical trials are for the treatment of advanced NSCLC,
another promising NovaRx pipeline therapy, Glionix™ for glioma (brain cancer) has
already been tested in a Phase 1 clinical trial.
Glionix™ functions similarly to Lucanix®. The Glionix™ vaccine consists of glioma cell lines in which TGF-β immunosuppression has been blocked. A phase III clinical trial for Glionix" is expected to commence within a year.
Universal Cancer VaccineThe current formulation for NovaRx vaccines that block TGF-β requires that a different vaccine be used for each different type of cancer. That also means that each different vaccine must be tested separately, which adds time to the development process and delays availability of the product.
NovaRx has begun research on a universal cancer vaccine. This vaccine will feature the blocking of TGF-β immunosuppression similar to its other products, but it will express molecules that would make it more potent and effective for a large number of different cancer indications, including their tumor initiating cells, not just a single cancer. Potentially, this would make the vaccine available to patients with colon cancer, breast cancer, and prostate cancer, among others.