Our therapeutic platform is based on the hypothesis that many diseases of aging may be caused by age-related dysregulation of the hypothalamic-pituitary-gonadal (HPG) axis. This platform is built on the premise that hormones associated with this axis are beneficial early in life, when they promote growth and development, but are harmful later in life when the mechanism for feedback is compromised, thereby leading to disease processes, including pathologies associated with Alzheimer’s disease and various cancers. We believe our discovery of a duplicate HPG axis at the cellular level in brain tissue from Alzheimer’s patients and in multiple tumors will enable us to develop significant new treatments for Alzheimer’s disease as well as many cancers.

Our Alzheimer’s Disease Program

Leuprolide acetate, a peptide hormone, has been widely used over the past twenty years for the treatment of a number of hormone-related disorders, most notably prostate cancer and endometriosis and precocious puberty, and has a well-established safety profile. Voyager has conducted extensive preclinical and clinical studies exploring the use of leuprolide acetate for the treatment of Alzheimer’s disease in mild-to-moderate patients. The results to date are very encouraging and point especially to a potentially significant new treatment for women with Alzheimer’s disease.

Women represent approximately two-thirds of Alzheimer’s patients. Men present greater challenges in the use of leuprolide to treat Alzheimer’s disease because leuprolide suppresses their production of testosterone, which could necessitate patient self-administration of supplemental testosterone and which can lead to wide swings in testosterone blood serum levels. Therefore, in the near-term, we plan to concentrate our development efforts on the use of leuprolide acetate to treat women, although we will continue our efforts to better understand mechanisms that might lead to optimum outcomes in men.

The next step in the clinical development of our Alzheimer’s candidate is to initiate enrollment and dose the first patient in a Phase II clinical trial in women with mild to moderate Alzheimer’s disease in 2010. This major step for our Company will signify the next stage in the development of Curaxis Pharmaceutical and a major milestone towards commercialization of our treatment for Alzheimer’s Disease.

Our Oncology Program

We have conducted an extensive preclinical research program in the use of leuprolide acetate to treat a number of cancers, including hormone refractory prostate cancer, brain cancers, kidney cancer, pancreatic cancer and non-small-cell lung cancer.

Our work in oncology is based on new insights into the growth of cancer cells that have been discovered by our scientists. In particular, our scientific findings relating to autocrine-paracrine signaling and the replication of the hypothalamic-pituitary-gonadal axis (the HPG axis) inside of cancer cells point to a previously unknown mechanism that drives the growth of cancer cells and an entirely new method of attacking those cancer cells; i.e., using high doses of leuprolide acetate to eliminate the gonadotropins that may be driving the growth of those cells.

Our preclinical testing of this new treatment approach has produced extremely encouraging results. In both in vitro and in vivo experiments, we have demonstrated a potentially important new therapy for the treatment of a number of cancers.

We plan to use the same compound for our various cancer Phase II clinical trials as we are using for clinical trials of VP4896. Since we have completed Phase I safety trials of VP4896, we believe that we will be able to commence our clinical programs for various cancers with Phase II clinical trials instead of Phase I safety trials. However, the FDA will have to agree to the commencement of these clinical programs with Phase II clinical trials when we submit our Investigational New Drug Applications, or INDs, to the FDA.