When medical imaging is used as a clinical trial biomarker, it’s critical that you select a centralized core lab provider whose experience, capabilities, and approach to medical imaging will help you meet your development objectives, whatever they are.
This applies whether you’re a small biotech needing reliable imaging data to demonstrate your compound’s potential as you seek funding to advance your research and/or to license it to a development partner. Or if you’re one of the world’s largest pharmaceutical companies needing data from a pivotal phase III study to demonstrate safety and efficacy as you seek regulatory approval. And every scenario in between.
Regardless of your objectives, when imaging data will make the difference between success and failure, you can trust Calyx Medical Imaging to help you succeed. Here we present different scenarios in which the scientific expertise, operational experience, and dedication of Calyx’s Medical Imaging team helped researchers on completely opposite ends of the clinical development spectrum achieve their development goals.
Case Study 1:
Small biotech – Early-stage research on rare neurological disease compound
A small biotech company was at the very early stages of investigating a compound for a rare neurological disease for which no approved treatments were available. The company needed an imaging partner with neurological expertise to help them characterize and determine the best modality for measuring disease progression and, eventually, the compound’s efficacy.
After talking to other imaging providers and finding their ‘cookie cutter’ approach not suitable to their research objectives, the company chose to partner with Calyx. The company valued Calyx’s expertise and ability to offer the customized services they needed to move forward in their research.
The relationship began with collaboration between Calyx Medical Imaging experts and the company’s scientific and medical team in compiling and reviewing all available data on the disease presentation, focusing on how medical imaging (MRI, CT) and pathology had been used to diagnose and track disease progression to date.
Calyx scientists then developed a briefing book which presented two imaging-based models of the disease progression and the role medical imaging would play in drug development. The briefing book was ‘FDA ready’ and as such, the company received regulatory approval to move forward.
Continuing the partnership on research of the rare disease, the company contracted Calyx for a natural history study to collect data on the disease presentation and progression for future development of novel therapies. Magnetic Resonance Imaging (MRI) was utilized to develop and evaluate imaging-based biomarkers for assessing the burden and tracking the natural history of this rare disease.
The findings from the natural history study guided and informed the client on the imaging-supported endpoints to be used in their Phase 2 clinical trial on a therapy/compound for the rare disease.
The company continued to rely on Calyx for the design and execution of the phase 2 and natural history studies, which involved Calyx’s standard imaging services and operations, including the development of an independent review charter, training of site personnel on image acquisition, and selection / training of neuroradiologists. In addition to performing thorough quality checks of images captured in the study, Calyx’s Medical Imaging team quickly responded to questions that arose during imaging reads and took an additional, hands-on approach with reviewers and the company’s scientists to ensure the quality of the read results.
During an investors’ event the company shared the promising data – the majority of which were the first to characterize the disease state – as well as updates on the natural history study and their plans to develop the compound further. The data and the rapid progress of the ongoing study were well received by the investors, which enabled the company to continue its research. In the word’s of the company’s VP, Clinical Development Sciences, “We could not have achieved this important milestone without Calyx’s support.”
Case Study 2:
Top five pharma – Phase III trial of prostate cancer treatment
One of the world’s top five pharmaceutical companies was in the late stages of development for a new treatment for metastatic, castration-resistant prostate cancer (mCRPC). Because this advanced form of prostate cancer doesn’t respond well to currently available treatments, mCRPC presents itself particularly challenging for patients and medical professionals alike.
The company selected Calyx Medical Imaging to support its pivotal Phase III trial, which enrolled over 900 patients from over 150 worldwide investigative sites. The imaging data collected throughout the four-year study would support the sponsor’s primary efficacy endpoint and be included in their submission for EU regulatory approval.
For this study, Calyx designed and delivered robust Medical Imaging services that included:
- A comprehensive imaging charter, following the Prostate Cancer Working Group 3 (PCWG3) criteria, developed by Calyx’s professional medical writing teamProven, scalable services to drive the collection of CTs, MRIs, and bone scans, which involved:
- Training of investigative sites on the correct image capture procedures
- Collection and quality review of over 22,000 CTs, MRIs, and Bone Scans
- Advanced internal processes to rule out false positives in bone scans
- Blinded Independent Central Review (BICR) of imaging reads by 20 expert reviewers
- A dedicated scientific/medical team with expertise across multiple oncology indications and imaging modalities
Calyx’s scientific and medical team (SciMed) remained intact over the four-year study, consulting with the sponsor and supporting the investigative sites and reviewers throughout to ensure the data derived from the important imaging analysis was of the highest quality.
Calyx met all the deliverable dates throughout the study and supplied reliable imaging data to support the study’s primary efficacy endpoint, demonstrating that the treatment significantly reduced the risk of disease progression or death compared to traditional treatment approaches.
As a result of this study the robust and reliable data supplied by Calyx Medical Imaging, the new and better treatment was approved in the EU and is now giving patients a safe and more effective treatment option for mCRPC.