Encouraging results from clinical Phase I study of Oncoral presented in a new publication

In continuation of the previously published poster presentation at ESMO in Munich, 19-23 October 2018, Ascelia Pharma has announced the encouraging Phase I results in a new publication titled Oral administration of irinotecan in patients with solid tumors: an open-label, phase I, dose escalating study evaluating safety, tolerability and pharmacokinetics.

The publication, which is available on pubmed.gov, contains data from a dose escalation study in adult patients with solid tumors to assess safety, tolerability and pharmacokinetics of Oncoral, an oral irinotecan formulation, given as single agent.

The data demonstrated that Oncoral was well tolerated; side effects were generally mild to moderate, manageable and similar in type to those observed with intravenous irinotecan.

Furthermore:

  • In total 25 patients were included across four cohorts. The age range was 51-82 years and the majority of patients had Cholangiocarcinoma, Colon, Pancreas or Prostate as primary cancer
  • Hematological toxicities were few and all were mild to moderate
  • Pharmacokinetic (PK) data showed consistent daily exposures during treatment at days 1 and 14 with no drug accumulation
  • The interpatient variability of the active metabolite, SN-38, was in the same range as after infusion of irinotecan
  • Consequently, in this heavily pre-treated patient population, Oncoral indicated activity even among patients previously treated with irinotecan

”These clinical data on Oncoral are encouraging since they indicate a future potential safe and efficient oral administration route of irinotecan. We look forward to presenting results from further clinical investigations next year where Oncoral is administered in combination with capecitabine, thus enabling a potential attractive all-oral chemotherapy combination”, said Carl Bjartmar, MD, PhD, Chief Medical Officer of Ascelia Pharma.

For further information contact:
Magnus Corfitzen, CEO, +46 735 179 110

About Ascelia Pharma
Ascelia Pharma is a specialty pharmaceutical company dedicated to the development of novel medicines to improve the life expectancy and quality of life for people living with cancer. The company is located at Medeon Science Park in Malmö, Sweden in the middle of Medicon Valley, a leading European life science cluster. For more information, please visit www.ascelia.com

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About Us

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 visualisation 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 www.ascelia.com

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