Peregrine Concludes Patient Recruitment In Cotara Dose Confirmation, Dosimetry Trial

Peregrine Pharmaceuticals (Peregrine) has completed patient enrollment in a dose confirmation and dosimetry trial of Cotara in patients with relapsed glioblastoma multiforme (GBM). Cotara is a targeted monoclonal antibody linked to a radioisotope being developed as a potential new treatment for GBM.

Cotara specifically targets cells at the center of brain tumors, so its radioactive payload is able to kill cancer cells while leaving healthy tissue largely unaffected. Cotara is also being tested in a Phase II clinical trial in patients with recurrent GBM.

Reportedly, in the ongoing dose confirmation and dosimetry study, patients received a single treatment of Cotara and were evaluated for specificity of drug localisation to the tumor, as well as for progression-free survival and overall patient survival.

Initial data from the trial show that all of the patients in the first two completed study cohorts have survived longer than the expected six-month median survival time for GBM patients and they confirm Cotara’s targeting capabilities, indicating that it delivers more than 300-fold higher radiation levels to the tumor than to normal organs.

The objectives of the open label dosing and dosimetry study are to confirm the maximum tolerated dose of Cotara, to determine radiation dosimetry and to assess overall patient survival, progression-free survival and the proportion of patients alive at six months following Cotara administration. In both ongoing clinical trials, Cotara is delivered using convection-enhanced delivery (CED).

Interim data from the dosimetry trial showed that in patients dosed in the first two cohorts of the study, the concentration of Cotara in brain tumors was on average more than 300-fold higher than in other normal organs. In addition, these patients had all either met or exceeded the expected median survival time for recurrent GBM patients.

Robert Garnick, head of regulatory affairs at Peregrine, said: “Completion of patient enrollment in this study is a significant regulatory milestone for Cotara, representing an important component of the Cotara clinical development program. With enrollment in this trial now completed, we are turning our attention to expanding the ongoing Cotara Phase II GBM trial to further advance the program. Given the encouraging data seen to date in the Cotara brain cancer trials, we plan to explore available clinical and regulatory options for expediting Cotara development.”