Adamis receives patents for APC-200 prostate cancer drug in South Africa, Singapore

Adamis Pharmaceuticals Corporation (OTCBB: ADMP), today announced the technology which constitutes its compound APC-200 was recently granted patents in Singapore and South Africa. These patents significantly strengthen the Adamis APC-200 patent portfolio for the use of APC-200 in the treatment of early and late stage prostate cancer.

APC-200 is a small molecule formulation that has been developed for oral administration. Pre-clinical studies confirming the use of APC-200 for the treatment of prostate cancer were pioneered by Dr. George Wilding and his team. Dr. Wilding is the Assistant Dean for Oncology and Director of the University of Wisconsin Carbone Cancer Center. The initial development of APC-200 is intended for patients with castration-resistant prostate cancer. However, APC-200 has the potential to be beneficial to patients in combination with androgen deprivation therapy (ADT), or where ADT has not been approved or is not effective or tolerated.

Although localized or acute inflammation is often associated with a protective reaction to injury, chronic inflammation can be associated with conditions such as autoimmune disease and cancer progression. Recent scientific data published by Dr. Michael Karin (Nature, Vol. 464, 2010) and his team at University of California, San Diego, Scripps Research Institute and the Engelhardt Institute of Molecular Biology has demonstrated that inflammation plays a significant role in prostate cancer progression, i.e. progressing from castration-sensitive to castration-resistant disease. Their results concluded that the inflammatory response triggered by the death of androgen-deprived primary cancer is an important contributor to the emergence of castration-resistant prostate cancer. Therefore, the dying primary tumor may contribute to the failure, rather than the previously proposed success of anti-cancer therapy. Although radical prostatectomy, radiation, and androgen ablation are effective therapies for androgen-dependent prostate cancer, metastatic castration-resistant prostate cancer still remains a major problem with high mortality. Based on what is known about the mechanism of action of Adamis' APC-200, this drug could play a significant role in specifically inhibiting the local inflammatory response and therefore prolonging or inhibiting the progression to castration-resistant prostate cancer.

Reactive oxygen species (ROS) are constantly created and eliminated in the body, and play important roles in a variety of normal biochemical functions and abnormal pathological processes. Levels of ROS such as hydrogen peroxide, superoxide, and free hydroxyl radicals have been described to be elevated in prostate epithelial cells and a link between ROS, the associated oxidative stress and prostate cancer development and progression has been suggested. Recently, it was furthermore found that androgen receptor signaling may be involved in raising ROS levels in prostate cancer cells. APC-200 inhibits ROS formation in prostate cancer cells, thereby helping to block not only tissue inflammation but also androgen-induced oxidative stress. Animal studies have documented not only APC-200's ability to inhibit chronic inflammation, but have also found that APC-200 can significantly delay prostate cancer progression and increase survival among diseased animals. To date, APC-200 is thought to have a favorable safety profile.

APC-200 has previously received the National Cancer Institute's (NCI) multi-year, multi-million dollar RAPID Award (Rapid Access to Preventative Intervention Development). Each year, this award is given by the NCI Division of Cancer Prevention, under the RAPID Program (now called PREVENT), to what it believes are the most promising new preventative/therapeutic anti-cancer drugs.

Dr. Dennis J. Carlo, President and CEO of Adamis, stated, "Since APC-200 could end up being a very important drug for the treatment of early prostate cancer, we have put together a substantial patent portfolio covering most of the major countries throughout the world. Being able to delay the progression between castration-sensitive and castration-resistant prostate cancer could very well equate to adding years of survival time to patients. APC-200 will be our next prostate cancer drug to enter clinical trials."