Regulatory

Patent for Oncoral approved in Japan

2020-04-16
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Ascelia Pharma AB (publ) (ticker: ACE) (“Ascelia”) today announced that the patent application for Oncoral has been approved in Japan. The approval in Japan adds to the already obtained patents in the US and a selected number of countries in Europe and China. The patent secures the intellectual property protection rights for Oncoral until year 2035 plus potential patent extension.

“We are very pleased to also have the patent for Oncoral approved in Japan as the unmet medical needs for gastric cancer treatment in Japan are significant. More than 115,000 Japanese were diagnosed with gastric cancer in 2018 and the incidence rate is around five times higher than US and Europe, so the need for improved treatment options for these patients is great”, said Carl Bjartmar, MD, PhD, Chief Medical Officer at Ascelia Pharma.

Ascelia Pharma is currently preparing Oncoral for Phase 2 development after the promising Phase 1 results, which were published in 2019. Oncoral is an oral tablet formulation of irinotecan intended for combination use as a chemotherapeutic treatment of unresectable and metastatic gastric cancer. Intravenous irinotecan has already demonstrated safety and efficacy in the treatment of colorectal and pancreatic cancer. Having an oral tablet formulation of irinotecan, Oncoral has the potential to provide gastric cancer patients with an opportunity to receive chemotherapy at home, and at the same time reduce resource requirements in the health care system.

The patent for Oncoral, with the international publication number WO/2015/107131, covers Solid Oral Dosage form of irinotecan for treatment of cancer.

For further information, please contact:
Magnus Corfitzen, CEO

Email: moc@ascelia.com
Tel:
46 735 179 110

Mikael Widell, Head of IR & Communications
Email: mw@ascelia.com
Tel: +46 703 11 99 60

 

The information was submitted for publication, through the agency of the contact persons set out above, at 1.45pm CET on 16 April 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, currently in the pivotal Phase 3 clinical study SPARKLE. Mangoral is developed to improve the visualisation of focal liver lesions (liver metastases or primary tumours) in patient with impaired kidneys that cannot tolerate current gadolinium contrast agents on the market. Oncoral is an oral chemotherapy tablet ready for Phase2 for the treatment of gastric cancer. Ascelia Pharma is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit http://www.ascelia.com.

2020-05-20

Updated SPARKLE timelines due to Covid-19 impact

Ascelia Pharma AB (publ) (ticker: ACE) (“Ascelia Pharma”) today announced updated timelines for the completion and top line results of the pivotal Phase 3 study SPARKLE with the lead compound Mangoral, which are now expected in H2 2021 instead of H1 2021 as previously communicated. The expected addition of three to six months reflects the impact of the Covid-19 pandemic.
2020-05-13

Interim Financial Report Q1-2020: First patient enrolled in Phase 3 study SPARKLE

Ascelia Pharma AB (publ) (ticker: ACE) today published its interim financial report for Q1-2020 (January – March 2020), which is now available on the company’s website: https://www.ascelia.com/tag/reports-presentations/
2020-05-06

Bulletin from the Annual General Meeting in Ascelia Pharma AB on 6 May 2020

Today, on 6 May 2020, an annual general meeting was held in Ascelia Pharma AB. A summary of the adopted resolutions follows below. All resolutions were adopted with the required majority.