Technology

NovaRx scientists were the first in the world to demonstrate that the innovation of blocking TGF-β rendered tumor cell vaccines more effective. In a study published in the prestigious scientific journal Proceedings of the National Academy of Sciences, these scientists showed that 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 glioma (brain cancer) and lung cancer. In other work, NovaRx researchers have also demonstrated that inoculation of colorectal cancer patients with allogeneic tumor cells induced immune responses that recognized and targeted the individual patients\' tumor cells.

NovaRx’s patented platform technologies, effective 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 vast majority of other forms of cancer are also characterized by TGF-β immunosuppression. Should the viability of this technology be proven out in pivotal Phase III trials, there could be many other therapeutic vaccines developed by NovaRx in the future to treat other types of cancer.


Lucanix™

NovaRx’s lead product candidate, Lucanix™, a whole cell-based therapeutic vaccine comprised of four allogeneic cell lines, has completed a Phase II clinical trial for the treatment of progressive non-small cell lung cancer. The phase II results confirmed:

Lucanix™, which was utilized to treat 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. These late-stage patients typically demonstrate a less than 30% one-year survival.  Typical two year survival for stage IV patients is 5% and for stage IIIB is 10% on average. In our clinical trial 49 of the above patients had stage IV and 12 patients had stage IIIB disease.  Currently, 59% of the patients who received Lucanix™ following one frontline regimen of chemotherapy and entered the trial with stable disease have lived over 41 months.  Of the 23 patients enrolled in the trial who are still alive, all have lived more than three years, ten have lived more than four years, and three have lived over five years.

Most importantly, Lucanix demonstrated the lack of significant toxicities.  Side effects were generally similar to what one might experience after a flu shot. This is in contrast to many current approved therapies that demonstrate median survival ranges of only 6-8 months with severe side effects. Thus, Lucanix demonstrates not only a median survival which is significantly longer than that of approved, highly toxic therapies, but the mild side effects offer the patient a greatly improved quality of life when compared to the standard of care.

Given these extremely promising results, NovaRx has been granted FDA approval to further Lucanix in a Phase III front-line clinical trial, which will commence in early 2008. Pending Lucanix Phase III success, the Company also plans to initiate prophylactic trials in non-small cell lung cancer, as well as to expand Lucanix into other cancer indications. Other NovaRx pipeline therapies already in development include Glionix™ for glioma, or brain cancer.