and We'll know by the 4 th Q 2010 ie nest year how it's all going.
cheers
PRIMA BIOMED HAS ENROLLED THE FIRST PATIENT FOR THE CVacTM
PHASE IIb TRIAL
Key points
First patient enrolled for US FDA Phase IIb clinical trial for CVacTM ovarian cancer therapy vaccine
Randomised trial to be conducted with 60 patients across multiple global clinical sites
Clinical assessments will be performed every 4 weeks and imaging via CT or MRI will be performed every 12 weeks
Prima BioMed Ltd (ASX: PRR) today announced that it has commenced patient enrolment for its Phase IIb clinical trial for the CVacTM ovarian cancer therapy vaccine
with the US Food and Drug Administration (FDA) with the first patient enrolled this week.
The study is being conducted with 60 patients across multiple global clinical sites, including key U.S. and Australian centers such as the Fred Hutchinson Cancer
Center in Seattle and the Peter MacCallum Cancer Center in Melbourne. Prima estimates that recruitment will be completed by first quarter 2011.
The study design is a randomised and open label trial, comparing treatment with CVac to current best available supportive therapy.
The primary objectives of the study are to confirm the safety of CVac and comparedisease progression- (PFS) between CVac and the control group. To assess PFS, clinical assessments will be performed every four weeks, and imaging withcomputed tomography (CT) or magnetic resonance imaging (MRI) will be performed every 12 weeks - until progression or withdrawal of the patient from trial.
Initial safety data is expected by end of Q4 2011, after completion of the treatment phase. Initial PFS data is expected by end of Q4 2012, after all patients complete 2 years of observation.
With this current trial, Prima seeks to augment promising efficacy data generated by previous studies, including the phase IIa pilot study completed in 2007 on 28
patients.
Prima BioMeds Chief Medical Officer Dr Neil Frazer said: CVac is an immunotherapy that utilizes the bodys own immune system to fight cancer, with far fewer side effects than traditional oncology treatments. Unfortunately, even with advances in ovarian cancer therapy, a large percentage of women who are successfully treated initially will relapse. Currently, no therapy has demonstrated survival benefit for ovarian cancer patients in remission. We believe that CVac may offer significant therapeutic opportunity for women in remission, extending the time they remain cancer-free and improving their quality of life.
The global market for ovarian cancer therapeutics was valued at US$2.1 billion in 2007, and is expected to be about US$3.6 billion this year. Prima aims to develop
CVac into the worlds first commercially available ovarian cancer cell-basedmaintenance therapy.
Commenting on the commencement of patient recruitment, Prima BioMed Chief Executive Officer Martin Rogers said: We are delighted to commence patient enrolment for our Phase IIb trial for CVac. Setting a pharmaceutical grade manufactured product is one of goals in this study and to be able to assemble such a high calibre clinical group across multiple global sites represents a major step forward toward helping women who suffer from ovarian cancer and toward the commercialisation of CVac.
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