According to the American Cancer Society, prostate cancer is the most common cancer in men outside of skin cancer. Estimates for 2010 calculated that 217,730 new cases of prostate cancer will be diagnosed and that more than 30,000 men will perish as a result of the disease throughout the year as it is the second leading cause of male death in American men; second to lung cancer.
Even more alarmingly, one in every six men will be diagnosed with prostate cancer in his life and one in 36 will die. There is some good news for those who are diagnosed, though, as more than two million men in the United States alone have been diagnosed, but are still living today.
Today, the biotechnology world took another step in battling the disease as Adamis Pharmaceuticals Corporation (OTCBB:ADMP) announced that it has received U.S. Food and Drug Administration approval of its Investigational New Drug application to proceed with clinical trials on its prostate cancer indication. The Del Mar, California-based company intends to begin Phase I/II human studies with APC-100 in men with castrate-resistant prostate cancer (CRPR).
Initially, the research will begin at the University of Wisconsin Carbone Cancer Center and then expand to Wayne State University Karmanos Cancer Institute in Detroit, MI. The team at the U of W Carbone Cancer Center conducted the majority of the pre-clinical research and was led by Dr. George Wilding, Assistant Dean of Oncology and Director of the Center.
The patients will be assessed for toxicity, biochemical response (Prostate Specific Antigen) and radiographic as well as clinical responses. APC-100 is an orally available drug that has demonstrated multiple activities in various model systems including delaying tumor progression and increasing survival rate in mouse models.
More biologically speaking, it has demonstrated blocking of PSA secretion and inhibited androgen-related transcriptional activation, blocked binding of androgens to the androgen receptor and inhibited reactive oxygen species formation in prostate cancer cells, amongst of host of other pre-clinical benefits that are hoped to be observed in human trials.
Previously, APC-100 was the recipient of the National Cancer Institute's multi-year, multi-million-dollar RAPID Award (Rapid Access to Preventative Intervention Development). This award is given annually by the NCI Division of Cancer Prevention, under the RAPID Program, to what it believes are the most promising new preventative/therapeutic anti-cancer drugs.
Even with the prestigious awards that have been presented for APC-100 research and the clearance given today by the FDA, shares of ADMP are struggling to gain traction. Perhaps a portion of the pending news has already been factored into the value of a share as ADMP has risen from the area of $0.165 in March to touch $0.29 in April since settling down recently between 21 and 23 cents for the last couple weeks.
News of human trials typically does provide a spark and although it did not springboard Adamis today, investors may be keeping an eye open in the future for any positive develops for a therapy to help join in the prostate cancer fight.
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