Project Outline


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Prostate Cancer

Target Market Overview
Prostate cancer is one of the most common types of cancer, and in the United States and Europe it ranks as the leading form of cancer among men. (Global Action Against Cancer, WHO and IUAC, 2005).
It was reported that in 2005 there were approximately 230,000 prostate cancer patients in the US, and approximately 30,000 deaths attributable to prostate cancer. (The changing face of prostate cancer, Introduction, Journal of Clinical Oncology 23(No32) November 10, 2005). In Europe, approximately 140,000 patients suffered from prostate cancer and approximately 60,000 prostate cancer patients died in 1998 (Should mass screening for prostate cancer be introduced at the national level ? WHO, 2005).
In Japan, there were 17,865 patients with prostate cancer in fiscal 1999 (Cancer Statistics in Japan ‘05 (Foundation for Promotion of Cancer Research)). However, in recent years, the prevalence rate has been increasing rapidly every year, and finding a cure for prostate cancer has now become an important priority. It is predicted that fatalities from prostate cancer will expand to approximately 13,000 per year by 2015.
Today, one major problem with prostate cancer is that no effective therapy has been developed for advanced hormone-refractory prostate cancer (HRPC), a type that is resistant to hormone therapy and anticancer drug treatment.

Technical Background
GreenPeptide is developing ITK-1 for the treatment of advanced HRPC. ITK-1 is composed of 14 peptides which were selected from among many cancer specific antigen peptides based on the clinical efficacy in exploratory clinical research carried out at the Kurume University School of Medicine.
By selecting a maximum of 4 optimal peptides for each patient from among these 14 candidate peptides, GreenPeptide aims to develop personalized peptide vaccines that are clinically effective and produce no serious adverse drug reactions.

Research and Development Overview
We have already filed an Investigational New Drug Application (IND) with the Pharmaceuticals and Medical Devices Agency (PMDA), and have started Phase I trials of personalized peptide vaccines for advanced HRPC.
Our target prostate cancer patients are medically castrated, refractory to hormone and estramustine (EMP) treatment, and have the HLA-A24 phenotype. We are administering personalized peptide vaccines in combination with EMP to these patients in order to confirm the safety and efficacy of the treatment in Japan.
We also plan to carry out preclinical studies of personalized peptide vaccines for prostate cancer patients with the HLA-A2 phenotype, targeting the US and European market. Toxicity and formulation studies of these personalized peptide vaccines will be carried out in animals.
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