Shares in Amplia Therapeutics Ltd (ASX: ATX) are having a day to forget after the company announced it had halted patient recruitment for its AMPLICITY clinical trial.
Shares in the drug developer, which is backed by big hitters such as former Macquarie Group Ltd (ASX: MQG) Managing Director Alan Moss, fell 31.2% in early trade and on high volume, to change hands at 16.5 cents.
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Concerning side effects
The company said it had halted recruitment for the clinical trial after three "dose limiting toxicities" related to the chemotherapy regimen, mFOLFIRINOX, emerged.
The trial was seeking to investigate the use of the company's lead drug narmafotinib in combination with the chemotherapy regimen modified FOLFIRINOX in treating advanced pancreatic cancer.
The company pointed out that its own compound was not the result of the toxicity.
As the company said:
Eight patients have been dosed with daily narmafotinib in combination with the mFOLFIRINOX regimen administered on its routine cycle and doses. Three events of protocol-defined dose-limiting toxicity (DLT) have been observed at this time, though importantly none have been attributed to narmafotinib and instead relate to the chemotherapy regimen. Five of the 8 patients remain on study and will continue to receive the narmafotinib – mFOLFIRINOX combination with continuing safety monitoring as before.
Amplia said it would "halt recruitment in AMPLICITY and focus its resources on exploring combinations other than with FOLFIRINOX''.
Amplia Managing Director Dr Chris Burns said regarding the results:
The dose limiting toxicities observed are very disappointing for the patients and their families; however, toxicity with FOLFIRINOX chemotherapy is well documented. Given these effects, and the evolving landscape for pancreatic cancer treatment, we will continue to build on our promising ACCENT trial data, as well as plan for additional studies with new, targeted agents being developed for pancreatic cancer. While efficacy data from AMPLICITY is early, four of the eight patients in the trial have recorded stable disease at their first (2-month) scan, with one of these patients subsequently recording a partial response at their 4 -month scan. No other efficacy data is available at this time though updates will be reported in due course.
ACCENT potential is large
While it was bad news for the company today, Bell Potter recently said there had been good recent news out of the ACCENT trial, where in a Phase 1b/2 trial in 64 pancreatic cancer patients, there had been four "complete responders''.
Bell Potter said the trial outcomes to date were "remarkable" and there was "compelling evidence that narmafotinib's anti-fibrotic mechanism is allowing chemo to exert greater effect and penetrate tumour tissue more effectively''.
Bell Potter has a speculative buy rating on the stock and a 42-cent price target, albeit this was before today's announcement about the AMPLICITY trial.
Amplia was valued at $135.9 million at the close of trade on Thursday.
