ST Pharm said that it has submitted an investigational new drug application to the U.S. Food and Drug Administration for STP1002, a colorectal cancer treatment candidate.
The company plans to confirm the safety and efficacy of the drug while trying to expand the candidate’s indications to treat patients with advanced solid cancers such as non-small cell lung cancer and breast cancer, it added.
STP1002 is a first-in-class colorectal cancer treatment that inhibits the growth of cancer cells by inhibiting the enzyme tankyrase. The candidate treats Kirsten rat sarcoma 2 viral oncogene homolog (KRAS) mutated colon cancer, which accounts for about 65 percent of all colon cancers and is hard to treat with the conventional colorectal cancer treatment agent, Erbitux.
While anticancer drugs using PARP-1 and PARP-2 inhibitory mechanisms significantly increase the toxicity and side effects, STP1002 showed no toxicity and side effects in a four-week repeated preclinical toxicity study.
Also, the drug showed a tumor growth inhibition of 49 to 70 percent in the effectiveness evaluation.
“The drug has also increased convenience for patients as it is being developed as an oral agent, while conventional anticancer drugs such as Erbitux and Avastin are administered through injections,” the company said.
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