Focal Medical’s implantable iontophoresis chemotherapy delivery device with Gemcitabine (ACT-IOP-003). Credit: Business Wire / Focal Medical.

Biopharmaceutical company Focal Medical has received clearance for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to commence a Phase Ib clinical trial of its targeted therapeutic product, ACT-IOP-003, for pancreatic cancer.

This implantable iontophoretic product can deliver high levels of gemcitabine directly to the pancreas, potentially reducing systemic drug exposure and toxicity.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

ACT-IOP-003 has shown promising results in orthotopic, patient-derived xenograft murine models of human pancreatic cancer, achieving a significant 40% reduction in tumour volume.

The modified dose escalation, open-label, multicentre trial aims to evaluate the tolerability, safety, and clinical activity of the product in patients with locally advanced nonresectable (LANR) pancreatic cancer.

Anticipated to begin in mid-2024, the trial will involve up to 12 subjects across two cohorts.

Participants will receive treatment once or twice a week over eight weeks.

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.

Focal Medical is focused on the development of products based on its patented iontophoresis delivery system.

The company’s technology seeks to overcome the challenges of traditional systemic drug delivery, such as systemic toxicity and barriers to therapeutic effect.

Focal Medical is also expanding its product pipeline to include therapies for other solid tumours and genomic medicine products.

Focal Medical chief technology officer Dr William Daunch said: “Once a locally advanced tumour is not resectable, treatment options are limited and these patients experience a significantly reduced survival outlook compared to resectable cases.

“Our thesis, which we have demonstrated in animal models of pancreatic cancer, is that localised delivery of high concentrations of gemcitabine via our implantable iontophoretic device can reduce tumour volume to a point where surgical removal may be possible while also minimising systemic exposure and associated toxicity.

“If successful, we may offer the opportunity of extended survival for the significant number of pancreatic cancer patients presenting with nonresectable disease.”