Completes recruitment of Phase IIa clinical trial
Public release date: 12-Oct-2005
Contact: Daniella Goldberg
Therapeutic vaccine for ovarian cancer in clinical trials
Prima BioMed (ASX: PRR) announced today at the "Thank You" Day celebration at Sydney Children's Hospital that it has completed initial recruitment of its Phase IIa clinical trial in ovarian cancer at the Austin Hospital.
The completion of the recruitment of the 20 patients represents an important milestone for the clinical trial using dendritic cell therapy. In order to obtain stronger data for the final evaluation report, the principal investigator for the trial, in consultation with Prima's Scientific Advisory Panel (SAP), sought and received approval from the Human Research Ethics Committee at the Austin Hospital to supplement the 20 patients already recruited. Up to a further ten patients will be invited to participate, allowing the company to collect additional data with only a minimal extension of the trial length.
Cancer cells evade detection by the immune system as the proteins on the cell surface are seen to be 'self proteins'. Prima's technology involves re-educating the immune system to recognise cancer cells as intruders. The treatment being trialled is designed to boost the immune response against a protein called mucin-1 found on the surface of ovarian cancer cells and those of other types of cancer.
Prima is trialling one of its three proprietary anti-cancer technologies which involves removal of a blood sample from patients, isolation of particular immune cells from the blood which are matured into dendritic cells and treated with the vaccine before their return to the body.
The patients' immune cells are incubated in the laboratory with the vaccine which is mucin-1 attached to a molecule made up of sugar units (a mannan) that strengthens the body's immune response to mucin-1.
When returned to the bloodstream, the treated cells are primed to marshal the immune system to mount a strong attack on cells carrying mucin-1 on their surface--in this case, ovarian cancer.
The primary end point of the trial is clinical response or disease stabilisation as measured by the decline in or plateau of the serum marker, CA-125. Secondary end points include progression-free survival, immune response, any adverse events, any interruptions or withdrawal from treatment and performance status.
Analysis of early results on the progress of patients already undergoing treatment, including the safety of the procedure and vaccine, is currently under way and is due for completion on schedule by December 2005.
The analysis will provide information to the SAP and form the basis of its recommendation to Prima management to continue the ovarian cancer trial to completion.
Prima has an exclusive worldwide license to mucin-1 from Biomira for use in its dendritic cell therapy for the treatment of cancer. Biomira has an option to secure commercialisation rights for the technology worldwide except for Australia and New Zealand, for which Prima has retained the rights.