Provectus Pharmaceuticals are to begin phase 1 clinical trials of new cancer treatment, PV-10, the company's new drug candidate for the treatment of metastatic melanoma (the most aggressive form of skin cancer), in which 53,000 new cases are diagnosed each year in the US.
According to the Melanoma Research Foundation, melanoma is the fastest growing cancer in both the US and worldwide across all age groups. Of these, 7,800 or 15 per cent are fatal. In addition, according to the foundation, no significant advances in medical therapies (or survival) for patients with advanced melanoma have occurred in the past 30 years.
PV-10 is an agent that is retained in tumour cells while leaving normal tissue unharmed, thereby killing the tumour cells and sparing healthy tissue.
"The Phase 1 study will allow us not only to assess the safety of injecting PV-10 into tumors but also ascertain potential effectiveness since we are testing at efficacy levels," said Provectus CEO, Craig Dees.
"Extensive pre-clinical studies, using laboratory models of melanoma, breast cancer, and liver cancer, have shown that PV-10 can destroy injected tumour tissue while leaving all other tissue alone."
"The treatment has been highly effective against spontaneous tumours in a number of animals, including mice, dogs, cats, and horses," he added.
The current five-year survival rate for melanoma therapies is 13 per cent once metastasis has occurred. Current treatments include surgical excision, chemotherapy and radiation therapy. Incidence of the disease continues to increase at a rate of over 2 per cent annually in the US. Five-year survival rates are less than 50 per cent for locally metastatic forms of the disease, and approximately 10 per cent once distant metastasis has occurred.
Eric Wachter, executive vice president and head of the company's pharmaceutical development program, noted: "We chose to begin clinical testing of PV-10 in Australia, due to the high rate of melanoma incidence and an abundant subject population."
"Not only is this an excellent starting point for our oncology clinical program, but it also allows us to gain important experience in a potentially important market for PV-10," he added.