COPENHAGEN, Denmark,
March 18, 2018 /PRNewswire/ --
Efficacy and Tolerability Results
With Oncofid®P-B in Patients With Papillary Bladder Cancer
- 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
(Logo:
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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 [1]. Approximately
75-85% of patients present with a disease confined to the mucosa or
submucosa (non-muscle invasive bladder carcinoma -
NMIBC)[2],[3].
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[4] (30%-60% rate).
"People with a diagnosis of papillary bladder
cancer are still in need of alternative treatment options with
favorable risk/benefit and tolerability profiles,
and fewer complications than current
standard care based on mitomycin C and
BCG after TURBT - said Prof. PierFrancesco Bassi, Principal Investigator
- These clinically relevant results support
the potential of Oncofid as an innovative option
that adds significantly to our therapeutic
armamentarium, with important benefits for
patients, in terms of
efficacy, safety and quality of
life."
"Our excitement with the clinical development
of Oncofid continues to grow - said Dr. Carlo Pizzocaro,
President and CEO of Fidia farmaceutici - Several decades
of R&D and know-how on hyaluronic acid have enabled
Fidia to develop a proprietary platform that combines
hyaluronic acid with pharmacologically active
ingredients, offering a unique therapeutic approach based on
a novel mechanism of action. Once again,
Italian excellence in R&D is underpinning ambitious
global projects, in collaboration with national
and international centers of
excellence."
Fidia farmaceutici
Fidia farmaceutici is part of Fidia Pharma Group, an Italian
multinational company, with R&D, manufacturing and sales
capabilities, and an extensive product portfolio mainly based on
natural and functionalized hyaluronic acid (over 650 patents), in
joint care, wound healing, ophthalmology, aesthetics and
regenerative medicine. Manufacturing operations are FDA-inspected
and approved, and the company extends its global reach through
wholly-owned subsidiaries and partners in 100 countries
worldwide.
References
1. Cumberbatch MG, Rota M, Catto JW, La Vecchia C The Role of
Tobacco Smoke in Bladder and Kidney Carcinogenesis: A Comparison of
Exposures and Meta-analysis of Incidence and Mortality Risks. Eur
Urol. 2016;70(3):458-66.
2. Smith, A. B. et al. Muscle-invasive bladder cancer:
evaluating treatment and survival in the National Cancer Data Base.
BJU Int. 2014; 719-26.
3. Burger, M. et al. Epidemiology and risk factors of urothelial
bladder cancer. Eur. Urol. 2013; 63:234-41.
4. J.A. Witjes, et al. Guidelines on Muscle-invasive and
Metastatic Bladder Cancer. European Association of Urology.
2015