Proactive Investors - Run By Investors For Investors

Redx Pharma calls a temporary halt to cancer trial to look at patient dosing

Chairman Iain Ross said he was confident the company could address issue
cancer cells
Redx said it is focused intently on patient safety

Redx Pharma Plc (LON:REDX) said it was temporarily halting the early-stage clinical trial of a cancer drug candidate in order to amend the dose-escalation process to start at a lower initial threshold.

The delay to the phase I/IIa study of its Porcupine inhibitor, RXC004, is expected to be “several months” as it consults with regulators at the Medicines and Healthcare Products Regulatory Agency (MHRA) as to the next steps.

READ: Redx Pharma inks option and licence agreement for NBTI programme

"It is our current intention to propose a protocol amendment that enables dose-escalation to re-start at significantly lower dose levels,” said chief medical officer, Dr Andrew Saunders.

“This protocol amendment will be finalised with consultation with both the MHRA and principal investigators."

On dosing of the first patient in the trial, Redx said it encountered what it described as “clinically significant adverse events”.

The drug developer and its academic colleagues said this was possibly related to “RXC004 on-target effects and Wnt pathway inhibition”.

“Importantly, analysis of data from this first patient indicates that their systemic RXC004 exposure was significantly higher than that predicted from preclinical studies,” it added.

Chairman Iain Ross said the Redx team continued to believe RXC004 had potential.

“However, in drug development, safety of patients is the first priority and it is appropriate that the board and management has taken the decision to suspend recruitment of further patients to the trial until the company has consulted with the MHRA and agreed a plan to move forward.

“While we remain confident that we can address this issue, we currently estimate that that this suspension will lead to a delay of several months.

“The board continues to believe it has sufficient resources to continue to progress RXC004 and its broader portfolio of oncology and fibrosis assets. We intend to provide a further update in due course.”

View full REDX profile View Profile

Redx Pharma Plc Timeline

Related Articles

lab worker
May 20 2019
Here we take a closer look at Scancell, which is at the vanguard of immuno-oncology
picture of a knee
May 21 2019
We take a closer look at Collagen Solutions, which received third-party validation of its business model in the form of outside investment from a blue-chip US agriculture company
1538160791_petri-dishes.jpg
September 29 2018
The biotech group revealed it had brought in $9.1mln via an oversubscribed placing

© Proactive Investors 2019

Proactive Investors Australia PTY LTD ACN:132787654 ABN:19132787654.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use