Nicholas Brant, Ron Berryman Tuesday, 19 July 2011
ONCOLOGY therapy developer Prima BioMed is gearing up for the final stage needed to gain regulatory approval for its ovarian cancer vaccine CVac.
Prima BioMed chief executive officer Martin Rogers
The company, which owns full intellectual property of the drug, is currently enrolling for a Phase 3 trial of ovarian cancer sufferers to nearly 800 patients in Europe, the United States, Australia and New Zealand.
Ovarian cancer has one of the lowest survival rates of all gynaecological cancers.
According to Thomson Business Intelligence, 73,000 women are diagnosed with ovarian cancer each year in the US, Europe, Australia and Japan.
Only 20-30% of patients with late stage ovarian cancer survive for five years.
Prima BioMed chief executive officer Martin Rogers told BTN he was confident the Phase 3 trial would help get the drug market approval after the company had positive results from its randomised Phase 2a and 2b studies.
The Phase 2a trial involved 28 patients with incurable ovarian cancer and a life expectancy of at least six months, who had undergone multiple courses of chemotherapy/radiotherapy.
They were given three injections of CVac over a 10-week period followed by four injections at 10-week intervals.
Rogers said 21% of patients responded to therapy and 47% had disease stabilisation.
There was no therapy-related toxicity and progression free survival averaged 127 days.
The Phase 2b trial will involve 60 ovarian cancer patients from the United States and Australia to assure comparability of multiple manufacturing centres, confirm safety and tolerability established in earlier trials and compare CVac to standard of care in terms of progression-free survival.
Prima BioMed is scheduled to start recruiting for its final trial in the vaccine?s development timeline next month.
The Phase 3 trial will involve 800 patients in a double-blind, placebo-controlled study of CVac versus standard of care.
?CVac is given to patients after surgery and after chemotherapy to prevent the relapse and control metastasis in the cancer patient,? Rogers said.
?It does this by taking the patient?s white blood cells and adding an antigen or protein called mucin-1 and injecting it into the patient?s shoulder and thighs after they have had surgery.
?It basically gives back the patient the white blood cells plus the antigen after chemotherapy.?
He said the drug was an autologous, dentritic cell-based therapy or cancer vaccine similar to Dendreon?s Provenge prostate cancer vaccine, which was recently approved by the US Food and Drug Administration.
Rogers told BTN nearly 76% of ovarian cancer patients relapse about 10 months after having surgery and chemotherapy.
?Technically they will have no evidence of disease straight afterwards, but what actually is there is micrometastasic disease,? he said.
?Typically the immune system is able to clear that out, but because the immune system is compromised after surgery and chemotherapy, sometimes they aren?t able to recover themselves.
?When they?re in remission there are no products available so they just have to sit there and wait until they relapse, then they take the same product that didn?t work for them in the first instance, chemotherapy.?
CVac can be taken before a patient relapses and doesn?t have the side effects that chemotherapy does.
?The difference between the Phase 2b and the Phase 3 studies is that one was a randomised open label study, while the other will be a randomised double blind placebo-controlled study, so one patient will receive the vaccine and one patient will receive the placebo,? Rogers said.
The company was buoyed by the approval for marketing and distribution of CVac in Dubai in May, allowing Prima BioMed to commence treatment of ovarian patients.
The vaccine will be made available through Dubai Healthcare City.
Rogers told BTN the Middle East made up nearly 1% of worldwide oncology sales, totalling around $517 million.
CVac received orphan drug status from the US FDA and the European Medicines Evaluation Agency last year.
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