Anchiano Therapeutics has commenced a Phase II Codex trial examining the efficacy and safety of inodiftagene vixteplasmid (BC-819) for the treatment of patients with non-muscle-invasive bladder cancer (NMIBC).

Inodiftagene vixteplasmid is a gene therapy and a recombinant DNA plasmid designed to direct the expression of a potent toxin specifically in malignant cells without affecting normal tissue.

The multicentre, open-label, single-arm trial aims to enrol 140 patients with NMIBC that have high-grade stage Ta or T1 papillary tumours or carcinoma in situ (CIS) and whose disease is unresponsive to bacillus calmette-guerin (BCG) therapy.

“BCG-unresponsive NMIBC represents an area of high unmet medical need with limited standard treatment options.”

Anchiano will administer 20mg of inodiftagene vixteplasmid as monotherapy via instillation into the urinary bladder for ten weeks, which will be followed by treatment every three weeks for up to two years or until disease recurrence.

The trial’s primary objective is complete response rate in patients with clinically isolated syndrome (CIS).

It is expected to observe patients with complete response for at least one year following the beginning of response.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Interim analysis will then be conducted on data from the first 35 CIS patients.

Anchiano Therapeutics chief medical officer Dr David Kerstein said: “BCG-unresponsive NMIBC represents an area of high unmet medical need with limited standard treatment options, outside of surgical removal of the bladder.

“NMIBC is a cancer that has been lacking in new therapies for two decades, and we are excited to embark on this important next step in the development of inodiftagene vixteplasmid.”