TTX for cancer-related pain

Our first indication, TTX for cancer-related pain, is in Phase III clinical development in Canada. This study is a multicentre, randomized, double-blind and placebo-controlled trial comparing the efficacy and safety of TTX to placebo with moderate to severe inadequately controlled cancer-related pain. The primary endpoint is a composite of pain outcome and quality of life measurements using validated pain assessment tools. The secondary endpoints include the onset and duration of pain relief.

Cancer-related pain

At present, the management of severe cancer pain generally includes the use of morphine and other opiates. This can often result in undesirable side effects, and treatment with this type of medication is not always effective, one in four patients using opioids to manage cancer-pain fails opioid therapy. Because currently available pain-relieving therapy is unsatisfactory for many patients, there is a need for new therapeutic approaches for the management of moderate or severe cancer pain.

In addition to the unmet medical need, the number of patients suffering from cancer continues to grow. In North America alone, based on estimates provided by the American Cancer Society and the Canadian Cancer Society, 1,650,350 were diagnosed with cancer in the United States and Canada in 2009. Between 75% and 90% of patients with metastatic or advanced stage cancer will experience significant cancer-related pain.