Radiopharm prepares to take cancer treatment to FDA

Medical technology specialist Radiopharm Theranostics is gearing up to approach the powerful US Federal Food and Drug Administration, or “FDA” to get its cancer treatment known as “Pivalate” to market after successfully concluding a phase II clinical trial in the UK. The trial indicated that Pivalate can detect and monitor secondary brain tumours known as “cerebral metastases” regardless of the origin of the primary cancer.

The trial showed that Radiopharm’s treatment could detect cerebral metastases that had metastasised from multiple other cancers including breast, lung and colorectal cancers.

Details of the trial outcomes will be presented later this month at a three-day meeting of cancer researchers in Barcelona, Spain.

The Radiopharm product, officially called F18-Pivalate, was invented by Professor Eric Aboagye of the Imperial College London.

Radiopharm says Pivalate demonstrates superior imaging performance to the current clinical standard in positron imaging tomography, or “PET” imaging of prostate and brain cancers and offers equal performance to products used in imaging breast cancer.

The company also says currently available technologies have limitations and Pivalate has a potentially transformational approach that attempts to overcome these limitations.

Radiopharm Theranostics Managing Director and CEO, Riccardo Canevari said: “We’re very pleased with the results. We are excited by the imaging data and even more by the possibilities ahead.”

"We have now completed the Phase II trial and are excited to look at the next step.”

That step, Canevari said, was to compile a case with oncologists, surgeons and nuclear physicians that it could take to the FDA and present its data.

Canevari said if a meeting with the FDA could be arranged, he expected one of two outcomes: the best-case scenario would be if Radiopharm were permitted to go straight to a phase II trial – effectively only one clinical trial away from commercialisation.

The other outcome might be a request from the FDA for another cohort of patients to be added to the phase II trial, which would take between six and nine months.

Radiopharm specialises in developing “radiopharmaceutical” products to both diagnose cancers through imaging and treat them.

Patients are given low doses of the radioactive medication into the bloodstream and the drugs then seek out tumours.

Pivalate is one of six molecules in Radiopharm’s pipeline and four new phase I clinical trials, two in the US and two in Australia, are planned in coming months.

At an investor briefing on the Pivalate trial, Radiopharm gave an indication of the size of the potential market for its product using imaging of prostate cancer as a comparison.

In the US, there are 248,000 new cases of prostate cancer every year, many of which require imaging to be undertaken. Radiopharm says the potential size of this market is  around US$800 million.

For American patients suffering brain metastases, the market is an estimated US$1.2 billion-plus according to the company.

Coinciding with the trial results, Radiopharm announced a new capital raising.

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