FKD Therapies Oy (‘FKD’ or the ‘Company’) has announced that it has received clearance from the United States (US) Food and Drug Administration (FDA) and the US Recombinant Advisory Committee (RAC) allowing it to commence a Phase II trial for Instiladrin™ in the US. Instiladrin™ (adenovirally mediated interferon alfa 2b/Syn3) is FKD’s breakthrough gene based medicine being evaluated for the treatment of refractory non-muscle invasive bladder cancer.
The Phase II trial is an open label study of up to 40 patients with high grade non-muscle invasive bladder cancer who are refractory to Bacillus Calmette-Guérin treatment. Patients will be randomised to a dose of either 1×1011 or 3×1011 viral particles of Instiladrin™, administered intravesicularly after tumour resection. Responders will be re-treated 3, 6 and 9 months after the initial dose. The primary end point will be tumour recurrence, with safety and durability of response as secondary endpoints.
Bladder cancer is the fourth most common cancer in the world, affecting some 75,000 new patients each year in the US alone1. It is the most costly cancer to treat on a lifetime survival basis2.
Dr Nigel Parker, Chairman and CEO of FKD said: “These important clearance milestones are consistent with the FKD business plan. We are now rapidly completing the logistics of trial set up and look forward to commencing enrolment. We have established FKD as a key player in the field of anti-cancer gene based medicines”.
About IFN alfa 2b and Instiladrin™
Interferon alfa 2b protein therapy is a well established anti-cancer therapy. Its efficacy for the treatment of bladder cancer is limited by the fact that after direct administration into the bladder, it is completely cleared within 24hrs. Instiladrin™ is an adenoviral (Ad5) vector based gene medicine, containing the interferon alfa 2b transgene with Syn3, an excipient to improve transfection.
Administered as one dose, the adenovirus carries the interferon gene into the bladder wall cells where it is transported to the nucleus causing the interferon protein to be made intracellularly. Evidence suggests that Instiladrin™ may produce a therapeutic concentration of interferon measurable in the bladder for seven days3 killing even cells that are resistant to externally administered interferon protein.
In a Phase 1 trial of Instiladrin™ involving 14 patients given a single therapeutic administration into the bladder after tumour resection, Instiladrin™ showed a 43 percent complete response (no tumour recurrence) at 3 months, with an average 23 month durability in patients receiving one repeat dose at 3 months3.
About bladder cancer
Bladder cancer is the fourth most common cancer in the world affecting some 75,000 new patients each year in the USA alone1 and is the most expensive cancer to treat on a lifetime survival basis2. Bacillus Calmette-Guerin (BCG) is the current first line therapy although its use is limited by its side effects profile. Over 60 percent of BCG treated patients fail the treatment within two years. Thereafter, therapeutic options are limited and average survival after tumour re-occurrence is about 2.5 years. As such this is an area of high unmet medical need.
1 American Society of Cancer
2 Botteman et al, Pharmacoeconomics 2003
3 Internal data
Source: FKD Therapies