ERYTECH Announces Completion of First Cohort in a Phase 1 Investigator Sponsored Trial of Eryaspase in First-Line Pancreatic Cancer
ERYTECH Announces Completion of First Cohort in a Phase 1
Investigator Sponsored Trial of
Eryaspase in First-Line Pancreatic Cancer
- No dose-limiting toxicity reported in the first dose cohort
- Encouraging clinical activity observed in first patients
Trial will be escalated to the next dose
Lyon (France) and Cambridge, MA (U.S.), April 19, 2021 – ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the completion of enrollment of the first treatment cohort and the escalation to the next and potentially final dose level in a Phase 1 investigator sponsored clinical trial (IST), named rESPECT, of its lead product candidate eryaspase for the first-line treatment of pancreatic cancer.
The rESPECT IST (NCT04292743) is a single arm, dose escalating Phase 1 clinical trial to evaluate the safety of eryaspase in combination with modified FOLFIRINOX. The trial is conducted by Dr Marcus Noel, Associate Professor of Medicine at Georgetown University, Washington DC, USA, and will enroll approximately 18 patients who have received no prior chemotherapy for the treatment of locally advanced or metastatic pancreatic cancer. FOLFIRINOX is one of the most commonly utilized first-line chemotherapy regimens for the treatment of pancreatic cancer, despite its toxicity.
The trial was launched at the end of last year and has now enrolled the first cohort of three patients. After review of the safety data, the Dose Escalation Committee concluded that no dose-limiting toxicity (DLT) had been observed in the first cohort treated at a therapeutic dose of 75 U/kg eryaspase, and as of the date of this press release, treatment was observed to be well tolerated in the cohort.
Interestingly, two of the three patients treated had a partial response and significantly decreased levels of CA19-9, a pancreatic cancer tumor marker, and the third patient had stable disease after the first cycle of treatment. The trial will now be escalated to the next cohort, where the dose level will be increased to 100 U/kg eryaspase. This will be the highest dose level cohort in the trial and the presumed maximum tolerable dose (MTD) assuming no dose limiting toxicity is observed.
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