Resiniferatoxin (RTX) is being developed for the treatment of intractable cancer pain. It is a non-opioid treatment that has demonstrated positive activity in early studies.
More than half of cancer patients experience cancer-related pain1. The number of cancer patients with pain is about 10 million2. The cost of management of cancer-related pain is significant. In the case of chemotherapy-treated patients, pain is experienced in up to half of treated patients, with a cost of management of $2.3 billion.3
There is a significant medical need for new treatments in the management of severe cancer pain. Currently, few treatment options exist for patients with severe cancer pain who fail to respond to oral therapies, typically high-dose opioids. Invasive treatments with nerve stimulation and intrathecal drug administration cost from $30,000 – $60,000 per year and are also associated with tolerability and safety risks.4 As a result, there is a significant need for alternative treatments.
RTX Key Characteristics
RTX is an innovative, non-opioid, non-addictive analgesic that works by selectively killing the neurons that are responsible for cancer pain while leaving other neurons intact. RTX is an ultra-potent agonist of the TRPV-1 receptor and initiates signal that leads to calcium influx-induced apoptosis of TRPV-1 nerve cells, resulting in a selective ablation and durable effect.
The RTX program has been tested successfully in a Phase 1/2 clinical trial led by the NIH. In the study, 12 patients with advanced cancer were treated by RTX administered by intrathecal infusion, which led to improved pain symptoms and a reduction in opioid use. Key findings include:
- Improved mobility and quality of life
- Greater than 50% Reduction in Pain Numerical Rating Scale (NRS)
- Up to 72% Reduction in Opiate Use 5
- No unexpected toxicities reported
Majority of data was already published in posters for ASRA AANS and WCOP, not sure we have plans to publish the rest in 2017.
Scintilla plans to commence a Phase 1/2 clinical trial in early 2017, with results expected in 2018. This data will be used to define the minimally effective dose for pivotal trials.
- Van den Beuken-van Everdingen et al. 2007
- NIH/NCI and Scintilla internal research
- Lema et al 2011
- Ferrell et al. 2000 & Scintilla internal estimates
- Data on file.