Oxford BioMedica has announced that a Phase II trial of TroVax in patients with prostate cancer that is unresponsive to hormone therapy is open for recruitment
This is the first clinical trial of TroVax in this cancer type.
The Phase II trial in prostate cancer is being conducted at the Methodist Hospital in Houston, Texas, USA.
The principal investigator for the trial is Robert Amato.
The trial is designed to enrol 24 men with hormone-refractory prostate cancer who have previously received chemotherapy or have refused chemotherapy and have progressive disease.
The trial is open label and will have two arms (12 patients each) to assess the activity of TroVax alone versus TroVax alongside an approved treatment for prostate cancer, granulocyte macrophage-colony stimulating factor (GM-CSF).
The primary objectives of the trial are to evaluate the safety and synergies of the combination treatment, and to assess whether GM-CSF, which is known to increase white blood cell count and hence boost the immune system, increases the anti-cancer immune response stimulated by TroVax.
Efficacy endpoints include objective response rate, progression-free survival, overall survival and changes in prostate-specific antigen (PSA) level, which is a recognised marker of disease status.
Prostate cancer is the leading cause of cancer in men.
Localised radiotherapy or surgery is potentially curative for early-stage disease although many patients relapse and require hormone therapy.
However, therapeutic options are limited when the cancer has progressed and no longer responds to hormone therapy, which is the setting for the Phase II trial of TroVax.
Initial data from this trial are expected in the first half of 2007.
According to Datamonitor, treatments for prostate cancer generated worldwide sales of $2.7 billion in 2004.
Commenting on the start of the Phase II trial in prostate cancer, Oxford BioMedica's chief medical officer, Mike McDonald, said: "We are delighted that Dr Amato is supporting a Phase II trial of TroVax in prostate cancer.
"Given what we know of the product's safety profile and the anti-cancer immune response that it stimulates, we are hopeful that TroVax can provide a new therapeutic option for patients with prostate cancer who have progressed despite hormone therapy and for whom there are few available treatments".
Robert Amato, director of the genitourinary oncology centre at the Methodist Hospital said: "TroVax could provide a significant benefit to patients with hormone-refractory prostate cancer, particularly when administered with an effective immunostimulant such as GM-CSF.
"Our team at the Methodist Hospital has seen some intriguing clinical responses with TroVax from our trial in renal cell carcinoma and we are delighted to expand our collaboration with Oxford BioMedica into prostate cancer".
Oxford BioMedica's chief executive officer, professor Alan Kingsman, added: "As we broaden and deepen the clinical development of TroVax, the value of our lead product candidate increases for potential partners".
Clinical evaluation of TroVax is ongoing in renal cell carcinoma, colorectal cancer and now prostate cancer.
Oxford BioMedica plans to start a Phase III trial in renal cell carcinoma in the second half of 2006.
The company recently secured a special protocol assessment agreement with the FDA for this Phase III trial.
An update on the clinical trials and development plan for TroVax will be released to coincide with TroVax presentations at the American Society of Clinical Oncology (Asco) Annual Meeting, to be held on 2-6 June in Atlanta, Georgia, USA.
