Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, has announced the entry of the first patient in its phase III trial for refractory bladder cancer. The patient was treated by Dr. Gary Steinhoff, Dr. Steinhoff clinical research, Victoria, British Columbia, Canada.
The US Food and Drug Administration (FDA) approved the company's refractory, open label study in February of this year, and subsequently granted it fast track designation in April. This means that Bioniche can expect an expedited review by the FDA following completion of the study. The refractory study is the first of two studies in the company's phase III bladder cancer program. The company expects to start its second phase III clinical trial comparing Urocidin to BCG in treatment-naive non-muscle invasive bladder cancer patients (first line therapy) in 2007. This study will involve more than 600 patients in North America and Europe. It is expected that this study will demonstrate that Urocidin is superior to BCG in terms of safety and is at least as efficacious.
"The start of our refractory study is an important milestone for Bioniche," noted Graeme McRae, president & CEO of Bioniche Life Sciences Inc. "With the level of interest and enthusiasm shown by our clinical trial sites throughout North America, we expect recruitment to progress quickly. We are pleased to be progressing toward introducing Urocidin as an alternative treatment for bladder cancer patients, improving their quality of life."
The study now underway uses the company's proprietary Mycobacterial cell wall-DNA complex (MCC - trademarked Urocidin) for the treatment of non-muscle invasive bladder cancer in patients who are refractory (unresponsive) to Bacillus Calmette-Guérin (BCG), a live, attenuated strain of Mycobacterium bovis and the current standard therapy. BCG therapy can result in treatment-limiting side effects in some patients.
Mycobacterial cell wall-DNA complex (MCC) is a composition prepared from from Mycobacterium phlei, a saprophytic mycobacteria. MCC has immune stimulatory as well as apoptosis (programmed cell death) inducing activity against cancer cells. Urocidin is a formulation of MCC for the treatment of high-grade non-invasive bladder cancer. Urocidin is produced at the Bioniche manufacturing facility in Pointe-Claire, Québec.
Bladder cancer is the seventh most common cancer malignancy worldwide (fourth most common in men) and is a life-long disease. Non-muscle invasive, the most common form of bladder cancer, is frequently treated with local surgery and, depending on the severity of the cancer, with immunotherapy or chemotherapy (adjuvant treatment) to prevent recurrence.
An estimated 203,000 new cases of bladder cancer are diagnosed each year in the US and Europe. Approximately 70 per cent of these (140,000) are diagnosed with non-muscle invasive bladder cancer and between 50-60 per cent will have a recurrence in their lifetime. More than 13,000 deaths per year (2005) are attributed to bladder cancer in North America alone. The 10- and 20-year survival rates of patients with aggressive grade 3 tumours are 35 per cent and 28 per cent, respectively. The risk of bladder cancer increases with age. More than 60 per cent of people with bladder cancer are between 65 and 85 years old. The average age at diagnosis is between 70 and 75 years.
As a result of long-term survival, continued treatment, and the need for lifelong routine monitoring, the cost per bladder cancer patient from diagnosis to death is the highest of all cancers ranging from $96,000 to $187,000. Overall, bladder cancer is the fifth most expensive cancer to the healthcare system in terms of total medical expenditures, accounting for almost $3.7 billion (2001 values) in direct costs in the US.
An unmet need exists for the treatment of high-risk non-muscle invasive bladder cancer where BCG is currently the standard of care. Toxicity associated with the use of BCG frequently limits the ability of a patient to continue a treatment, and maintenance therapy is discontinued in over 80 per cent of cases. BCG-induced cystitis, which affects more than 45 per cent of treated patients, is one of the main reasons that patients halt therapy. Although uncommon, treatment with BCG may result in disseminated sepsis, which requires aggressive treatment with antimicrobial agents and may result in death.