Fidia Farmaceutici announced the positive results of a Phase II study evaluating the efficacy and tolerability of Oncofid®PB, an innovative anti-cancer cell-directed paclitaxel-hyaluronan bioconjugate in patients with primary or recurrent papillary Ta G1-G2 bladder cancer.
The multicentre, open-label, non-randomized, international study evaluated 600mg of Oncofid®PB administered in 6 weekly intravesical instillations, followed by a 6 + 6-month maintenance phase in 60 patients with papillary bladder cancer.
The Complete Response (CR) rate was 45.0% (27 CR / 60 patients), with excellent safety and tolerability. In the subgroup of patients not previously treated with chemotherapy or immunotherapy, a higher complete response rate (57.1% – 16/28 patients) was observed.
Only one single adverse event (urinary tract infection) was treatment-related and resolved within 5 days with antibiotic therapy. None of the patients has been exposed to treatment because of the occurrence or severity of adverse events.
Bladder cancer is the fifth most common malignant disease in western countries, and the second most common urological cancer after prostate cancer in men [1] . The disease is limited to the mucosa or submucosa in about 75-85% of patients (Non-Muscle Invasive Bladder Carcinoma – NMIBC).
The standard of care in papillary NMIBC is transurethral resection (TURBT), followed by intravesical instillation with chemo- (mitomycin C) or immunotherapy (Bacillus Calmette-Guérin – BCG) to prevent recurrence [4] (rate of 30% -60%) ,
” Patients with papillary B la senkarzinom diagnosed were still require alternative treatment options with favorable risk / benefit and tolerability profiles and fewer complications than the derzei term standard treatment with mitomycin C and BCG after a TURBT – said Prof. Pierfrancesco Bassi , Principal Investigator – These clinically relevant results underscore the potential of Oncofid as an innovative option that significantly extends our therapeutic arsenal ,with important benefits for patients in terms of efficacy, safety and quality of life ” .
” Our excitement for Oncofid’s clinical development continues to grow – said Dr. Carlo Pizzocaro , President and CEO of Fidia Farmaceutici – Through decades of research and development and its specific hyaluronic acid expertise , Fidia has succeeded in developing a proprietary platform, H yaluron acid with pharmacologically active Inhaltsst open and combined with a unique therapeutic approach based on a novel mechanism of action . I tali e n ic peak power in R & D thus supports again ambitious global projects in cooperation with national and international centers of excellence ” .
