GC Biopharma said Thursday it has received an investigational new drug (IND) approval from the Ministry of Food and Drug Safety for the researcher-led administration of Neulapeg on the same day after anticancer chemotherapy.

The company said it is the first such clinical trial to be held in Korea.

GC Biopharma has received IND approval from the Ministry of Food and Drug Safety for administering neutropenia treatment Neulapeg on the same day of anticancer chemotherapy.
GC Biopharma has received IND approval from the Ministry of Food and Drug Safety for administering neutropenia treatment Neulapeg on the same day of anticancer chemotherapy.

Neulapeg is a second-generation neutropenia treatment independently developed by GC Biopharma. The treatment’s remedial effect lasts longer as it increases half-life compared to the existing granulocyte colony-stimulating factors (G-CSF). In addition, Neulapeg prevents side effects, such as fever and infection, as it is administered after anticancer chemotherapy.

Patients experience the inconvenience of prolonging hospitalization or revisiting hospitals as neutropenia treatments should be administered 24 hours after administering anti-cancer drugs.

The company said that the recently approved clinical trial aims to provide the basis for the inevitable administration of treatments within the same. According to a study published in the journal Blood in 2014, G-CSF was administered to 13 percent of solid cancer and hematologic malignancy patients on the day of anti-cancer treatment in defiance of the G-CSF’s recommended use.

The purposes of the upcoming clinical trial include the non-inferiority evaluation of preventing neutrophil depletion by dividing 160 colorectal cancer, pancreatic cancer, and small cell lung cancer patients into two groups and administering Neulapeg on the day of anti-cancer treatment and after 24 hours.

Professor Park Kwon-oh of hemato-oncology of Pusan National University Yangsan Hospital will lead the trial with three researchers at the palliative care of the Korean Cancer Study Group (KCSG).

“Anti-cancer treatment will become easier for patients if we can confirm the safety of administering Neulapeg on the same day of anticancer chemotherapy through this trial,” Professor Park said.

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