Preclinical Safety in Cancer Drug Development: “Attitude to Safety Needs to Change”

Many companies involved in cancer drug research and development need to re-think their use of safety data in helping to bring new drugs to cancer patients.

Dr Richard Knight of Alderley Park-based ApconiX told last month’s conference, Accelerating Cancer Drug Development – from target to patients, that greater focus on pre-clinical safety should be fundamental to the development of new cancer therapies.

He said: “There is still huge unmet need in effective cancer treatment and it can be tempting for companies researching new drugs to focus mainly on efficacy data with safety issues relegated to secondary importance. However, an improved safety profile is not only an important way to reduce the high rate of drug failure, it can also expedite clinical trials and, above all, it’s the best thing to do for patients.

“With most cancer drugs, patients have to put up with a wide range of adverse effects in return for promised benefits. But that shouldn’t mean patients having to tolerate side effects that could potentially be designed out in the research stage when companies are choosing between candidate chemicals.”

Dr Knight outlined his views as part of the Accelerating Cancer Drug Development conference at Alderley Park on 27 February. Currently more than 50% of ApconiX’s non-clinical safety work is involved with oncology drug development.

“Eliminating pre-clinical safety signals makes everything else easier, from patient recruitment to speed and overall cost. It’s a positive attribute and companies should be taking every opportunity to advance the compound with the best overall profile.

“There is a widespread misunderstanding about what pre-clinical safety is there to do. Many see it largely as a box-ticking exercise but it can be of real value in moving new agents rapidly through clinical trials.”

ApconiX was founded in 2015 by Professor Ruth Roberts, Dr Richard Knight and Dr Michael Morton following many years working at AstraZeneca and uses a group of leading scientists with wide-ranging skills in preclinical drug safety.

The company’s early success is based on delivering expertise in drug safety toxicology and ion channel screening and assay development to a changing pharmaceutical sector, in which more companies are outsourcing their essential drug safety testing and analysis.

By |2018-07-11T10:12:48+00:00March 27th, 2018|Toxicology|Comments Off on Preclinical Safety in Cancer Drug Development: “Attitude to Safety Needs to Change”

About the Author:

Dr Richard Knight PhD, ERT, is a Director and Co-founder of ApconiX, a preclinical toxicology and ion channel company that brings together a team of world-renowned nonclinical safety experts. Richard graduated from the University of Bradford in 1989 with a degree in Biomedical Sciences (Pharmacology) before gaining a PhD at the University of Leeds researching the role of adenosine receptors in renal function and toxicity. His research then included post-doctoral studies at University of California, Los Angeles (UCLA) into the effects of ischaemia/reperfusion injury on cardiac metabolism. Richard joined Zeneca Pharmaceuticals, Safety of Medicines Group in 1996 as a Study Director, and then Project Toxicologist across multiple therapy areas, from early discovery through to market. As Lead Toxicologist for Oncology, Richard was a member of both the Drug Safety and Metabolism, and Oncology Leadership teams with responsibility for safety across the AZ oncology portfolio. In this senior role he provided leadership and mentoring support to other project toxicologists. Richard has worked on many drug platforms over this time including small molecules, biologics, proteins and oligonucleotides and has been involved in bringing over 30 new candidate drugs into clinical trials and 5 to marketing approval.