TASQ – The most common form of cancer among men
Active Biotech’s TASQ project is developing a pharmaceutical product that can be administered orally for chronic treatment of prostate cancer. Active Biotech is collaborating on this project with Professor John T. Isaacs of Johns Hopkins University in Baltimore, Maryland, in the US.
Prostate cancer
Prostate cancer is the most common cancer form among men. Its occurrence is strongly age-related and it is very rare before the age of 50. Prostate cancer has highly varying degrees of severity. Despite a relatively good prognosis, prostate cancer is the second most common cause of cancer death among men.
Suspicion of prostate cancer arises when a man has an elevated level of blood prostate specific antigen (“PSA”) or a hard and/or uneven prostate. A diagnosis is verified by a prostate biopsy. In the early stages, prostate tumors can be surgically removed, through a prostatectomy, or treated with radiation. In over half of the cases, however, the disease spreads to other locations in the body, whereupon surgery is no longer a viable alternative. Instead, treatment then focuses on removing the growth promoting effect of testosterone. This, however, produces a number of undesirable effects, such as sterility and impotence. At a later stage of the disease, the cancer becomes resistant to hormonal therapy. The metastases are often located to the skeleton which often leads to severe pain. At this stage, the tumor is treated with chemotherapy and median survival is approximately 20-25 months.
Every year, about 260,000 new cases are diagnosed in the US alone (Datamonitor, forecast 2009). The global market for drugs used in the treatment of prostate cancer was 2009 estimated at USD 5.4 billion (GlobalData 2010).
Ongoing research
The ongoing Phase II study designed to document TASQ’s ability to impede disease progression in symptom-free patients with metastatic, castrate-resistant, prostate cancer was recently successfully reported. This is a randomized, placebo-controlled, double-blind, Phase II study of 1 mg/day of TASQ versus placebo in over 200 patients that is being conducted in the US, Canada and Sweden under an IND application (Investigational New Drug).
The primary endpoint of the study was to measure the proportion of patients that do not display disease progression after six months of TASQ therapy compared with placebo.
The top line data presented in December 2009 are based on the local review of disease progression and an additional central review is currently ongoing. Complete results from the trial including additional details and data from the central review will be presented at an upcoming scientific conference and in scientific publications.
Current results
In December 2009, top line data from the ongoing Phase II study were successfully reported. In the analysis, safety, efficacy and certain biomarkers were evaluated. The primary endpoint, to show a difference in the number of patients with disease progression at six months, was reached. The fraction of patients with disease progression during the six month period was 43 % for patients treated with TASQ compared to 67 % for placebo treated patients. The median progression free survival was 24.7 weeks for the TASQ group, compared to 12.9 weeks (p=0.0001) for the placebo group. TASQ treatment also had a positive effect on several biomarkers relevant for prostate cancer progression and was generally well tolerated. No safety concerns significantly affecting the risk/benefit ratio for TASQ were identified.