Medpacto, a subsidiary of Theregen ETEX, said Wednesday the company plans to present its phase 1 clinical trial results on Vactosertib, an immunotherapy agent, during the upcoming 2018 American Society of Clinical Oncology next month.

Vactosertib is a drug candidate that selectively inhibits TGF-β, a mechanism that inhibits the therapeutic effect of immunotherapy.

The company has been conducting a monotherapy trial on 29 patients since 2014. During the trial, Medpacto gave 30 to 340 mg of Vactosertib orally to patients, who had end-stage solid tumors and had no therapeutic effects while using conventional anticancer drugs.

As a result, the company saw no dose-limiting toxicity (DLT) in the maximum dosage group. The drug also showed no significant side effects or adverse reactions.

Medpacto has also carried out studies related to using Vactosertib as a combination therapy with other immunotherapeutic drugs on specific biomarkers. The company has already proved in nonclinical studies that the treatment improves therapeutic effects when combined with other immunotherapeutic drugs such as Keytruda and Obdivo.

The company expects that the treatment will be able to inhibit cancer stem cells, one of the primary mechanisms that resist existing cytotoxic anticancer drugs.

Regarding the side effect controversy, Medpacto explained that although pulmonary edema and cerebral infarction occurred in two of its patients, it is unlikely that the symptoms directly relate to the drug.

“The patients were 63 and 75 years old, respectively, and were suffering from long-term diabetes and hypertension,” the company said in a statement. “Also, all of them recovered within a week and were discharged.”

The company only disclosed the information as regulations mandate companies to report all symptoms that occur in the subject, regardless of whether its relationship with the drug, a company official added.

Vactosertib is currently in clinical trials for phase 1b and 2a clinical trials for pancreatic cancer in Korea. In the U.S., the company is conducting phase 1 and 2 clinical trials for multiple myeloma in bone marrow dysplasia.

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