New Drug Test a Major Step Forward in Fight Against Cancer
MolMed, a Milan medical biotechnology company which focuses on cancer therapies
, has announced its first patient in a random, phase II trial of its anti-cancer drug NGR-hTNF. The new drug is designed to treat platinum-resistant/refractory ovarian cancer
The trial, which will enrol around 100 patients, will test the new drug in combination with the standard treatment of another drug, pegylated liposomal doxorubicin, versus the standard treatment alone.
The primary end-point of the trial, whose results are expected in 2012, is to evaluate clinical activity in terms of progression-free survival (PFS). Secondary end-points include response rate, overall survival and safety.
"The assessment of NGR-hTNF plus doxorubicin in ovarian cancer with a new trial is based on the very promising outcome of a recently-completed single-arm trial, which met its overall primary end-point after the enrolment of less than half of the planned study population," said Claudio Bordignon, MolMed's chairman and CEO. "The new trial involves patients affected by relapsed disease-resistant or refractory to prior platinum-based standard therapy."
The results of a completed, non-randomised Phase II trial (NGR012) of NGR-hTNF in combination with doxorubicin, conducted on 37 pre-treated patients affected by relapsed ovarian cancer, were presented at ASCO 2011 in June. The trial met its primary endpoint after the first 17-patient study stage, while disease control was achieved in two-thirds of patients.
At the cut-off date of May 2011, the average progression-free survival was five months, with the one-year survival rate exceeding 70%: results far superior to the clinical activity reported for an anthracycline alone in patients with relapsed ovarian cancer.
"If the test results are successful as is hoped, NGR-hTNF will be a welcome addition to the arsenal of anti-cancer treatments currently available and will be a major step forward in the fight against some of the most hard-to-beat cancers we know," commented Emma Costin, Head of Industrial Disease
at Simpson Millar LLP. "It'll be especially welcome for those who are affected by work related cancers such as mesothelioma
- a cancer which is notoriously aggressive and which we now understand to be far more widespread than was initially thought."