Uniquely reimagining the future together

What makes CEB-01 unique?

CEB-01 is the first local control system for soft tissue sarcoma (STS) whose safety, tolerability and efficacy have been demonstrated and validated in regulatory preclinical studies.

In addition, initial results from Phase I clinical development show that patients presented no toxicity or postoperative complications associated with CEB-01.

Lastly, we have our own GMP-graded machine for production, and both the production process and final product are GMP-certified.

There is no other product like CEB-01 on the market.

CEB-01 Phase I Clinical Trial

First clinical trial in humans (3+3, extension to 21 patients), to determine recommended doses and the safety and tolerance of PLGA CEB-01 membranes in patients with recurrent or locally advanced retroperitoneal STS after surgery.

  • 5 active hospitals
  • 12 patients: 4 women and 8 men
  • Mean age: 62.1 years (range: 40–77)

Tumour:

  • Dedifferentiated liposarcoma: 5
  • Well-differentiated liposarcoma: 4
  • Liposarcoma: 2
  • Leiomyosarcoma: 1

5 are recurrences and 7 are new cases.

Conclusions

CEB-01 Phase I Clinical Trial

  • CEB-01 is safe and well tolerated.
  • DLT has not been observed with either dose.
  • Adverse effects are similar to those following sarcoma surgery.
  • Recurrence in the membrane area in 2 cases treated with the lowest dose.
  • 5 patients with 1-2 years without local recurrence.