Efficacy and tolerability results with Oncofid®P-B in patients with papillary bladder cancer

Italian pharmaceutical R&D excellence at the 33rd Congress of the European Association of Urology

Copenhagen, March 18, 2018 – Fidia farmaceutici today announced the positive results from a phase II trial evaluating efficacy and tolerability of Oncofid®P-B, an innovative Paclitaxel-Hyaluronan Bioconjugate targeted to cancer cells, in patients with primary or recurrent Ta G1-G2 papillary bladder cancer.

The multicenter, open-label, non-randomized, international study evaluated 600mg Oncofid®P-B administered in 6 weekly intravesical instillations, followed by a 6+6-month maintenance phase, in 60 patients with papillary bladder cancer.

Rate of complete response (CR) was 45,0% (27 CR/60 patients), with excellent safety and tolerability. A higher CR rate (57,1% - 16/28 patients) was observed in the subgroup of patients who had not previously been treated with chemo- or immunotherapy.
Only one adverse event (urinary tract infection) was treatment-related and resolved in 5 days with antibiotic therapy. No patient suspended treatment for occurrence or severity of adverse events.

Bladder carcinoma is the 5th most common malignant disease in Western countries, the 2nd most prevalent urologic cancer after prostate cancer in men . Approximately 75-85% of patients present with a disease confined to the mucosa or submucosa (non-muscle invasive bladder carcinoma – NMIBC) , .

Standard of care for papillary NMIBC includes transurethral resection (TURBT), followed by intravesical instillation with chemo- (mitomycin C) or immunotherapy (Bacillus Calmette-Guérin - BCG) to prevent recurrences (30%-60% rate).

No new drug treatments for primary or recurrent papillary bladder cancer in 15 years

Oncofid®P-B is a Paclitaxel-Hyaluronan Bioconjugate developed and patented by Fidia farmaceutici, a leading Italian pharmaceutical multinational company


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