Pain Therapeutics, Inc. (PTIE) recently presented encouraging data on its metastatic melanoma candidate, PTI-188. The company said that the administration of a single dose of PTI-188, a radio-labeled monoclonal antibody, resulted in the stabilization or decrease in the size of a number of melanoma tumors.
In one of the phase I studies, about 70% of the patients showed stable disease in target lesions at the end of six weeks. The second phase I study showed that about 40% of the patients showed stable disease at week fourteen. PTI-188 was well-tolerated at all doses.
Preliminary analysis showed that the median overall survival time based on data from both the studies was 13 months. This represents an improvement over the current median survival time of 9 months in metastatic melanoma patients. The 5-year survival rate is approximately 3%.
According to the American Cancer Society, more than 8,000 people died of melanoma in the United States during 2009. Any treatment that improves the survival for patients would see significant uptake in the melanoma market.
While the data on PTI-188 is encouraging, we note that the candidate is still in very early stages of development and has a long way to go before hitting the market. Pain Therapeutics intends to seek a partner for the development and commercialization of PTI-188. Pain Therapeutics hopes to strike a suitable deal by year end.
The most advanced candidate at Pain Therapeutics is Remoxy, which is being developed in collaboration with King Pharmaceuticals (KG). Remoxy is a unique abuse-resistant controlled-release oxycodone, which is yet to gain approval from the US Food and Drug Administration agency. King is looking to re-submit the new drug application on Remoxy in the fourth quarter of 2010.
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