ERYTECH Pharma Inc. (NASDAQ: ERYP) stock gained by 0.98% at the last close while the ERYP stock price surges by 3.88% in the after-hours trading session. ERYTECH is a clinical-stage pharmaceutical business focused on the development of novel red blood cell-based therapies for cancer and orphan illnesses.
ERYP stock’ Important Update
The MTD for ERYTECH Pharma’s primary product candidate eryaspase has been announced in a Phase 1 investigator supported clinical trial (IST) called rESPECT. This is used to cure pancreatic cancer as first-line therapy, with 100 U/kg being the suggested dosage for future clinical trials in this indication.
The rESPECT IST (NCT04292743) is a single-arm, dose-escalating Phase 1 clinical study that aims to determine the safety of eryaspase in conjunction with modified FOLFIRINOX. Besides its toxicity, FOLFIRINOX is one of the most widely used first-line chemotherapy regimens for the treatment of pancreatic cancer. Three and six patients were enrolled in each of two dosage groups of 75 U/kg and 100 U/kg eryaspase, correspondingly.
Moreover,
The dose-escalation committee determined that the unique combination of mFOLFIRINOX + eryaspase was well taken with no DLT after reviewing the safety data. As a result, the MTD has been established at 100 U/kg eryaspase. Surprisingly, all six patients who were assessed for response had disease control, with four having an objective response and two having a stable illness.
Additional patients will be enrolled in the experiment at the 100 U/kg dosage level to further examine the trial’s safety and clinical efficacy. The stated MTD of 100 U/kg eryaspase corresponds to the dosage presently utilized in second-line patients in clinical trials.
Dr. Iman El-Hariry, ERYTECH’s Chief Medical Officer, stated,
They are ecstatic to be working with Dr. Noel at the University of Georgetown and to have reached the significant milestone of eryaspase MTD in first-line pancreatic patients. They also anticipate top-line findings from the TRYbeCA-1 Phase 3 clinical study in second-line pancreatic cancer in the fourth quarter of this year. They aim to initiate a pivotal study in first-line pancreatic cancer and maybe additional situations such as locally advanced pancreatic cancer if that trial validates the survival advantage they saw in the previous Phase 2 trial.