02/19/2020 | Press release | Distributed by Public on 02/19/2020 11:30

First patient enrolled in pivotal Phase III clinical study SPARKLE with lead candidate Mangoral

First patient enrolled in pivotal Phase III clinical study SPARKLE with lead candidate Mangoral
Ascelia Pharma AB (publ) (ticker: ACE) today announced that the first patient
has been enrolled in the company's global pivotal Phase III clinical study
SPARKLE with Mangoral in patients with severely reduced renal function and with
known or suspected liver lesions.

'It is an important event for patients seeking a safe agent to detect liver
lesions that this pivotal Phase III study is now enrolling study subjects. We
see the interest from premier hospitals and expert doctors to participate as a
testimony to the unique potential offered by Mangoral and the large unmet
medical need for these patients. The addressable market for Mangoral is $350-500
million annually, and Mangoral, if approved, will be the only product on the
market for this patient segment. We are excited to now be one step closer to
launch Mangoral to the market, which we expect to happen in 2022,' said Magnus
Corfitzen, CEO of Ascelia Pharma.

Mangoral is the first oral imaging drug being developed for liver MRI. In
addition, Mangoral is covered by an Orphan Drug Designation in the US, targeting
the unmet need in patients who cannot tolerate currently marketed contrast
agents due to impaired kidney function.

'Liver metastases and primary liver malignancies are very serious manifestations
of cancer. It is therefore essential to early and accurately detect and diagnose
liver lesions to be able to offer patients the best treatment options. This can
have significant impact on patient survival', said Dr. Carl Bjartmar, Chief
Medical Officer of Ascelia Pharma.

'Mangoral has the potential to fill this specific unmet medical need for
patients that today are restricted from using currently available contrast
agents for liver imaging. The management of these patients today is an MRI of
the liver without any contrast agent. Mangoral offers the potential for improved
liver images in this patient group and may consequently enable better treatment
options which ultimately can improve their chances of survival', he continued.

SPARKLE is a global multicenter, registration-enabling study of Mangoral in up
to 200 patients with severely reduced renal function and with known or suspected
liver lesions. Ascelia Pharma expects full study report in first half of 2021.

The study aims to demonstrate the efficacy and safety of Mangoral in terms of
improved lesion visualization as compared to unenhanced MRI, with each patient
being their own control subject. Primary efficacy, in terms of lesion
visualization compared to unenhanced MRI, will be evaluated by three independent
blinded readers.

MRI will be performed before and shortly after oral Mangoral administration, and
basic safety parameters will be evaluated for five days following
administration. Further details of the SPARKLE study can be found at with the identifier NCT04119843.
For more information, please contact:
Magnus Corfitzen, CEO
Email: [email protected]
Tel. 46 735 179 110

Mikael Widell, IR & Communications Manager
Email: [email protected]
Tel: +46 703 11 99 60
This information is such information as Ascelia Pharma AB (publ) is obliged to
make public pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the contact person set out
above, at 6.30 p.m. CET on 19 February 2020.

About Ascelia Pharma
Ascelia Pharma is an oncology-dedicated orphan drug development company located
in Malmö, Sweden. The company's strategy is to develop drugs, which target unmet
medical needs, have an established mode of action and a relatively low
development risk. Ascelia Pharma has two drug candidates - Mangoral® and Oncoral
- currently under development.

Mangoral is a novel contrast agent for MR-scans and is ready for Phase III
clinical studies. Mangoral is developed to improve the visualization of focal
liver lesions (liver metastases) in patient with impaired kidneys that cannot
tolerate current gadolinium contrast agents on the market. Oncoral is an oral
chemotherapy tablet ready for Phase II for the treatment of gastric cancer.
Ascelia Pharma is listed on Nasdaq Stockholm (ticker: ACE). For more
information, please visit