CEP

CEP Program

(Chemotherapy Enhancement Program)

Veyonda® alone, and in combination with carboplatin for patients with refractory solid tumours in the breast, head and neck, lung, prostate or ovaries

Objective - to demonstrate that in advanced solid tumours:

  • Veyonda® plus lower dose chemotherapy achieves similar efficacy to standard dose chemotherapy

CEP-1

Phase-1 multi-centre study – complete

CEP-1 delivers proof-of-concept with Veyonda® + chemotherapy

CEP-1 was a two-part study:

  • In part 1 Veyonda® (400 or 800 mg) was administered alone
  • In part 2 Veyonda® was administered in combination with carboplatin.

Of the 9 patients allocated to the higher dosage (800 mg) of Veyonda®, 5/9 (56%) showed stable disease (no tumour growth and no new tumours) or a partial response (up to 99% shrinkage of measurable lesions) over the 8-month term of the study.

The Company and its medical advisors regard this outcome as significant, given that all patients had received considerable prior treatment and their cancer was classified as extensive and progressive Stage 4 chemotherapy-resistant disease.

Findings from this study have been published in the independent peer-reviewed Journal Current Therapeutic Research in 2021.[i]

CEP-2

Phase-1 multi-centre study – in planning stage

Study achieved approval from FDA under the IND (Investigational New Drug) process based upon evidence that Veyonda® may increase generally poor response rates of sarcoma cancers to chemotherapy

CEP-2 builds on the positive results of CEP-1, using higher dosages of Veyonda® and recruiting patients undergoing first-line treatment for soft tissue sarcoma.

Approximately 40 patients with a range of soft tissue sarcomas will receive the Veyonda®/doxorubicin combination as a first-line treatment.

The clinical protocol has been established, site selection is underway and the study will start enrolling patients following ethics approvals 

[i] Kiknavelidze K, Shavdia M, Chikhladze N, Abshilava L, Messina M, Mautner G, Kelly G. NOX66 as Monotherapy, and in Combination With Carboplatin, in Patients With Refractory Solid Tumors: Phase Ia/b Study. Curr Ther Res Clin Exp. 2021 Mar 28;94:100631. DOI: 10.1016/j.curtheres.2021.100631

 

Veyonda® is currently not approved in Australia or any other country