The successful completion of patient enrollment in Ascelia Pharma's pivotal phase 3 clinical study, SPARKLE, has been announced by CEO Magnum Corfitzen. The study involved the lead candidate drug Orviglance, the company’s novel MRI contrast agent for patients with impaired kidney function. Photo courtesy of Ascelia Pharma.
March 2, 2023 — Ascelia Pharma, a biotech company focused on improving the life of people living with rare cancer conditions, has announced the successful completion of patient enrollment in its pivotal phase 3 clinical study, SPARKLE, with the lead candidate drug Orviglance, the company’s novel MRI contrast agent for patients with impaired kidney function. This milestone is the latest step towards Orviglance completing the regulatory process and becoming available to patients for whom the use of current gadolinium-based contrast agents increases the risk of the serious and potentially fatal condition Nephrogenic Systemic Fibrosis (NSF).
Ascelia Pharma’s SPARKLE study aims to demonstrate that Orviglance improves the detection and visualization of focal liver lesions, including liver metastases and primary tumors, in patients with severe kidney impairment. The study is the last of nine studies in the extensive clinical development program for Orviglance, which will enable Ascelia Pharma to complete a New Drug Application (NDA) submission to the FDA.
In a statement, the company, based in Malmö, Sweden, noted that Orviglance, which has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA), is the first contrast agent in development for use in liver magnetic resonance imaging (MRI) in patients with severely impaired kidney function.
“We are very pleased to have reached our enrollment target of 80 patients,” said Magnus Corfitzen, CEO of Ascelia Pharma in a statement, adding, “This is a major milestone in the history of Ascelia Pharma and a key step on the journey to making Orviglance available to patients around the world." Corfitzen further noted: "The focus will now switch to the evaluation of MRI images by independent radiologists, as required by regulatory standards, and the headline results from this pivotal study are expected in mid-2023. Based on strong results in earlier clinical studies, we are optimistic of a positive outcome of SPARKLE and look forward to the next steps in bringing Orviglance through the regulatory process and making it available to patients for whom the use of gadolinium-based products may be medically inadvisable."
Ascelia Pharma is a biotech company focused on orphan oncology treatments which develops and commercializes novel drugs that address unmet medical needs and have a clear development and market pathway, and currently has two drug candidates – Orviglance (previously referred to as Mangoral) and Oncoral – in clinical development. According to the company, Orviglance aims to give cancer patients with poor kidney function access to safe and effective liver imaging to live longer and healthier lives, noting that the unmet need for these patients represents an addressable market potential of USD 500-600 million in the US, Europe and Japan.
More information: http://www.ascelia.com