A positive meeting with the United States Food and Drug Administration (USFDA) has boosted Radiopharm Theranostics' approval prospects for an investigational new drug (IND) clinical trial for its brain cancer treatment.
The company’s F18-pivalate (RAD 101) is a novel radiotracer that combines a molecule and a radioisotope for the detection, characterisation and monitoring of brain metastases and glioblastoma – an aggressive form of brain cancer.
Radiopharm says the meeting with the USFDA is a significant milestone towards its looming IND application for late-stage clinical trials. Based on feedback from the meeting, the company will file its IND application to begin a multi-centre trial for imaging brain metastasis next quarter, with plans to have the first patient dosed before the end of the year.
About 20 to 40 per cent of cancer patients will develop metastatic cancer in the brain during their illness.
Last year data released by Imperial College London added significant weight to the company’s belief its F18-pivalate tracer can be used to monitor brain cancer. It complements initial results Imperial College released in October from a phase-two trial it conducted on the efficiency of the tracer.
Radiopharm Theranostics managing director and chief executive officer Riccardo Canevari said: “We are engaging with the FDA to expedite clinical development of RAD 101, considering the high unmet medical need in around 300,000 patients that are diagnosed with brain mets in the U.S. every year. Being so close to late stage development is highly exciting for us and for the medical community.”
The Imperial College trial results were presented in November at a cancer conference in the Spanish city of Barcelona.
Radiopharm has previously stated its next steps on the pathway to commercialising RAD 101 included a meeting with the USFDA to determine a regulatory pathway to accelerate its product for use in imaging. The company’s treatment targets the fatty acid synthetase, which is selectively overexpressed by tumours, but not by normal brain cells.
Management believes RAD 101 demonstrates imaging performance superior to the current clinical standard in positron imaging tomography of prostate and brain cancers. The company holds an exclusive global license for the pivalate platform technology and also has a collaboration in place with Imperial College to develop a therapeutic candidate leveraging the same mechanism of action.
Radiopharm develops products that transmit low levels of radiation directly to cancerous cells in the body, both for diagnostic and therapeutic purposes. It has been calculated that about 10 million people die annually from various cancers, the most common of which are lung, breast, bowel and prostate.
The company has previously estimated the market for imaging brain metastases is in the region of a whopping US$1.25 billion (AU$1.91 billion).
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